AHA’s decision follows those by Blue Cross and Blue Shield and PhRMA, which made similar announcements earlier this week.
The Medicare Payment Advisory Commission doesn’t expect the recommendations to decrease Medicare beneficiaries’ access to care or lower quality.
The rapid expansion of COVID-19 vaccinations to senior citizens across the U.S. has led to bottlenecks, system crashes and hard feelings in many states because of overwhelming demand for the shots.
Workers filed a class-action suit against cleaning companies contracted by Memorial Sloan Kettering Cancer Center over allegations that they were not paid overtime wages for hours worked.
Meditech continues to hold the largest EMR market share in Canada, but it is losing customers — mostly to Epic, which has seen a rapid rise in popularity, a new KLAS report shows. The report delves into market share data and customer satisfaction insights to assess EMR vendors’ positions in the Canadian market.
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The reverberations from the Jan. 6 storming of the U.S. Capitol by supporters of President Donald Trump continue. A broad array of business groups, including many from the health industry, are halting contributions to Republicans in the House and Senate who voted against certifying the victory of President-elect Joe Biden. Meanwhile, Republicans in the House who have refused to wear masks or insisted on carrying weapons are being subjected to greater enforcement, including significant fines.
Away from the Capitol, the Trump administration has granted a first-in-the-nation waiver to Tennessee to turn its Medicaid program into a block grant, which would give the state potentially less federal money but more flexibility to structure the federal-state health program for those with low incomes. And in its waning days, the administration is moving to make its last-minute policies harder for Biden to undo.
This week’s panelists are Julie Rovner of KHN, Joanne Kenen of Politico, Margot Sanger-Katz of The New York Times and Kimberly Leonard of Business Insider.
Among the takeaways from this week’s podcast:
- The decision by industry groups to cut their political contributions to some Republican lawmakers could reshape businesses’ relationships on Capitol Hill. But it’s still not clear if this announcement will affect the vast sums of political contributions that come through PACs and other unnamed sources, as well as individual contributions from corporate officials.
- The slow start of the covid vaccination campaign points to the tension between the need to steer the vaccine to people at high risk of contracting the disease and the concerns about wasting the precious medicine. Because the vaccines that have been approved for emergency use have a relatively short shelf life, some doses may go to waste if they are reserved for specific populations.
- The response to the vaccine among health care workers varies widely. In some areas, staffers are eager to get the shots, while in other places, some workers have been hesitant and the shots are going unused. And the federal government has not provided a strong public messaging campaign about the vaccines.
- The Trump administration’s announcement last week that it would move to convert Tennessee’s Medicaid program to a block grant program is raising concerns among advocates for the poor, who fear that the flexibility the state is gaining could lead to enrollees getting less care, especially since the state will get a hefty portion of any savings it finds in running the program.
- It may not be easy for the Biden administration to change this decision. Federal officials in recent weeks have been sending states, including Tennessee, letters to sign that could protect the Medicaid waivers they have received from the Trump administration and could serve as a legal guarantee that would require a long, difficult process to unwind.
- Mental health care may be a casualty of the coronavirus pandemic. As states look to balance their budgets after a year in which revenues were slashed, they may turn to cutting mental health care services provided through Medicaid and other programs.
Also this week, Rovner interviews KHN’s Victoria Knight, who wrote the latest KHN-NPR “Bill of the Month” feature — about an unusually large bill for in-network care. If you have an outrageous medical bill you’d like to share with us, you can do that here.
Plus, for extra credit, the panelists recommend their favorite health policy stories of the week that they think you should read too:
Julie Rovner: The Washington Post’s “Young ER doctors Risk Their Lives on the Pandemic’s Front Line. But They Struggle to Find Jobs,” by Ben Guarino
Margot Sanger-Katz: The New York Times’ “Why You’re Probably Not So Great at Risk Assessment,” by AC Shilton
Joanne Kenen: The Atlantic’s “Why Aren’t We Wearing Better Masks?” by Zeynep Tufekci and Jeremy Howard
Kimberly Leonard: Business Insider’s “I Was Offered a Covid Vaccine Even Though I’m Young and Healthy. Here’s How I Did It,” by Kimberly Leonard
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In November, The Covid Tracking Project stopped reporting recovery figures for the United States as a whole, and yesterday we also removed many, though not all, of the state-level “recovered” values from our website. We want, above all, to provide accurate and meaningful information. Unfortunately, when it comes to recovery data at both the national and state levels, accurate and meaningful information is hard to come by.
There are several reasons to remove these data from our website. First, several states and territories, including large states like California and Florida, don’t report any kind of recovery data, and it doesn’t make sense to report a national total that excludes so much of the country. A second and crucial reason is that “recovered” has no standard definition, and states report it in many different ways. Just as important, many people who have had COVID-19 and have lived to tell the tale—and many of whom are categorized as “recovered”—don’t consider themselves to have actually recovered.
COVID-19 can have many long-term health consequences, and none of the definitions for counting people who have “recovered” from COVID-19 accounts for latent or ongoing health issues that can be caused by COVID-19. Children who develop multisystem inflammatory syndrome because of COVID-19 and “long-haulers,” who continue to suffer worrying symptoms months after first falling ill with COVID-19, are often wrongfully included in recovery statistics, since not all pandemic-burdened public-health departments have the resources to do the individual follow-up investigations that they would ordinarily do for an infectious disease. Moreover, when public-health offices do conduct individual case investigations, many COVID-19 patients do not respond to inquiries, leaving case investigators in the dark about the process of convalescence—the sometimes slow and always individual voyage back to health. Determining how many people have recovered from COVID-19, then, is currently more like trawling with a net than fishing with a pole: Every attempt dredges up a lot of scaly things we don’t want.
The CDC has not provided an official definition of what it means for a COVID-19 patient to recover, in the sense of returning to a pre-COVID-19 state of health, but it does provide some guidance on when COVID-19 patients no longer need to be isolated. In its guidance for “discontinuation of Transmission-Based Precautions” for persons with COVID-19, the CDC recommends using a “symptom-based strategy,” which calls for releasing people with mild cases of COVID-19 from isolation 10 days after their illness began, if and only if their symptoms have improved without the need of medication. Those who are asymptomatic or immunocompromised should still be tested to see if they have any remaining virus in their system, but they should consult with local health experts instead of relying only on negative test results.
A key aspect of these CDC guidelines is that they are aimed at controlling infection, not at judging health. This is an important distinction, especially given the demonstrable long-term health effects of COVID-19 that extend beyond the respiratory symptoms stated in the guideline. Many states use these CDC definitions to inform their own reported data of how many people have “recovered” from COVID-19, which means that states are really reporting the number of people who are no longer infectious, not the number of people who have returned to a pre-COVID state of health.
In the absence of federal guidance, and as with many other COVID-19 metrics, different U.S. jurisdictions rely on different definitions for reporting recoveries. Some states and territories have still not adopted the CDC’s mid-July recommendation to primarily take symptom improvement into consideration when estimating how many people are no longer infectious, some states have begun tracking recovery data for “probable” cases of COVID-19 identified by rapid antigen tests, and several states that once reported recovery data have recently stopped.
Among the 48 jurisdictions that have reported a version of a “recovered” value, available definitions generally fall into one of four categories: days since diagnosis/onset; symptom improvement; hospital discharged; or definitions that are unclear. The first category bases “recovery” on a certain number of days—generally between 14 and 30—after a positive test result or symptom onset where the patient has not died. This is the most common type of recovery definition among U.S. states and territories; 18 jurisdictions have provided definitions that include similar criteria. Definitions in the second resemble the CDC’s multilevel guidance for releasing patients from isolation and include information about whether a patient’s COVID-19 symptoms have improved. The third category simply refers to people diagnosed with COVID-19, hospitalized, and then discharged from the hospital; it does not include the majority of people who contract COVID-19, because most people with COVID-19 are never hospitalized. States in the final category report a “recovery” figure but do not provide any publicly available definitions. Unfortunately, all of these definitions still do not capture the complete spectrum of health issues experienced by COVID-19 patients.
Six states that once reported recovery statistics have stopped, many citing their difficulties with collecting complete or reliable data. And eight jurisdictions have never provided any recovery statistics. This could be due to many factors, including a lack of understanding of the disease or the difficulty of collecting relevant data, as many cases experience mild symptoms or no symptoms at all. Washington, for example, has never reported recovery data, and according to The Seattle Times, the Washington Department of Health “doesn’t track how many people have recovered … because so little is known about what recovery looks like.” Similarly, Rhode Island estimates recovery figures but does not publish them, due to the lack of a standard definition. The state also attributes difficulties in reporting this figure to the fact that many of those who were infected were not tested.
It became clear to us months ago that reporting this incomplete patchwork of unlike statistics at the national level would be a distortion. We believe that under the current lack of standardization and complete reporting, the total number of people in the U.S. who have actually recovered from COVID-19 cannot reasonably be inferred.
While we collect thousands of data points about COVID-19, these numbers cannot capture the varied experiences of the more than 22 million people who have tested positive in the U.S. to date. Since March, more than 371,000 people have died, and different individuals who are said to have “recovered” based on states’ definitions may be in dramatically different states of health. One study found that people with severe cases of COVID-19 continued to suffer related health problems three months after being discharged from the hospital. Most or even all such cases would likely be considered recovered by CDC and U.S. state definitions.
Similarly, the impressive group of researchers born out of the Body Politic support group for “long COVID” patients points out in a summary of its patient-led research that “recovery is volatile, includes relapses, and can take six or more weeks.” The group asked people who had tested positive for COVID-19 to define “recovery” for themselves—partly because of the lack of a clinical definition, and partly as a way to honor the lived experience of people who actually got the disease. In their report, “What Does COVID-19 Recovery Actually Look Like?,” the researchers wrote that in the future, they hope to create a standardized definition of recovery based on the types of symptoms and the severity of the illness.
As we approach the one-year anniversary of the first COVID-19 diagnoses in the United States, few public-health departments have had the capacity to follow up on each case and assemble an accurate picture of how many people in a given jurisdiction have genuinely recovered. Good recovery data for the first year of the U.S. pandemic are—and will likely remain—impossible to produce.
Many people at The COVID Tracking Project contributed to the research and data-compilation efforts that made this story possible. We would like to thank Jennifer Clyde, Elizabeth Eads, Rebecca Glassman, Kate Hurley, Nicole King, Daniel Lin, Michal Mart, Barb Mattscheck, Daria Orlowska, Kara Schechtman, Erika Thomson, and other contributors for their tireless work on this and many other data-quality efforts.
This article has been adapted from its original version, which can be read in full at The COVID Tracking Project.
Healthcare may be historically more recession-resistant that other industries, but the COVID-19 pandemic has left many providers hurting financially, as many patients struggle to pay their bills. Patient collections were already a challenge, with declining Medicaid coverage and rising co-pay obligations putting patients on the hook for more of their healthcare expenses. Now, with millions of Americans out of work and missing out on employer-sponsored insurance, providers are being forced to adapt their collections processes to fit this unstable insurance landscape, or risk losing more dollars to bad debt.
Four key strategies can help providers seal the cracks in patient collections and stem the surge in uncompensated care. With compassionate processes that treat each patient as an individual, providers can use data and automation for more efficient healthcare charity screening, find missing coverage and identify both propensity to pay and the best financial pathway to minimize the chances of bills going unpaid.
1. Screen for charity eligibility early and often
Nearly 4 in 10 unemployed Americans have been without work for more than 27 weeks – the most since November 2013. As unemployment persists and benefits dwindle for many, more patients may be eligible for charitable support to cover their healthcare costs. Running presumptive healthcare charity screening as part of the collections workflow can help providers identify those who should be getting extra support.
Patient Financial Clearance runs automated checks when a patient registers, so individuals can be automatically enrolled as soon as eligibility is confirmed. Checks are repeated throughout the patient journey, should their financial situation changes.
Caye Mauney, Patient Access Director for Palo Pinto General Hospital, says the automated checks can confirm eligibility within just three seconds. This saves a huge amount of time for her team, while giving patients financial clarity without worrying waits: “All the information we need is now at our fingertips. The patient no longer needs to bring in check stubs or go back to a former employer to ask for information. It’s been a game changer.”
2. Find forgotten coverage quickly
Automation can help providers cut uncompensated care by finding missing and forgotten coverage, even when patient case mix and payer rules are constantly changing. Healthcare organizations that quickly uncover previously unidentified coverage are often are paid sooner and avoid the collections challenges of self-pay receivables.
Experian Health’s Coverage Discovery uses best practices around search, historical information, multiple proprietary data sources and demographic validation to find previously unknown coverage. It continuously scans for insurance coverage to maximize reimbursements and minimize accounts sent to collections and to charity.
Learn from Banner Health how Coverage Discovery has helped the organization find 30+% unidentified coverage earlier in the revenue cycle.
Register for the webinar here.
3. Improve the collections experience with compassionate billing
Speedy coverage checks are just one way to give patients peace of mind when it comes to medical expenses. The collections process is often opaque and intimidating, hitting patients when they’re already stressed and vulnerable. The more compassion that can be built in, the better the patient financial experience will be. Unpaid bills go down, while patient loyalty goes up.
Transparent pricing, data-driven payment plans, personalized communications, and easy ways to pay all contribute to a positive patient financial experience. A good place to start is with Collections Optimization Manager, which allows providers to segment, support and monitor patients throughout the entire collections cycle. By connecting to a host of other patient-facing tools, this helps members feel taken care of from start to finish.
4. Use data to put patients on best payment pathway
None of these strategies will work without reliable, accurate data. Healthcare organizations traditionally rely on demographic and behavioral datasets, but this leaves gaps in how much is known about patients’ financial situations. Incorporating credit data can add a layer of valuable insights about a patient’s propensity to pay, so collections resources can be directed to the appropriate accounts. If you know a patient has a missed mortgage payment or delinquent loans, you can help them find alternative coverage and redirect them to a better payment pathway.
Experian Health combines demographic, behavioral and credit data so you can help your members navigate their health expenses with confidence. The result? Better financial health for both your members and your organization.
Find out more about how to optimize patient collections, whatever 2021 has in store, in our recent eBook, Recession-proof your revenue cycle.
Google has completed its purchase of wearables company Fitbit following an approval by EU regulators. But the U.S. Justice Department says its probe into the deal is ongoing.
Traditions adds to post-acute care platform
Traditions Health is adding to its growing post-acute care business.
The College Station, Texas-based home health and hospice provider announced a handful of new acquisitions at the start of January. Financial terms of the transactions were not disclosed.
In Oklahoma, Traditions acquired two home health agencies: Traditions Home Care and Secure Home Care. The provider likewise inked two hospice agencies in Louisiana: Grace Hospice & Palliative Care and Heritage Hospice.
The new hospice acquisitions mark the company’s initial entry into the Louisiana market.
“I am delighted to grow the Traditions family in Louisiana and to deepen our capabilities in Oklahoma through the addition of eastern Oklahoma’s premier home health agencies,” Bryan Wolfe, president and CEO of Traditions Health, said in a statement. “This announcement is a fitting way to cap off what’s been an exciting year for Traditions Health.”
Overall, Traditions — a portfolio company of PE firm Dorilton Capital — provides post-acute care services to 5,000 patients across 14 states. The provider has been particularly active in the hospice market, with seven hospice transactions since June 2020.
Help at Home lands Adaptive
Help at Home is on the M&A hunt. Its latest purchase comes just a few months after it was acquired by a consortium of private equity buyers.
Earlier this month, the Chicago-based Help at Home reportedly executed a deal for The Adaptive Group, a home health, hospice and home care services provider that operates across the state of Indiana. Financial terms of the transactions were not disclosed.
On its end, Help at Home is a home- and community-based services provider with a 13-state footprint that features 160 total locations. Centerbridge Partners and The Vistria Group teamed up to purchase Help at Home from Wellspring Capital Management in November.
Founded in 2011, The Adaptive Group is made up of Adaptive Companion Services, Adaptive Hospice, plus Adaptive Nursing and Healthcare Services. The provider has 23 locations across the Hoosier State.
“The winning combination of Adaptive and Help at Home not only means that we will be able to set the bar for high-quality care and service excellence in the state of Indiana, but also throughout the Midwest and across the broader United States,” Adaptive co-founder Mike Root said in a press release. “By partnering with Help at Home, we are better positioned to execute on our mission — to positively impact as many lives as possible through the delivery of exceptional, patient-centric home care services.”
Amedisys board approves stock repurchase plan
Amedisys Inc. (Nasdaq: AMED) announced at the end of last year that its board of directors has authorized a stock repurchase program, under which the company may repurchase up to $100 million of its outstanding common stock through Dec. 31.
The stock repurchase program gives Amedisys the green light to repurchase its common stock “from time to time, in amounts, at prices, and at such times as the company deems appropriate, subject to market conditions and other considerations.”
As of mid-day trading Thursday, Amedisys stock was listed at $291.73 per share.
Founded in 1982, the Baton Rouge, Louisiana-based Amedisys has 21,000 employees who work across 516 care centers in 39 states and the District of Columbia.
“Given our strong cashflow and low leverage, we feel it is prudent to have authorization to buy-back shares throughout the course of the year, including shares granted under the company’s Omnibus Incentive Plan as they vest in 2021,” CFO Scott Ginn said in a statement. ‘This will become a recurring part of our capital deployment strategy; however, our first priority is and will continue to be accretive acquisitions in both home health and hospice.”
The post Traditions Health Acquires 4 Agencies; Help at Home Buys Adaptive appeared first on Home Health Care News.
Six months later, as the COVID-19 pandemic began to spread across the U.S., this effort to increase access to data across the organization was paying dividends…
So far, so good. But what we still don’t know are the correlates of protection: which of these antibody levels are enough to keep a person from getting the coronavirus and to what extent? The same goes, of course, for the T-cell data. The paper shows levels of both CD4+ and CD8+ T cells after vaccination, but how these relate to protection is an open question. And for all of these, such numbers might be different in different patient groups (particularly older versus younger patients). Fortunately, we should soon within two weeks, I’d say) be getting actual efficacy data from the single-dose trial, so I’m not going to spend much energy speculating.
There’s another thing to watch: the New York Times reported yesterday that J&J has told the US government that they might have fallen as much as two months behind on their production schedule for the vaccine. No word as to what the problem might be. Adenovirus vectors have vulnerabilities of their own, with a whole set of manufacturing steps that are distinct from the other types. What you gain in not having everything reliant on a single pathway, you can lose when unique problems crop up. But overall it’s still far better to have a diverse set of things under development than not.
Now for another vaccine candidate, the inactivated virus one from SinoVac. I discussed that one here after an earlier publication, and when last heard from there was an odd report from Turkey of 90% efficacy in a small trial with no data to back it up. Then just a few days ago there was a figure of 78% efficacy from the trial in Brazil, but that has now been revised to 50%. Meanwhile, Indonesia says that a preliminary analysis shows about 65% efficacy – the government there has approved the vaccine, but the rollout is apparently not going well. To be honest, these are about the efficacy numbers one could expect from an inactivated-virus vaccine. It’s an old technology, and it doesn’t always work that well. The chaotic release of these data (and the lack of comment from SinoVac themselves about any of these numbers) does not build confidence, with the consequences that you can see in that last link.
But that takes us back around to what the true efficacy of another vaccine is: the Oxford/AZ one. The statistics on that are a mess too, and their public presentation has been a mess, and we can only hope that things come into better focus when their US trial reports (other data are coming as well). But at the moment, I wouldn’t be prepared to put money on how much better it is than the SinoVac one. To be sure, a 50% or 60% effective vaccine (with a reasonable safety profile) is surely better than no vaccine at all. But it means that you have to vaccinate a lot more people before you start to make a dent in a pandemic like this one, which is a significant real-world limitation. Of course, here in the US we’re not doing that great a job in rolling out the 95% effective ones, either, if we want to talk real world effects!
The post Global Partnership Leads the Way to Advance Digital Health appeared first on Health IT Buzz.
Walk-In Interviews for Multiple Departments -Production / Packing / Quality Control / Quality Assurance @ Theon Pharmaceuticals Ltd
Theon Pharmaceuticals Ltd-Walk-In Interviews for Multiple Departments On 17th Jan’ 2021
The same thing happened a few more times over the next year and a half, always after long-haul flights. I began to think of it as “airplane hip,” and the condition was annoying but temporary; I don’t spend much time on planes, and a yoga move called “pigeon pose” would stretch my stiff waddle back into a walk in a day or two. Usually, the discomfort was worth it—a small musculoskeletal price to pay for the occasional privilege of seeing parts of the world still new to me.
One morning in May, I rolled out of bed to find that my hip flexors were at it again. Dragging my rolled-up yoga mat to the middle of the floor to arrange my body into the now-familiar contortion—one leg straight back, the other forward and bent against the floor, then switch—I tried to piece together what was going on. Like most Americans, I hadn’t been on an airplane since February. I had been sitting at home virtually all the time, a situation of relative comfort and incredible luck. But in the weeks that followed, I folded my body into pigeon pose again and again, with minimal returns. As I lost hip flexibility, I also gained other problems, which accumulated over the next several months—low-grade headaches, sore shoulders, a stiff neck, dry skin.
At first, these ailments felt isolated, because my body was isolated. I couldn’t see co-workers also struggling to stretch their back as they got up from their office chair, or friends gobbling up ibuprofen as I was. I couldn’t see anyone doing anything. But as we barrel toward the first anniversary of the World Health Organization declaring the coronavirus a pandemic, the physical consequences of extended disruption, isolation, and stress have begun to make themselves known en masse, in doctors’ offices and telehealth video calls. The coronavirus itself, of course, has had a devastating impact on the physical health of millions of Americans. But even for those who have avoided the virus so far, the by-products of living through an extended disaster have often been painful; for some, they’ve been catastrophic. Even if you don’t get COVID-19, the pandemic might destroy you anyway.
