Category: COPD

In a recent interview with PharmaShots, Jonas Duss, US CEO and Co-Founder at Kaia Health shared his views on the Kaia Health’s COPD Pulmonary Rehabilitation App and their collaboration with Chiesi Group to commercialize the app in EU.

Shots:

• Kaia Health signs an exclusive agreement with Chiesi Group to commercialize the Kaia Health COPD Pulmonary Rehabilitation app in the EU
• The app is CE marked in the EU as a Class 1 medical device and has been investigated in one pilot trial and is the subject of an ongoing randomized control trial in the EU
• The Kaia COPD solution consists of a mobile app and an interface for motivational support that aims to deliver a personalized pulmonary rehabilitation experience through education, daily training sessions, and stress relief exercises, boosted with human coaching support and individualized therapy

Tuba: Please share the specifications of the Kaia Health Chronic Obstructive Pulmonary Disease (COPD) Pulmonary Rehabilitation app with our readers?

Jonus:  The Kaia COPD solution consists of a mobile app-based software program and an interface for motivational support that can be delivered by a provider such as health coaches or healthcare professionals. It digitises and delivers affordable, accessible, physical Pulmonary Rehabilitation (an essential component of COPD treatment) – directly to patients’ homes on their smartphone. The Kaia Health COPD app delivers comprehensive education and customised daily training sessions, along with mindfulness and stress relief exercises, augmented with human coaching support and individualised therapy. The Kaia COPD solution has been investigated in one pilot trial and is currently the subject of an ongoing RCT in Europe. The Kaia Health COPD app is CE Marked in Europe as a Class 1 medical device.

Tuba: Can we have a glance at Kaia’s partnership with the Chiesi group? How this partnership will improve the QoL of patients living with COPD?

Jonus:  Currently, only very few COPD patients get access to pulmonary rehabilitation, as in many countries the main access to this therapy is via the inpatient setting, which is very limited due to the high costs. In some countries the range of yearly available slots lies somewhere between only 0.5%-1% of all COPD patients. What we try to do is complement the traditional offering with something more scalable, so that more patients can get access to a sustainable way to self-manage their condition. The partnership with Chiesi will allow us to do so in close collaboration with the stakeholders of the existing healthcare system: prescribers, payers and regulators.

Tuba: What would be a key feature of Kaia’s COPD App?

Jonus:  There is no one key feature we would mention as the strength of Kaia COPD is that it incorporates a multimodal approach, with each of the modules (self-management education, mindfulness and physical activity) being similarly important and multiplying the effectiveness of the therapy when used in combination with other modules.

Tuba: Could you share the clinical evidence supporting Kaia’s COPD solution?

Jonus:  A first pilot study was published in 2018. Details here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6260122/

A larger, randomized controlled trial is currently underway, details can be found here: https://clinicaltrials.gov/ct2/show/NCT04299165

Tuba: Please showcase the different digital programs of Kaia targeting other indications except for COPD.

Jonus: 

• Kaia MSK, targeting the full musculoskeletal spectrum (hip and knee, back, shoulder and neck pain)
• Kaia COPD

Tuba: What next, we can expect in terms of digital therapies?

Jonus:  We will double down on our core competencies and continue to commercialize our solutions in a way that leverages the existing pathways in our healthcare system.

Tuba: Are you looking for more collaborations to expand the reach of the COPD app across the globe?

Jonus:  We are open and actively pursuing more collaborations that are compatible with our existing partners.

Tuba: Would you like to share something specific about your company’s growth with our readers/subscribers?

Jonus:  More than 450’000 users have used Kaia up to date.

Image Source: Medical News Today

About Author:

Jonas Duss is the US CEO and Co-Founder at Kaia Health. He focusses on the US health plan, employer market, developing international market access and go-to-market strategies with pharma & med. tech.

Related Post: ViewPoints Interview: Vigeo Therapeutics’ Dr. Lou Vaickus and Dr. Jing Watnick Share Insights on VT1021 Data Presented at SITC 2020

The post ViewPoints Interview: Kaia Health’s Jonas Duss Shares Insights on COPD Pulmonary Rehabilitation App first appeared on PharmaShots.

In a recent interview with PharmaShots, Dr. Riju Ray, MD, PhD, Senior Medical Lead at GSK, leading US medical affairs across asthma and COPD shared his views on how community-based pulmonologists are improving COPD management and education among referring PCPs.

Shots:

• Pulmonologists identified 12 strong to moderate predictors of future COPD exacerbations, some of which were evaluated less frequently. COPD is frequently underdiagnosed, and this may be partially due to a lack of adequate knowledge and testing at the primary care level, highlighting the need for further education improve patient care
• When evaluating COPD traits, pulmonologists were most likely to evaluate behavioral traits, exacerbation history and recovery time rather than traits that require testing, as acknowledged by the standard of care (GOLD guidelines). Failure to evaluate testing-based traits creates an overdependence on physician-patient communication, which is already a recognized key challenge
• Community-based pulmonologists play an important role in the management of COPD, and the majority of respondents were also in a position to influence COPD management practices of colleagues. However, the opportunity to educate primary care physicians on COPD management and exacerbation prevention was not utilized by the majority of survey respondents, suggesting a need to more strongly engage specialists in education efforts

Tuba: Please discuss the epidemiology of the chronic obstructive pulmonary disease (COPD)?

