Category: access

  • CMS coverage decision restricts access to treatments for Alzheimer’s disease

    This year’s Alzheimer’s and Brain Awareness Month offers an important opportunity to remember the severe toll that Alzheimer’s takes on patients and family caregivers. Unfortunately, this year also provides a painful reminder that Medicare patients are facing severe access restrictions to the first class of treatments that could change the underlying progression of the disease. […]

  • FDA advisors back COVID jabs for very young children

    The FDA’s vaccines advisors have voted in favour of extending the use of mRNA-based COVID-19 vaccine from Moderna and Pfizer/BioNTech to include children from the ages of six months. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to zero in favour of both vaccines in this age group, in light of rising […]

  • UK grants early access to Argenx’ efgartigimod for myasthenia gravis

    The UK regulatory authority has cleared the path for some patients with generalised myasthenia gravis (gMG) to get early access to Argenx’ efgartigimod while it reviews the marketing application for the drug. The Medicines and Healthcare products Regulatory Agency (MHRA) has given a positive opinion on efgartigimod to be included in the Early Access to […]

  • Coalition aims to improve cancer drug access in poorer nations

    Several of the top pharmaceutical companies have joined a new coalition that aims to improve access to cancer medicines in low- and lower-middle-income countries (LLMICs). The new initiative – called ATOM (Access to Oncology Medicines) – pledges to tackle the issue that fewer than 50% of the cancer medicines on the World Health Organization’s essential […]

  • NICE backs Biogen’s Vumerity for multiple sclerosis

    Patients with relapsing-remitting multiple sclerosis (RRMS) in England, Wales and Northern Ireland can now access treatment with Biogen’s oral therapy Vumerity, after NICE recommended the drug for routine NHS use. The decision means that Vumerity (diroximel fumarate) – a follow-up to Biogen’s older oral therapy Tecfidera (dimethyl fumarate) – is now available to eligible patients […]

  • Drugmakers pledge shorter launch times for drugs in EU

    Pharmaceutical companies have said they will try to carve months off the time between approval and launch for new medicines in Europe, and reduce disparities between access between countries. The drugmakers – all members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) trade organisation – said the key to reducing the launch time […]

  • NICE verdict on Trodelvy threatens unequal access to drug in UK

    In draft guidance, NICE has said it cannot recommend Gilead Sciences’ Trodelvy in triple-negative breast cancer (TNBC), setting up a disparity in access to the drug via the NHS in the UK. The health technology assessment (HTA) agency  said that while Trodelvy (sacituzumab govitecan) increases the time people have before their disease worsens and how […]

  • Moderna squares off with US government over COVID jab patent

    After being hailed as a triumph of public-private drug development, Moderna’s partnership with the US government on its COVID-19 vaccine looks like it may descend into acrimony. That is according to a New York Times report, which says Moderna is now in dispute with the National Institutes of Health (NIH) after it filed a US […]

  • Cautious welcome as NICE backs Forxiga for chronic kidney disease

    Tens of thousands of people with chronic kidney disease in England could be eligible for treatment with AstraZeneca’s SGLT2 inhibitor Forxiga, after NICE backed NHS use of the drug in draft recommendations. AZ said that the decision is a “milestone” in the treatment of CKD, becoming the first new treatment option for patients in nearly […]

  • Novavax gets first authorisation for its COVID-19 jab

    Novavax has been granted its first emergency use authorisation in Indonesia for COVID-19 vaccine NVX-CoV2373, and expects other regulators in India, the Philippines and other countries to follow suit in the coming weeks. The vaccine is the first based on recombinant protein to be approved anywhere in the world, and has the key advantage over […]

  • Merck takes further steps to expand access to oral COVID pill

    Merck & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture its much-anticipated oral antiviral for COVID-19. The agreement would provide royalty-free licenses to companies manufacturing molnupiravir – originally developed by Ridgeback Biotherapeutics – for distribution in 105 low- and middle-income […]

  • NHS fast tracks access to Amgen’s just-approved KRAS cancer drug

    Amgen’s first-in-class KRAS inhibitor Lumykras has been approved in Great Britain and arrives already armed with an agreement to allow early access while its cost-effectiveness is appraised by NICE. The MHRA has approved Lumykras (sotorasib) for patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation, and […]

  • Should hospitals pay for housing for ED frequent flyers?