It’s too early for expansive data on how (and how much) people were hurting in 2020, but according to doctors and health-care workers, some clear trends have emerged, and the complaints stretch to the far reaches of the human body. Among the earliest and most enduring have been the type I’ve experienced—aches and pains that emerge without obvious injury, then stick around. “By May, I was seeing a lot more neck and upper back pain, also accompanied with headache,” Jaspal Singh, a pain- and rehabilitation-medicine specialist at Weill Cornell Medicine in New York, told me in an email. These problems have since taken over Singh’s practice—he estimated that before the pandemic, 70 percent of his patients were complaining of lower-back and leg pain. Now more than half have the kinds of aches that come from hours at ad hoc workstations—curving your shoulders forward, jutting your head out in front of your body to look at a laptop whose screen is too low, and maintaining that position for hours at a time, all while sitting in a chair meant to support a human for the duration of a meal, not a workday.
And people aren’t just working in more challenging physical circumstances; they’re also spending more time doing it. “In the office, people work for eight or nine hours, but now they find themselves working 10 or 12 hours at home just because there’s no commute time,” Natalia Ruiz, a physical therapist at NYU Langone Orthopedic Center, told me of her patients. “Expectations of productivity have increased because you’re working from home.” In her practice, she’s seen more complaints of back and neck pain, but also more “repetitive strain” injuries such as carpal tunnel syndrome, tendinitis in the hands and forearms, and pinched nerves in the elbows.
The circumstances of work have changed in some way for millions of Americans, whether that has meant working from home, working longer and more physically punishing hours, or being laid off and largely stuck at home to job-search online. The problems emerging in doctors’ offices are mostly those bothering people who can work from home, because, among other reasons, their jobs are more likely to offer health insurance and time off to seek care than those held by essential workers. People who suddenly shifted to working from home were caught without the basic ergonomic equipment found in many offices, such as adjustable-height desk chairs and laptop stands that can raise screens up to eye level. Some people cobbled together healthier setups as it became clearer how long they would be out of the office, but for many who have lost work or taken pay cuts, spending hundreds of dollars on equipment isn’t feasible. For those living in cramped housing with kids who go to Zoom school and other family members who also need space to work, building a personal mini office simply isn’t an option.
For people who aren’t of working age, the orthopedic concerns are a little different. Elderly people, who are at the highest risk from the virus itself, have also experienced some of the worst physical consequences of isolation. “The elderly are not taking their walks and are getting weaker in their legs,” Singh said. “They are losing confidence in their gait, which causes further weakness, and they enter a vicious cycle.” Many people have sharply reduced their exercise this year as gyms have closed, or they fear catching the coronavirus at those that have reopened, but for younger adults, who are generally more physically fit and less prone to injury, regaining some movement in creative ways is easier, and novel, unsupervised exercise is less risky (although Singh noted that he has seen some injuries from people who have used their new Pelotons vigorously but incorrectly). For older Americans, maintaining a baseline of essential flexibility and stamina while isolated increases the risk of an unsupervised fall—a source of potentially deadly injuries that appears to have become more common since early 2020.
On average, kids are more resilient in the face of the physical stresses of isolation than their brittler-bodied parents or grandparents, but watching online classes—and skipping recess, gym class, and all the incidental opportunities to be rambunctious with friends that in-person school provides—has still taken a toll on many children. Nancy Durban, a pediatric physical therapist at Cincinnati Children’s Hospital, told me that a combination of increased anxiety and uncomfortable computer setups has created a pain spiral for some of her patients. Anxiety “increases their muscle tension, which then makes them hurt more, which makes them move less, which makes them then sleep worse,” Durban told me. “That increases their anxiety and decreases their ability to move again.” As some schools have reopened and resumed extracurricular activities, she has also noted an uptick in sports injuries among kids, who might not have understood that months of isolation diminished their physical capacity to play soccer or run track, or who were simply overexcited to be back with their teammates.
It’s not just our muscles and bones that are burdened. People spending more time gazing at screens have found that their vision is suffering, too. “When people stare at the screen all day, they don’t blink very often, and their eyes tend to dry out,” Sunir Garg, a clinical spokesperson for the American Academy of Ophthalmology and a professor at Wills Eye Hospital in Philadelphia, told me. “When the eyes feel kind of dry, scratchy, and prickly, it can make things blurry.” That can be exacerbated by spending all your waking hours indoors, in bone-dry heating and cooling systems.
Even for people who spent their workdays indoors and on a computer before the pandemic, the routine of going into work—the process of getting dressed, going outside, getting in a car or boarding a train, interacting with co-workers, attending a meeting or two, and maybe going to happy hour afterward—likely provided enough variation and visual novelty to head off some of the vision problems people are having now. One thing Garg cautions against faulting, though, is the light given off by computers and phones—so-called blue-light glasses have become a hot commodity in the past year; sales of at least one brand have more than doubled as people look for ways to soothe their strained, tired eyes. Absorbing that light in the evenings can throw off sleep patterns, but there is no evidence that it harms vision or strains eyes. “There’s a ton of blue light coming from the sun,” Garg said. “When most people had outdoor jobs, we were getting oodles more blue light from the sun than we ever would from our screens.”
The pandemic also seems to be causing a litany of skin and hair issues, according to research provided by the American Academy of Dermatology, some of which has not yet been published and has yet to be peer-reviewed. The number of reported eczema flares on the hands has increased during the pandemic, a phenomenon thought to be caused by more frequent hand-washing and use of hand sanitizer. Other dermatological problems that have spiked in the past year are closely tied to emotional well-being. Hair shedding is a common symptom of extreme stress, and one study of two hospitals in some of the low-income New York City neighborhoods hit hardest by the pandemic’s first surge found a 400 percent increase in reported hair loss over the summer. Another recent study found that self-reported symptoms of “body-focused repetitive behaviors,” such as skin-picking, nail-biting, and hair-plucking, have increased during the pandemic. When people are suffering inside, those struggles often make their way to the surface.
For many people, the physical ramifications of a year or more in isolation will be temporary, or at least largely reversible. For some, though, the accumulated toll of the pandemic’s disruptions to daily life could be deadly. All the doctors I spoke with worried about patients delaying or avoiding care because of the potential for coronavirus exposure in doctors’ offices or hospitals. Athena Poppas, the president of the American College of Cardiology and the chief of cardiology at Brown University, said that she saw the dire consequences of that fear almost immediately, during the virus’s first surge. “When patients did come in, they were coming in late or very sick, and we had very few options for them,” she told me. People died of heart attacks who might otherwise be alive today.
Poppas worries that isolation’s worst cardiovascular ramifications may be ahead of us, though. Depression and anxiety, both of which have surged among Americans during the pandemic, are enormous risk factors for heart problems, especially among people over 50. Quarantine itself is also a risk factor. “Loneliness and social isolation increase the risk of myocardial infarction and stroke by up to 30 percent,” she told me. “I had a patient who said she hasn’t seen [anybody else] in months, and it just broke my heart.”
The early symptoms of these problems can be subtle, and in isolation, they may go unnoticed. “It might have been their neighbor who saw them every day who said, ‘Gee, Mr. Jones, you seem more short of breath,’” Poppas told me. “In addition to the internal problem, there’s not the external social checks.” She has noticed that some of her patients, without the support and interaction they’d usually have from family, home health aides, or even chance encounters with acquaintances, have been less likely to take their medication on schedule, keep up with at-home health routines, stay hydrated, or eat a balanced diet.
While Poppas described these problems, I thought of how most of them had shown up, in lesser ways, in my own life. In the past year, I’ve lost 30 pounds from terror and then gained it back from stress eating. At some point in the past few months, I switched from three meals a day to two, because the third simply did not feel worth the effort. As I type this, my head is pounding for reasons that are not clear to me. If I had to guess, I’d say it is related to how I am sitting in my chair, where I’ve been for hours. I try to keep my water bottle filled, but right now, I don’t know where it is in my apartment. And I’m one of the lucky ones.
The consequences of the past year for our bodies are, as far as I can tell, limitless. In the richest nation in the world, an obscene—and rising—number of people cannot afford to feed themselves. People are cracking their teeth from mental and physical stress. Millions of people now spend little time in shoes, which is screwing up their feet.
It didn’t have to be like this. Those in power in the United States could have decided to take the pandemic seriously, and after a few months we could have returned to more normal versions of our lives, as people across the globe have done. Instead, we’ve been strapped into an interminable long-haul flight for months, with all of the stress and expense and discomfort that the worst of air travel implies—except we’ve gone nowhere.
It is not enough to be “not racist.” Health organizations have a solemn duty to heal and facilitate health. We must actively eradicate racism from our policies and practices.
What You Should Know:
– Healthcare private equity firm Heritage Group launches a $300M fund to invest in high-growth healthcare services and technology companies.
– Heritage is backed by some of the leading healthcare organizations in the nation, including large provider systems, payers, and healthcare service providers.
Heritage Group, a Nashville, TN-based healthcare-focused private equity firm, today announced the closing of over $300 million in its oversubscribed third fund, an increase of nearly $100 million over its prior fund in 2016. Heritage will continue its successful strategy of investing in solution-oriented, high-growth healthcare services, and technology businesses that are addressing the industry’s most pressing challenges.
“We are very pleased with the market’s response to our offering, especially during such a challenging economic environment,” said Paul Wallace, partner at Heritage. “We are grateful for the ongoing support of our longtime investors, and we’re excited to welcome several new LPs. We’re fortunate to have a great team and a unique model, which combine to create value for all of our stakeholders.”
Investment Model & Approach
The firm was founded by Rock Morphis and David McClellan in 1986, Heritage seeks to make majority and minority investments, ranging from $20 to $40 million per portfolio company, in high-growth healthcare services and healthcare technology businesses that address the challenges of the U.S. healthcare system. Heritage engages deeply with its strategic investors, who provide unique value and insights through all stages of the deal process, including the identification, evaluation, and subsequent growth of its portfolio companies. The firm’s strategic investors operate over 550 hospitals, with 90,000 beds, and handle approximately 3M discharges annually.
Heritage’s strategic investors and partners represent
national leaders in the payer, provider, IT, and service sectors of healthcare.
This diversity is particularly valuable as these sectors begin to converge in
the shift towards value-based care. Limited Partners include Adventist Health
System (Florida); Amedisys (Louisiana); Cardinal Health (Ohio); Cerner Corp.
(Missouri); Community Health Systems (Tennessee); Health Care Service
Corporation (Illinois); Horizon Healthcare Services (New Jersey); Intermountain
Healthcare (Utah); LifePoint Health (Tennessee); Memorial Hermann Health System
(Texas); Sutter Health (California); Tenet Health (Texas); Trinity Health
(Michigan); and UnityPoint Health (Iowa).
“Heritage’s strategic engagement is outstanding and allows us to work together as true partners. We are able to lend our expertise and share the key pain points that we encounter as we strive to provide care in a value-based model, which requires new ways of reaching and treating consumers and patients,” said Scott Nordlund, chief strategy and growth officer at Banner Health. “Heritage has been instrumental in identifying innovative businesses that solve these concerns for our organization.”
Heritage has invested in some of the leading healthcare
services and technology companies, including Aviacode, AllyAlign Health, Medical Solutions,
Sharecare, Abode Healthcare, MDLIVE, Lumere, Reload, Spero Health, etc.
This week, Michigan received one of the lowest number of doses since mid-December, 60,450, which resulted in fewer distributions by five-fold than what health systems, local health departments and federally qualified health centers requested, system executives said.
When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although there’s no shortage of candidates that have failed despite positive mid-stage trial results.
Some analysts have intimated that given the small size of the study at just over 270 patients, rival amyloid drug developers Biogen and Eisai could claim the biggest benefit from the data in positive sentiment ahead of an FDA decision later this year.
Goldman Sachs analyst Terence Flynn said the result was a “positive surprise” after Lilly revealed top-line data from the TRAILBLAZER-ALZ study showing that donanemab slowed cognitive decline by a third in people with early Alzheimer’s and completely resolved the amyloid beta plaques that are a hallmark of the disease.
Flynn also said the data was an “incremental positive” for Biogen, whose Eisai-partnered aducanumab is already filed for approval and awaiting an FDA decision by 7 March, as it lends further weight to the amyloid beta hypothesis of Alzheimer’s.
Biogen is nearest to market with aducanumab but a positive verdict from the US regulator is far from assured. In November, an FDA advisory committee voted ten to one against approval, saying the clinical data backing the drug was inconclusive, but that came on the back of a positive assessment by the FDA’s own reviewer.
Wolfe analyst Tim Anderson said in a research note issued ahead of the donanemab readout that the FDA could be influenced by the donanemab data and – if positive – that would raise the chances of a greenlight for aducanumab.
There’s an alternative view however that donanemab’s data might actually harm aducanumab’s prospects. Analysts at Jefferies told Barron’s this week that the FDA may have been minded to approve Biogen and Eisai’s drug because there were no other late-stage candidates in play, but Lilly’s drug could change that perception.
Donanemab is unlike most other amyloid-targeting drugs – including aducanumab – because it targets a pyroglutamated form of amyloid beta called N3pG that is found only in amyloid plaques and according to some research can stimulate misfolding of proteins.
Lilly’s hypothesis – as yet unproven – is that clearing those plaques has a direct association with cognitive benefits.
Lilly says TRAILBLAZER-ALZ met its primary endpoint, slowing decline on the Integrated Alzheimer’s Disease Rating Scale in the donanemab group by 32% compared to placebo, with trends towards improvement on secondary endpoints that didn’t hit statistical significance.
On safety, around 27% of the treatment arm showed ARIA-E – an inflammatory reactions also seen with other amyloid-targeting antibodies – but there’s little other data available yet.
Lilly started a 500-patient phase 2 trial called TRAILBLAZER-ALZ-2 last June that it suggests could serve as a confirmatory pivotal study and potentially support regulatory filings – dramatically shortening the development timeline for the drug. That’s due to read out in next year or later.
The post Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects? appeared first on .
Prosecutors are revisiting how Flint’s water system was contaminated with lead during one of worst human-made environmental disasters in U.S. history.
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Massachusetts General Hospital says it has discontinued its plan to acquire Exeter Hospital after the New Hampshire attorney general’s office opposed the merger because of antitrust concerns.
The merger that would have brought Exeter Hospital under the same leadership as Wentworth-Douglass Hospital in Dover, which was acquired by Mass General in 2017.
Seacoastonline.com reports Mass General “did not feel there was a way forward after the investment of resources, time and energy spent in a regulatory process that has taken two years,” said Mark Whitney, Exeter Hospital’s vice president of strategic planning. Whitney said the merger would’ve improved health care on the Seacoast and “improved the sustainability of our organization.”
In 2019, Attorney General Gordon MacDonald said Exeter Hospital and Wentworth-Douglass offered many of the same services and there are a limited number of other healthcare systems of the “size and breadth” of the two hospitals in the Seacoast region.
“New Hampshire patients already pay some of the highest prices for health care in the country,” he had said. “This transaction implicates our laws protecting free and fair competition and therefore threatens even higher health care costs to be borne by New Hampshire consumers.”
Exeter Hospital’s contracts with Mass General’s Center for Cancer Care, pediatric care and telestroke care will continue.
Of the total, 23% of consumers were new and the rest renewed coverage. Repeat consumers who actively chose a new plan and those who were automatically re-enrolled both increased.
- The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter
- Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated the review for AZ’s COVID-19 vaccine. Meanwhile, AZ’s AZD1222 met its primary endpoint in preventing COVID-19
- Our team at PharmaShots has summarized and complied with the insights of Q4’20
Date – Oct 01, 2020
Product – Tetraxim
- Sanofi’s Tetraxim combines four vaccines into one and provides protection against four diseases – Diphtheria, Pertussis, Tetanus and Polio. The launch reduces the number of injections, increases comfort, and improves vaccination compliance for children
- Booster vaccines are designed to boost the immunity acquired during prior vaccination. With the launch, Sanofi currently protects school children in 100+ countries, with 63M doses distributed globally
- Tetraxim (DTaP-IPV) is a 4-in-1 booster vaccine and the only inactivated poliomyelitis containing combination vaccine in India that has full-dose antigenic strength of Diphtheria, Tetanus and acellular Pertussis (whooping cough) for preschoolers
Date – Oct 08, 2020
Product – Palynziq (pegvaliase-pqpz)
- The US FDA has approved the sBLA to increase the maximum allowable dose of 60mg with Palynziq for PKU. Previously, the maximum dose was 40mg
- The label expansion is based on OLE study out to 3yrs. demonstrating that 66% had a blood Phe level ≤360 μmol/L consistent with the Phe target ACMG recommended guidelines @2yrs. of treatment and 50% had blood Phe levels ≤120 μmol/L @2yrs. 75%, 66% & 48% had a blood Phe ≤600, 360, and 120 μmol /L, respectively @3yrs. of treatment
- Additional, safety data with over 6yrs. of follow up remains consistent with the previous safety profile of Palynziq irrespective of dose. Moreover, BioMarin has dosed the first participant in the global Phearless P-I/II study of BMN 307 for PKU
Date – Oct 08, 2020
Product – Skyrizi (risankizumab)
- The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study
- Results: ~63% of patients with moderate to severe plaque psoriasis treated with SKYRIZI achieved completely clear skin for 172 wks., as measured by 100% improvement from baseline in the PASI 100. New results from the P-III LIMMitless study were presented at the 29th EADV Virtual Congress
- Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. It is part of a collaboration between Boehringer Ingelheim & AbbVie, with AbbVie leading development & commercialisation globally
Date – Oct 09, 2020
Product – REGN-COV2
- Regeneron has submitted a request to the US FDA seeking EUA for its REGN-COV2 investigational Ab regimen to treat COVID-19. If EUA is granted, the US govt. has committed to making REGN-COV2 available in the US at no cost and would be responsible for its distribution
- The company reported that there are doses available for ~50,000 patients and expects to have doses available for 300,000 patients in total within the next few months
- REGN-COV2 is a combination of two mAbs, REGN10933 & REGN10987, designed to block the infectivity of SARS-CoV-2. The company reported that a single 8g dose of REGN-COV2 was given to President Donald Trump following a compassionate-use request from doctors as part of a treatment regimen
Date – Oct 29, 2020
Product – BI 764198
- The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission
- The therapy has shown a reduction in cellular damage and lung edema in preclinical studies and may provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 was well tolerated in P-I study in healthy adults
- BI 764198 is potent & selective inhibitor of TRPC6, focusing to reduce the need for ventilator support and to improve patient recovery rate
Date – Oct 30, 2020
Product – Tecentriq + Avastin
- The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a cohort of Chinese patients (n=194) from the same study
- Results: Tecentriq in combination with Avastin reduced the risk of OS by 56% (among Chinese patients) and 42% (global results) & the PFS risk by 40% (among Chinese patients) and 41% (global results) as compared with sorafenib
- IMbrave150 is the 1st P-III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Additionally. in May 2020, the US FDA approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy
Date – Oct 30, 2020
Product – Keytruda
- Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors
- In preclinical studies, THOR-707 demonstrated the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as a single agent as well as in combination with an anti-PD1 mAb
- THOR-707 is currently being evaluated by Sanofi in an ongoing P-I dose escalation and expansion trial assessing THOR-707 and determining its recommended P-II dose alone and in combination with anti-PD-1 and anti-EGFR antibodies
Date – Oct 30, 2020
Product – Tremfya
- The P-II GALAXI 1 study involves assessing of Tremfya vs PBO in patients with mod. to severely active CD with intolerance to conventional therapies. In interim analyses, patients were randomized equally into 5 arms, with Tremfya (200/600/1200 mg (IV) @0, 4 & 8wks. respectively or with ustekinumab, dosed at ~6mg/kg (IV) @0wk. and dosed 90 mg (SC) @8wks. or PBO
- @12wks. (Tremfya vs PBO), reductions in CDAI (154.1, -144.3, -149.5 vs -36.0); patients achieving clinical remission vs PBO (CDAI<150): (54.0%, 56.0%, 50.0% vs 15.7%); clinical remission among conventional therapy failures & among patients who had previously failed biologic therapy, (61.6% vs 18.5% & 45.5% vs 12.5%) respectively
- @12wks, Tremfya induced greater improvement across key clinical and endoscopic outcome measures, with a safety profile consistent with approved indications. Tremfya is a mAb that selectively binds to the p19 subunit of (IL)-23 and inhibits its interaction with the IL-23 receptor
Date – Nov 02, 2020
- Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI
- The MHRA’s decision is based on a rolling submission, including data from the P-III study, demonstrating 95% efficacy in participants without & with/ out prior SARS-CoV-2 infection, in each case measured from 7 days after the second dose
- This marks the first EUA following a WW P-III trial of a vaccine to combat the pandemic. The companies are anticipating further regulatory decisions across the globe in Dec’2020
Date – Nov 02, 2020
- Grünenthal to acquire EU rights (Ex- Spain and the UK) of Crestor & its associated brands for ~$350M and will take over bulk production and packaging by 2025. The deal is expected to be closed in Q1’21
- The payments will be made in two tranches: $320M will be paid upon transaction closing and $30M as additional milestones
- Crestor is a statin, a lipid-lowering agent used to treat blood-lipid disorders & to prevent CV events, such as heart attacks & strokes, and is approved as a lipid-regulating medicine in 100+ countries
Date – Nov 02, 2020
- The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively
- Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs -0.2); no new or unexpected safety signals were identified respectively
- Xolair is the first biologic for the treatment of nasal polyps that targets and blocks IgE. In the US, Novartis & Genentech work together to develop and co-promote Xolair
Date – Nov 03, 2020
Product – CT-P17(biosimilar,adalimumab)
- The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
- Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
- Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre- filled syringe (PFS)
Date – Nov 03, 2020
Product – FPI-1434
- Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
- The collaboration leverages Fusion’s TAT platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of Abs and cancer therapies, including DDRis
- Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s FPI-1434) and AstraZeneca’s therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets
Date – Nov 03, 2020
- Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy
- The acquisition will boost Janssen’s eye disease portfolio & strengthens its gene therapy capabilities
- HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent further damage to the retina and preserve vision. The P-I study of the therapy for patients with geographic atrophy is completed while the P-I study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate the long-term safety
Date – Nov 04, 2020
- The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis
- The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of deucravacitinib was consistent with previously reported P-II results
- Deucravacitinib (BMS-986165, PO) is the first & only novel selective TYK2 inhibitor, currently being evaluated in psoriasis, PsA, lupus, and IBD
Date – Nov 04, 2020
- The BLA is based on the P-I CHRYSALIS study assessing amivantamab as a monothx. and in combination with lazertinib in adult patients with advanced NSCLC
- The company has established an EAP for patients in the US who may be eligible to obtain access to mivantamab during the review of the BLA
- Amivantamab is an EGFR & MET bispecific Ab with the immune cell-directing activity that targets tumors with activating & resistance to EGFR & MET mutations & amplifications. Amivantamab has received the US FDA’s BTD in Mar’2020
Date – Nov 05, 2020
- Merck will acquire all the outstanding shares of VelosBio for $2.75B in cash. The transaction is expected to be closed by the end of 2020
- The acquisition will bolster Merck’s oncology pipeline with the addition of VelosBio’s VLS-101, which is an investigational ADC targeting ROR1 to treat hematological malignancies and solid tumors
- In Oct’2020, VelosBio has initiated P-II study to evaluate VLS-101 for the treatment of patients with solid tumors, including patients with TNBC, HR+/HER2+ BC, and NSCLC. Additionally, VelosBio is developing a preclinical pipeline of ADCs and bispecific Abs targeting ROR1 to complement VLS-101 by offering alternative methods of tumor cell killing
Date – Nov 05, 2020
- Iktos will leverage its de novo generative design technology to be used in a structure-enabled context, facilitating the rapid & cost-effective design of Merck KGaA’s drug discovery program
- The collaboration follows the previous agreement of the companies signed in 2019. Merck KGaA is utilizing Iktos’ de novo design software platform Makya for MPO
- Iktos’ AI technology is based on deep generative models that help bring speed & efficiency to the drug discovery process by automatically designing virtual novel molecules having desired activities for treating a disease
Date – Nov 05, 2020
- Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community
- The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per individual, administered 21 days apart.