Riju: COPD, or chronic obstructive pulmonary disease, is a progressive lung disease. There are more than 16.4 million people in the U.S. that are diagnosed with COPD, and it is one of the leading causes of death worldwide. While there is no cure for COPD, it is treatable, and with daily management, those with the disease can maintain good quality of life.

Tuba: Can we have a key point of the whitepaper published in Chest Clinical Perspectives in a non-scientific way?

Riju: In the recent study funded by GSK and co-developed by CHEST and GSK, we assessed the approaches pulmonary specialists take when they think of managing COPD exacerbations (or flare-ups) and what clinical perspectives come to mind when they consider future risk of these COPD exacerbations for their patients. These COPD exacerbations, or COPD flare-ups, speed up lung function decline and often lead to hospitalizations, which impact the health and quality of life for people with COPD. Research shows that frequent exacerbations that require hospitalization are also associated with higher mortality. Hospitalizations also lead to greater impact on daily life, decreased ability to work and increased burden on family caregivers, so it is important to help people with COPD reduce their chances of experiencing a COPD exacerbation.

Tuba: What were the objectives of the research conducted by CHEST?

Riju: The objectives of the survey were to:

• Assess the frequency with which pulmonary, extrapulmonary, and behavioral traits of COPD patients are evaluated in pulmonology practices.
• Assess which disease characteristics pulmonologists use to predict the occurrence and severity of exacerbations in patients with COPD, including those who have no history of exacerbations.
• Identify barriers to assessing these disease characteristics in pulmonology practices.
• Assess how often pulmonologists are actively involved sharing their knowledge of COPD treatment and management with their referring primary care physicians.

Tuba: Discuss the role of pulmonologists in improving the management of COPD.

Riju: Pulmonologists work with patients to develop a proper COPD management plan and participate in the development of treatment plans. Pulmonologists are also in a position to better educate their referral primary care physicians. According to the survey, COPD is frequently underdiagnosed, which may be partially due to primary care physicians’ (PCPs) lacking knowledge on the disease. It’s important for pulmonologists to utilize their position to educate PCPs on how to administer tests, and interpret results, and plan tailored disease management plans for their patients with COPD.

Tuba:  What were the findings of the research conducted by CHEST/GSK?

Riju: The survey uncovered a few key insights on COPD exacerbation predictors and the role of pulmonologists in better managing future COPD exacerbation risk:

• There are 12 strong disease characteristics that pulmonologists determined to be predictors of a COPD exacerbation.
• Pulmonologists are more likely to evaluate behavioral traits that do not require testing than pulmonary and extrapulmonary factors.
• Most (71%) of pulmonologists surveyed use a strategy-based approach like the GOLD while 29% said their management approach is dependent on a patient’s symptoms.
• The opportunity to educate other physicians on COPD management and exacerbation prevention is not utilized.In fact, only 16% of respondents said they make a routine practice of proactively engaging or informally educating referring physicians on how to evaluate and manage COPD.

Tuba: Can you showcase the GOLD guidelines used by the pulmonologist?

Riju: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy document is used broadly by physicians to guide COPD treatment plans. It categorizes patients according to their level of airflow limitation, symptoms, and comorbidities, and disease stages. However, patients symptom burden and exacerbation history are recommended as 2 key guiding principles for determining optimal treatment. Patients grouped in the same stage of the disease often have variation in symptoms, exacerbations, and risk of mortality, so understanding how to identify and test those characteristics is important to developing a personalized treatment plan.

Tuba: What were the different traits evaluated by the pulmonologist during the research?

Riju: In the survey, pulmonologists evaluated various behavioral, pulmonary and extrapulmonary traits and determined 12 strong COPD exacerbation predictors. The behavioral characteristics include treatment adherence, tobacco use, exacerbation history (especially exacerbations leading to hospitalizations), which do not require testing. Pulmonary and extrapulmonary factors include frailty or airflow limitation, which are evaluated less frequently. This study emphasizes the importance of pulmonologists’ recognition of disease characteristics, laboratory testing, in-office assessments and physician education when developing treatment plans. 

• When testing-based characteristics are not routinely evaluated as indicated by surveyed pulmonologists, it creates an overdependence on physician-patient communication. While this study did not specifically address communication, we know that both patients and physicians think there is room for improvement in terms of physician-patient communication during medical appointments. It is an extremely important component of the patient-physician relationship and should be considered in any disease management plan.

Tuba: What are the different predictors of future COPD exacerbations? What you consider is the best predictor for exacerbation?

Riju: The best predictor for an exacerbation is exacerbation(s) history; however, it is important for pulmonologists to evaluate other disease characteristics, especially in the absence of exacerbation history. A focus on behavioral elements like smoking cessation and adhering to their treatments especially controller medicines also ranked high from the surveyed pulmonologists. Regardless of exacerbation history, recent studies suggest triple therapy with an ICS, LAMA, and LABA showed the greatest benefit for improving both lung function and preventing exacerbations.

Tuba: What are the educational benefits of using an approach to COPD management?

Riju: As mentioned, COPD is frequently under-diagnosed, so it is important for pulmonologists to utilize all tools available to them between in-office testing, reference of GOLD and evaluation of a patient’s health history when treating people with COPD symptoms. It’s also critical pulmonologists engage PCPs in formal or informal education activities to improve patient care from the front line.