    That is one approach being explored in Philadelphia according to an article in Kaiser Health News. Using funding from Temple University, two Pennsylvania Medicaid health plans, and some grant funding, the Template University Health System: …launched a two-year program last year to help 25 homeless Medicaid patients who frequently use its emergency room and other […]

  • Healthcare bills to pay? Let pick up the tab

    Just over a year ago, launched an app that takes the legwork out of submitting reimbursement claims to private health insurers. Now, the startup has taken another leap forward, settling users bills immediately.  Fredrik Debong The addition to the app acts as a digital health expense account, according to the company’s co-founder and […]

  • Beyond Reference Management: How Literature Management is a Win for the Life Science Organization

    Scientific literature is a critical component to virtually all aspects of a life science enterprise, including Medical Affairs, Pharmacovigilance and R&D. However, the process of curating and sharing literature can lead to significant challenges in organizing content, facilitating collaboration and enforcing copyright compliance. In many cases, reference management tools (e.g. EndNote, Zotero) are used to […]

  • Getting the 340B program back on track in 2021

    As our nation continues to fight a global pandemic, the need for access to affordable and quality health care feels even more pressing. This is especially true for vulnerable patients who have been disproportionately impacted by COVID-19. That’s why it has never been more important for policymakers to ensure federal programs, like the 340B program, […]

  • Why hospitals want CMS, FTC to examine two UnitedHealthcare policies

    Two UnitedHealthcare policies have raised several concerns among providers, including that they may display anti-competitive behavior and could block patient access to certain healthcare services. The American Hospital Association is asking the FTC and CMS to review and potentially block these policies.

  • Patients report unmet care needs despite rising telehealth use

    Roughly a third of adults had a telehealth visit in the first 6 months of the pandemic, according to a new survey conducted by the Urban Institute. But not everyone who wanted a telehealth visit was able to access it, leaving some adults with unmet care needs.

  • After NICE okay, Scots denied access to Vifor’s Veltassa

    The Scottish Medicines Consortium (SMC) has ruled that there’s not enough evidence to support NHS funding of Vifor Pharma’s Veltassa for excess potassium in the blood (hyperkalaemia), even though patients in England can access the drug. It’s the second time that the SMC has rejected Veltassa (patiromer), having previously turned it down for hyperkalaemia in […]

  • Alvotech and Cipla Collaborate to Ensure Access to Biosimilars in South Africa

    Shots: Alvotech and Cipla entered an exclusive partnership to provide patients with better access to high quality and cost-effective biosimilar medicines in South Africa Alvotech will be responsible for the development and supply of the products and Cipla will be responsible for the registration and commercialization The biosimilar portfolio will include five biosimilars- two for […]

  • Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine

    The US government has signed another big coronavirus vaccine supply deal, snapping up 100 million doses of Moderna’s mRNA jab for a little over $1.5 billion –around $15 per dose or $30 per course. That’s a steep discount on the $32 to $37 price per dose in its earlier smaller deals, revealing that purchasing power […]

  • UK places order for 60m doses of Sanofi/GSK’s COVID-19 vaccine

    The UK government has signed its fourth coronavirus vaccine deal, snapping up 60 million doses of an experimental shot being developed by Sanofi and GlaxoSmithKline. The order has come in even before the vaccine has started clinical development, with a phase 1/2 trial not due to get underway until September. Sanofi is providing the vaccine […]

  • US places $1.95 billion order for Pfizer/BioNTech’s COVID-19 vaccine

    The US government has agreed to pay Pfizer and BioNTech $1.95 billion to secure access to 100 million doses of their coronavirus vaccine on approval, just days after promising results in a clinical trial. The deal – part of the Trump administration’s Operation Warp Speed that aims to deliver 300 million coronavirus vaccines in early […]