- NVX-CoV2373 is evaluated in P-ll trial in the UK and 2 ongoing P-ll studies that began in Aug’2020, a P-llb trial in SA, and a P-l/ll continuation in the US and Australia. Additionally, Novavax has multiple agreements for the supply of NVX-CoV2373 directly to the US, UK, Canada, and through partnerships, supply to Japan, South Korea, and India
Date – Nov 07, 2020
- The 4 pivotal HAVEN studies (HAVEN-1, 2, 3, 4) included pooled data from 401 people with hemophilia A with/ out factor VIII inhibitors, with a median duration efficacy period of 120.4wks.
- Hemlibra maintained low treated bleed rates with ABR remaining low throughout the evaluation period at 1.4. The proportion of participants who experienced 0 treated bleeds (70.8-83.7%) increased with each consecutive 24wks. period
- Roche also presented the first interim analysis of the EUHASS database suggesting that the safety profile of Hemlibra in the real-world setting is consistent with the clinical trials, with no new/ emerging safety signals. Hemlibra is a bispecific factor IXa- and factor X-directed Ab
Date – Nov 09, 2020
Product – CT-P59
- The P-I clinical trial involves assessing CT-P59 (20/40/80 mg/kg) vs PBO in 18 patients with mild symptoms of SARS-COV-2 infection who were randomized into 3 cohorts
- Results: patients demonstrated a 44% reduction in mean clinical recovery time, while no patients required hospitalization or antiviral therapy
- Celltrion has submitted the IND application for the clinical trial globally & plans to conduct global P-II & P-III trials including Korea. Additionally, Celltrion has also initiated a post-exposure prophylaxis study assessing CT-P59 as a protective treatment, by investigating the efficacy of the treatment in those who have been in contact with confirmed SARS-CoV-2 infected patients
Date – Nov 10, 2020
Product- Calquence (obinutuzumab)
- The approval is based on P-lll ELEVATE-TN study assessing Calquence + obinutuzumab or Calquence alone vs obinutuzumab + CT in patients with previously untreated CLL and ASCEND study assessing Calquence vs rituximab + idelalisib/ bendamustine in patients with r/r CLL
- ELEVATE-TN results: a reduction in the risk of disease progression or death (90% and 80%). ASCEND results: patients remained alive and free from disease progression @12mos. (88% vs 68%)
- Calquence is a selective inhibitor of BTK, binds covalently to BTK, thereby inhibiting its activity. The approval follows CHMP’s recommendation received in Jul’2020
Date – Nov 12, 2020
- The P-lll JADE REGIMEN study involves assessing of Abrocitinib (100/ 200mg) vs PBO in 1233 patients aged ≥ 12 yrs. in a ratio (1:1:1) with mod. to sev. AD following response to initial open-label induction treatment with abrocitinib (200mg)
- Result: The study met its 1EPs i.e. probability of not experiencing a flare @52wks. (81.1%, 57.4% vs 19.1%) and 2EPs i.e. patients maintain an IGA response of clear or almost clear relative
- Following an initial 12wks. induction treatment phase, fewer patients experienced a flare at any point in the trial @40wks. Abrocitinib is a JAK inhibitor, which modulates multiple cytokines involved in the pathophysiology of AD, including IL-4, IL-13, IL-31, IL-22, and TSLP
Date – Nov 13, 2020
Product – Handl Therapeutics
- The acquisition will bolster UCB’s pipeline program, capabilities, and platforms in the gene therapy space. The Handl Therapeutics will continue to be based in Leuven, Belgium while working closely with UCB’s international research teams
- In addition, the UCB collaborated with Lacerta to focus on CNS diseases, under which Lacera will lead research, preclinical activities, and the early manufacturing process development, while UCB will complete IND-enabling studies, manufacturing, and clinical development
- The collaboration will allow UCB to access Lacerta’s expertise in AAV-based CNS targeted gene therapies, fortifying UCB’s ability to produce effective treatments for neurodegenerative diseases
Date – Nov 16, 2020
- The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment
- The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
- The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products
Date – Nov 20, 2020
- collaborate to focus at developing & commercializing transformative therapies in Greater China. Both the companies will leverage their clinical development, regulatory and commercial expertise
- Pfizer will contribute ~$70M of non-dilutive capital toward in-licensing & co-development. At LianBio’s discretion, products will be presented to Pfizer for joint development
- Pfizer will have a right of first negotiation to obtain commercial rights to jointly developed assets & each company will carry separate financial considerations. Additionally, Pfizer may provide in-kind support for marketing, development & regulatory activities
Date – Nov 23, 2020
Product – AZD1222
- Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported
- One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose of at least 1 mos. apart & another dosing regimen showed 62% efficacy when given as 2 full doses at least 1 mos. apart. The combined analysis from both dosing regimens resulted in the efficacy of ~70%
- AZ will plan regulatory submission of the data across the globe and will seek an Emergency Use Listing from the WHO for an accelerated pathway to vaccine availability in low-income countries.
Date – Dec 15, 2020
Product- Cobas PIK3CA Mutation Test
- Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark
- The IVT test is a real-time PCR test for the qualitative detection & identification of 17 mutations in exons 2, 5, 8, 10 & 21 in the gene encoding the catalytic subunit of PIK3CA in DNA isolated from FFPET and is intended to identify patients with m-BC harboring mutations
- This test reports automated results, with flexible throughput to process 30 samples/ run on the widely available cobas z 480 analyzers. The test can detect 17 mutations in the PIK3CA gene and can help clinicians to identify patients who may benefit from PI3K targeted therapy
Date – Dec 16, 2020
Product- SARS-CoV-2 IgG II Quant test
- Abbott received CE Mark for its new quantitative SARS-CoV-2 IgG lab-based serology test. The test measures levels of IgG Abs to help in the evaluation of a person’s immune response
- The study to determines the clinical performance of Abbott’s SARS-CoV-2 IgG II Quant test on its Alinity i instrument showed that it had 99.60% specificity & 99.35% sensitivity in patients tested 15 days or more after symptoms began
- The test will be available on both the Abbott ARCHITECT and Alinity i platforms. Abbott plans to submit its test for US FDA’s EUA imminently
Date – Dec 15, 2020
Product- COVID-19 vaccine
- Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use
- Following an agreement to supply 20M of doses for the Government of Canada, AstraZeneca seek out Health Canada’s clearance in Oct’2020, leading to data submission done on a rolling basis for accelerating the review process
- Health Canada is looking to give Canadians access to COVID-19 vaccines asap without compromising its safety, efficacy, and quality standards
Related Post: PharmaShots’ Key Highlights of Third Quarter 2020
The post PharmaShots’ Key Highlights of Fourth Quarter 2020 first appeared on PharmaShots.
The transaction, once completed, will leave the behavioral health startup with about $250 million in cash, which it plans to use to build its user base, add partnerships and expand internationally.
I have a low bar for recommending people avoid foods that aren’t particularly health-promoting in the first place. Remember when that acrylamide story broke, about the chemical found concentrated in french fries and potato chips? (See my video Acrylamide in French Fries for more.) My take was pretty simple: Look, we’re not sure how bad this acrylamide stuff is, but we’re talking about french fries and potato chips, which are not healthy anyway. So, I had no problem provisionally bumping them from my list of yellow-light foods into my red-light list, from “minimize consumption” to “ideally avoid on a day-to-day basis.”
One could apply the same logic here. Junk foods made out of brown rice syrup, rice milk, and white rice are not just processed foods, but also arsenic-contaminated processed foods, so they may belong in the red zone as red-light foods we should avoid. What about something like whole brown rice? That is more difficult, because there are pros to help outweigh the cons. I discuss this in my video Is White Rice a Yellow-Light or Red-Light Food?, where you can see a graphical depiction of my traffic light food system at 0:49.
The rice industry argues that the “many health benefits of rice consumption outweigh any potential risk,” which is the same sentiment you hear coming out of Japan about the arsenic-contaminated seaweed hijiki: Yes, “the cancer risk posed by hijiki consumption exceeds this acceptable [cancer risk] level by a factor of 10,” an order of magnitude, but the Japanese Ministry of Health stresses the “possible health benefits,” such as lots of fiber and minerals, as if hijiki was the only weed in the sea. Why not choose any of the other seaweeds and get all the benefits without the arsenic? So, when the rice industry says the “many health benefits of rice consumption outweigh any potential risk,” it’s as if brown rice was the only whole grain on the planet. Can’t you get the whole grain benefits without the risks by eating oatmeal, barley, or quinoa instead? Or, is there some unique benefit to rice, such that we really should try to keep brown rice in our diet?
Consumer Reports recommended moving rice to the yellow-light zone—in other words, don’t necessarily avoid it completely, but moderate your intake. The rice industry, in a fact sheet entitled “The Consumer Reports Article is Flawed,” criticized Consumer Reports for warning people about the arsenic levels in rice, saying “[t]here is a body of scientific evidence that establishes…the nutritional benefits of rice consumption; any assessment of the arsenic levels in rice that fails to take this information into account is inherently flawed and very misleading.” The rice industry cites two pieces of evidence. First, it asserts that rice-consuming cultures tend to be healthier, but is that because of, or despite, their white rice consumption? And what about the fact that rice-eating Americans tend to be healthier? Perhaps, but they also tend to eat significantly less saturated fat. So, once again, how do we know whether it’s because of—or despite—the white rice?
The rice industry could have cited the study I discuss at 3:12 in my video that showed that brown rice intake of two or more servings a week was associated with a lower risk of diabetes, but presumably, the reason it didn’t is because intake of white rice is associated with an increased risk of diabetes, and white rice represents 95 percent of the U.S. rice industry. Switching out a third of a serving of white rice a day for brown rice might lower diabetes risk by 16 percent, but switching out that same white rice for whole grains in general, like oats or barley, might work even better! So, other grains have about ten times less arsenic and are associated with even lower disease risk. No wonder the rice industry doesn’t cite this study.
It does cite the Adventist studies, though, and some in vitro data. For example, in a petri dish, as you can see at 4:05 in my video, there are rice phytonutrients that, at greater and greater doses, can inhibit the growth of colon cancer cells while apparently leaving normal colon cells alone, which is exciting. And, indeed, those who happened to eat those phytonutrients in the form of brown rice once or more a week between colonoscopies had a 40 percent lower risk of developing polyps. (The consumption of green leafy vegetables, dried fruit, and beans were also associated with lower polyp incidence.) But, the only reason we care about the development of polyps is that polyps can turn into cancer. But, there had never been studies on brown rice consumption and cancer…until now, which I discuss in my video Do the Pros of Brown Rice Outweigh the Cons of Arsenic?.
For those unfamiliar with my traffic light system, I talk about it in my book trailer. Check out How Not to Die: An Animated Summary.
Almost there! This is the corresponding article to the 12th in my 13-video series on arsenic in the food supply. If you missed any of the first 11 videos, see:
- Where Does the Arsenic in Chicken Come From?
- Where Does the Arsenic in Rice, Mushrooms, and Wine Come From?
- The Effects of Too Much Arsenic in the Diet
- Cancer Risk from Arsenic in Rice and Seaweed
- Which Rice Has Less Arsenic: Black, Brown, Red, White, or Wild?
- Which Brands and Sources of Rice Have the Least Arsenic?
- How to Cook Rice to Lower Arsenic Levels
- Arsenic in Infant Rice Cereal
- Arsenic in Rice Milk, Rice Krispies, and Brown Rice Syrup
- How Risky Is the Arsenic in Rice?
- How Much Arsenic in Rice Is Too Much?
Ready for the finale? See Do the Pros of Brown Rice Outweigh the Cons of Arsenic?.
And you may be interested in Benefits of Turmeric for Arsenic Exposure.
Michael Greger, M.D.
PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:
- 2019: Evidence-Based Weight Loss
- 2016: How Not To Die: The Role of Diet in Preventing, Arresting, and Reversing Our Top 15 Killers
- 2015: Food as Medicine: Preventing and Treating the Most Dreaded Diseases with Diet
- 2014: From Table to Able: Combating Disabling Diseases with Food
- 2013: More Than an Apple a Day
- 2012: Uprooting the Leading Causes of Death
The UK-based global medical authentication provider added that supply chain security is especially important with the world’s largest ever mass immunisation program currently under way for COVID-19 vaccines.
According to the enterprise, the UK could become the world’s foremost nation for drug security by implementing blockchain-based technologies, which, it said, are more advanced and future proof than the solutions implemented by the FMD. It added that these technologies would position the UK ahead of the US, whose Drug Supply Chain Security Act (DSCSA) is widely acknowledged as the current gold standard.
“While we currently have an active fake medicines risk for the UK – especially with the scale of COVID-19 immunisation programme – it is also an ideal moment to re-evaluate our entire medicines supply chain. Blockchain-based solutions – which are immutable by definition – were not widely available when the EU directives came in and can provide far greater visibility and a full custody of medicines. It is a future-proof solution that undoubtably advanced nations will gradually switch to and, with Brexit, the UK has the opportunity to implement the world’s safest medicine supply chain right now.
“This type of solution will also prevent critical medicines being diverted away from UK shores and identify sub-standard drugs quickly for recall all in real-time – currently not possible with the EU’s FMD solution. It means patients and doctors will be reassured, as they will have a transparent digital record of every medicines journey from factory to pharmacy or surgery. With even the exact details of shipping and storage conditions retained – which is so critical to many medicines’ efficacy, for example, several of the recent COVID-19 vaccines which require extreme cold storage,” commented Raja Sharif, Chief Executive Officer at FarmaTrust.
Estimates suggest that one in seven medicines are counterfeit. The EU’s FMD (FMD, 2011/62/EU) and Delegated Regulation (EU/2016/161) were designed to secure medicine within the EU. However, the UK no longer has access to this system and many experts warn that without action, the UK is at risk of having counterfeit medicines enter its healthcare system.
Securmed, the UK National Medicines Verification Organisation (UKNMVO), announced to solution providers in October 2020 that, with the exception of Northern Ireland – which will remain using the European system – mainland UK will be removed from the database used to track serialised medicine digital barcodes in Europe. While, the Department of Health and Social Care are aware of this issues, FarmaTrust said they are yet to comment.
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- The approval is based on Tislelizumab + CT regimen vs CT as monothx. in 360 patients with a ratio (1:1:1) as a 1L for patients with advanced squamous NSCLC
- The trial met the 1EP, i.e. improvement in PFS, as assessed by IRC in the pre-planned interim analysis. The safety profile of tislelizumab in both combinations was consistent with the known risks of each study treatment, and no new safety signals were identified
- Tislelizumab is a humanized IgG4 anti-PD-1 mAb specifically designed to minimize binding to FcγR on macrophages. The approval marks the third approval for tislelizumab in China and its first in a lung cancer indication
Click here to read full press release/ article | Ref: Businesswire | Image: Memorial Sloan Kettering Cancer Center
The post BeiGene’s Tislelizumab (BGB-A317) + CT Receive NMPA’s Approval as 1L Therapy for Advanced Squamous NSCLC first appeared on PharmaShots.
The groups say that collaboration among the global community has resulted in safe and efficacious vaccines being authorised by stringent regulatory agencies, which are already being manufactured and distributed. Additional vaccines are expected to follow.
The biopharmaceutical industry acknowledges the considerable challenges governments are facing to urgently address the enormous strain the pandemic is placing on healthcare systems, societies and economies. In light of the urgent need to reach as many people as possible with COVID-19 vaccines, there are emerging discussions regarding dosing strategies that may not be supported by the authorised labelling or published clinical data.
The groups say that the biopharmaceutical industry commits to work in partnership with regulatory agencies and recommending bodies to gather further clinical data on several ongoing scientific questions with regard to COVID-19 vaccines. The industry believes that vaccine deployment strategies should be based on the outcome of these continuing clinical studies and the evolving knowledge. Therefore, the biopharmaceutical industry supports adhering to the dosing that has been assessed in clinical trials and urges that any changes from the tested and approved vaccine dosing and vaccination schedules for COVID-19 vaccines should follow the science and be based on a transparent deliberation of the available data.
“The biopharmaceutical industry will continue to develop and test vaccine candidates for COVID-19 through a sound, scientific and deliberative process,” the groups say in their statement. They also highlight that vaccine manufacturers have pledged to only submit vaccine candidates for approval or emergency use authorisation after demonstrating safety and efficacy in clinical trials that are designed and conducted to meet the requirements of regulatory authorities.
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The results are from the first part of the randomised, double-blind, placebo controlled global Phase II/III clinical trial evaluating the safety and efficacy of CT-P59. In this part of the study, 327 patients with mild-to-moderate symptoms of COVID-19 were split into three treatment groups: one receiving 40mg/kg of CT-P59, another 80mg/kg of CT-P59 and the last receiving placebo. According to the company, approximately 60 percent of those with moderate symptoms suffered from COVID-19 related pneumonia.
The data analysis has demonstrated that at Day 28, CT-P59 treated patients presented with a significantly reduced risk of COVID-19 related hospitalisation and oxygenation without mortality. Those treated with 40mg/kg had significantly reduced disease progression rates to severe COVID-19, compared to placebo (reduction of 54 percent for mild-to-moderate patients and 68 percent for moderate patients aged 50 years and over).
CT-P59 treatment groups also reported significantly shortened time to clinical recovery:
- Patients treated with 40mg/kg of CT-P59 recovered 3.4 days earlier than those in the placebo group.
- Patients with pneumonia treated with 40mg/kg reported shortened recovery time by 5.1 days compared to placebo.
- Moderate patients aged 50 years and over treated with CT-P59 (40mg/kg) reported a shortened recovery time by 6.4 days compared to placebo.
In addition, CT-P59 was shown to have a positive safety profile, with no serious adverse advents reported. Infusion related reactions were mild and transient, with the CT-P59 treatment group having reported 0.5 percent, compared to 1.8 percent reported with placebo.
“The data demonstrate that CT-P59 could contribute to both a reduced time to clinical recovery, as well as a reduced proportion of patients who progress to severe disease,” said Professor Joong-Sik Eom, Infectious Disease Division at Gil Medical Center of Gachon University, South Korea. “The treatment’s safety profile was comparable to that of placebo and generally well-tolerated. Therefore, it is anticipated that CT-P59 would positively contribute to the management and control of the current COVID-19 pandemic across the world.”
“Our top-line data from the global Phase II/III clinical trial have demonstrated that CT-P59 is effective for the treatment of COVID-19 in mild-to-moderate patients and especially in moderate patients aged 50 years and over. We are encouraged by the robust and consistent nature of the top-line clinical profile of CT-P59 and our clinical studies are on track in more than 10 countries,” said Dr HoUng Kim, Head of Medical and Marketing Division at Celltrion Healthcare. “We are planning to manufacture doses for around two million patients in 2021 and hope to improve access to this treatment option for those that require.”
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In this second ‘Nine for 2021‘ article, IQVIA’s Sarah Rickwood looks at four issues which will directly impact pharma in 2021: the permanent changes in customer engagement models, the implications of a geographic re-balancing towards the East, CNS as the new value growth area for the 2020s, and the new biologics environment as biosimilars accelerate.
Focus on customer engagement impact
The customer engagement story of 2020 could be summarised in three themes: trend break, agility and remote interaction. The trend break was the most immediately measurable commercial model impact. For April 2020 almost all face-to-face contact with healthcare professionals (HCPs) ceased. Preventing virus transmission, as well as “getting out of the way” of healthcare professionals pivoting to address the virus was key, and HCPs largely welcomed the way pharma reacted as responsible and necessary.
However, qualitative interviews conducted by IQVIA with HCPs in the top 5 European countries on their experience of engagement with pharma during 2020 show that doctors still valued interaction, including face to face interaction, with pharma and missed it when it was absent.
Pharma moved rapidly to remote interactions, even to the point of all virtual launches of new products. The overall volume of interactions fell, and those remaining became more remote and less interactive. The agility of many organisations effecting this rapid change was impressive, and a more resilient hybrid model seemed to be emerging as face-to-face interactions returned post the first wave.
This has, of course, been more recently challenged in Europe by second wave infections and new lockdowns, but this masks more fundamental and as yet unresolved challenges for 2021’s commercial model, which could be defined by environment divergence and the need to achieve impact.
The promotional environments of major pharmaceutical markets were already divergent in 2019 – some, like Italy and Spain were very high on traditional face to face interactions, others, like the UK, were the complete opposite, and still others, like Japan and the US, had high volumes of both digital and face to face contacts. The ways in which country promotional environments recovered from the first lockdowns has accentuated that divergence. This has implications for the commercial model companies employ by geography.
Environment divergence has been accelerated by recovery post the first infection wave – IQVIA ChannelDynamics data shows that in Europe, countries have recovered to a different promotional mix.