Tuba: Why do you think COPD management is necessary to improve the condition of patients?

Riju: Like any disease, proper disease management is essential to ensuring patients receive optimal care and lead a high quality of life as possible. COPD can worsen over time, especially for people who experience frequent exacerbations, but patients don’t have to settle for a life of breathlessness. Better days are possible for people living with COPD through consistent and comprehensive disease management.

Image Source: Dimerix Limited

About Author:

Dr. Riju Ray is an MD, PhD senior medical lead within the Respiratory team at GSK US medical affairs leading teams across both Asthma and COPD. He is based out of Research Triangle Park in North Carolina.

Related Post: ViewPoints Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

The post ViewPoints Interview: GSK’s Dr. Riju Ray Shares Insights on the Role of Community-Based Pulmonologists in Improving COPD Management Among PCPs first appeared on PharmaShots.

What
You Should Know:

–
Wolters Kluwer, Health launches new Alexa skill, Emmi Care Plan to keep patients
engaged with their care team at home following discharge from the hospital.

– Using a natural dialogue that automatically adjusts to patient responses, customers can engage with the skill on Alexa-enabled devices simply by saying, “Alexa, ask Emmi Care Plan” to complete periodic health assessments, reminders, and additional education.

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To keep health consumers engaged with their providers
while recovering at home, Wolters Kluwer, Health is
launching Emmi® Care Plan, a new Alexa healthcare skill that
restores the patient-provider dialogue after discharge simply by using the
voice service.

Every day, patients who are discharged from hospitals return
home to face the often-daunting journey of a successful recovery. For their
care providers, the stream of valuable patient information essential for
quality care decreases to the occasional phone call once patients leave the
hospital.

How Emmi Care Plan Works

Emmi Care Plan empowers patients to play a proactive role in their health, whether they are in recovery at home or are managing chronic conditions. Using a natural dialogue that automatically adjusts to patient responses, customers can engage with the skill on Alexa-enabled devices simply by saying, “Alexa, ask Emmi Care Plan” to complete periodic health assessments, reminders, and additional education.

How are you feeling today? Have you used a rescue inhaler? Have you smoked or been around someone smoking today? Are you taking your medications?

Jason Burum adds, “For providers, the Emmi Care Plan skill adds a new layer of interaction to stay connected to consumers using the Alexa-enabled devices that are already an integral part of their day-to-day activities.” As clinicians engage with patients over time, they will gain new insights on their care journey at home. When risks for a change in the patient’s condition are identified, their care team is notified for follow-up.

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Integration with Health System & Clinical Workflows

The new skill is part of Wolters Kluwer’s EmmiTransition solution which
keeps patients connected to their care teams post-discharge
through empathetic voice design, interactive phone calls and now, Alexa-based
interactions. EmmiTransition can be seamlessly integrated in a healthcare
system’s IT and
clinical workflows. Patients can access the Alexa skill through
participating healthcare providers by using an Alexa-enabled
smart speaker or device.

The new skill focuses on chronic conditions
like COPD, and targets health challenges that not only incur high costs
for patients and hospitals, but also exact a high toll on a patient’s
quality of life. By giving the care team access to connect with patients via Alexa-enabled
devices, they have visibility to a more longitudinal stream of patient
condition information. As a result, they can tailor and optimize care plans
in real-time, with an aim to improve engagement and outcomes.

Early feedback from test users has been overwhelmingly
positive, saying the skill “made them feel heard, cared for, and
offered encouragement.” Other feedback included “easy to answer the questions,”
“the skill was efficient and well-planned,” and they liked “not
having to speak to a human.”

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In the first episode of our Health Innovators series, Paul Tunnah speaks to David Van Sickle, CEO of Propeller Health about how digital technologies are revolutionising the field of respiratory medicine.

The post Health Innovators: David Van Sickle on digital innovation in respiratory medicine appeared first on .

What You Should Know:

– Apstar Pharma acquires the assets of respiratory health company Cohero Health to expands its digital portfolio with a focus on respiratory disease management.

– Cohero Health develops digital tools and technologies to improve respiratory care, reduce avoidable costs, and optimize medication utilization.

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AptarGroup, Inc., a global leader in consumer dispensing, active packaging, drug delivery solutions, and services, announces that it has acquired all operating assets and the proprietary portfolio of Cohero Health, Inc. (“Cohero Health”), a digital therapeutics company transforming respiratory disease management for asthma and chronic obstructive pulmonary disorder (COPD). Financial details of the acquisition were not disclosed.

Start breathing smarter

Founded in 2013, New York-based Cohero Health develops innovative digital tools and technologies to improve respiratory care, reduce avoidable costs, and optimize medication utilization. With this transaction, Aptar Pharma acquires Cohero Health’s turnkey digital health platform and device assets including:

· BreatheSmart Connect digital health platform – care coordination and HIPAA-compliant SaaS cloud service which captures and securely stores data from Cohero Health’s devices and BreatheSmart® software for remote monitoring and patient communications to help manage patient therapy;

· BreatheSmart® App – designed for patient habit creating and behavior change, driving appropriate medication utilization. Provides real-time tracking of medication adherence and lung function, along with reminders, educational materials, and symptom/trigger recording;

·
HeroTracker® Sensors – Bluetooth enabled medication smart inhaler sensors
designed for both control and rescue medications. Attaches to respiratory
medications to automatically record time and date of doses taken

· mSpirometer™ and cSpirometer™lung function diagnostic sensors – enable comprehensive pulmonary lung function testing in a handheld wireless device.

