With over 70% of Medicaid beneficiaries being enrolled in plans from managed care organizations (MCOs), managed care has become a major player in the American health insurance industry. A new article by the Kaiser Family Foundation (KFF) takes a look at five of the largest MCOs and how they are […]
ICER Faces Backlash for Proposed Changes to Value-Assessment Framework
The Institute for Clinical and Economic Review has received industry backlash over changes to its value-assessment process it proposed in June. The changes, if implemented, would lower the threshold ranges for cost-effectiveness down to $50,000 to $100,000 a year, a net drop of $50,000 at each end […]
Biden Administration Rolls Back Limit on Short-Term Health Plans
The Biden administration and the US Department of Health and Human Services (HHS) have put forward a proposed rule that would set the limit for short-term health insurance to 4 months, reversing a Trump-era rule that gave them durations up to one year with the chance of renewal. Democrats derided […]
Study Finds Many New Drug Indications Don’t Add Value
A newly published study in the BMJ finds that almost 60% of drugs receiving new indications from the US Food and Drug Administration (FDA) do not add high therapeutic value to patients. As a result, the researchers argue that patients and providers should be aware and that prices should be set […]
Alzheimer’s Drug Leqembi Gets Full FDA Approval and Medicare Coverage
Eisai and Biogen’s Alzheimer’s treatment Leqembi (lecanemab) has received full approval by the US Food and Drug Administration (FDA). This marks the first full approval for an Alzheimer’s disease treatment in decades and clears the path to Medicare reimbursement, which previously required providers […]
Expert Panel Agrees Recent Regulation has Advanced Real-World Data Applications
A panel of regulatory experts discussed how regulatory initiatives have advanced the use of real-world data (RWD) at this June’s Drug Information Association’s global meeting. The panelists, who came from the US Food and Drug Administration (FDA), Health Canada (HC), European Medicines Agency (EMA), […]
Major Hospitals Join Legal Battle Over High Generic Drug Prices
The Mayo Clinic, Mount Sinai, and around 150 other hospitals have joined other care centers in suing major drug manufacturers over inflated prices for generic medications. The lawsuit alleges that drugmakers like Pfizer, Sandoz, and Teva have illegally collaborated for over a decade to keep generic […]
Clinical Trial Diversity on the Decline
According to a recent IQVIA report, clinical trial diversity is on the downswing despite recent efforts to the contrary. The research specifically identified significant under-representation for Black and Hispanic patients. Industry action is needed, according to IQVIA, as clinical trial […]
Samsung and Pfizer Expand Collaboration to Accelerate Biosimilar Production
Samsung Biologics and Pfizer have announced they are expanding their current collaboration to ramp up production of biosimilars, bringing the agreement to a value of $897 million. The announcement comes as Pfizer and another branch of Samsung both prepare for US launches of their Humira […]
UK Public Okay with NHS Data Storage with Some Reservations
The UK’s NHS generates massive amounts of real-world data (RWD) every day, but recently data security has become a concern. However, a recent survey found that 59% of participants feeling comfortable with the agency storing their data, although most (89%) felt it was important that the data was […]
US Senator Bernie Sanders Looks to Cap Prices on Publicly Funded Drugs
US Senator Bernie Sanders (I – VT) is looking to include price caps on drugs developed with federal funding into a reauthorization of the 2006 Pandemic and All-Hazards Preparedness Act. The proposal would place a ceiling price that matches the lowest price for a given drug in France, Germany, Japan, […]
ICER to Perform Value-Assessment for KarXT Schizophrenia Treatment
The Institute for Clinical and Economic Review (ICER) will perform a value-assessment on KarXT (xanomeline tartrate/trospium chloride), Karuna Therapeutics’ experimental therapeutic for schizophrenia. Public discussion of the assessment will take place next February at the 2024 New England CEPAC […]
Amicus Therapeutics Gets EU Approval for Pompe Disease Drug
Amicus Therapeutics has received approval from the European Commission (EC) for Opfolda (miglustat), its treatment for Pompe disease, a rare disorder that causes progressive muscle weakness. The approval specifically covers the drug in combination with Pombiliti (cipaglucosidase alfa). Results from […]
Examining Representation Disparities in aRCC Clinical Trials
A recently published abstract in the Journal of Clinical Oncology examined patient populations in clinical trials for advanced renal cell carcinoma (aRCC), finding that significant underrepresentation based on age, ethnicity, and racial backgrounds. The study examined data from multiple real-world […]
A Wave of Humira Biosimilars Hit the US Market
Several new biosimilars to AbbVie’s Humira (adalimumab) have just hit the US market in the past week, bringing a new wave of competition for the expensive top-selling therapeutic of all time. The copycats come from companies like Organon, Samsung Bioepsis, Sandoz, and Boehringer Ingelheim. Hadlima, […]