The UK has diverged most – it was always the country with the lowest volume of face-to-face contacts, and those contacts remain at negligible levels, replaced (but not completely) with remote rep contacts, creating a near 100% remote engagement model.
Other European countries have seen face to face contacts recover, then fall back because of second waves, but the model that emerged towards the end of 2020 was lower in volume and much more hybrid – a greater proportion of interactive contact was remote. The US, Japanese and Chinese promotional environments saw contact volumes recover to close to or greater than 2019 levels, with a channel mix that was more heavily remote.
The divergence of promotional environments is especially stark in the difference in the total interactive time the pharma industry had with healthcare professionals in 2020, compared to 2019. Up to November, the US and Japan actually saw increases in interactive time in 2020. Not so China, and especially not so the lead five European countries – on average European pharmaceutical companies saw a loss of 30% of the interactive time they previously had with healthcare professionals in 2020. Much of this lost time would have ordinarily been spent introducing and establishing new innovations and building growing products.
The need to achieve impact
As interactive time with HCPs is likely to be scarce, companies need to be even more ruthless in prioritising content and in deciding what content to generate in the first instance – for example, in Real World Evidence, as outlined in IQVIA’s white paper, ‘Excellent Launches are winning the Evidence battle’.
CNS (re) emerges
The 2010s were the decade of oncology: the decade started with oncology tipping hypertension off the top spot as the world’s most valuable therapy area, and during the next ten years, via continuous introduction of significant innovation, oncology grew its share of global prescription medicine value from 8% to 13% of sales. Oncology will continue to dominate the world market in the 2020s, albeit with slower growth, but that is not news. Instead, we will focus on therapy areas which will take on new significance in the 2020s. Of these, the most significant in terms of the conditions’ prevalence, and unrealised therapeutic potential, is CNS.
CNS is a “Back to the Future” story – scroll back to the 1990s and 2000s and CNS was one of the largest segments of the Rx market by value, driven by anti-depressants, atypical neuroleptics, anxiolytics and hypnotics. Then, by the 2010s, a wave of genericisations took down the blockbusters across all leading classes, and innovation stalled. Hopes for an effective disease modifying Alzheimer’s treatment, the holy grail of CNS research, were repeatedly dashed by late stage failures. By the end of the 2010s, CNS as a whole was highly genericised, with low innovation and few important launches. From 2021 onwards, this will change. Over the next five years we expect the global CNS market to accelerate ten-fold in list price value from near-flat historical growth of 0.4% CAGR for the past 5 years to 3-5% CAGR for the period of 2020-2025 to reach $100 billion globally by the middle of the decade.
The drivers behind this transformation are two classic elements – perennial unmet need and innovation, but with some very specific 2020s twists. The pandemic and consequent lockdowns have led, in some countries, to an explosion of mental health disorders. The pandemic has accelerated the trend to remote and digital healthcare at a time when the development and use of digital diagnostics and biomarkers has become possible and very relevant to many CNS conditions. Psychiatry has proven one of the areas of clinical practice most amenable virtual delivery.
Underlying this all, long term innovative investment is finally yielding fruit in a range of CNS therapy areas, for example new therapies for treatment-resistant depression (e.g. Janssens’s Spravato), the novel CGRP inhibitors for migraine, or dual orexin receptor antagonists (DORAs) developed for insomnia. Two of the three largest selling products launches in 2020 by 2020 sales were CNS products: the oral migraine treatments Ubrelvy and Nurtec. Progress on the holy grail of an effective disease modifying Alzheimer’s treatment is also possible in 2021, but not a foregone conclusion.
CNS will end 2021 with a renewed relevance and powered by new innovation, both molecular and digital, placing the therapy class in a strong position to re-ascend the rankings as one of the most valuable therapy areas for the remainder of the 2020s.
Biosimilars are now a long-established feature of European markets, and an increasingly well-established element in the US. 2021 marks the start of the era when these healthcare systems really need biosimilars to come good on their promise to realise cost savings. As economic crisis leads to healthcare spend constraints, the proportion of product value that will lose exclusivity in the next five years that is biologic has never been higher, at 44% of the $200m of the 2019 pharmaceutical market which will lose exclusivity in the next five years.
Counting from infliximab, the first of the monoclonal antibodies to face biosimilar competition, uptake of the biosimilar into the originator molecule has improved significantly, with the last volley of biosimilar launches reaching 40% of all treatment days within 12 months of in Europe, compared to nearly three years for infliximab to reach that level. Bevacizumab (Avastin) is on track to achieve 40% average European biosimilar treatment day penetration in six months, the first to do so. However, biosimilar uptake is not evenly distributed, and savings are still not always realised where they are most needed. Given the very powerful incentives that especially European countries will have to realise savings on medicines budgets where they can, we expect further measures to be implemented to promote the use of biosimilars in 2021.
Pharma pivots East
Increasingly, pharmaceutical companies add China to their launch priority countries group, typically the US, EU, and Japan, and from 2021, this trend is likely to accelerate. Europe, still in the throes of lockdowns and second waves will be living with healthcare system disruption for much of 2021, as well as economic austerity. Fragmentation of the European top 5 as the UK pursues its own regulatory regime post Brexit may also impact Europe’s attractiveness. The US, also still to effectively manage the infections crisis, will enter a new phase with the Biden presidency, and that could mean changes to healthcare system and pharmaceutical pricing reform.
China entered the first wave of the pandemic crisis earliest and emerged earliest, and (as at January 2021) has so far managed to avoid the debilitating second waves which have precipitated further lockdowns and healthcare system disruption in Europe and the US. Whilst the details of China’s economic recovery have been disputed, one forecaster, the Centre for Economics and Business Research, has predicted that China will now overtake the US as the world’s leading economy in 2028, five years earlier than was previously forecast.
China has been the world’s second most valuable pharmaceutical market since 2013, but it has not been an important market in terms of contribution to the sales of the newer innovative pharmaceutical products – in fact, whilst China ranked second on total Rx market sales, it ranked below 30 in terms of sales of newly launched innovative products. This is now changing and will be accelerated in 2021 by how China exits the pandemic crisis.
Pre-pandemic, China had already worked hard to reform its regulatory systems, reducing the backlog of medicines applications under or awaiting review by 80% by the end of 2019. New Active Substances, as monitored by IQVIA audits, entered the Chinese market in 2020 at historically high rates – by August 2020, 27 new active substances were in the Chinese market, as opposed to a five-year historic average of 15 by that point in the year for China.
Approval is not everything, and there remain significant market access and pricing challenges for innovative launches in China, but China’s domestic appetite for innovation is growing fast – the innovative branded products segment of the market grew by 12% in value between 2015 and mid-2020, while the remainder of the market grew by 3%. In addition to China, Japan, already one of the key country contributors to early innovative launch sales, has also accelerated the introduction and uptake of innovation in recent years. Japan has also emerged from the pandemic relatively unscathed, in terms of healthcare system, although economic recovery might be slow.
Because of these trends, from 2021, the importance of China and Japan to innovative product value is likely to progressively increase, driven both by increases in attractiveness of these two markets, and challenges in the European (and possibly US) environment. This will tip the geographic balance of the global pharmaceutical industry east, which will not just influence where pharmaceutical companies get their value from, but also usher a new collection of Chinese innovators into the global market.
If 2020 was the crisis year, 2021 is the year of transformation. Some of our nine 2021 trends were set pre-crisis, for example the re-emergence of CNS, but may see some acceleration or change because of the crisis. Others, for example the transformation of the commercial model and the renewed focus on impact, have been dramatically shaped by the events of 2020, leading the industry into a much-accelerated change and possibly taking commercial environments in directions they would not have moved without the pandemic. Others, and especially the pandemic-accelerated tilt towards the East in terms of innovative market, have ramifications that will be decades long in realisation. 2020 was a year in which, by rising to the challenge of the pandemic, the pharmaceutical industry demonstrated it can accomplish that which would previously have been labelled impossible. Whatever the challenges, the pharmaceutical industry enters 2021 with a new sense of purpose.
About the author
Sarah Rickwood has 26 years’ experience as a consultant to the pharmaceutical industry, having worked in Accenture’s pharmaceutical strategy practice prior to joining IQVIA. She has wide experience of international pharmaceutical industry issues, having worked for most of the world’s leading pharmaceutical companies on issues in the US, Europe, Japan and leading emerging markets, and is now vice president, European thought leadership at IQVIA, a team she has run for eight years.
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According to the report, the North America antibiotics market for antibiotics facilities accounted for $15,132.8 million in 2019 and it is estimated to generate a revenue of $19,950.2 million by the end of 2027. Higher extent of prescribed antibiotics along with strict government and industry regulations for business processes are some of the factors propelling the antibiotics market growth in the region, the researchers say.
The report also says that the fluoroquinolones drug class segment is expected to grow at a notable CAGR of 5.2 percent registering a revenue of $10,143.1 million by 2027. The segment accounted for $6,823.1 million in 2019. Fluoroquinolones are extremely effective antibiotics with multiple beneficial pharmacokinetic properties, such as large volume of distribution and broad-spectrum antimicrobial activity, which is expected to be one of the major growth factors of the segmental market.
The broad-spectrum antibiotics sub-segment is also expected to surpass $52,366.7 million by 2027, increasing from $38,018.1 million in 2019. The rising prevalence of infectious diseases, major development of innovative antibiotics and extensively increasing healthcare expenditure are the major growth boosters of the market.
The growth of the global market for antibiotics is mainly attributed to the novel product innovations for the treatment of severe bacterial infections combined with a large number of clinical trials. In addition to this, the growing prevalence of infectious diseases like pneumonia, HIV/AIDS, tuberculosis and malaria is one of the major factors anticipated to enhance the global market growth during the forecast period.
Substantial investments in R&D activities by biotech companies, availability and massive adoption of generic medicines, discovery of advanced molecules and increasing expenditure in healthcare facilities will be some of the factors providing attractive opportunities to the global antibiotics market growth in the coming years.
Development of antibiotic resistance, particularly in the case of bacterial infections, is one of the major reasons which is negatively affecting the global antibiotics market. On the contrary, incorporation of novel computing technologies for antibiotic discovery may further create positive opportunities for the market growth.
According to the report, the top five leading players of the global antibiotics market are Abbott Laboratories, Sanofi, Merck, Bristol-Myers Squibb Company and Janssen Global Services. These players are currently focusing on R&D activities, mergers, acquisitions, partnerships and collaborations to sustain the growth of the market.
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ViiV’s Tivicay is to become available in Europe in a new dispersible tablet form to treat children living with HIV.
The joint venture, majority-owned by GlaxoSmithKline with Pfizer and Shionogi as shareholders, said the European Commission had granted a marketing authorisation for the new formulation.
These tablets are used in combination with other antiretroviral agents for treatment of human immunodeficiency virus type-1 infection in paediatric patients.
To be eligible, children must be at least four weeks of old, weighing at least 3kg and must not have been treated with an integrase inhibitor, although it doesn’t matter whether they have been treated with other drugs classes.
This authorisation includes updated dosing recommendations, for Tivicay (dolutegravir) film-coated tablets (10mg, 25mg and 50mg) for children six years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands.
Approval is based on data from the ongoing P1093 and ODYSSEY studies, which are being conducted in collaboration with international paediatric research networks.
P1093 is a a safety, tolerability and dose finding registrational study in paediatric patients aged four weeks to 18 years being conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) network in the USA, Brazil, Thailand, South Africa, Zimbabwe, Kenya and Tanzania.
ViiV Healthcare, the Division of AIDS (DAIDS) at the US National Institutes of Health (NIH) are collaborating in this trial.
ODYSSEY is a randomised control efficacy trial in first and second- line treatment, in paediatric patients aged four weeks to 18 years being conducted by the PENTA network in Europe, South America, Thailand, Uganda, Zimbabwe, and South Africa.
Originally designed to support World Health Organization (WHO) guideline recommendations by WHO weight bands, this study will now also provide data to support revised dosing and continue to 96 weeks.
ViiV Healthcare, the Paediatric European Network for Treatment of AIDS (Penta) and the Medical Research Council (MRC) Clinical Trials Unit at University College London for ODYSSEY are collaborating in this trial.
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- Biond to receive $125M up front in cash and will be eligible to receive ~$1B+ as development, regulatory & commercial milestones, along with royalties on sales of the therapy
- Biond will lead P-Ia study of BND-22, assessing its safety & tolerability as a single agent and in combination with approved cancer therapies as well as exploring potential associations b/w BND-22 anti-tumor activity, select tumor and blood-based biomarkers. Sanofi will be further responsible for clinical development and commercialization of BND-22
- BND-22 is a humanized IgG4, antagonist Ab targeting ILT2 receptor in development for solid tumors. The first P-Ia study of BND-22 is anticipated to start by mid-2021
Click here to read full press release/ article | Ref: PRNewswire | Image: 20 Minutes
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Previous COVID-19 infection provides some immunity for at least five months, but people may still carry and transmit the virus, according to a study by Public Health England.
A first report from PHE’s SIREN study found antibodies from previous COVID-19 infection provide 83% protection against reinfection for at least five months.
It found that reinfections in people with antibodies were rare, with only 44 potential reinfections among 6,614 participants who showed evidence of previous infection.
But a small number of people with antibodies may still be able to carry and transmit COVID-19 according to the study.
As a result, PHE stressed the importance of following “stay at home” rules currently in place in the UK to prevent the virus from spreading.
Public Health England has been regularly testing tens of thousands of health care workers across the UK since June for new COVID-19 infections as well as the presence of antibodies, which suggest people have been infected before.
SIREN study leaders are clear this first report provides no evidence towards the antibody or other immune responses from COVID-19 vaccines, nor should any conclusions be drawn on their effectiveness. The SIREN study will consider vaccine responses later this year.
Professor Susan Hopkins, senior medical advisor at Public Health England and the SIREN study lead said: “This study has given us the clearest picture to date of the nature of antibody protection against COVID-19 but it is critical people do not misunderstand these early findings.
“We now know that most of those who have had the virus, and developed antibodies, are protected from reinfection, but this is not total and we do not yet know how long protection lasts. Crucially, we believe people may still be able to pass the virus on.”
The news comes as the UK continues to endure high levels of infections despite a national lockdown.
There have been more than 74,000 deaths following coronavirus infections and nearly 43,000 new cases were recorded in the last day.
Last year the government announced that PHE is to be scrapped and merged with the NHS test and trace programme and the UK’s Joint Biosecurity Centre.
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UK biotech Synairgen is pushing ahead with a phase 3 trial of SNG001 in hospitalised COVID-19 patients, after encouraging topline results from a phase 2 study that started last March.
The inhaled formulation of interferon beta-1a – delivered using a nebuliser – will be tested in 610 hospitalised COVID-19 patients who require supplemental oxygen in around 20 countries in the study, called SG018.
Interferon beta-1a is already used in an injectable form for multiple sclerosis, and before the pandemic took hold Synairgen was already putting its inhaled version through its paces in trials involving subjects with asthma and chronic obstructive pulmonary disease (COPD).
The cytokine is part of the body’s response to a viral infection, and there is some evidence to suggest that people who get dangerously sick after being infected with the SARS-CoV-2 virus have lower than usual levels of interferon beta in the lungs.
The Southampton-based company says it has appointed contract research organisation (CRO) Parexel to help conduct the phase 3 trial, with several UK sites now set up and others in the US and the EU expected to follow soon.
The first patient received the treatment at Hull Royal Infirmary this week, and Synairgen is hoping to get results available in the summer, which means emergency approvals could be feasible by the autumn.
Preliminary results from Synairgen’s 100-patient phase 2 trial SG016 were published in The Lancet last November, and found that patients treated with SNG001 had greater odds of improvement and recovered more rapidly from SARS-CoV-2 infection than patients who received placebo.
The main endpoint in the trial was Ordinal Scale for Clinical Improvement (OSCI) – a standard nine-point measure developed by the World Health Organization (WHO).
Patients taking SNG001 were more likely to show an improvement on the OSCI scale on day 15 or 16 after dosing started, and were more likely than those receiving placebo to recover to an OSCI score of 1 – with no limitation of their daily activities – during treatment.
There were also three deaths in the placebo group and none among patients taking SNG001, although the trial wasn’t statistically powerful enough to gauge whether that was a real effect or due to chance.
The UK’s National Institute for Health Research (NIHR) has given the phase 3 trial Urgent Public Health status, so it qualifies for support by the NIHR’s clinical research network. Meanwhile, the FDA has awarded fast-track status to SNG001 for COVID-19.
While the vaccine roll-out is raising spirits in the midst of the pandemic, Synairgen chief executive Richard Marsden said treatments are still needed for “cases where vaccines are not effective, for those who do not get vaccinated, and in case the virus mutates to the point where vaccines become less effective.”
“We believe this trial presents an opportunity for a significant UK scientific breakthrough and, if given the right support, our drug could rapidly assist with the global crisis,” he added.
Synairgen told the BBC that a course of treatment with SNG001 would cost around £2,000, which according to Marsden will represent “good value for money”.
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- The P-II/III study involves assessing of CT-P59 (40mg/kg, 80mg/kg) vs PBO in 327 patients with mild-to-mod. symptoms of COVID-19
- Results: reduction in progression rates (54% for mild-to-mod. patients & 68% for mod. patients aged ≥50yrs.); recovery days (5.4 vs 8.8 days); recovery time in patients with pneumonia & patients aged ≥50yrs. (5.7 vs 10.8 & 6.6 vs 13days) respectively. CT-P59 showed reduction in viral load @day7 with SAEs reported
- The preclinical data demonstrated a 100-fold reduction in viral load of SARS-CoV-2 and improved recovery time in animal models, that has been published in Nature Communications journal
Click here to read full press release/ article | Ref: Businesswire | Image: Medicircle
The post Celltrion Report Results of CT-P59 in P-II/III Study for COVID-19 first appeared on PharmaShots.
Healthcare technology firm Seqster has introduced a new version of its service that aims to help pharma companies work with patients’ data while on virtual clinical trials.
Seqster announced the new version of its platform had been launched on the Microsoft Azure cloud at the annual JP Morgan Healthcare Conference.
The new Seqster 7.1 service will allow secure access to real-world data from electronic health records (EHRs), DNA analysis and fitness wearables.
However, the company’s head of strategic business development Parsi Parsinejad said that the system is differentiated from competitors by its focus on putting patients in control of their data.
By making pharma companies sign data use agreements directly with the patient, Seqster says it has been able to create a platform that allows patients to create a one-point login they can control many forms of US health data.
This can range from health records to ancestry data, allowing patients to track their data in a similar way that the Mint budget tracker allows people to control their expenditure.
The platform is FDA 21 CFR Part 11 compliant enabling secure delivery of EHR documents directly to regulated clinical trial management systems and allowing eConsent-based visualisation of participants’ data.
Parsinejad told pharmaphorum in an interview: “You have been seeing a proliferation of cloud services. They are introducing a cloud-based service and industry specific applications.
“What Seqster does for pharma clinical trials is it brings together in real time a health record for participants. Patients can bring together their data wherever it resides.”
He added the tool could be used to help run virtual trials, which have become increasingly common due to the shift towards electronic technology in healthcare because of the pandemic.
The data gathered can be used as the basis for filings with the FDA, although for now the system works only with data gathered by US-based services.
The company adds that it has split data into two silos to prevent hackers from using it in the unlikely event of a breach.
Parsinejad said: “It’s highly secure, 256 bit encryption the same as Azure. Patient identified data is in a separate container from health data. If there is a breach they would not be able to make sense of the data.”
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US cost effectiveness watchdog ICER found 10 examples of substantial price rises for top-selling medicines in 2019, and concluded that seven of those were not backed by any clinical evidence.
The cost to the American taxpayer from those increases? Around $1.2 billion for the seven drugs alone, says the organisation, which also found that for all but one the list price increase was at least double the US rate of inflation in that year.
Amgen’s venerable TNF inhibitor Enbrel (etanercept) for arthritis and other inflammatory conditions topped the list of offenders in terms of the added cost to the healthcare system, which ICER – the Institute for Clinical and Economic Review – estimated to be $403 million.
Enbrel’s list price rose 5.4%, but the net price was up almost 9% once adjusted for other factors, which could include rebates, wholesale fees and other variables like patient assistance programmes.
Second place was Johnson & Johnson’s schizophrenia treatment Invega Sustenna/Invega Trinza (paliperidone), with a 6.8% increase in the list price – and 10.7% net – which added $203 million to US drug spending.
The biggest price increases were seen with Salix’ irritable bowel syndrome therapy Xifaxan (rifaximin) – up 8.4% and 13.3% respectively – which added $173 million to the national spend.
The rest of the seven were: Bristol-Myers Squibb’s arthritis drug Orencia (abatacept) at a cost of $145 million; Biogen’s multiple sclerosis therapy Tecfidera (dimethyl fumarate) at $118 million; AbbVie’s TNF drug Humira (adalimumab) at $66 million; and UCB’s Vimpat (lacosamide) for epilepsy which swelled spending by $58 million.
“Several of these treatments have been on the market for many years, with scant evidence that they are any more effective than we understood them to be years ago,” said ICER’s chief medical officer David Rind.
The increases came against a backdrop of relatively modest price increases overall in 2019, a time when the US administration had recently published a series of proposals to tackle high prescription drug prices, although many of those failed to come to fruition.
It’s worth noting that the scale of the increase identified in the latest report is considerably lower than was seen in ICER’s last edition in 2019. That also identified seven hefty price hikes for products – including Humira and Tecfidera – but cumulatively they all added a massive $4.8 billion to the US drugs bill.
According to a 2019 report by the OECD group of industrialised nations, the US spends roughly twice the average amount spent by other member countries on pharmaceuticals per head.
Three drugs also saw sizeable price increases, but ICER says those may have been justified by new clinical evidence – although the organisation notes it hasn’t run a full cost-effectiveness analysis.
The three were Novartis’ heart failure therapy Entresto (sacubitril/valsartan), Takeda’s Entyvio (vedolizumab) for ulcerative colitis and Astellas’ prostate cancer therapy Xtandi (enzalutamide).
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For weeks, doctors’ phones have been ringing off the hook with anxious older patients on the other end of the line.
“When can I get a covid-19 vaccine?” these patients want to know. “And where?”