Acquisition Expands Aptar’s Digital Portfolio

“Cohero Health further strengthens and expands Aptar’s digital portfolio, in this case, with a focus in respiratory disease management,” commented Sai Shankar, Aptar Pharma’s Vice President, Global Digital Healthcare Systems. “Aptar has made previous investments in digital respiratory company Sonmol in China and digital health company Navia Life Care in India. With this strategic bolt on, Aptar now has global capabilities to deploy digital respiratory health, utilizing either the Cohero or Aptar device portfolio/platform. The investment will also facilitate Aptar’s ability to provide diagnostic solutions in respiratory and a significant number of other disease categories.”

What You Should Know:

– Mayo Clinic announced a collaboration with Vocalis
Health to to research and develop new voice-based tools for screening, detecting
and monitoring patient health, beginning with a study to identify vocal
biomarkers to detect pulmonary hypertension (PH).

– The clinical validation study will utilize Vocalis
Health’s proprietary software, which can operate on any connected voice
platform (mobile, computer, tablet, etc.) to analyze patients’ health based on
voice recordings.

– Following this initial phase, researchers will work to
identify vocal biomarkers targeting additional diseases, symptoms and
conditions.

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Mayo Clinic and Vocalis Health, Inc., a company
pioneering AI-based
vocal biomarkers for use in healthcare, today announced a collaboration to
research and develop new voice-based tools for screening, detecting and
monitoring patient health. The collaboration will begin with a study to
identify vocal biomarkers for pulmonary hypertension (PH) which could help
physicians detect and treat PH in their patients.

Impact of Pulmonary Hypertension

Pulmonary hypertension is a severe condition causing high blood pressure in the lungs, but
as the symptoms are similar to other heart and lung conditions, it is often not
detected in routine physical exams. While traditional blood tests can sometimes
detect pulmonary hypertension, it frequently goes undiagnosed. This
strategic collaboration aims to provide an
alternative and highly scalable method to check patients for PH, using only a recording of the patient’s voice, to understand their health and the progression of the disease. 

Study Establishes Relationship Between Certain Vocal Biomarkers
& Pulmonary Hypertension

In a previous trial with Vocalis Health, the Mayo research
team established a relationship between certain vocal characteristics and PH.
In this new collaboration, Mayo will conduct a prospective clinical validation
study to further develop PH vocal biomarkers. The clinical validation study
will utilize Vocalis Health’s proprietary software, which can operate on any
connected voice platform (mobile, computer, tablet, etc.) to analyze patients’
health based on voice recordings. Following this initial phase, researchers
will work to identify vocal biomarkers targeting additional diseases, symptoms
and conditions.

Vocalis Health Background

Vocalis Health is an AI healthtech company pioneering the
development of vocal biomarkers – where health-related information is derived
from analysis of people’s voice recordings – to screen, detect, monitor and
predict health symptoms, conditions and diseases.  Vocalis Health is currently focused on
screening users for COVID-19 and on monitoring patients with chronic diseases
such as COPD.

“We have seen the clinical benefits of voice analysis for patient screening throughout the COVID-19 pandemic, and this collaboration presents an opportunity for us to continue broadening our research, beginning with pulmonary hypertension,” said Tal Wenderow, CEO of Vocalis Health. “Voice analysis has the potential to help physicians make more informed decisions about their patients in a non-invasive, cost-effective manner. We believe this technology could have important clinical implications for telemedicine and remote patient monitoring in the very near future. We are excited to work with Mayo Clinic and have already started planning clinical trials for additional indications.”

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The COVID-19 virus is ravaging the planet at a scale not seen since the infamous Spanish Flu of the early 1900s, inflicting immense devastation as the U.S. loses more than 200,000 lives and counting. According to CDC statistics, 94% of patient mortalities associated with COVID-19 were simultaneously suffering from preexisting conditions, leaving a mere 6% of victims with COVID-19 as their sole cause of death. However, while immediate prospects for a mass vaccine might not be until 2021, there is some hope among rural hospital health information technology consultants where the pandemic has hit the hardest. 

The fact that four in ten U.S. adults have two or more chronic conditions indicates that our most vulnerable members of the population are also the ones at the greatest risk of succumbing to the pandemic. From consultants laboring alongside healthcare administrators and providers, all must pay close attention to patients harboring 1 of 13 chronic conditions believed to play major roles in COVID-19 mortality, particularly chronic kidney disease, hypertension, diabetes, and COPD.

Vulnerable rural populations must be supervised due to their unique challenges. The CDC indicates 80% of older adults in remote regions have at least one chronic disease with 77% having at least two chronic diseases, significantly increasing COVID-19 mortality rates compared to their urban counterparts.

Health behaviors also play a role in rural patients who have decreased access to healthy food and physical activity while simultaneously suffering high incidences of smoking. These lifestyle choices compound with one another, leading to increased obesity, hypertension, and many other chronic illnesses. Overall, rural patients that fall ill to COVID-19 are more likely to suffer worsened prognosis compared to urban hubs, a problem only bolstered by their inability to properly access healthcare. 

