Pharma and FDA Wary of Dueling Texas and Washington Abortion Pill Rulings
Last week’s ruling in a US federal court that struck down the decades-old approval of mifepristone, a key drug in the abortion pill, has the US Food and Drug Administration (FDA) and the entire pharma industry on edge. The ruling, according to some legal experts, would undermine the agency’s ability to independently approve drugs based on scientific evidence. Another ruling last Friday ordered the FDA to continue providing the drug to 17 states.
Patient-Reported Data Collection to Grow Through Medicare Drug Pricing Negotiations
A recent guidance from the US Centers for Medicare and Medicaid Services (CMS) stated that patient experiences will be factored into the upcoming Medicare drug pricing negotiations. As a result, patient-reported data collection is set to grow significantly. However, significant uncertainty surrounds the process and meeting as of yet unset parameters for the datya.
Mark Cuban’s Pharmacy Offers Invokana
Mark Cuban’s Cost Plus Drug Company has announced it now offers Invokana, an SGLT-2 inhibitor used to manage diabetes. The mail-order pharmacy will now provide a total of three brand name versions of the drug, Invokana, Invokamet, and the combination therapy Invokamet XR, which pairs the drug with metformin.
5 Tips for Achieving Reimbursement for Digital Health Solutions
The reimbursement landscape has shifted notably during the pandemic, opening pathways for digital health technologies and telehealth services. However, achieving reimbursement status can be challenging, especially considering the uncertainties surrounding the process. In a new Mobi Health News article, Timothy Lee and Dr. Liz Kwo give 5 takeaways to help digital health developers navigate this new environment. The first tip is to work with self-insured employers.
US HHS Secretary Becerra Warns Texas Abortion Pill Ruling Could Imperil Entire FDA Approval Process
Following a ruling invalidating the approval of mifepristone, a key component of the abortion pill, US Health and Human Services Secretary Xavier Beccera noted that such a decision undermines the Food and Drug Administration’s authority to approve therapeutics. Beccera said that the decision could let judges make the final call on whether drugs are approved, which may be weaponized against politically polarized drugs like COVID vaccines or new Alzheimer’s drugs.
Washington Judge Rules FDA Cannot Rollback Abortion Pill Access
The same day that a Texas judge issued a ruling invalidating the US Food and Drug Administration’s (FDA’s) decades long approval of mifepristone, a key component of the abortion pill, a federal judge in Washington state ruled that the FDA may not roll back access to the drug in 17 states. The ruling , delivered by US District Court Judge Thomas Rice, is in direct opposition by the nationwide ruling issued in Texas.
US Democrats Prepare Bill to Combat Abortion Pill Ruling
In response to a ruling by US District Court Judge Matthew Kacsmaryk that invalidated the 20-year-old approval of mifepristone, a key component of the abortion pill, US House Democrats have begun preparing a bill that would codify the agency’s right to approve the drug. The bill, which will likely face stiff resistance from the Republican House majority, was announced by representatives Pat Ryan (D-NY) and Lizzie Fletcher (D-Texas).
FDA Releases Guidance on Patient-Centered Drug Development
A final draft guidance regarding patient-focused drug development (PFDD) has been issued by the US Food and Drug Administration (FDA). The guidance covers data collection methods about patient care experiences and how they can be used in regulatory decision-making processes, specifically clinical outcomes assessments (COA).
NHS to Cover Lynparza for Breast and Prostate Cancer
Shortly after a recommendation from the UK’s National Institute for Care and Health Excellence (NICE), the NHS agreed to provide Lynparza, Merck and AstraZeneca’s prostate and breast cancer drug, to patients in Wales and England. The move comes after positive results showing the drug lowered mortality in breast cancer patients by a third.
NIH Announces Winners for RADx Tech Maternal Health Challenge
The US National Institutes of Health (NIH) announced the next round of winners selected to move forward in the Rapid Acceleration of Diagnostics Technology (RADx Tech) for Maternal Health Challenge, a contest to develop and assess digital health solutions to reduce post-partum maternal mortality. The winners will be awarded $75,000 for their efforts and entered into the next round of competition.
Unlocking the Potential of Price Transparency Data to Advance Value-Based Care
Despite new rules in the US requiring providers to collect and report pricing transparency data, just over three quarters of hospitals are lagging behind. If this data can be accurately collected and analyzed, it could help establish fair value-based pricing models that could benefit both patients and providers. In addition, the law targets payer-related data.
US Senators Looking to Make Changes to Upcoming Legislation on Generics and PBMs
US Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA) are looking to April 19th when they can start deliberating on changes to an upcoming piece of legislation about generic drugs and the pharmacy benefit manager (PBM) industry. The bipartisan effort comes after increasing public and congressional pressure on PBMs and drug prices.