Frustration and confusion are rampant as states and counties begin to offer vaccines to all seniors after giving them first to front-line health care workers and nursing home residents — the groups initially given priority by state and federal authorities.
My 91-year-old mother-in-law, who lives in upstate New York, was one of those callers. She said her doctor’s office told her it could be several months before she can get her first shot.
That was before New York’s Gov. Andrew Cuomo announced on Friday that the state would begin offering vaccines to residents age 75 and older starting Monday. On Tuesday, the state changed vaccine policies again, this time making residents 65 and older eligible.
In this chaotic environment, with covid cases and deaths skyrocketing and distribution systems in a state of disarray, it’s difficult to get up-to-date, reliable information. Many older adults don’t know where to turn for help.
Since the holidays, I’ve heard from dozens of people frustrated by poorly informed staffers at physicians’ offices, difficult-to-navigate state and county websites, and burdensome or malfunctioning sign-up arrangements. Below are some questions they posed, with answers drawn from interviews with experts and other sources, that may prove helpful.
Keep in mind that states, counties and cities have varying policies, and this is a rapidly shifting landscape with many uncertainties. Foremost among them are questions regarding vaccine supply: how many doses will become available to states and when and how those will be allocated.
Q: How can I make an appointment to get a vaccine? — James Vanderhye, 77, Denver
Vanderhye is a throat cancer survivor who suffers from sarcoidosis of the lungs and heart — an inflammatory disease.
Colorado Gov. Jared Polis announced on Dec. 30 that residents 70 and older could start getting covid vaccines, but Vanderhye wasn’t sure whether he needed to sign up somewhere or whether he’d be contacted by his physicians — a common source of confusion.
UCHealth, the system where Vanderhye’s doctors practice, has created a registry of patients 70 and older and is randomly selecting them for appointments, Dr. Jean Kutner, its chief medical officer told me. It’s reaching out to patients through its electronic patient portal and is planning to notify those who don’t respond by phone down the line. Then, it’s up to patients to finalize arrangements.
Nearly 200,000 people 70 and older are patients at UCHealth’s hospitals and clinics in Colorado, Wyoming and Nebraska.
TIPS: Although some health systems such as UCHealth are contacting patients, don’t assume that will happen. In most cases, it appears, you will need to take the initiative.
Check with the physician’s office, hospital or medical clinic where you usually receive care. Many institutions (though not all) are posting information about covid vaccines on their websites. Some have set up phone lines.
Some health systems are willing to vaccinate anyone who signs up, not just their patients. Kaiser Permanente, which operates in California, Colorado, Georgia, Hawaii, Oregon, Washington, Washington, D.C., and parts of Virginia and Maryland, is among them, according to Dr. Craig Robbins, co-leader of its national covid vaccination program. (Within the next few weeks, it will post an online registration tool on plan websites.) Check with major hospitals or health systems in your area to see what they’re doing. (KHN is not affiliated with Kaiser Permanente.)
Most places are asking people to sign up online for appointments; some sites require multiple steps and their systems may seem hard to use. If you don’t have a computer or you aren’t comfortable using one, ask a younger family member, friend or neighbor for help. Similarly, ask for help if you aren’t fluent in English.
If you can’t figure out how to sign up online, call your local county health department, Area Agency on Aging or county department on aging and ask for assistance. Every state has a covid-19 hotline; see if the hotline can direct you to a call center that’s taking appointments. Be prepared for long waits; phone lines are jammed.
Q: My mother has stage 3 renal failure, high blood pressure and dementia. She’s unable to take care of herself or be left alone. When can I get her vaccinated with the COVID shot? — Wendy, 61, Chandler, Arizona
Wendy had checked Maricopa County’s website days before we talked on Jan. 5 and couldn’t figure out when her 84-year-old mother might get a vaccine appointment. The week before, her 90-year-old father died, alone, of renal failure complicated by pneumonia in a nursing home.
Three days after our conversation, Maricopa County announced that people 75 and older could start making appointments to be vaccinated on a “first-come, first-served” basis on Monday, Jan. 11. (The state’s appointment site is https://podvaccine.azdhs.gov/; callers should try 844-542-8201 or 211, according to information provided by the county.)
In Arizona, “it’s up to each county to come up and execute a plan for vaccine distribution,” said Dana Kennedy, state director of AARP Arizona.
Demand is high and vaccine supplies are limited, other places have found. For example, on Jan. 7, a 1,200-slot vaccine clinic in Oklahoma City for adults 65 and older filled up within four minutes, according to Molly Fleming, a public information officer at the Oklahoma City-County Health Department.
“Once we get more vaccine supplies coming more frequently, we will do more clinics,” Fleming said. “The challenge we have right now is, we need the vaccine and we don’t know when it’s coming in.”
TIPS: Consult AARP’s state-by-state covid vaccine guides, focused on older adults and updated daily. (To access, go to https://www.aarp.org/coronavirus/. In the right-hand column, click on “the vaccine in your state.”) More than 20 states are listed there now, but guides for all states should be available by the end of January.
Meanwhile, check local media and your county’s and state’s health department websites regularly for fresh information about covid vaccine distribution plans.
On Monday, for example, Washington, D.C., unveiled a new vaccination registration site for residents 65 and older and health care workers. The week before, Illinois announced it would extend vaccines to residents 65 and older when it moved into the next phase of its vaccination plan, and the city of Chicago followed suit. The timetable for those transitions remains unclear.
Be prepared to be patient as problems with distribution surface. States and counties around the country are learning from problems that have arisen in places such as Florida — crashed phone lines, long lines of older adults waiting outdoors, massive confusion. It may take some time, but vaccine rollouts should become smoother as more sites come online and supplies become more readily available.
Q: When can a 72-year-old male with chronic lymphocytic leukemia expect to be vaccinated at Kaiser Permanente in Southern California? — Barry
California last week announced that counties that have made significant progress and have adequate supplies can move toward offering vaccines to residents 75 and older.
How soon this will happen isn’t clear yet; it will vary by location. But even then, Barry wouldn’t qualify immediately since he’s only 72 and it could take several months for vaccines to become available to people in his age group (65 to 74), said Robbins, who’s helping lead Kaiser Permanente’s vaccination program.
Barry is at especially high risk of doing poorly if he develops covid because of the type of cancer he has — leukemia. But, for the most part, medical conditions are not being taken into account in the initial stages of vaccine distribution around the country.
An exception is the Mayo Clinic. It’s identifying patients at highest risk of getting severe infections, being hospitalized and dying from covid at the Mayo Clinic Health System, a network of physician practices, clinics and hospitals in Iowa, Minnesota and Wisconsin. When states allow older adults outside of long-term care institutions to start getting vaccines, it will offer them first to patients at highest risk, said Dr. Abinash Virk, co-chair for Mayo Clinic’s vaccine rollout.
TIPS: Even if vaccines aren’t available right away, production is increasing, new products are in the pipeline, and new ways of distributing vaccines — notably mass distribution sites — are being planned. If you have to wait several weeks or months, don’t give up. Persistence is worth the effort, given the vaccine’s benefits.
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In these first lumbering weeks of the largest vaccination campaign in U.S. history, Dr. Julie Vaishampayan has had a battlefront view of a daunting logistical operation.
Vaishampayan is the health officer in Stanislaus County, an almond-growing mecca in California’s Central Valley that has recorded about 40,000 cases of covid-19 and lost 700 people to the illness. Her charge is to see that potentially lifesaving covid shots make it into the arms of 550,000 residents.
And like her dozens of counterparts across the state, she is improvising as she goes.
From week to week, Vaishampayan has no idea how many new doses of covid vaccines will be delivered until just days before they arrive, complicating advance planning for mass inoculation clinics. The inoculation clinics themselves can be a bureaucratic slog, as county staffers verify the identities and occupations of people coming in for shots to ensure strict compliance with the state’s multitiered hierarchy of eligibility. In these early days, the county also has provided vaccines to some area hospitals so they can inoculate health care workers, but the state system for tracking whether and how those doses are administered has proven clumsy.
With relatively little help from the federal government, each state has built its own vaccination rollout plan. In California, where public health is largely a county-level operation, the same departments managing testing and contact tracing for an out-of-control epidemic are leading the effort. That puts an already beleaguered workforce at the helm of yet another time-consuming undertaking. A lack of resources and limited planning by the federal and state governments have made it that much harder to get operations up and running.
“We are flying the plane as we are building it,” said Jason Hoppin, a spokesperson for Santa Cruz County. ”All of these logistical pieces are just a huge puzzle to work out.”
It’s a massive enterprise. Counties must figure out who falls where in the state’s multitiered system for eligibility, locate vaccination sites, hire vaccinators, notify workforce groups when they are eligible, schedule appointments, verify identities, then track distribution and immunizations administered.
Some of that burden has been eased by a federal program that is contracting with major pharmacies Walgreens and CVS to vaccinate people living in nursing homes and long-term care facilities, as well as a California mechanism that allows some large multicounty health care providers to order vaccines directly. As of this week, some smaller clinics and doctors’ offices also can get vaccine directly from the state.
But much of the job falls on health departments, the only entities required by law to protect the health of every Californian. And they are doing it amid pressures from the state to prevent people from skipping the line and a public eager to know why the rollout isn’t happening faster.
As of Monday, only a third of the nearly 2.5 million doses allocated to California counties and health systems had been administered, according to the most recent state data available. Gov. Gavin Newsom has acknowledged the rollout has “gone too slowly.” Health directors counter it’s the best that could be expected given the short planning timeline, limited vaccine available and other strictures.
“I would not call this rollout slow,” said Kat DeBurgh, executive director of the Health Officers Association of California. “This isn’t the same as a flu vaccine clinic where all you have to do is roll up your sleeve and someone gives you a shot.”
It has been one month since the first vaccines arrived in California, and just over five weeks since the state first outlined priority groups for vaccinations, then passed the ball to counties to devise ways to execute the plan.
Like most states, California opened its rollout with strict rules about the order of distribution. The first phase prioritized nursing home residents and hospital staffs before expanding to other broad categories of health care workers. In the weeks after the vaccines first arrived, state officials made clear that providers could be penalized if they gave vaccinations to people not in those initial priority groups.
Multiple counties said there had been little in the way of line-skipping, but stray reports in the media or complaints sent directly to community officials need to be chased down, wasting precious public health resources. The same goes for reports of vaccine doses being thrown away. One of the vaccines in circulation, once removed from ultra-cold storage, must be used within five days or discarded.
State officials have since loosened their rules, telling counties and providers to do their best to adhere to the tiers, but not to waste doses. On Jan. 7, California officials told counties they could vaccinate anyone in “phase 1a,” expanding beyond the first priority group of nursing homes and hospitals to nearly everyone in a health-related job. Once that wide-ranging category is finished, counties were supposed to move to “phase 1b,” which unfolds with its own set of tiers, starting with people 75 and older, educators, child care workers, providers of emergency services, and food and agricultural workers before expanding to all people 65 and older.
Mariposa and San Francisco both said they would be vaccinating people in the first 1b categories this week. That means residents will start seeing inequities among counties, said DeBurgh, noting that some counties had not yet received enough vaccine doses to cover health care workers while others are nearly finished. Stanislaus County, for example, had received approximately 16,000 first doses as of Jan. 9, but estimates it has between 35,000 and 40,000 health care workers phase 1a.
And the orders are changing yet again, forcing counties to pivot. On Tuesday, U.S. Health and Human Services Secretary Alex Azar said the Trump administration would begin releasing more of its vaccine supply, holding onto fewer vials for second doses; and he encouraged states to open up vaccinations to everyone age 65 and older. In response, California officials said Wednesday that once counties are done with phase 1a, people 65 and older are in the next group eligible for vaccines.
Some local health directors expressed dismay at the prospect, saying they welcome the influx of vaccines but need to prioritize people 75 and older who represent the bulk of hospitalizations. They also noted that states already offering broader access have had their own challenges, including flooded health department phone lines, crashed websites and fragile seniors camping out overnight in hopes of securing their place in line.
While sensible in theory, California’s phased approach to the rollout has proved cumbersome when it comes to verifying that people showing up for shots fall under the umbrella groups deemed eligible. In Stanislaus, for example, 6,600 people qualify as in-home support workers. Someone from another county department has to sit with health department staffers to verify their eligibility, since the health department doesn’t have access to official data on who is a qualified member of the group.
Complicating matters, about half the county’s in-home workers are caring for a family member, and many are bringing that person with them to get vaccinated. The county is required to turn those family members away if they don’t meet the eligibility criteria, Vaishampayan said.
A range of other hiccups hampered the rollout. Across the state, uptake of vaccination slowed to a crawl from Christmas to New Year’s. Health workers, particularly those who do not work in hospitals, were on vacation and enjoying a few days off with family after a tough year, several county officials said. Many chose not to get vaccinated during that time.
Others are choosing not to get vaccinated at all. Across the state, health care workers are declining vaccinations in large numbers. The health officer for Riverside County has said 50% of hospital workers there have declined the vaccine.
And in Los Angeles and Sonoma, officials described software challenges that prevented them from quickly enrolling doctors’ offices to receive vaccines and perform injections.
Still, statewide, officials said they were confident that the pace would pick up in the coming days, as more doses arrive, data snags get sorted out and more vaccination sites come on board. Los Angeles County announced this week it would convert Dodger Stadium and a Veterans Affairs site from mass testing sites into mass vaccination clinics. Similar plans are underway at Petco Park in San Diego and the Disneyland Resort in Orange County. Officials hope Dodger Stadium alone can handle up to 12,000 people a day.
The move solves one problem, but potentially exacerbates another: The two Los Angeles sites have been testing 87,000 people a week, according to Dr. Christina Ghaly, Los Angeles County Department of Health Services director. That will put new constraints on testing, even as covid cases in the nation’s most populous county continue to rise and hospitals are beyond capacity.
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The vaccines themselves are delicate and require a fair bit of focus over time. Consider Moderna’s instructions for preparing its doses: Select the number of shots that will be given. Thaw the vials for 2.5 hours in a refrigerator set between 36 and 46 degrees. Then rest them at room temperature for 15 minutes. Do not refreeze. Swirl gently between each withdrawal. Do not shake. Inspect each vial for particulate matter or discoloration. Store any unused vaccine in refrigeration.
And then there’s this: Once open, a vial is good for only six hours. As vaccines go, that’s not very long. Some flu vaccine keeps almost a month.
“This is very different, administering this vaccine. The process, it takes a whole lot longer than any mass vaccination event that I’ve been involved with,” said Suri, a member of the Loudoun Medical Reserve Corps who joined her first clinic Dec. 28, to vaccinate first responders.
Of the first two covid vaccines on the market, Moderna’s is considered more user-friendly. Pfizer-BioNTech’s shot must be stored in specialized freezers at 94 degrees below zero. Once out of deep freeze, it lasts just five days, compared with 30 days for Moderna’s.
One thing the shots have in common: They last a paltry six hours once the first dose is removed from a vial. That short shelf life raises the stakes for the largest vaccination effort in U.S. history by forcing clinicians to anticipate the exact number of doses they’ll need each day. If they don’t get it right, precious stores of vaccine may go to waste.
During one recent clinic over several hours, Suri estimated she gave “maybe 25” shots, many fewer than the number of flu shots she’s given during similar clinics over the years.
With covid, she said, “the vaccine itself slows things down.”
The slow rollout has frustrated people who at Thanksgiving imagined millions of vaccines in arms by Christmas. Promises that 20 million would be vaccinated by New Year’s fell well short: Just 2.8 million had the first of two required shots by the end of December, according to data from the Centers for Disease Control and Prevention.
Public health officials say many factors are at play, including a shortage of workers trained to administer shots, covid protocols that require physical distancing at clinics and vaccine allocation numbers from the federal government that fluctuate by the week.
And then there are the logistics of the first covid vaccines, which are complex and make hyper-vigilant practitioners wary of opening too many vials over the course of each day, for fear that anything unused will have to be tossed. Vaccine providers also report wasted or spoiled doses to public health authorities.
“If you get to the end of your clinic and every nurse has half a vial left, what are you going to do with that vaccine?” Suri said. “The clock is ticking. You don’t want to waste those doses.”
That impulse has led some health personnel to make dramatic decisions at the end of a day: calling non-front-line health workers or offering shots to whoever is at hand in, say, a grocery store, instead of scrambling to find the health workers and residents of nursing homes in the government’s first tier for injections.
“We jumped and ran and got the vaccine,” said Dr. Mark Hathaway, an OB-GYN in the District of Columbia who received the first dose of a Moderna vaccine on Dec. 26 along with his wife, a registered nurse specializing in nutrition. Both clinicians received vaccines faster than anticipated at a Unity Health Care clinic when there were extra doses because fewer front-line health care workers than expected showed up.
“Health care workers have been priority 1a, so our first attempt has always been our staff,” said Dr. Jessica Boyd, Unity Health Care’s chief medical officer. Since then, the community health center network has broadened its criteria for extra doses to include staff members or high-risk patients visiting a clinic, she said.
Health officials encourage using the doses to get as many Americans vaccinated as quickly as possible. Public health experts say the need to vaccinate people is especially urgent as a new and more contagious variant of the virus first detected in the United Kingdom is showing up in multiple states. Some states, including New York and California, have loosened their guidelines on who can get vaccinated after an outcry over health care providers throwing away doses that didn’t meet officials’ strict criteria.
The tiers “are simply recommendations, and they should never stand in the way of getting shots in arms instead of keeping vaccine in the freezer or wasting vaccine in the vial,” Health and Human Services Secretary Alex Azar said Jan. 6, referring to CDC guidelines saying health care workers and residents and staff of long-term care facilities should be first in line, then people at least 75 years old. The Trump administration this week also said it would make more shots available by releasing second doses and urged states to broaden rules to allow anyone 65 or older and any resident with a serious medical condition to get a shot.
Pfizer-BioNTech’s ultra-cold storage requirements have made it less ideal for local public health departments and rural areas.
Both of the available vaccines arrive in multidose vials — Pfizer-BioNTech’s contains about five doses, Moderna’s 10. Neither contains preservatives and they are viable for only six months frozen. By contrast, during the H1N1 pandemic roughly a decade ago, the swine flu vaccines lasted 18 weeks to 18 months, Sen. Chuck Grassley (R-Iowa) wrote in a May 2010 letter to then-HHS Secretary Kathleen Sebelius.
“We can’t get the vaccine out fast enough; we have people dying. But, at the same time, we have to get it right,” said Claire Hannan, executive director of the Association of Immunization Managers.
The added risk of losing doses due to quick expiration is another thing “causing angst,” Hannan said. “You can’t just draw it up and let it sit. It can’t just sit out like that.”
The Trump administration fell significantly short of its promise that 20 million Americans would be vaccinated by the end of December, partly the result of a disjointed and underfunded public health system that has received limited guidance from federal officials. As of Jan. 11, 25.5 million vaccine doses had been distributed nationwide but only 9 million administered, according to the CDC.
Federal officials have released sparse data about who is getting vaccinated, but state information has shown significant variation in vaccination rates depending on the facility. New York Gov. Andrew Cuomo on Jan. 4 said New York City’s public hospital system had used only 31% of its allocated vaccines, while private health systems NewYork-Presbyterian and Northwell Health had used 99% and 62%, respectively.
“When you target a priority group, it’s inefficient. When you open it up to a larger group, it’s efficient … but you’re not going to have enough supply,” Hannan said. “You still have the challenge of getting those health care workers vaccinated and no matter any way you slice it, you still have limited supply. You can’t please everyone.”
While Pfizer’s vaccine has largely been earmarked for large institutions like hospitals and nursing homes, Moderna’s has been more widely distributed to smaller sites like public health departments and clinics run by volunteers. State and local officials have begun or will soon vaccinate other priority populations, including police officers, teachers and other K-12 school employees, and seniors overall.
Unlike the covid vaccines, many flu vaccines come in prefilled syringes — each syringe’s cap is removed only when a shot is given, which speeds the process and eases some concerns about storage. However, relying on prefilled syringes during a pandemic has its own complications, according to Michael Watson, former president of Valera, a Moderna subsidiary: They take up more fridge space. They’re more expensive. And they can’t be used for frozen products, he said.
“For all these reasons, a vial was the best and only option,” he said.
In Ohio, Eric Zgodzinski, health commissioner for Toledo-Lucas County, said two-thirds of first responders the county surveyed said they would get the vaccine. Still, he said, his department has encountered situations in which a covid vaccine dose is left over in an open vial and officials have turned to a waiting list to find someone who can arrive within minutes to get a jab.
His department also has an internal running list of potential vaccine takers, including health department staffers, people in congregate care settings or those who had scheduled vaccination appointments for later on.
“We’re not going to open up a vial for one individual and figure out nine other people right away,” said Zgodzinski, whose department planned to distribute 2,200 doses of the Moderna vaccine the week of Jan. 4.
“If I have one dose left, who can I give it to?” he added. “A shot in the arm for anybody is better than it being wasted.”
San Francisco editor Arthur Allen and senior correspondent JoNel Aleccia contributed to this report.
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I’d seen coverage of some final covid messages during this terrible year. They were usually directed to spouses, but my No. 1 concern was how to explain my own death to my 3-year-old, Marigold, whom we call “Goldie.” How much of me would she remember, and how would she make peace with what happened to me, when I could barely believe it myself?
After the emergency room doctor confirmed pneumonia in both of my lungs on Dec. 17, I was whisked upstairs to the hospital’s covid unit, where I got a blood thinner injection, infusions of steroids and remdesivir, and continued on the supplemental oxygen they had started in the ER.
Immediately after the treatments, my mind was clearer and more focused than it had been in the nine days since my husband, daughter and I had all received positive covid results (and when my raging fevers began). As I lay in my hospital bed, my roommate’s TV blaring, I started thinking about my daughter’s understanding of death. A lapsed evangelical married to a Jewish man, I had adopted his family’s perspective on the afterlife — that discussing it wasn’t very important — but had also inadvertently abdicated the death discussion to Hollywood.
Goldie’s afterlife education began with the movie “Coco,” about the Mexican Day of the Dead, in which families put pictures of their ancestors on a home altar, or ofrenda. Then came “Over the Moon,” in 2020, about a little girl in China who loses her mom to illness and struggles to accept a new stepmother, all while her mom’s spirit visits her in the form of a crane.
That prompted her first question about my death.