Virus Helping Push New Technologies

COVID-19 has shown the cracks in the U.S. healthcare technology system that must be addressed for the future. As the pandemic unfolds, it’s worth noting that not all lasting effects will be negative. Just as the adoption of the Affordable Care Act a decade ago spurred healthcare organizations to digitize their records, the COVID-19 pandemic is accelerating overdue technological shifts crucial to providing better care.

Perhaps the most prominent change has been the widespread adoption of telehealth services and technologies that connect patients with both urgent and preventive care without their having to leave home. Perhaps the most prominent change has been the widespread adoption of telehealth services and technologies that use video to connect patients with both urgent and preventive care without their having to leave home.

Even if COVID-19 were to fade away on its own, the next pandemic may not. Furthermore, seasonal influenza serves as a reminder that healthcare is not a skirmish, but a prolonged war against disease. Rather than doom future generations to suffer the same plight our generation has with the pandemic, now is the time to develop innovative IT strategies that focus on protecting our most vulnerable citizens by leveraging existing healthcare initiatives to focus on proactive responses instead of reactive responses.

On the Right Road

While some of the most vulnerable people are the elderly, rural residents, and the poor, the good news for them is that CMS has long advocated the use of preventive care initiatives such as Chronic Care Management (CCM) and Remote Physiologic Monitoring (RPM) to track these geriatric patients. To encourage innovation in this sector, CMS preventive care initiatives provide generous financial incentives to healthcare providers willing to shift from conventional reactive care strategies to a more proactive approach focused on prevention and protection. This should attract rural hospital CEOs who have been struggling even more than usual because of the virus.

These factors led to the creation of numerous patient CCM programs, allowing healthcare executives and providers to remotely track the health status of geriatric patients suffering from numerous chronic conditions. The tracking is at a rate and scope unseen previously through the use of electronic media. Interestingly enough, the patients already being monitored by CCM programs overlap heavily with populations susceptible to COVID-19. To adapt existing infrastructure for the COVID-19 pandemic is a relatively simple task for hospital CIOs. 

As noted earlier, one growing CCM program that could be retrofitted to deal with the COVID-19 pandemic are the use of telehealth services in rural locations. Prior to the pandemic, telehealth services were one of the many strategies advocated by the CDC to address the overtaxed healthcare systems found in rural locations. 

Better Access, Funding and User Experience for Telehealth

Today, telehealth is about creating digital touchpoints when no other contact is possible or safe. It offers the potential to expand care to people in remote areas who might have limited or nonexistent access, and it could let other health workers handle patient screening and post-care follow-up when a local facility is overwhelmed. As a study published last year in The American Journal of Emergency Medicine affirms, virtual care can cut the cost of healthcare delivery and relieve strain on busy clinicians.

Telehealth has also gotten a boost from the $2 trillion CARES Act stimulus fund, which provides $130 billion to healthcare organizations fighting the pandemic. The effort also makes it easier for providers to bill for remote services.

The reason for the CDC and hospital administrators’ interest in telehealth was that telehealth meetings could outright remove the need for patients to travel and allow healthcare providers to monitor patients at a fraction of the time. By simply coupling existing telehealth services with CMS preventive care initiatives focused on COVID-19, rural healthcare providers could detect early warning signs of COVID-19. 

Integration Key to Preemptive Detection

This integration at a faster and far greater scale could mean much greater preemptive virus detection through routine telehealth meetings. The effect of telehealth would be twofold on hospitals serving rural and urban health communities. It could slow the spread of COVID-19 to a crawl due to decreased patient travel and improved patient prognosis through early and intensive treatment for vulnerable populations with two or more chronic health conditions.

This integrated combination would shift standard reactive care to patient infections to a new monitoring methodology that proactively seeks out infected patients and rapidly administers treatment to those most at risk of mortality. This new combination of preventive care and telehealth services would not only improve patient and community health but would relieve the financial burden incurred from the pandemic due to the existing CMS initiatives subsidizing such undertakings.

In conclusion, preventative care targeting patients with pre-conditions in rural locations are severely lacking in the context of the COVID-19 pandemic. By leveraging CMS preventive care initiatives along with telehealth services, healthcare providers can achieve the following core objectives.

First, there are financial incentives with preventive care services that will relieve the burden on healthcare systems. Second, COVID-19 vulnerable populations will receive the attention and focus from healthcare providers that they deserve to slow the spread through the use of early detection systems and alerts to their primary health provider. Third, by combining with telehealth service, healthcare providers can efficiently and effectively reach out to rural populations that were once inaccessible to standard healthcare practices.

What You Should Know:

– Today, Blue Cross and Blue Shield of North Carolina partners
with Carrot Inc. and Virta Health to help address two of the largest ongoing
health issues facing Americans today – smoking and type 2 diabetes.

– Virta and Carrot’s programs will be available to
individual under-65 members and fully insured group members beginning November
2020.

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Blue Cross and Blue Shield of North Carolina (Blue Cross NC), today announced it is teaming up with Carrot Inc. and Virta Health to launch no-cost virtual programs to help members quit smoking and reverse type 2 diabetes. Virta and Carrot’s programs will be available to individual under-65 members and fully insured group members beginning November 2020 at no cost. They support Blue Cross NC’s commitment to make health care better, simpler and more affordable by providing members easy access to care through digital technology. 