Examining the Effect of CMMI Value-Based Care
The Association of American Medical Colleges (AAMC) released an issue brief that details the impact of Centers for Medicare and Medicaid Innovation (CMMI) value-based care on patient outcomes and healthcare costs. The AAMC notes that although these value-based care payment models have helped patients, better data collection practices are needed to advance health equity.
US Senators Propose Bill to Cap Insulin Costs for Every Patient
US Senators Raphael Warnock (D-GA) and John Kennedy (R-LA) have advanced a new bill that would lock the max price of insulin at $35 a month for all patients. The bill, entitled the Affordable Insulin Now Act of 2023, comes after manufacturers have voluntarily lowered insulin prices following price caps for Medicare patients in the Inflation Reduction Act.
US CMS Passes Rule Targeting Misleading Ads for Medicare Advantage Programs
The US Centers for Medicare and Medicaid Services (CMS) has implemented a new rule to limit misleading advertisements for Medicare Advantage programs. The rule would ban companies from producing advertising that would lead consumers to believe they are official government messaging. In addition, it would force companies to name the specific plans in their advertising.
NICE Declines to Recommend Cabometyx for Thyroid Cancer Treatment
In a new draft guidance, the UK’s National Institute for Health and Care Excellence (NICE) decided against recommending Ipsen’s small molecule drug Cabometyx (cabozantinib) for the treatment of differentiated thyroid cancer (DTC). The recommendation comes after approval for the indication was made last year.
NIA Announces Real-World Data Project to Advance Alzheimer’s Disease Research
Decades of research has generated vast amounts of real-world data (RWD) that can be leveraged to advance research into Alzheimer’s disease. The US National Institute on Aging (NIA) has announced a new effort to create the Real-World Data Platform (RWDP) to consolidate these disparate data sources, which cover the majority of people living with Alzheimer’s and other dementias.
Most Accelerated Approval Confirmatory Studies are Turned in Late
Accelerated approval by the US Food and Drug Administration (FDA) requires drug and device manufacturers to conduct confirmatory studies to support full approval. A newly published paper in JAMA Health Forum found that over half of these studies are turned in late to the agency. These delays were more common in trials for small molecule drugs and non-oncologic therapeutics
Defragmenting Community Health to Improve Outcomes
Fragmentation of care delivery systems results in patients falling through gaps in care, imperiling health outcomes and exacerbating health disparities. In a new Stat News article, Chris Dodd of the University of Washington School of Public Health and CMO of Emcara Health talks about how the Sea Mar Community Health Centers created an integrated approach to care that alleviated barriers to access for many patients.
Longitudinal Study Finds Racial and Ethnic Inequalities in Wealth and Health Relationship
Wealth is associated with better health outcomes, but a recently published study finds that this relationship differs significantly between racial and ethnic groups. The results, taken from the Longitudinal Survey of Youth 1997, found that wealth was strongly associated with wealth in white and Hispanic people, but was only associated with better outcomes in the wealthiest of Black young people.
Canada’s PAAB Releases Draft Guidance on Pharma Advertising Based on Real-World Evidence
The Canadian not-for-profit Pharmaceutical Advertising Advisory Board (PAAB) has just released a draft guidance covering pharma advertising to healthcare professionals (HCPs) based on real-world evidence (RWE). The guidance provides direction on assessing the validity and importance of RWE and the real-world data (RWD) it is derived from when making advertising decisions.
28 US States Will See Medicaid Enrollment Drop to Near Pre-Pandemic Levels
Just as US states begin the Medicaid redetermination process, a new report by Moody’s Investors Services finds that 28 states will see enrollment drop to numbers equivalent to pre-pandemic levels. Some states, the report notes, will settle on enrollment levels higher than those seen before the pandemic-era Medicaid redetermination pause.
Home Medical Equipment and Value-Based Care
Although value-based care models have become increasingly prevalent in recent years, they have yet to be implemented in several areas of care, including home medical equipment (HME). Speakers at a Medtrade panel session discussed the importance of moving to such models and what that entails for the HME industry.
FDA Clears Robotic Bassinet as Medical Device
Happiest Baby’s Snoo robotic bassinet was granted medical device approval by the US Food and Drug Administration (FDA). Snoo rocks infants with a built-in motor system and helps soothe babies with calming sounds, all while keeping them on their back. The device is intended to reduce sudden infant death syndrome (SIDS), which kills over 3,500 infants in the US each year.
Reducing the Financial Impact of Tuberculosis in India
Despite concerted efforts like the END TB Strategy, India faces the highest disease and economic burden for tuberculosis. A newly published study in PLOS Global Public Health, explores the financial burden and consequences for patients with TB in the nation. Regardless of the free diagnostic and treatment provided by the state, patients spent significant funds on care.
