CER Daily Newsfeed

Value Viewpoint: March 9, 2025

(3/9, Kimberly Westrich, LinkedIn) comments “New research published in the Journal of Managed Care and Specialty Pharmacy assesses how often U.S. commercial health plans reference health technology assessments (HTAs) in their coverage policies of specialty medicines. Authors reviewed the specialty drug coverage policies of 17 U.S. commercial health plans and found that HTAs were referenced in just 3.2% of policies. Ex-US HTAs were cited more frequently than US-based HTAs, with NICE being the most cited HTA organization. ICER citations accounted for only 0.5% of total citations.” Full

Policy Strategies To Propel Community Health Centers Into Value-Based Payment

(3/10, Hope Glassberg, Henry Chung, Jordanna Davis, Adam J. Falcone, Anthony Shih, Health Affairs Forefront) comments “...To support CHCs under VBP models, policymakers should prioritize enhancing visibility into VBP participation and performance. Dedicated funding is also essential, including temporary infrastructure payments or grants to help CHCs build capacity and take on additional financial risk. Standardizing VBP contracting terms can further reduce administrative burdens and streamline payer-provider collaboration.” Full

Makary Signals Some Interest In US FDA Staff Cuts, Fighting Patent Thickets

(3/7, Sarah Karlin-Smith, Pink Sheet) reports “...FDA Commissioner nominee Martin Makary said during his Senate confirmation hearing that he planned to assess agency personnel and did not seem opposed to some reductions. Makary also was interested in tackling patent thickets that prevent cheaper biosimilar and generic drugs. Makary seemed supportive of clinical trial diversity, but was unaware of Trump Administration actions in the area.” Subscription Required

Experts Propose Restricting Trademarks On Accelerated Approval Drugs to Speed Confirmatory Trials

(3/7, Jeff Craven, Regulatory Focus) reports “...Manufacturers might be incentivized to speed up completion of confirmatory trials for their accelerated approval drugs if they are restricted from using a brand name until the drug is granted full regulatory approval by the US Food and Drug Administration (FDA), according to a recent Viewpoint article published in JAMA Health Forum.” Full

FDA's Accelerated Approval Guidance Gets Pushback from Industry

(3/7, Joanne S. Eglovitch, Regulatory Focus) reports “...The pharmaceutical industry has some questions regarding the US Food and Drug Administration's (FDA) recent guidance on its accelerated approval program for drugs and biologics. Industry groups also asked for greater clarity about when the agency will provide feedback on confirmatory trials and how the guidance would align with the agency's other policies on accelerated approval.” Full