“We resolve to make whole person care a priority, and that means we have to think beyond treating conditions, and work to prevent and reverse them,” said Von Nguyen, vice president of clinical operations and innovations at Blue Cross NC. “We are excited to team up with Carrot and Virta and bring their innovative, life-changing programs directly to the homes of our members and address some of North Carolina’s most pressing health issues.”

Carrot’s Clinically-Proven Program Empowers People to
Quit Smoking 

In addition to being the leading cause of preventable death in the U.S., smoking remains a tremendous burden on our nation’s health care system. According to the Centers for Disease Control and Prevention, more than 16 million Americans are living with a disease caused by smoking, and for every person who dies because of smoking, at least 30 people live with a serious, smoking-related illness such as diabetes, COPD, heart disease, or cancer. Smoking-related illness costs the State of North Carolina over $13 billion every year.  

Carrot’s clinically-proven, app-based program Pivot, combines innovative technology, human-centered design, and behavioral science to empower people to quit smoking and remain non-smokers. In a recent clinical study 42 percent of participants achieved a successful quit over the course of the study, and seven months after the onset of the study, 86 percent of those who quit were smoke-free.

Pivot’s digital solution includes text-based access to
trained tobacco experts, a first-of-its-kind personal breath sensor to track
progress, nicotine therapy products, and access to Pivot’s online community for
collective wisdom and inspiration.  

“Carrot is excited to collaborate with Blue Cross NC to ease the burden smoking has long placed on the state of North Carolina and the American health care system,” said David S. Utley, M.D., CEO of Carrot Inc. “Quitting smoking is hard – every year, millions try to stop smoking. We’re proud to bring Pivot to the hundreds of thousands of Blue Cross NC members who want to live life tobacco free and help them prevent or reverse the severity of chronic conditions like diabetes, heart disease and COPD.”

Diabetes Reversal with Virta Health
More than 3.7 million people in North Carolina—nearly half of the adult
population—have either prediabetes or type 2 diabetes.  According to the
CDC, diabetes increases the risk for severe illness for those with COVID-19.

Virta Health, the leader in type 2 diabetes reversal, uses an innovative virtual care model that helps patients achieve normal blood sugar while eliminating the need for diabetes-specific medications. Patients receive near-real-time access to board-certified physicians and health coaches who provide expert, individualized guidance on nutrition and behavioral change through the Virta app. Virta also serves as a partner to Primary Care Providers, integrating its specialized diabetes reversal treatment into existing care plans.

In Virta’s peer-reviewed clinical outcomes, at one year 94
percent of participants reduced or eliminated the need for insulin. The
majority of patients eliminated all diabetes-specific prescriptions while
achieving normal blood sugar. Results also include 12 percent (30lbs) weight
loss, and improvement in over 20 markers of cardiovascular health, including
blood pressure.

“This is a massive opportunity to change the direction of health of an entire state, save lives, and significantly reduce healthcare spend along the way,” said Sami Inkinen, Virta Health co-founder and CEO. “Our collaboration with Blue Cross NC provides strong optimism that we can solve the type 2 diabetes crisis our nation is facing.” 

Shots:

• The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere in 15500+ patients globally across 11 trials
• P-III ETHOS study results reported that triple-combination therapy showed a reduction in the rate of moderate or severe exacerbations compared with the Bevespi Aerosphere over 52wks. In both trials, the safety and tolerability of Trixeo Aerosphere were consistent with the profiles of the dual comparators
• Trixeo Aerosphere is a single-inhaler, fixed-dose triple combination of formoterol fumarate, glycopyrronium bromide with budesonide, delivered in a pressurized metered-dose inhaler, and is approved under the brand name Breztri Aerosphere in Japan, China & the US for COPD

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: TeleTrader.com

The post AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat COPD first appeared on PharmaShots.

AireHealth, which makes portable nebulizers for patients with respiratory conditions, plans to launch its first connected product next year.

Verona Pharma is to develop its lung drug ensifentrine for patients with COVID-19, joining the legions of drug companies repurposing their medicines to fight the pandemic.

Based in the UK and US, Verona is due to start a phase 3 trial of ensifentrine in chronic obstructive pulmonary disease (COPD) later this year after encouraging results in phase 2.

But president and CEO David Zaccardelli said the company has received clearance from the FDA to begin a pilot clinical trial in patients hospitalised with COVID-19.

The randomised double-blind, placebo-controlled study will test ensifentrine delivered through a pressurised metered-dose inhaler at the University of Alabama at Birmingham, Zaccardelli said in an update accompanying the firm’s half year results.

He added: “Clinical data from prior studies of ensifentrine in other respiratory diseases have demonstrated ensifentrine improves lung function and reduces cellular markers of inflammation in the lungs.

“We believe ensifentrine, with its novel mechanism of action, has the potential to improve oxygenation and lung function assisting recovery from COVID-19.”

But the pandemic has impacted development of ensifentrine – in March the company postponed the start of the second multiple dose part of the phase 2 study, with an inhaled formulation in patients with moderate to severe COPD.

This trial is slated to start in the third quarter and the company says it has sufficient funding for the phase 3 trial ensifentrine, which will test a nebulised formulation of the drug.

In July, Verona raised around £159 million ($200 million) with a private placement to fund phase 3 development, keeping around £145 million ($183 million) after deducting agent fees and expenses.

Like many biotechs Verona is loss-making as it does not have a marketed product and nearly all revenues are directed towards R&D and operating costs.

