News from Thursday, December 11, 2025
Articles
Do Medicare’s IPAY 2027 Negotiated Drug Prices Reflect Value For Money?
(12/11, Peter J. Neumann, Joshua T. Cohen, Sean D. Sullivan, Feng Xie, Health Affairs Forefront) comments “...One idea, advanced by health economist, Darius Lakdawalla, is to add the value-based price as a floor to balance the IRA’s ceiling price. The floor would provide a check against arbitrarily large price cuts and the vagaries of the political process. Another idea is to follow the practice of many health technology assessment organizations abroad and require manufacturers to submit comparative value information to CMS to inform the agency’s judgments.” Full
What IRA Drug Prices Will Mean for PBMs, Health Plans and Patients
(12/11, Denise Myshko, Managed Healthcare Executive) reports “...[The IRA] does not say that the negotiated products need to be preferred on formularies. The Magnolia Market Access surveys showed that some payers plan to increase utilization management efforts for these products as well as across the formulary, including delaying prior authorizations, excluding or limiting the number of nonnegotiated options or requiring step edits. Most plans surveyed said they will add utilization management and step therapy requirements to negotiated products and prefer products with rebates over negotiated drugs, and others said they would add step therapy or prior authorization beyond the clinical limits on the drug label.” Full
What Makes Evidence Matter? Examining the Real-World Evidence Decision Paradox
(12/11, The Evidence Base) reports “Despite significant advances in real-world evidence (RWE) methodology, its impact on regulatory and health technology assessment (HTA) decision-making remains inconsistent. This Deep Dive, based on a session at ISPOR Europe 2025, analyzes the structural, methodological and institutional factors that continue to limit RWE’s credibility, and outlines what is needed to generate evidence that decision-makers can confidently adopt.” Full
Ministers Seek Power to Control NHS Drug Approvals to Support US Pharma Deal
(12/11, Elisabeth Mahase, The BMJ) reports “Plans to give ministers more power over the UK drug watchdog risk opening the door to political interference in decisions over new treatments, health economists have warned...Proposed changes to the current legislative framework would also mean NICE no longer needing to consult on changes to the methods it uses in the development of its advice and recommendations when such changes are put forward by the health secretary.” Full
Press Releases
New Research Explores Future of Gene Therapy Financing in the U.S.
(12/11, National Pharmaceutical Council Press Release) “...‘Innovative Contracting for Gene Therapies: Current Landscape and Perspectives on the Future of Gene Therapy Financing in the USA’ illustrates lessons from the current landscape of innovative contracts between payers and manufacturers for gene therapies. The study is authored by Real Chemistry’s Jacqlyn W. Riposo, MBA, Kendra M. Gould, MSPH, Claire M. Csenge, MSc, and Theresa Schmidt, MA, consultant James T. Kenney, RPh, MBA, and NPC’s Tyler D. Wagner, PharmD, PhD, and Jon D. Campbell, PhD. ‘Gene therapies have the potential to reshape treatment paradigms through one-time, potentially curative interventions. Yet we're trying today to pay for these therapies with yesterday’s reimbursement system,’ says Dr. Wagner, NPC Director of Research. ‘Our landscape analysis of both literature and insights offers a multi-stakeholder view of the challenges and opportunities in gene therapy financing.’” Full
Institute for Clinical and Economic Review Releases Draft Evidence Report on Therapies for IgA Nephropathy
(12/10, ICER Press Release) “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of sibeprenlimab (Voyxact®, Otsuka Holdings Co., Ltd.), atacicept (Vera Therapeutics, Inc.), and delayed-release budesonide (“Nefecon”, Tarpeyo®, Calliditas Therapeutics AB) targeting abnormal complexes of immunoglobulin for IgA nephropathy.” Full
Institute for Clinical and Economic Review Publishes Evidence Report on Medication for Smoking Cessation
(12/11, ICER Press Release) “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of cytisinicline (Achieve Life Sciences, Inc.) for smoking cessation. Our primary comparison was with the smoking cessation drug varenicline.” Full
Canadian HTA Assessments Recognize Therapeutic Value of QALSODY™ (tofersen injection) and its Potential to Modify Disease Progression in Individuals Living with SOD1-ALS
(12/11, Biogen Canada Press Release) “Biogen Canada Inc. is encouraged by the recent Health Technology Assessment (HTA) evaluations issued by Canada's Drug Agency (CDA) and the Institut national d'excellence en santé et en services sociaux (INESSS) for QALSODY™ (tofersen injection), the first therapy designed to target a known genetic cause of amyotrophic lateral sclerosis (ALS).” Full
Journals
Comparative Effectiveness of Kyphoplasty and Radiation with or Without Radiofrequency Ablation in Spinal Metastases from Lung Cancer
Kamal Shaik, et al.
November 28, 2025, Healthcare (Basel)