Using Patient Registries to Accelerate Rare Disease Research
In a recent interview with Clinical Leader, , PhD, of the Indo US Organization for Rare Diseases (IndoUSrare) talks about the challenges facing rare disease research and how the use of patient registries can accelerate research and clinical development. Patient registries allow the collection of […]
Celltrans Secures FDA Approval for First Type 1 Diabetes Cell Therapy
The US Food and Drug Administration (FDA) has approved Lantrida (donislecel), the first cell therapy for diabetes type 1. Celltrans’ treatment is now approved for use in adults with “brittle” diabetes type I, a rare form of the disease wherein patients have recurrent severe hypoglycemic episodes. […]
Exploring Health Disparities in Childhood Epilepsy
A recently published article in Clinical Psychology in Medical Settings finds that health disparities faced by children and youth with epilepsy (CYE) are poorly explored in the scientific literature. The authors of the paper noted that very few epilepsy studies actually focused on identifying health […]
CMS Publishes Revised Guidance for Medicare Drug Pricing Negotiations
As the upcoming Medicare drug pricing negotiations approach, the US Centers for Medicare and Medicaid Services (CMS) have released a revised guidance that better outlines the process. Pharma companies and industry groups have been anxiously awaiting such clarification, but the new information has […]
Looking to the Future of AI in Healthcare
Artificial Intelligence (AI) is increasingly being incorporated into every aspect of society, including healthcare. From diagnostics to reimbursement, AI is taking a foothold in healthcare and medicine from drug development to the clinic. However, significant barriers to realizing the potential of […]
CMS Makes Changes to Upcoming Medicare Drug Pricing Negotiations
In response to a series of lawsuits from the pharma industry, the US Centers for Medicare and Medicaid Services (CMS) have announced changes to upcoming Medicare drug pricing negotiations. The agency dialed back a confidentiality policy associated with the negotiations, a sticking point for some […]
Healthcare Costs to Jump by 7% in 2024
A report by PwC projects that healthcare costs will rise by 7% next year. The report was based on interviews with major payer organizations covering over 110 million patients in the US. Estimated increases in costs are attributed to labor shortages, rising drug prices, provider contracts, and […]
BioMarin Nets First FDA Approval for Severe Hemophilia A Gene Therapy
BioMarin Pharmaceuticals has received full approval by the US Food and Drug Administration (FDA) for its gene therapy Roctavian (valoctocogene roxaparvovec-rvox) for severe hemophilia A in adults. This marks the first gene therapy for patients with severe cases of the disease, which causes bleeding […]
NPPA Caps Prices for 51 Medications
India’s National Pharmaceutical Pricing Authority (NPPA) has announced its latest round of ceiling prices for medications, this time capping the prices of 51 medications and 2 formulations for anti-coagulant therapeutics. The other drugs covered include 24 diabetes treatments. The NPPA is India’s […]
Canadian Agency for Drugs and Technologies in Health Publishes Real-World Evidence Guidance
As real-world evidence (RWE) and real-world data (RWD) increasingly supplement data from randomized controlled trials (RCTs) in regulatory decision-making in Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH) has issued a guidance for RWE reporting. The guidance, published in […]
The Next US Presidency Doesn’t Look Friendly to Pharma
No matter who wins the next US presidency, it doesn’t look that there will be a friend to the pharma and biotech industries in the White House, according to a new Axios article. Donald Trump, the current Republican front-runner has already repeated his previous campaign promise of not letting the US […]
Looking at How Medicaid Expansion Affect Sexual and Reproductive Health
Extensive research has explored how Medicaid expansion has impacted health outcomes in 40 US states, generally finding that it improves health outcomes for patients and provides financial benefits for state governments. A new report by the Kaiser Family Foundation reviews the recent literature […]
Study Explores Real-World Data Reporting Quality According to RECORD Statement
With the rise of real-world data (RWD) and real-world evidence (RWE), a lack of transparency impairs reproducibility and quality assessment. The Reporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement was drafted to help address this issue. A newly […]
CMS Will Cover New Alzheimer’s Drugs with Real-World Data Registry Participation
The US Centers for Medicare and Medicaid Services (CMS) has provided more insights into coverage details regarding new therapeutics for Alzheimer’s disease. Once a drug receives approval by the Food and Drug Administration (FDA), Medicare will cover them if clinicians participate in a real-world […]
Turning Real-World Data into Action in the NHS
Despite recent high-profile examples, biopharma startups face difficulties partnering with the UK’s NHS. This represents a missed opportunity due to the agency’s vast repository of healthcare real-world data (RWD), which could be used to accelerate drug development, value-assessment, and regulatory […]