In the first six months, the company reported a loss after tax of £16.9 million ($22.2 million), compared with £14.4 million ($18.9 million) in the corresponding period last year.

Ensifentrine, which could be used in other respiratory diseases such as asthma and cystic fibrosis, combines bronchodilator and anti-inflammatory properties in one compound.

It works by inhibiting phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes – a very different mechanism of action from approved drug classes to treat COPD such as corticosteroids, beta2-agonists and anti-muscarinic drugs.

Zaccardelli took over as CEO in February, replacing Jan-Anders Karlsson, who retired after eight years to pursue non-executive roles.

The post Verona Pharma to trial lung drug ensifentrine for COVID-19 appeared first on .

What You Should Know:

– Innovaccer has recently partnered with CareSignal to
address healthcare’s urgent need amidst the COVID-19 pandemic: to create and
maintain solid, clinically actionable relationships with patients in a new set
of predominantly virtual care.

– CareSignal offers evidence-based end-to-end support services for chronic medical conditions such as asthma, CHF, COPD, diabetes, depression, hypertension, and hospital discharge support, and maternal health monitoring.

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Innovaccer, Inc., and CareSignal today announce a partnership to address healthcare’s urgent need amidst the COVID-19 pandemic: to create and maintain solid, clinically actionable relationships with patients in a new setting of predominantly virtual care.

Partnership Details

The partnership combines more than two dozen
condition-specific patient monitoring programs with population
health data insights for a more integrated care and improved clinical
outcomes with industry-leading financial returns.

CareSignal offers evidence-based end-to-end support services for chronic medical conditions such as asthma, CHF, COPD, diabetes, depression, hypertension and hospital discharge support, and maternal health monitoring. With a focus on prevention and addressing the social determinants of health, each program offers personalized clinically-validated features to deliver even more value from Innovaccer’s population health, care management, and organization-specific offerings. 

“Innovaccer has always stayed on top of delivering on promises to our customers, and our partnerships with leading organizations have been instrumental in achieving 100% client satisfaction,” says Abhinav Shashank, CEO at Innovaccer. “Working with CareSignal supports our mission to help healthcare care as one. With CareSignal as our partner, we will strengthen our approach towards better patient engagement and enable smart deviceless remote patient monitoring.”

Shots:

• The approval is based on P-III ETHOS study assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) vs dual therapies [Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate)] with mod. to sev. COPD and a history of exacerbation(s) in the previous year
• The P-III ETHOS study demonstrated a reduction in the rate of moderate or severe exacerbations. Additionally, the P-III KRONOS study also support the approval of the therapy
• Breztri Aerosphere is an approved therapy in Japan and China for patients with COPD and is under regulatory review in the EU. As per the agreement to acquire Pearl Therapeutics, AstraZeneca paid $150M as a milestone on US approval of the therapy for COPD

Click here to read full press release/ article | Ref: AstraZeneca | Image: 

Related News: AstraZeneca Reports Results of Breztri Aerosphere in P-III ETHOS Study to Treat COPD

AstraZeneca’s triple therapy for chronic obstructive pulmonary disease (COPD), Breztri Aerosphere (budesonide+glycopyrrolate+formoterol fumarate), has been approved in the US following a rejection last year.

Approval follows a rejection by the FDA in October last year after the FDA refused to grant a licence based on findings of the KRONOS clinical trial and asked for further clinical data to support its filing.

AZ has since submitted data from its second phase 3 trial, ETHOS, allowing the FDA to approve.

The approval was based on the clinical data showing that Breztri outperformed AZ’s already marketed dual therapy Bevespi Aerosphere (glycopyrrolate+formoterol fumarate) and a combination of budesonide and formoterol fumarate.

FDA approval triggers a $150 million milestone payment under the terms of its agreement to buy Pearl Therapeutics in 2013, which was worth up to $1.15 billion.

Approval in the US was also supported by efficacy and safety data from the phase 3 KRONOS trial.

The deal, based on a $560 payment up front plus development milestones, added the main components of the double and triple therapies to AZ’s pipeline – a fixed-dose combination of the long-acting beta-2 agonist formoterol fumarate and glycopyrrolate.

Breztri Aerosphere is approved in Japan and China for patients with COPD and is under regulatory review in the EU. It is not indicated for relief of acute bronchospasm or asthma in the US or other countries.

The US respiratory diseases market is highly competitive after the FDA finally approved a generic of GSK’s blockbuster COPD and asthma drug Advair.

Sales of Advair had been propped up because the FDA has tough requirements for manufacturers who are trying to make generic copies of drug/device combinations.

This meant that Advair had not been directly challenged until last year even though its main patent expired in 2010, and the patent on the Diskus inhaler expired in 2015.

Aside from Advair generics GSK also markets Trelegy in COPD, and there are other potential competitors in the pharma pipeline.

Last week Verona Pharma raised $200 million in an oversubscribed private fundraiser, which will finance phase 3 development of its COPD drug ensifentrine.

This has a different dual mechanism of action, opening the airways and reducing inflammation in the lungs by inhibiting the enzymes phosphodiesterase 3 and 4.

The post AZ’s COPD triple therapy approved in the US appeared first on .

Teva has launched new digital inhaler and drug combination in the US, containing built-in sensors that connect to a phone to help manage asthma and COPD symptoms. 