“Are you going to die like Fei Fei’s mom did?” Goldie asked me in November, before I got sick. I told her at the time that no one knows when they’re going to die, but that I would love her with all of my heart for as long as I lived.
After that, Goldie would sometimes randomly declare, “I don’t think you’re going to die,” or she would ask if we could all die together, at the same time — to which I’d say, “Sure!”
My covid symptoms started Dec. 7, and we got our positive results back the next morning. Thankfully, my husband and daughter had almost no symptoms except stuffy noses and a day of low fever. But I started off with a fever that would burn me up to 104 degrees, over and over again. Tylenol and Advil could bring it down only to 100 or 101. I would cry as the painful fevers reached their peak and wondered if God had been preparing Goldie all along this year for my eventual death.
My breathing problems began eight days later. The scariest moment during that time was when I was in the middle of a shower (much needed after days of sweaty fevers) and realized I was gasping for air. I punched the shower curtains out of my way and ran to my bed, where I could lie on my stomach and get my oxygen levels up again. As I lay there, hyperventilating, soaking wet, with shampoo still in my hair, the pulse oximeter monitor registered 67, before inching back up to 92. I began thinking of what I wanted to say to Goldie in my final letter to her, but I was too weak to type it out.
Two more uterine procedures led to a successful embryo transfer, but a miscarriage put me in the ER on Oct. 8. By then, Los Angeles County had seen 278,665 cases and 6,726 deaths — horrifying numbers that I monitored and reported on as a health journalist, but data points I couldn’t, or wouldn’t, use to alter the decision-making in my own life.
With four miscarriages now under my belt and no more viable embryos left to use, my husband, Simon, and I decided we’d give in vitro fertilization one final try. I started my injections for an egg retrieval in late November, and by the time the procedure rolled around on Dec. 3, L.A. was well into its scary, almost vertical holiday season ascent, posting 7,854 new cases that day — up fivefold from a month earlier.
A close friend was supposed to start her IVF injections at the same time, but she decided to postpone at the last minute because covid cases were so high in our area. By that point, we were so driven in our pursuing of pregnancy that I was startled to hear her say that, as the thought had never even crossed my mind.
I have no way of knowing for sure if I was exposed to the virus sometime during this last fertility treatment. The surgical center is located on a large medical campus that also hosts a covid-19 testing drive-thru in the garage where we parked. We waited, masks on, for almost an hour outside the building, which we thought was a safer choice than the fertility clinic waiting room, but that actually put us in proximity to a lot of sick people waiting for rides home.
I also had to remove my mask just before the actual egg retrieval, because I was under anesthesia and the doctors needed quick access to my mouth in case I needed a breathing tube.
Five days after the egg retrieval, we found out we were covid-positive. I called the clinic right away to warn them; the fertility doctor told me a few days later that none of her staffers had gotten sick. And also that none of the eggs they retrieved from me had developed properly. We had no embryos to use.
Of course, as anyone who has done fertility treatments knows, all the dangers and risks we undertook would have been “worth it” if it had worked. Because it didn’t work for us, I felt defeated and foolish.
In sum, we wanted to give Goldie a sibling, but attempting to do so may have been what threatened her mother’s life. This thought haunts me and will stay with me forever, even though I’ll never know how exactly the virus entered our home.
Our nanny, who also experienced covid symptoms and tested positive three days before us, could have picked it up at the supermarket. We could have gotten it from her or while walking around our neighborhood or playing in the park. But the act of choosing, over and over again, to engage in fertility treatments as the pandemic raged on, fills me with doubt and remorse.
This was all too much to put in my goodbye letter to Goldie. Instead, this is some of what I wrote:
Around Halloween, you and I were eating breakfast together and I asked you how your life was going, and if there were any improvements I could make for you. You said, with absolute seriousness, “I’m afraid of ghosts.”
Now that I’m a ghost, I hope there’s less reason to be afraid.
Please put my picture on the ofrenda once a year. I’ll always be in your heart and in your memories. I will try to visit you too. But not in a spooky way, just a gentle way.
I will always love you. Thank you so much for being born to us. You made everything better.
After finishing my goodbye letter, I went to sleep. In the morning, I woke up, got a second infusion of steroids and remdesivir, and then was released home with oxygen tanks and an oxygen concentrator. I stayed in bed, on oxygen, for another week before my lungs were strong enough for me to stand and walk on my own. We had a wonderful Christmas morning together opening presents during a Zoom call with my family. Other than fatigue, I am now almost back to normal.
After the holidays, I sat down with Goldie for breakfast as we usually do. Feeling morose about how the year had turned out, I asked, dreading her response, if she would like to have a baby brother or sister one day.
She put her hand on my neck and pressed her forehead into mine, a face-to-face embrace that we call a “pumpkin hug.”
“No, Mom,” she said. “I want it to be just you and me, forever.”
I took a deep breath, and then sighed with relief.
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Gilead and Vir Biotechnology Establish Clinical Collaboration
Gilead Sciences, Inc. and Vir Biotechnology, Inc. announced that the companies have entered into a clinical collaboration to assess novel therapeutic combination strategies to develop a functional remedy for chronic hepatitis B virus (HBV).
The companies schedule to initiate a Phase 2 trial assessing combination therapy for both treatment-experienced and treatment-naïve people living with HBV. The multi-arm trial will gauge various combinations of selgantolimod, Gilead’s investigational TLR-8 agonist; VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA); and a commercially-sourced, marketed PD-1 antagonist.
People in the trial with HBV treatment experience may also receive Gilead’s Vemlidy (tenofovir alafenamide fumarate, TAF). The study’s primary result will be the proportion of patients attaining a functional treatment, defined as an off-therapy loss of hepatitis B surface antigen (HBsAg) and HBV DNA from the serum.
Both companies retain full rights to their product candidates and discuss the potential path forward for any future combination studies based on the outcome of the Phase 2 trial.
Tessera Therapeutics scores USD 230 Million to cure disease
Technologists are getting better at coding biology, and venture firms are flooding a new generation of startups with cash to commercialize their technology bringing in the next wave of genetic innovation.
Tessera Therapeutics, the Boston-based spin-up from Flagship Pioneering, is the latest company to enter the mix with USD 230 million in new financing to build up its platform for better biological programming.
The round was led by Alaska Permanent Fund Corp., Altitude Life Science Ventures, and the second SoftBank Vision Fund, with participation from the Qatari Investment Authority and other undisclosed investors.
Last year, the company disclosed its gene-writing service, which combined various gene editing, manufacturing, and synthesizing technologies to provide more tailored therapeutic instructions to genetic code.
By providing more instructions to genetic material, the company aims to increase the precision of therapies while expanding the number of potential pathogens or mutations they can target, the company said in a statement.
Teladoc Health, Dexcom offers CGM-powered insights to Type 2 Diabetes patients
Teladoc Health, Inc., the first and only complete virtual care system, and DexCom, Inc., the leader in real-time continuous glucose monitoring (CGM), announced that joint Livongo for Diabetes and Dexcom members will now get CGM-powered insights, a new set of features and reports, which help members more easily visualize their health information and comprehend how lifestyle decisions affect their blood glucose levels.
Combining Dexcom CGM data with more signals from Teladoc Health, comprising activity data and food intake, CGM-powered insights proffer members a complete health profile and recommendations that back ongoing diabetes management.
In January 2020, Livongo merged with Teladoc Health in October, and Dexcom announced the first phase of their strategic relationship, a data-sharing deal for Livongo for Diabetes members using Dexcom CGM technology.
Teladoc Health and Dexcom will launch a pilot exhibiting the impact of CGM-powered insights for people affected with Type 2 diabetes. Eligible members will get an integrated product experience, comprising the Livongo for Diabetes program, Dexcom CGM technology, and CGM-powered insights at no cost. Through the pilot, members will receive a new experience that examines their health data and trends with the mutual goal of improving health outcomes. Teladoc Health and Dexcom plan to launch the pilot more broadly throughout 2021.
Verve Therapeutics unveils its lead program for treating genetically high cholesterol
The treatment, VERVE-101, is a base editor; that is, it does not cut DNA as CRISPR gene editing systems do. Instead, it changes one base, or letter, in the genome to a different one without affecting the letters around it. Its first target is an inherited form of high cholesterol called heterozygous familial hypercholesterolemia, or HeFH.
People affected by HeFH have a gene mutation in the liver that causes very high cholesterol levels and leads to heart attacks or strokes relatively early in life. VERVE-101 is designed to cut those cholesterol levels by hindering the PCSK9 gene.
The treatment is a lipid nanoparticle involving a guide RNA to search the target letter on the PCSK9 and an mRNA that changes an A base in the gene to a G, hence inactivating the gene and lowering cholesterol.
- The approval is based on P1093 & ODYSSEY (Penta20) studies assessing safety, tolerability & dose-finding of Tivicay (5mg) in pediatric patients aged 4wks.-18yrs. while the second study assessed the 1L & 2L treatment in patients of the same age
- The approval includes updated dosing recommendations for Tivicay film-coated tablets (10/25/50mg) for children aged ≥6yrs. and weighing at least 14kg, bringing these in line with the WHO weight bands
- Dolutegravir is the first integrase inhibitor used in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least 4wks. and weighing at least 3kg.
Click here to read full press release/ article | Ref: VIIV Healthcare | Image: Smart Industry News
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- Evoq to receive ~$240M up front & milestones along with royalties on the sales of therapies emerges from the collaboration
- The companies collaborated on preclinical development, while Amgen will be responsible for clinical development and commercialization
- The collaboration will bolster Amgen’s autoimmune offerings as its portfolio contains innovative medicines, including Otezla and Enbrel, and biosimilar products, such as Amgevita (a biosimilar to Humira) and Avsola (a biosimilar to Remicade)
Click here to read full press release/ article | Ref: PRNewswire | Image: Stat
The post Amgen Collaborates with Evoq to Develop Novel Therapies for Autoimmune Disorders first appeared on PharmaShots.
- Kamada signs an agreement with two undisclosed international pharmacies to commercialize three biosimilar product candidates in Israel. The two pharmaceutical companies will be responsible for the development, manufacturing, and supply of three products
- Following the approval from EMA and IMOH, the three products are expected to be launched in Israel b/w 2022 and 2024
- The collaboration will expand Kamada’s biosimilar portfolio in Israel which already includes six products previously licensed from Alvotech
Click here to read full press release/ article | Ref: GlobeNewswire | Image: Globes English
The post Kamada to Commercialize Three Biosimilar Products in Israel first appeared on PharmaShots.
It turns out that our premonition was correct, based on the findings from the American Cancer Society’s 2021 Facts & Figures report.
From 1991 to 2018, the cancer death rate has fallen 31%. This includes a 2.4% decline from 2017 to 2018—a new record for the largest 1-year drop in the cancer death rate.
Improvements in health behaviors (e.g., smoking) and new treatments have paved the way for this improvement, particularly for lung cancer.
Reductions in the lung cancer death rateaccount for almost half of the total drop in the cancer death rate from 2014 to 2018. This is thought to be due to declines in smoking, advances in early detection, and improved treatments, especially for non-small cell lung cancer (NSCLC), the most common subtype.
Note that the data don’t include the impact of COVID-19 as they only run through 2018. Further, despite the dramatic improvement in mortality, cancer is still the #2 killer in the US (ignoring COVID), just behind heart disease. However, COVID-19 has passed cancer in terms of US mortality in the spring and with the recent surge has almost certainly surpassed cancer in the fall/winter of this year.
As always, there is lots of interesting information in the ACS report.
- Janssen reported the BLA submission to the US FDA seeking approval of Amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
- The filing is the first regulatory submission for patients with exon 20 insertion mutations and it also marks Janssen’s first filing for the treatment of patients with lung cancer
- Amivantamab is an investigational bispecific antibody that targets both a driver mutation as well as a resistance mechanism and has received BTD in March, is being studied as a monothx. & combination therapy in NSCLC with EGFR mutations, including in earlier lines of therapy
Tuba: A quick highlight of clinical data submitted for the BLA submission of Amivantamab to the US FDA?
Kiran: On December 3, 2020, Janssen submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
The BLA is supported by data from the monotherapy arm of the Phase 1 CHRYSALIS study, a multi-center, open-label, multi-cohort study. The study evaluated the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib, a novel third-generation EGFR tyrosine kinase inhibitor (TKI), in adult patients with advanced NSCLC.
The submission of this BLA is an important step as we hope to advance a new therapeutic option for patients with NSCLC and exon 20 insertion mutations for whom there are currently no approved targeted therapies. The current standard of care for EGFR Exon 20 insertion mutation-positive NSCLC is chemotherapy.
Tuba: What is the mechanism of action of Amivantamab and how does it work?
Kiran: Amivantamab is an investigational, fully-human, EGFR, and mesenchymal-epithelial transition factor (MET) bispecific duo-body with immune-cell directing activity that targets tumors with activating and resistance EGFR and MET mutations and amplifications. As a monotherapy, amivantamab has shown activity in patients with diverse EGFR mutant disease.
Tuba: Why is Janssen focused on metastatic NSCLC with EGFR exon 20 insertion mutations?
Kiran: Lung cancer is the leading cause of cancer deaths worldwide. In the U.S., lung cancer is the second most common cancer in both men and women, after skin cancer and NSCLC makes up 80 to 85 percent of all lung cancers. EGFR genetic alterations are among the most common driver mutations for NSCLC and are present in 10 to 15 percent of patients with NSCLC. Additionally, EGFR exon 20 insertion mutations identify a distinct subset of lung adenocarcinomas, accounting for at least nine percent of all EGFR mutations.
Currently, there are currently no FDA-approved targeted therapies for patients with NSCLC who have EGFR exon 20 insertion mutations. Given this significant unmet need, we are committed to improving outcomes for patients diagnosed with this complex, deadly disease. Janssen is committed to advancing targeted therapies for patients living with genetically defined lung cancer where there remains a high unmet need for new treatment options.
Tuba: When can we expect approval and launch of amivantamab in the US?
Kiran: The BLA submission was completed on December 3, 2020. In March 2020, amivantamab received FDA Breakthrough Therapy Designation, which is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. We do not speculate on potential approval timelines.
Tuba: When can we expect results from the CHRYSALIS combination arm?
Kiran: We presented interim data from the CHRYSALIS combination arm at the ESMO 2020 Virtual Congress in September. Data showed the combination of amivantamab and lazertinib achieved a 100 percent overall response rate in the cohort of patients with treatment-naïve EGFR-mutated NSCLC. We look forward to the continued evaluation of amivantamab in combination with lazertinib in EGFR mutation-positive NSCLC patients.
Tuba: How many patients have been part of the expanded access program (EAP) in the US?
Kiran: Jansen established an expanded access program (EAP) for EGFR Exon 20 insertion patients in the U.S. who may be eligible to obtain access to amivantamab during review of the BLA. For information about Janssen’s pre-approval access program, visit https://www.janssen.com/compassionate-use-pre-approval-access. We cannot disclose patient enrollment numbers for the EAP.
Tuba: Has Janssen started any HCP awareness, HCP education, and patient support and awareness programs?
Kiran: We recently launched a website, Hidden EGFR Threats, intended to inform physicians and patients about the multiple threats of EGFR-mutated advanced NSCLC.
Tuba: Is Janssen planning to assess amivantamab in other indications?
Kiran: The results from the CHRYSALIS study have led to new studies to further evaluate the potential of amivantamab and lazertinib combination therapy. The Phase 3 MARIPOSA study will compare amivantamab in combination with lazertinib with osimertinib in untreated advanced EGFR-mutated NSCLC, and a Phase 2 trial, CHRYSALIS-2 is ongoing and enrolling patients who have progressed after treatment with osimertinib and chemotherapy.
Tuba: Any near-future plans to file for EU or any other geographies?
Kiran: We have plans to pursue approval of amivantamab in other markets with the goal of bringing this novel therapy to patients around the world who may benefit, but it is premature to speculate about timing.
Image Source: Medical Forum
Kiran Patel is a Vice President of Clinical Development, Solid Tumor Franchise at Janssen and is serving Janssen since 2015.
As healthcare spending continues to rise, so too does the inherent risk for bad actors to take advantage. Today, the United States is estimated to spend nearly 18 percent of its GDP, or $3.6 trillion, on healthcare, and is expected to increase to one-fifth of GDP within the next decade, according to the latest data. This alone provides ample motivation for fraud and abuse. While the full extent of healthcare fraud is difficult to measure,
The National Health Care Anti-Fraud Association (NHCAA) conservatively estimates that 3 percent – $68 billion – of all healthcare spending is lost to fraud each year. Others, such as the Federal Bureau of Investigation (FBI), estimate fraud accounts for up to 10 percent of healthcare expenditures.
Unfortunately, the COVID-19 pandemic has only accelerated the motivation for fraud and abuse amid the increased fear, confusion, and a relaxed regulatory environment. From fake cures to malware and illegitimate charities, fraudsters are taking advantage. Telehealth, which has experienced exponential growth aided by regulatory accommodations to facilitate its widespread adoption, is an area of particular concern. In turn, states and healthcare organizations must optimize their program integrity operations and telehealth strategy to stay protected amid healthcare’s new normal.
Greater Access Brings Greater Risk
The pandemic-driven expansion of telehealth has been profound in terms of enabling care access and continuity while reducing the risk of infection. When the Centers for Medicare and Medicaid Services (CMS) temporarily expanded telehealth coverage at the start of the pandemic, adoption soared to unprecedented levels.
According to a McKinsey report, providers have seen 50 to 175 times more patients through telehealth appointments compared to any year prior. At the same time, once-strict regulations governing telehealth services have been relaxed during the COVID-19 emergency, and the federal government has proposed to make permanent many of the regulatory changes initially meant to temporarily increase access to telehealth.
In parallel and perhaps unsurprisingly, there is a growing sentiment that telehealth is here to stay. According to a recent CynergisTek survey, 70 percent of consumers plan to continue using telehealth post-pandemic. From a provider perspective, new research from Bain & Company found that more than 80 percent of providers will continue to use telehealth as much or more than they do now.
All this considered, we must acknowledge the inherent risks of this technology. Telehealth has a poor track record for fraud, waste and abuse, with some of the largest healthcare fraud schemes involving telehealth providers. This September, for example, the Department of Justice announced the largest case of healthcare fraud in history, involving more than 300 individuals who submitted over $6 billion in fraudulent claims, with telehealth accounting for $4.5 billion of those claims.
With providers struggling to meet fluctuating demand amid unprecedented revenue shortfalls, improper billing practices — both intentional and inadvertent — are, to some degree, inevitable. Factor in hundreds of new telehealth codes and coding considerations as well as the overall stress on the healthcare system, and it is clear we must examine existing risk mitigation measures through a new, post-pandemic lens.
Strategies for Mitigating Telehealth Fraud & Abuse
For healthcare organizations and, specifically, special investigation units (SIUs) tasked with combatting fraud and abuse, the shift to telehealth adds an additional layer of complexity. Fortunately, there are strategies healthcare organizations can implement to successfully navigate the evolving landscape while strengthening the integrity of their operations for healthcare’s new normal.
Data visualization is a key component of an effective fraud investigation. Charts and graphs provide a clear representation of trends and outliers, including connections that could indicate a kickback or collusion scheme. Critical to the success of these tools, however, is the quality of the data that underlies them. Collecting sample data based on the appropriate modifiers and conducting thorough background research provides an accurate portrayal of events from which SIUs can clearly identify and pursue potential fraud schemes.
Integrating qualitative research into telehealth strategies is a great way to capture fraud at the source. When appropriate, conducting interviews with patients can validate whether services were in fact rendered as billed. For instance, a provider may bill for audio-only services as if they were delivered in an audio-visual capacity, resulting in an unjustifiably higher reimbursement rate. Similarly, using data visualization techniques to identify suspect trends, such as blanket billing or an implausibly high volume of services during a known low-demand period, can inform pointed questions for patients.
As we traverse this unprecedented territory, being on high alert for potential indicators of fraud and abuse is critical to protecting healthcare organizations and consumers. If something doesn’t make sense, whether clinically or in the context of the larger healthcare landscape, it is worth investigating. Understanding the limitations of telehealth and other key considerations surrounding its use will help to ensure we are maximizing the benefits of these services while mitigating their inherent risks.
Healthcare providers and patients alike have embraced telehealth during the COVID-19 crisis and, in doing so, confirmed what advocates have been saying for years — that telehealth promotes greater access to care. While ultimately good news for stakeholders across the healthcare spectrum, the environment we find ourselves in today has also created new avenues for fraudsters to take advantage. As telehealth becomes an inseparable part of the healthcare ecosystem, we are quickly learning how to identify telehealth fraud schemes, and, more importantly, strategies to mitigate the risks they post to integrity and security in the space.
About Gary Call, M.D.
Gary Call, M.D., is senior vice president and Chief Medical Officer at HMS, where he leads the company’s clinical program development and execution. Dr. Call has more than 25 years of experience in the practice of medicine and managed care. Dr. Call graduated from the University of Washington School of Medicine and completed his residency training at the University of Utah. He is a board-certified family physician.
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Vital Pharma -Walk-In Interviews for Production/ Stores/ Maintenance Dept. On 18th & 19th Jan’ 2021 @ Hyderabad
Providence will lean on technology to help recover from the financial damage the COVID-19 pandemic wrought on the Renton, Wash.-based health system.
At home, you can reduce food waste by simply organizing your fridge.
A clean, organized refrigerator is an often-overlooked healthy eating habit.
When your fridge is a mess, you may end up snacking on chips because you can’t find the carrot sticks and hummus you planned to eat — or wasting a pricey carton of cage-free eggs that you bought with the intention of making healthy breakfasts.
“A well-organized fridge can reduce waste and ultimately save you money,” says Beth Stark, R.D.N., L.D.N.
Learning how to organize your fridge saves you time when cooking and snacking.
Here are nine simple fridge organization ideas.
1. Give it a good clean
To get a fresh start on fridge organization, empty it out, recommends Hailey Gorski, R.D.
“This way you can wipe down the shelves and toss anything that is expired — or not serving you and your health goals anymore.”
Goodbye, week-old takeout and half-eaten jar of marshmallow cream from who knows when.
Hello, space to actually store the healthy meals you prepped!
2. Check the temperature
“Make sure your fridge temp is at or below 40 degrees and avoid overfilling it, because it can hamper air flow and disrupt the temperature control,” explains Stark.
The temperature control panel in your fridge likely lists the ideal setting, and you can pick up a small thermometer to keep close tabs on the temp.
Your refrigerator shouldn’t resemble a game of Tetris.
Keep it about two-thirds full for optimal air flow and to provide ample space to see what’s inside.
This will save major time when you’re whipping up a quick dinner.
3. Divide and conquer the fridge
Group like items together to make it easier to find them. While produce and meat often have their own, clearly labeled spaces, what about the rest of your healthy eats?
“Clear bins are a great way to divide up your food while still being able to see everything,” says Gorski.
You could have one bin for healthy breakfasts, one for tomorrow’s prepped meals, and another for leftovers.
Or, assign a bin to each person you live with.
4. Use storage containers and bags
Meal prep containers and bags are great for speeding up weekday cooking.
They also help you organize your fridge without overstuffing it. Glass bowls or plastic containers with lids are tidier, sturdier alternatives to plastic- or foil-covered plates.
Clear containers make it harder to overlook leftovers, too.
Adding a piece of masking tape with the contents and an “eat-by” date written on it is also helpful.
5. Keep ready-to-eat foods up front
“On the upper shelves and those in your direct line of sight, place grab-and-go foods like pre-cut veggies, hard-boiled eggs, cubed cheese, and yogurt for snacking or efficient meal prep,” says Gorski.
What you see is what you’ll want to eat. This tip is a win-win since you’ll see the “good” stuff first, and it won’t go to waste!
6. Separate fruits and veggies
“The purpose of the crisper drawer is to keep fruits and vegetables at maximum freshness,” says Gorski.
However, fruits and veggies don’t always mix because some spoil faster than others.
Some refrigerators have dual crisper drawers, one with low humidity and another with high humidity, which is a perfect guide for how to organize your fridge.
Keep veggies in your high-humidity drawer, and ripe fruit and mushrooms in your low-humidity one.
If you only have one compartment, keep items that wilt in the drawer and place fruit in a colander or other container elsewhere in the fridge.
7. Don’t forget about the door
Even though many fridge doors have designated compartments for milk and eggs, ignore them when you’re deciding how to organize your fridge.
Instead, store those items on a lower shelf.
“The door is typically the warmest part of the fridge, so store condiments in it,” recommends Gorski.
You can also store nut butters there, along with sparkling water and other beverages for easy access.
8. Store perishables on the bottom shelves
Keep raw meat, poultry, and seafood on the bottom shelves.
That’s the coolest part of your fridge, and you’ll avoid cross-contamination of prepared foods, recommends Gorski.
Wipe up spills immediately to prevent bacteria growth.
To be extra safe, store these foods in a clear bin, and wash it with hot, soapy water at least weekly.
9. Check dates and rotate
“Follow the ‘first in, first out’ rule, which means rotating highly perishable foods — like milk, eggs, and even leftovers — to the front so you use them before items you’ve just purchased,” says Gorski.
The head of Operation Warp Speed believes the COVID-19 virus is here to stay, and how the country has responded to this crisis can act as a playbook for dealing with the next global pandemic.
As a result, consolidation is beginning to ramp up again, setting the stage for a potentially record-setting year for dealmaking. Prior to the coronavirus, most industry insiders expected 2020 to be that historic year for M&A due to the Patient-Driven Groupings Model (PDGM).
“We have been anticipating this historic consolidation opportunity in our industry to materialize in home health as a result of PDGM,” LHC Group Chairman and CEO Keith Myers said Wednesday during a presentation at the annual JP Morgan Healthcare Conference. “While the pandemic and the stimulus funds forestalled it temporarily, the consolidation has unfolded in a multitude of positive ways that we didn’t originally anticipate.”
Headquartered in Lafayette, Louisiana, LHC Group provides home health, hospice and personal care services across 35 states and the District of Columbia. In addition to its wholly owned in-home care locations, the company is also a joint venture partner with nearly 400 hospitals and health systems.
Combined, the five largest home health providers — Kindred, Amedisys Inc. (Nasdaq: AMED), LHC Group, Encompass Health Corp. (NYSE: EHC) and AccentCare Inc. — still account for only 20% of the national market share.
On its end, LHC Group is working to carve out a bigger piece of that pie in 2021 by pulling multiple levers.
Those plans include launching de novos in new markets and maintaining organic growth across existing operations. The company also expects to continue negotiating better rates with payers outside of fee-for-service Medicare while adding new referral sources.
Overall, LHC Group saw a 22% increase in new physician referral sources in 2020 compared to the previous year.
“This is a highly fragmented industry,” Myers said. “And the market is ripe for consolidation.”
By the numbers: LHC Group’s ‘growth levers’
LHC Group has seen particularly strong growth across its JV operations. That’s partly due to the public health emergency, with hospital and health system partners leaning heavily on LHC Group as they shifted a wide variety of care into the home.
In the fourth quarter of 2020, for example, same-store admissions for LHC Group’s wholly owned home health business were down 0.7% on a year-over-year basis. JV same-store admissions were up 6.5%, in comparison.
Meanwhile, in the third quarter of last year, same-store admissions for the company’s wholly owned home health segment were up 2.8% on a year-over-year basis, with JV same-store admissions up 7.4%. Q1 and Q2 had a similar breakdown.
“We’ve never really presented data like this that breaks apart our organic growth between joint ventures and our wholly owned assets,” LHC Group President Joshua Proffitt said at the JP Morgan Healthcare Conference. “But I do think it really tells a pretty compelling story to further drive home that differentiated strategy we have with our JVs.”
When it comes to outside acquisitions, LHC Group’s M&A team has started to see more inbound calls, the executives noted.
That was the case in early 2020, too, until the market froze because of the COVID-19 virus.
“The pipeline was robust,” Myers said. “And we know by name many of those providers that should have consolidated this year.”
As for gains outside of traditional Medicare, LHC Group grew its non-Medicare episodic admissions by about 35% in 2020 over 2019. Additionally, the majority of those admissions were at Medicare-equivalent rates.
The company’s rate per visit on all non-Medicare payers improved by 8% in 2020 over 2019. It has improved almost 12% over the last three years, reflective of payers’ heightened recognition of home-based care.
“We have an unprecedented number of tailwinds ahead,” Myers said.
COVID-19 volume hits new high
After operating through COVID-19-related disruption last spring, LHC Group’s home health census has fully recovered, according to the company.
In the fourth quarter of 2020, LHC Group’s average daily home healthy census reached 83,686 patients, 6,700 more than in Q1. Hospice admissions were similarly up.
Although the company has recovered from coronavirus-related challenges, it can still feel the impact of the pandemic, which continues to take its toll on the U.S. A count from Johns Hopkins University shows that the country eclipsed 4,300 deaths on Tuesday alone — another single-day high.
In total, LHC Group admitted 7,046 COVID-positive home health patients during the first three quarters of last year. It then admitted 7,544 COVID-positive patients in Q4 alone.
“I think that really goes to drive home … the value proposition and what we’ve been able to prove throughout the [duration] of this pandemic of what the home health benefit can provide to the patients,” Proffitt said. “I think it also points to the spike that we’ve all seen and all the national numbers throughout the fourth quarter, even here starting into the first quarter. We’re really pleased and proud of our front-line workers for the work that they’ve been able to do, taking care of all of those patients who are struggling in their homes with the virus.”
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Under the terms of the agreement, Amgen and EVOQ will team up when it comes to preclinical development, while Amgen will be responsible for clinical development and commercialization. In exchange for exclusive rights to certain autoimmune programs, Amgen will make upfront and milestone payments potentially totaling more than $240 million, as well as pay royalties on sales of resulting therapies.
Amgen specializes in treating autoimmune disorders, with a résumé featuring Otezla and Enbrel, along with biosimilar products, such as AMGEVITA (a biosimilar to Humira) and AVSOLA (a biosimilar to Remicade). Michigan-based EVOQ Therapeutics is developing technology focused on the activation of dendritic cells. The two companies will work together to use dendritic cells to develop immune tolerance.
Unveiled in November, the initiative has been growing rapidly, especially of late. On its end, CMS hopes the emerging hospital-at-home models can increase acute care capacity and keep patients where they’re most comfortable.
Allegheny Health Network (AHN) was the eighth organization to have its hospital-at-home program approved by CMS. It was given the go-ahead under an expedited process due to its experience with the model prior to the government initiative.
Pittsburgh, Pennsylvania-based Highmark Health is the parent company of AHN. Its businesses include a hospital and physician network plus home- and community-based services, as well as the Highmark Health Plan.
AHN’s “Home Recovery Care” program is facilitated by a joint venture with Nashville, Tennessee-based Contessa Health, a home-based care startup that has cut its teeth shifting hospital-level care into the home.
Now that its program is certified through CMS, it can be offered to Medicare beneficiaries in the regions that AHN serves.
“We’ve been looking at ways that we could provide high-quality, effective clinical care — in other places beyond the hospital — way ahead of the pandemic,” Christina Weir Ripley, VP of clinical transformation at Highmark Health, told Home Health Care News. “And as we were going through that evaluation process and looking for ways to get there, that’s when we landed on our JV partner, Contessa.”
Contessa was a logical match. It had worked with other hospital-at-home models before, including Mount Sinai Health System’s, which was one of the earliest in the U.S.
AHN began offering its program to Medicare Advantage beneficiaries in January 2020.
For AHN, patients can be admitted into the Home Care Recovery program in multiple ways. They can be admitted after an emergency room visit or in-patient visit, as well as upon observation in the hospital — or without going to the hospital at all.
The organization had already treated dozens of patients in the program before it applied for a waiver from CMS. That led AHN to believe that the transition to the Acute Hospital Care at Home Initiative would be seamless.
AHN also had a natural advantage: It owns and operates its own in-house home care services, which play a key role in the hospital-at-home concept.
“As far as the home health agency piece of it, we certainly had an advantage here as an enterprise, because we own and operate a number of different home care businesses,” Weir Ripley said. “So we were able to utilize a pretty strong and structurally organized home health network to assemble and deliver the care.”
Before the newly launched CMS program, a major barrier to hospital-at-home models was reimbursement. Reimbursement will likely continue to be a challenge moving forward, considering CMS has only made its new waiver available during the public health emergency.
“I think probably our biggest hope is that through the CMS waiver, there’s a demonstration of the value of this type of program,” Weir Ripley said. “We clearly believe in it. We implemented this ahead of the pandemic. We’re hopeful that CMS is going to codify a more permanent reimbursement path so we can continue to offer this once we get past the public health emergency.”
There were just 56 hospitals approved by CMS as of Jan. 4.
Working with patients at home
AHN’s capabilities within the home are extensive, Dr. Harshit Seth, the medical director of the Home Recovery Care model, told HHCN.
When AHN does treat patients within the home, it most often deals with COPD, pneumonia, asthma, acute renal failure and other conditions. Recently, that list also includes COVID-19.
Currently, AHN is working on treating COVID-19 patients with more advanced therapy treatments and expanding its overall offerings.
“With the program, we can decompress our hospitals, which have censuses that are blowing up,” Seth said. “I’m glad that we did this because of the pandemic, and because we can take some of these patients and keep them away from the infection. But the other reason why we started this was because the overall patient satisfaction and overall quality of care has been shown to be better — and the complications happen less.”
U.S. hospital beds were over 70% filled as of Jan. 13, with nearly 18% of them occupied by a COVID-19 patient, according to data from the U.S. Department of Health and Human Services (HHS).
The preliminary results of AHN’s program from a patient-satisfaction perspective have been good, one of the most promising aspects thus far, Seth noted.
“Everybody loves when they can be at home and get the care there, and we also have quality protocols and escalation protocols in case of an unforeseen event,” Seth said. “There’s no visitations in the hospital, which patients don’t like. So there’s a lot of mental health problems happening in patients, especially our older patients.”
Alternatively, at home, loved ones can even help with the recovery process.
In Pennsylvania, over 75% of in-patient beds were filled as of Jan. 13, with over 20% of those filled by COVID-19 patients. Nearly 80% of all ICU beds were also occupied, according to the HHS data.
As hospital-at-home models become more popular and more beneficial to both patients and health care organizations, those that have recognized the perks of home-based care prior to the COVID-19 crisis may have the upper hand.
“This is, for us, the beginning of starting to extend the type of care that we can provide in the home,” Weir Ripley said.
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Arizona, currently facing the worst COVID-19 infection rate in the country, is teetering on the brink of having to ration life-saving care, leaders of the state’s major hospitals said Wednesday.
The decision of whether to mandate COVID-19 vaccinations for home health and home care workers is toward the top of that list. Other emerging legal battles that will shape 2021 include telehealth dos and don’ts.
To keep in-home care operators in the legal loop, Home Health Care News reached out to four attorneys who specialize in the field. The group of legal experts offered their take on the biggest focus areas of 2021.
Their responses are below, edited for length and clarity.
* * *
An enormous challenge home care and home health providers face is remaining compliant with the myriad of federal, state, and local laws and regulations that continue to change at a record pace. It is critically important that providers have a comprehensive legislative tracking process and adopt proactive compliance strategies to both identify changes and modify their policies and procedures to conform appropriately. Providers that operate in multiple jurisdictions or states are especially confronted with this challenge.
One of the most straightforward examples is ensuring compliance with the payment of varying minimum-wage rates. The federal minimum wage is currently $7.25 per hour. However, the Biden administration will likely seek a $15 federal minimum wage. Many states already require a higher minimum wage, such as Colorado’s $12.32 requirement. Some states — such as California — have local jurisdictions, each with its own unique minimum wage requirements that often depend on the number of employees within a given business.
Another major trend to watch out for is the enactment of Domestic Workers Bills of Rights (DWBRs) across the nation. These laws provide specific requirements that employers within a given jurisdiction must adhere to with regard to minimum wages, overtime wages, discrimination and harassment complaints, training requirements and much more. Last year, Philadelphia became the 10th jurisdiction to enact employment legislation to protect domestic workers — and some may recall the federal DWBR legislation sponsored by Kamala Harris in 2019.
We can anticipate a revival of that effort under the Biden administration.
— Angelo Spinola, co-chair of the home health and home care industry group at Littler Mendelson
* * *
If I had to pick one legal issue to watch in 2021, it would be health care payment and coverage reform. While the Affordable Care Act was enacted over a decade ago, its wake continues to make waves in the health care sector. Legal challenges remain unresolved in the courts. Twelve states have not expanded Medicaid. Over 10% of Americans remain uninsured. Federal agencies continue to use their broad regulatory authority to push providers toward value-based reimbursement.
With the inauguration of Joe Biden, I anticipate seeing significant efforts to build on the ACA and, potentially, legislative attempts to expand coverage. While Democrats will control the White House and both chambers of Congress, their razor-thin margin in the Senate makes “Medicare for All” proposals unlikely.
Although the regulatory proposals have been overshadowed by recent events, the Trump administration has proposed or finalized rules that could have a significant impact on provider payment and oversight. A significant theme in 2021 will be the extent to which the Biden administration alters or replaces those rulemaking efforts
As we emerge from the pandemic — hopefully soon — federal and state governments and private payers will examine the many regulatory waivers and flexibilities granted during the public health emergency. Which ones will stay? Which will go? Only time will tell.
— Matt Wolfe, partner at Parker Poe
* * *
2020 shined a spotlight on the importance of home health care, as in-person doctor visits were no longer accessible to seniors and facility-based providers dealt with depleted resources and fewer available beds. As access to services dwindled and remote care began to flourish, a massive inequity affecting home health care was revealed.
Remote care services are frequently not reimbursable in a home health setting — and any home health visits delivered via telehealth do not count toward LUPA thresholds during an episode of care. That policy essentially punishes these home health providers that use telehealth to supplement in-person care. In an environment swiftly moving toward value-based outcomes and technology-driven efficiencies, this disparity became evident to policymakers, who are now working toward a remedy.
For those companies who rely on fee-for-service income, the motivation to transform businesses using new technologies will continue to lag unless we figure out a way to increase financial incentives to enable such transformation. We should expect to see innovative home health companies form or participate in value-based enterprises under the newly published Anti-Kickback Statute safe harbors as a way to compensate for the current lack of reimbursement for virtual services.
— Rebecca Gwilt, partner at Nixon Gwilt Law
* * *
The first half of 2021 will keep providers occupied with getting their employees and patients vaccinated. The pandemic has caused, in many respects, the reduction of home care hours as patients are concerned about aides bringing COVID-19 into the home.
The vaccine offers providers the opportunity to reassure their patients that the aides are not bringing the virus into the home. In turn, it’s a way to increase hours. Therefore, we anticipate that providers will launch wide-scale efforts to get their workers vaccinated. This will involve helping the caregivers understand the importance of being vaccinated and, in some cases, conditioning future and continued employment on the employees’ agreement to become vaccinated.
— Emina Poricanin, managing attorney of Poricanin Law
The post Top Home Health, Home Care Legal Concerns for 2021 appeared first on Home Health Care News.
Sanofi will have full global rights to KY1005, a fully human monoclonal antibody that has a novel mechanism of action. KY1005 binds to OX40-ligand and has the potential to combat various immune-mediated diseases and inflammatory disorders.
Paul Hudson, Sanofi’s CEO, notes that this addition further establishes the company’s interest in fighting immune-related illnesses.
“The Kymab acquisition adds KY1005 to our dynamic pipeline, a potential first-in-class treatment for a range of immune and inflammatory diseases. The novel mechanism of action may provide treatment for patients with suboptimal responses to available therapies,” he said. “We understand from our ongoing work in debilitating immunological diseases how critical it is to find the right treatment for each patient. We look forward to rapidly developing this investigational medicine.”
What You Should Know:
– NRC Health today released its 2021 Healthcare Consumer
Trends Report, which surveyed 2 million healthcare consumers against the
backdrop of the ongoing coronavirus pandemic.
– The latest report highlights the major trends that came to light last year, and how they will continue to impact the healthcare industry in 2021 and beyond – from declining brand loyalty, increased care deferment, the fast adoption of telehealth, a rise in wearable tech, and a broader focus on social media marketing.
– Hospital leaders will also find value in learning how
to recapture patient volumes lost in 2020 and how to bring more human
understanding into the care experience.
NRC Health, a provider of in-depth
customer intelligence in healthcare, today released its 2021 Healthcare Consumer Trends Report. For its
third-annual industry review, NRC Health surveyed millions of healthcare
consumers against the backdrop of the ongoing coronavirus pandemic. From
declining brand loyalty, increased care deferment, the fast adoption of
telehealth, a rise in wearable tech and a broader focus on social media
marketing, NRC Health’s latest report shines a light on consumers’ evolving
preferences and behaviors related to key healthcare trends and offers insight
into how provider organizations can recapture patient volumes in 2021.
COVID-19 Accelerated the Trajectory of Consumerism in
“It cannot be overstated just how dramatically COVID-19 has accelerated the trajectory of consumerism in healthcare,” said Helen Hrdy, Chief Growth Officer, NRC Health. “The onus falls on healthcare leaders to move the industry forward by ensuring patient safety, building consumer trust and bringing more human understanding into every care experience. Those organizations that are willing and able to evolve with the times will be best-positioned for success in the aftermath of COVID-19.”
“For years, consumers have made consistent appeals for autonomy, convenience, and freedom of choice,” said Hrdy. “As unsettling as it’s been, COVID-19 has brought some of these consumerist-driven measures to the forefront. While healthcare leaders have proven they can be nimble and adaptable, even in the face of crisis, consumers want a partnership with their providers and a care experience that exceeds their expectations moving forward. But only with the right data and the right understanding, can we ensure that healthcare is capable of adapting.”
4 Key Healthcare Consumerism Trends to Know in 2021
1. Consumers favor convenience, provider rapport over brand loyalty
Consumer loyalty is a major driver of health system
profitability, but unfortunately for hospitals and health systems, overall
brand preference among healthcare consumers continues to decline, from 31% in
2018 to 36% in 2020. More than a third of consumers expressed no particular
preference for a healthcare brand, when compared against independent
practitioners, and 62% anticipate their brand preferences to change after the
Ironically, providers themselves are in the best position to
earn back consumer trust. An analysis from NRC Health’s Real-time Feedback
database shows that consumers report an overwhelming fondness for their
providers, especially since the outbreak began. To capitalize on that goodwill
and bring patients back into the healthcare fold, all evidence points to
convenience. Almost half of consumers say a convenient location is the number
one factor in their healthcare decision-making.
2. Patient deferment rates will continue to rise
Prior to the pandemic, healthcare deferral rates were
approaching a five-year low. But with consumer anxiety at an all-time high due
to the pandemic, those rates rose significantly in 2020, up from 22.4% at the
end of March to 30.4% by the end of June. Forty percent of patients who delayed
care in 2020 cited the coronavirus as the reason, while 17.2% said they prefer
to manage their care on their own for now.
Delaying care can have a number of repercussions, from
threatening hospital revenue streams in the near term to causing far more
serious outcomes for consumers in the long term. Patients 75 and older
accounted for nearly 68% of all care delays, revealing a huge challenge for
health systems as they try to recruit this generation back into regular care.
3. Future of care delivery looks
uncertain after rapid telehealth adoption
Lagging in widespread adoption for years, the pandemic fast
tracked virtual care delivery from optional luxury to operational necessity.
Fortunately, consumers have been receptive to the shift, with an overwhelming
92% reporting positive telehealth experiences during this time. However, only
27% of consumers say they will consider telehealth as a potential alternative
for future visits, underscoring what is still an uncertain future for virtual
health and overall care delivery beyond the pandemic. Prioritizing provider
time and attentiveness, as well as financial transparency, will be key as
healthcare organizations work to cultivate effective telehealth practices long
4. Patients and providers still disconnected over digital
may have brought healthcare into consumers’ homes, but it is by no means the
only avenue to reach customers outside of the healthcare facility. By and
large, consumers are enthusiastic about digital innovations that bring them
closer to their provider — even as these innovations are underutilized by
tech, for example, has become a huge part of the average consumer’s daily
life in regards to how they manage their health and wellness from home. Yet
only 50% of providers are asking about wearable tech data during appointments,
despite the fact that 57% of consumers believe this data would be useful in
conversations with their healthcare providers.