Israel-based Teva said the system conveys information to patients, who can use the product branded as ProAir Digihaler (albuterol sulfate) for patients with asthma and chronic obstructive pulmonary disease (COPD). 

Teva noted it is the first and only digital rescue inhaler indicated in patients four years or older for the treatment or prevention of bronchospasm who have reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB). 

The inhaler detects, records and stores objective inhaler event data, including timestamp and inhalation characteristics such as peak inspiratory flow. 

Patients are then able to view this data on the app, which informs patients if their inhaler technique may need improvement. 

The patients can choose to share these data with their healthcare providers to help facilitate dialogue around the assessment and management of their condition and discuss if their inhaler technique may need improvement. 

Teva is developing a suite of digital inhaler products in the US – AirDuo Digihaler (fluticasone propionate and salmeterol) and ArmonAir Digihaler (fluticasone) are both used for maintenance of asthma in patients. 

Both products are expected to become commercially available to patients in the coming months. 

Last year saw a key development in the US respiratory diseases market when Mylan finally launched its generic version of GlaxoSmithKline’s blockbuster inhaler Advair (fluticasone+salmeterol). 

The competition for the product approved in asthma and COPD had been delayed for years because of the FDA’s stringent approach to copies of drug-device combination products. 

The main patent on Advair had expired as long ago as 2010, while the patent on GSK’s Diskus inhaler ran out in 2016. 

Mylan launched its Advair generic at a 70% discount compared with GSK’s original drug and was the first of a group of potential generics, although a rival from Hikma has hit trouble with the FDA and was refiled late last year. 

The post Teva launches digital asthma and COPD rescue inhaler in US appeared first on .

What You Should Know:

– Propeller Health announced
it will co-package a new asthma medication from Novartis, which was
approved by the European Commission this week for use in the EU.

– Enerzair®
Breezhaler® plus Propeller Health sensor is the first asthma medication to be
co-packaged and co-prescribed with a digital health platform.

– Propeller’s solution
works by attaching a sensor to the Enerzair® Breezhaler® inhaler, which then
delivers objective data on medication use to the Propeller app on the patient’s
smartphone

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Propeller Health today announced a collaboration with Novartis to co-packaged the Propeller digital health platform with Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]), a recently approved Novartis medication developed to treat uncontrolled asthma. Propeller previously announced a collaboration with Novartis to develop a custom add-on sensor for the Breezhaler® inhaler, a device used for the company’s portfolio of COPD treatments (Ultibro® Breezhaler®, Onbrez® Breezhaler®, and Seebri® Breezhaler®), connecting these medications to Propeller’s digital health platform. The same sensor will be co-packaged with Enerzair® Breezhaler®.

Why It Matters

This collaboration marks the first time a digital health tool will be packaged and prescribed alongside an inhaled asthma medication. Enerzair® Breezhaler® and Propeller sensor and app received approval from the European Commission in July and will launch across Europe starting in 2020. Healthcare professionals in Europe will have the option to prescribe Enerzair® Breezhaler® with or without the companion digital health platform. The medication is not available in the U.S.

Enerzair® Breezhaler® was approved as a maintenance treatment of
asthma in adult patients not adequately controlled with a maintenance
combination of a long-acting beta₂-agonist
(LABA) and a high dose of an inhaled corticosteroid (ICS) who experienced one
or more asthma exacerbations in the previous year.

Impact of Uncontrolled Asthma

Asthma affects an estimated 358 million people worldwide and can cause a significant personal, health, and financial burden when not adequately controlled. Despite current therapy, over 40% of patients with asthma at Global Initiative for Asthma (GINA) Step 3, and over 45% at GINA Steps 4 and 5 remain uncontrolled. Patients with uncontrolled asthma may downplay or underestimate the severity of their disease and are at a higher risk of exacerbation, hospitalization, or death. Barriers, such as less than optimal adherence, incorrect inhaler technique, treatment mismatch, safety issues with oral corticosteroids, and ineligibility for biologics, have created an unmet medical need in asthma.

Enerzair Breezhaler 

Enerzair Breezhaler is provided in a transparent capsule that allows patients to see that they have taken their medication and will be administered via the dose-confirming Breezhaler^® device, which enables once-daily inhalation using a single inhaler. The digital companion includes a sensor that attaches to the Breezhaler device and can be linked to the Propeller Health smartphone app, providing patients with inhalation confirmation, medication reminders, and access to objective data that can be shared with their physician in order to help them make better therapeutic decisions.

Propeller’s solution works by attaching a sensor to the
Enerzair® Breezhaler® inhaler, which then delivers objective data on medication
use to the Propeller app on the patient’s smartphone. The app also sends the
patient reminders to take their prescribed dose and keeps a record of adherence
data over time. The patient can share that data with their clinician to help
inform the patient’s treatment plan.

In previous clinical studies unrelated to this collaboration, the Propeller platform has been shown to increase asthma control by up to 63 percent, increase medication adherence by up to 58 percent, and reduce asthma-related emergency department visits and hospitalizations by as much as 57 percent.

“Our collaboration with Novartis to co-package Propeller with Enerzair® Breezhaler® is the first time a pharmaceutical company and digital health company have worked together to package a digital health platform with an asthma medication,” said David Van Sickle, co-founder and CEO of Propeller Health. “The ability to prescribe a maintenance medication with Propeller will make it easier for healthcare professionals to engage their patients in self-management.”