Social media is another under-used digital venue for patient
interaction. Even though 72% of Americans have some kind of social media
profile, many health systems have not yet found an optimal strategy for
engagement. And while currently, only 23% of Internet users are actively
seeking health information on social media, that number is likely to soon rise
as 70% percent of consumers expressed interest in getting healthcare
information via social channels. Another 62% said they trust the health information
they get on social media, so long as it comes directly from their provider.
This was especially true during the worst of the pandemic, when consumers
trusted news from local healthcare organizations more than any other sources.
A Tower spokesperson declined to say why Gary Conner is leaving, but the health system is in significant financial distress and has hired a restructuring consultant.
Overall, the 37 ACOs earned about $461.9 million in shared savings. The model is now in its final performance year.
As the clinic enters its centennial year on the heels of an extraordinary 2020, CEO Dr. Tom Mihaljevic gave his annual address virtually this year. Mihaljevic focused on telling the stories of caregivers’ battle against COVID-19 and looking to the system’s future.
It was anarchy at the deli counter. On Sunday afternoon in Washington, D.C.’s Shaw neighborhood, a couple dozen masked people had crowded into a corner of a Giant supermarket, where they swiveled their heads warily. As I approached them, a slightly haggard man in an orange down jacket stopped me. “Here for the extra vaccine doses?” asked the man, who was part of the group, not a Giant employee. He handed me a scrap of paper with the number 24 scrawled on it.
For more than a week, lines have quietly been forming at certain D.C. supermarket pharmacies, which have started giving away leftover vaccine doses each day just before closing time, usually to between one and three people. Vaccine lines for eligible recipients have already become a common sight in some places, but these shots are available to anyone—not just the health-care and frontline emergency workers who qualified weeks ago in most states, or even those 65 and older, who became eligible in D.C. on Monday. And the lucky few who get a shot also get scheduled for a second dose. At the Giant in Shaw, the crowd by the deli included people who looked old enough to meet the age cutoff and people who looked young enough to be students—all hoping to strike the vaccine jackpot. The most hard-core among them had been up since 4:30 in the morning.
Grocery stores’ decision to skirt the established order of distribution is a last-ditch effort to save a precious resource at risk of going to waste. Both the Pfizer/BioNTech and Moderna vaccines must be stored in extreme cold and administered soon after thawing, and both spoil quickly and cannot be refrozen. Already, reports have emerged across the U.S. of doses going bad. The federal government has delivered more than 27 million doses to distributors so far, but only 9 million people have received at least one. In D.C., the health department’s mandate is to not let any vaccine perish. At least several grocery-store pharmacies are doing what they can to get shots into as many arms as possible—but the lines and crowds that have ensued offer a particularly vivid illustration of how even good intentions can lead to trouble in the absence of a fully fleshed-out national vaccination plan.
This week, I visited four of D.C.’s five Giant pharmacies to see the lines for myself. In Brentwood, people started queuing not long before noon. On H Street, the line started at 4 o’clock one morning, in the freezing cold, two hours before the store unlocked its doors; the next day, it snaked out the door by early afternoon. Shaw was by far the most chaotic. The whole scene had serious Lord of the Flies energy—the extreme fatigue, the undercurrents of cutthroat competition, the physical danger of infection looming over it all. The group had even begun to hash out the basics of self-governance. “Yesterday was a little bit of a disaster,” a young woman who’d been waiting for nine and a half hours on Sunday told me. “So that’s why we started doing the informal deli-number system—to try to create some order.” (I explained to the man in the orange jacket that I was not there to get vaccinated and returned my paper scrap, which he promptly handed to another newcomer.)
Giant and the D.C. Department of Health both declined to answer specific questions about lines at pharmacies, including how widespread the phenomenon might be within the city. A Giant spokesperson acknowledged only that lines had formed in at least one of the company’s D.C. branches on Sunday, and said that stores “are not accepting wait lists for extra vaccines, nor do we want people lining up to receive extra vaccines.” The health department reiterated its nothing-goes-to-waste approach: “Pharmacists should follow our guidance, if doses will expire due to missed appointments, they should administer the vaccine to anyone who wants to take it,” a spokesperson told me over email.
(The health department did not say whether lines were forming at any other pharmacies. I reached out to Safeway, another major D.C. grocer that reportedly has given out end-of-day vaccines to lucky shoppers, to inquire about lines, and a spokesperson simply told me that the company’s pharmacies follow local guidelines when administering vaccines. I also reached out to CVS, whose spokesperson said it is not currently offering vaccines at its pharmacies. Walgreens did not return a request for comment.)
The line trouble seems to have begun with a TikTok. On New Year’s Day, a law student named David MacMillan posted a video in which he recounted how, as he and a friend were shopping at a D.C. Giant, a pharmacist had flagged them down and offered to vaccinate them. Since then, reports have circulated about these and other winners of random last-minute vaccine giveaways at the city’s supermarkets. Two middle-aged architects lucked out at a Safeway. So did a shopper looking for Hot Pockets.
These surprise doses exist for two reasons. The vaccines are currently shipped in multidose vials, rather than prefilled syringes or single-dose vials, so each batch comes with a little extra. And sometimes eligible people fail to show up for their vaccination appointments. As word got around that anyone could get a leftover vaccine if they happened to be in the right place at the right time, people started trying to engineer being in the right place at the right time. Some succeeded, and soon more and more people were loitering around supermarket pharmacies near closing time in the hope of getting lucky. Lines formed at a number of supermarkets around the city. They got longer and longer and longer.
At the Shaw Giant, the woman who had been waiting for nine and a half hours told me that she’d heard about the extra doses two Sundays ago, when a pharmacist at D.C.’s L Street Safeway unexpectedly offered to vaccinate two of her best friends. The next day, she and her partner showed up at the H Street Giant at 3 p.m., the time her friends said they’d been vaccinated. By then, though, a line had already formed. (The woman, who identified herself as a restaurant server, requested anonymity to protect her and her partner’s privacy.)
So began the arms race. The next day they arrived at 2 p.m., and again they found a line. The day after, noon—and another line. When I spoke with the couple on Sunday, they’d tried every day for the past week, without success. That morning, they’d decided to go all in, showing up at the H Street location at 4:50 a.m.—only to find that they were third and fourth in line. The first person had arrived at 4 o’clock. Rather than stick around, they rushed to another Giant. They arrived at the Shaw store at 5:08 a.m., they told me, 52 minutes before its doors opened, and nearly five hours before the pharmacy did. This time, they were first in line. And by a mile, too—no one else showed up until close to noon.
Getting vaccinated wouldn’t change her behavior, the young woman told me as she waited; she knows that the evidence remains unclear as to whether she could still transmit the virus to friends who have not been vaccinated, so she will continue to practice social distancing. But the vaccine would make her feel safer at the restaurant where she works. If she didn’t wait in line at Giant, she’d have to wait much, much longer for the third stage of the vaccination campaign, after health-care personnel, residents of long-term-care facilities, frontline essential workers, and people 65 and older have all been vaccinated.
In theory, random extra-dose lotteries give anyone a chance at early vaccination. In practice, though, they privilege those who have the time to wait all day and the wherewithal to know that’s even an option. The lines are not organized by vulnerability or social good; they’re organized by who wakes up earliest. At the H Street location, Angelean Redman seemed to be in prime position on Sunday morning. She arrived at about 4:30 a.m., early enough to snag the second spot in line. Redman, a retiree who told me she’d worked for more than 40 years at the Pentagon, falls within two of the pandemic’s most vulnerable demographics: She is Black and older than 65. (On Sunday, the city had not yet opened its vaccination campaign to people older than 65.)
In line, Redman slept in a chair, did crossword puzzles, and made a pact with the young man ahead of her to save each other’s place when one of them went to the bathroom. At the end of the day, the pharmacist announced that only one extra dose remained, and it went to someone less vulnerable. Redman had waited 10 hours around other people for nothing, at considerable risk of exposure to the virus.
To some extent, this whole mess was inevitable. “The fact that there’s some doses left at the end of the day is the nature of the beast,” Saad Omer, a vaccinologist and the director of the Yale Institute for Global Health, told me. Pharmacies have no choice but to decide what to do with the leftovers, and anything is better than letting precious doses go to waste. “It’s obviously not ideal to have that kind of a situation, where you have high-risk groups and they’re not receiving it,” Omer said. “One thing I hope people realize is that the staff there are trying to do their best.”
Still, he stressed, the problem is that no clear, widespread plan exists for what to do with the extra vaccines, and the root of that problem is the lack of guidance from the federal government. Because the Trump administration did not issue a comprehensive national vaccination plan, states have no recommendations to refer to when faced with a tricky situation like this one. And because states could not begin developing their own vaccination plans in earnest until late December, when Congress finally allocated nearly $9 billion for vaccine distribution, they had virtually no time to run the simulations and tabletop exercises that could have foreseen these sorts of problems. At a moment when the pandemic is infecting 250,000 people and killing more than 3,000 every day, these delays matter.
As far behind as the U.S. is, there’s still time to solve these problems before the vaccination campaign’s next phases, the logistical challenges of which will be far greater. One solution, Omer said, would be for states or companies to institute a system to notify unvaccinated people in the highest-priority groups when an extra dose was available nearby. Within each group, recipients could be chosen by lottery, and if a candidate didn’t respond quickly enough, the system could select a new one. No one would have to wait for hours in dangerously crowded conditions for an extra dose that, on any given day, might or might not exist.
For now, though, individual pharmacies have no choice but to work out solutions for themselves. At the Shaw Giant on Sunday afternoon, the crowd was growing far too large for effective social distancing. Samir Balile, who is in charge of clinical programs at all 153 Giant pharmacies in the Mid-Atlantic and happens to live right down the street from the Shaw store, was called in to help manage the situation. He stood in front of the crowd and announced that the pharmacy would be prioritizing store employees and people 65 or older that day. Everyone else had to leave.
For a moment, no one moved. Some had been standing there for hours. One woman refused to go. A man asked if he should return at closing time. “Please don’t even come back,” Balile said. “It’s too dangerous.” After a few minutes, the waitress and her partner gave up. That, they said, was their last try.
Redman, the retiree, for her part, was back at it the next day. On Monday, she arrived at the H Street Giant just after 6 a.m. with some fruit and her crossword puzzles. When I met her there, she was second in line again, this time behind a government worker who spent most of the day rereading the sixth Harry Potter book. “If I don’t don’t do it today, Jesus, I’ll be No. 1 tomorrow,” she told me.
As the line stretched out the door and the tension built, Redman befriended the government worker, who asked to be identified by her middle name, Elizabeth, to protect her privacy. The two women were told that the pharmacy had about 20 doses to administer that day, so they counted down as people came in with appointments. At the end of the day, the pharmacist announced that three doses were left. Redman and Elizabeth did celebratory elbow bumps and took a group photograph with the man who was third in line. In a few weeks, when they return for their second dose, Elizabeth is going to drive Redman to the pharmacy.
The objective of the webinar is to discuss the need for affordable healthcare in India and the role of economic evidence for affordable healthcare in India.
- Dr. K. Srinath Reddy, MD
President, Public Health Foundation of India (PHFI)
Topic: The need for affordable healthcare in India
- Dr. V. M. Katoch, MD
FNASc, FASc, FAMS, FNA. NASI-ICMR Chair on Public Health Research at (RUHS), Jaipur
Topic: The Role of economic evidence in India for affordable healthcare
- Dr. Rajesh Balkrishnan, PhD
Professor of Public Health Sciences, University of Virginia School of Medicine
Clinical Professor, University of Virginia School of Nursing
Topic: Real World Evaluations of the Effectiveness of Medical Care: Relevance in the Current Scenario
Topic: HEOR & HTA studies for healthcare delivery in India – An Industry Perspective
- Mr. A Vaidheesh
Chief Executive Officer Northstar Asis LLP, Former manager director/VP south Asia glaxosmithkline & former VP India Johnson & Johnson
- Mr. Manoj Saxena
Managing Director, Bayer Zydus Pharma & CDH south Asia Bayer Pharma
- Mr. Omar Sherief Mohammad
General Manager, Roche Diabetes Care India Pvt. Ltd.
- Dr. Anish Desai
Director. IntelliMed Healthcare Solutions & Honorary Professor, Pharmaceutical Medicine MUHS.
- Mr Vivek Padgaonkar
Independent Healthcare Consultant Former-Director, Former Director OPPI (Project & Policy), Former GSK (Sales & Marketing)
But the process of distributing those tests, and then reporting their results, has been slow and uneven. The results from most of the antigen tests that have been sent to states have been unreported, according to separate data from the COVID Tracking Project at The Atlantic and the U.S. Department of Health and Human Services, leaving gaps in our knowledge of the pandemic. In some cases, the tests are not getting used at all. Almost a year into this crisis, the U.S. still does not have a clear picture of how many people are being tested for COVID-19.
The value of antigen tests is based on a simple tradeoff. They’re not as sensitive as polymerase chain reaction (PCR) tests, which are the gold standard for diagnosing COVID-19, but they’re most effective when people with the virus are most infectious. And since they’re cheaper, faster, and easier to perform, the ability to do more tests can balance out the lower sensitivity. If their convenience means you take eight antigen tests a month, versus, say, two PCR tests a month, the antigen regime might catch cases that the PCR regime misses. One recent analysis suggests that using antigen tests on a population three days a week would be virtually as effective in catching infections as using the superior PCR test the same number of times.
But for an effective antigen-testing plan to work, the tests have to be given frequently and the results quickly reported. While PCR tests are done at labs, which are practiced in reporting results to health agencies, antigen tests are intended for places such as schools and nursing homes, which have to develop their own reporting systems. And that’s been a problem since the tests started going out in May. By August, the test manufacturers Quidel and BD combined to produce 3 million antigen tests a week. But by mid-September, states had reported only 215,000 antigen-test results. There was, as The Atlantic’s Alexis Madrigal and Robinson Meyer wrote then, “a hole where data about antigen testing should be.” At the time, only six states made antigen-testing numbers available (now 20 states do), and extrapolating those results suggested that only 1.4 million antigen tests had been conducted nationwide.
The federal government pressed on with antigen testing, though, and ordered 150 million tests from Abbott when the company’s more advanced technology came online. In October, the Associated Press reported that while about half of the country’s testing capacity consisted of antigen tests, the overall reported test numbers didn’t reflect the flood of antigen tests that had made their way to states. In November, The New York Times found the same hole in the data, reporting that state and local public-health officials were on the hunt for rapid-testing facilities that were not disclosing their data.
And that hole doesn’t seem to have gone anywhere. On December 14, during a biweekly CDC call with laboratory representatives to address their issues in dealing with COVID-19, the Department of Health and Human Services said that a majority of the more than 50 million antigen tests that have been distributed to states “do not have test results flowing to HHS.” According to the CDC data, that number is now up to 94.4 million. Data collected by the COVID Tracking Project similarly suggest that states are not reporting antigen-test results. Out of more than 235 million test results reported since June, only about 9 million are clearly reported as antigen-test results. Admittedly, many states still don’t split out separate figures for antigen tests and PCR tests. But even among the states that do, antigen tests make up only about 10 percent of all tests they have reported. Extrapolated nationwide, that would be about 27 million tests, or a bit more than a quarter of the tests the federal government has distributed to date.
Collecting antigen-test results has been a struggle, says Richard Danila, the deputy state epidemiologist in Minnesota, which does report antigen tests separately. The state needed four people working full time for three weeks to set up a reporting system with its 300 nursing homes after they received the antigen tests—not just getting results from frequent testing, but ensuring that those results are always connected to the patient’s name and demographic information. In the best-case scenario, the department helped them create flat electronic files like Excel sheets, but some of the data came in as faxes or emails. “We certainly don’t have, probably, full reporting of the Abbott BinaxNOW positive tests,” Danila says. “You’re relying on the good nature of people that remember to report to us.” All in all, Minnesota has reported nearly 273,000 antigen tests during the pandemic, compared with nearly 5.7 million PCR tests. (Some of this gap, Danila says, is due to Minnesota’s investment in a saliva-based PCR test, making the state less dependent on antigen tests.)
If tests are being given but not reported, that doesn’t mean they’re completely useless; people and individual institutions can obviously take action based on the results. But it means that crucial information isn’t available to health officials. “This lack of visibility can lead to a lot of challenges, especially as the administrators are trying to conduct contact tracing or decide where to distribute additional testing supplies, and identify hot spots,” Kristen Honey, a senior adviser to the assistant secretary of HHS, said on the CDC call.
Perhaps more worryingly, officials on the same call said that in some cases, the antigen tests the government ordered are not being used at all. Marcus Plescia of the Association of State and Territorial Health Officials described a nationwide survey his organization had conducted in November about the use of Abbott’s BinaxNOW rapid tests. One of the highest priorities for these tests was using them in schools, to catch infections early and help keep facilities open. But “use in K–12 has not been substantial so far,” Plescia said. An antigen-testing program’s logistics can be daunting, and as an article in The New England Journal of Medicine put it, schools have received “strikingly little substantive guidance on testing” from federal and state officials. When ASTHO did its November survey, 60 percent of respondents were still in the planning stage. That may be changing: Massachusetts, for example, had been using rapid antigen testing for symptomatic students and staff in 134 of its 403 school districts since November, but is now rolling out pooled testing across the state for all students and staff, regardless of symptoms, which will greatly boost the number of tests being used. Other school systems, such as Chicago Public Schools and New Orleans Public Schools, had instituted remote learning, but are going back to in-person education with antigen-testing plans.
New technologies may ease and speed antigen-test reporting, filling in the data hole that’s been lingering for months. At-home tests that don’t require a prescription are going on sale this month, and the kit includes a device that transmits the results via Bluetooth to an app on the user’s phone. And the CDC recently launched a new interface, SimpleReport, to make it easier for institutions such as K–12 schools and universities to submit testing results. But these systems still require people and institutions to take the tests and choose to report their results. Better tests alone won’t solve that problem.
The agency has finalized a rule that allows it to provide immediate Medicare coverage for FDA-approved products that are deemed “breakthrough devices.” The new coverage process would enable seniors to get access to these devices more quickly, but some provider and payer groups are concerned that this could cause patient harm.
What You Should Know:
– The ONC released the first ONC Standards Bulletin, a new communication tool ONC will use to periodically update the healthcare industry about ONC health IT standards and policy initiatives.
– Based on a HITAC recommendation, the Bulletin is part of the
ONC’s ongoing efforts to communicate, coordinate, and promote the adoption and
use of health IT standards to facilitate the access, exchange, and use of
electronic health information.
– The inaugural ONC Standards Bulletin 2021-1 (SB21-1)
discusses the United States Core Data for
Interoperability (USCDI) and the Standards-Version Advancement Process (SVAP).
– The USCDI
Draft v2 is the result of wide-ranging public input into the elements that
should be included to enhance the interoperability of health data for patients,
providers, and other users. ONC encourages the public to review this draft
standard, including the list of data elements that didn’t make it into the
standard, and provide comments through the USCDI home page by April 15, 2021.
– ONC also released the Standards
Version Advancement Process (SVAP) Approved Standards for 2020. Under the
SVAP, health IT developers can incorporate newer versions of health IT
standards and implementation specifications used in certified health IT and
update systems for their customers without undergoing certification testing
What You Should Know:
– Modernizing Medicine announced it has acquired
orthopedics EHR vendor Exscribe bringing together two of the healthcare
industry’s leading, all-in-one orthopedic EHR vendors.
– As part of the acquisition, Exscribe Founder and CEO,
Dr. Sachdev and other members of the Exscribe team will be joining Modernizing
Specialty-specific EHR provider Modernizing Medicine announced it has acquired
health records (EHR) vendor Exscribe.
The acquisition brings together two of the healthcare industry’s leading,
all-in-one orthopedic EHR vendors with a shared mission of increasing practice
efficiency by transforming how healthcare information is created, consumed and
utilized. Modernizing Medicine and Exscribe will work together to accelerate
innovation and bring to market advanced EHR, practice management, and
technology solutions intended to improve physician efficiency, reduce burnout,
and support value-based care.
“Exscribe and Modernizing Medicine have a shared commitment to customer success and improving patient outcomes and we are excited to work together to leverage our combined orthopedics expertise to move the industry forward,” said Dan Cane, CEO of Modernizing Medicine. “Both companies were founded on the belief that the best EHRs are built specialty specific ‘by physicians, for physicians,’ and that product excellence is a direct reflection of the strength of our team. With that, we are excited to welcome the talented individuals at Exscribe to the Modernizing Medicine family and are confident that we can leverage our combined expertise to enhance and grow our solutions to meet the needs of customers of virtually any size and orthopedic specialization.”
Orthopedic Healthcare Solutions
Exscribe was founded in 2000 by nationally-renowned
orthopedic surgeon Ranjan Sachdev, MD, MBA, CHC, who was looking for a better
way to manage his orthopedic practice. Working with a team of orthopedists and
IT professionals, Dr. Sachdev developed the Exscribe Orthopaedic EHR, which today
is among the leading specialty-specific healthcare technology solutions
available. Leveraging machine learning and artificial intelligence, Exscribe’s
EHR is intuitive, enabling orthopedists to use one-click treatment plans for
specific conditions, including orders for surgery and therapy, prescriptions,
patient education, referral letters, and more.
Exscribe Founder and CEO, Dr. Sachdev and other members of
the Exscribe team will be joining Modernizing Medicine, and through the
increased scale and combined expertise, both companies intend to continue
providing world-class technology solutions and support to orthopedic customers.
Modernizing Medicine’s top-rated specialty-specific orthopedic electronic
health records (EHR) system, EMA® Orthopedics, has been named the number one
EHR in orthopedics for three consecutive years by Black Book™.
“Modernizing Medicine is known for its state of the art web based offerings, growing presence in the orthopedics space and commitment to working with customers to build solutions that meet the needs of orthopedists and their office staff,” said Dr. Sachdev. “Existing Exscribe customers will experience very few immediate changes. In the long term, we look forward to leveraging the decades of expertise from both companies to build fully interoperable EHR technologies that solve administrative inefficiencies and promote orthopedic excellence.”
Financial detail of the acquisition were not disclosed.
The FDA will issue draft guidance encouraging developers to explain how they plan to upgrade artificial intelligence and machine learning software in medical devices, among other steps.