CER Daily Newsfeed

Value-Based Insurance Design In The Modern Era

(5/12, Kimberly Westrich,Yevgeniy Feyman, John Michael O'Brien, Health Affairs Forefront) comments “...In October 2025, Cigna's Evernorth division, which operates Express Scripts, announced a new rebate-free pharmacy benefit that would replace the traditional rebate structure and make drug discounts negotiated with manufacturers available to patients at the pharmacy counter...Whether the rebate-free model represents a sea change will depend on other actors in the system. Employers have become reliant on rebate revenue to offset other health care costs and keep premiums down...Nonetheless, reducing reliance on rebates may create conditions more conducive to value-based formulary design by tying a drug's pricing, cost sharing, and utilization management requirements to its clinical value, thereby incentivizing the use of high-value products.” Full

Podcast: Are We Pricing Drugs Right? A Conversation with Peter Neumann on How Innovation is Valued Globally

(5/11, Leerink Partners: Perspectives) comments “...The discussion covers: Whether cost-effectiveness analysis captures all the factors that are considered when pricing a drug; How payers use outcomes assessments to shape, and sometimes restrict, coverage decisions; What Medicare drug price negotiations and MFN proposals reveal about ‘value-based pricing’; The distinction between price and value and whether current frameworks adequately reward innovation; The growing debate around centralized health technology assessment in the U.S.; Why the field may be moving toward narrower definitions of value over time.” Full

Video: Why Early RWE Planning Matters for Market Access

(5/12, Tommy Bramley, Stephen Appezzato, Pharmaceutical Commerce) “...[Tommy Bramley, SVP, Global Consulting at Cencora,] explains that RWE can help manufacturers identify unmet needs, better understand how a therapy compares against the standard of care, and evaluate endpoints that matter not only from a regulatory perspective, but also from an HTA and payer standpoint. He notes that these insights can help companies define a therapy’s place in treatment earlier in development and support more informed discussions around comparative effectiveness and patient value.” View Video

US FDA Mulls Repurposing Approved Drugs to Expand Access

(5/11, Reuters) reports “...The FDA is seeking information from patients, clinicians, researchers, and others on priority disease areas and potential candidates for drug repurposing, especially where data supports new uses but incentives to seek approval are limited...‘Too many patients lack effective treatment options, even when promising science exists,’ said FDA Commissioner Marty Makary, adding that, ‘Drug repurposing can make better use of available scientific data to deliver effective treatment options for patients in need.’” Subscription Required

Makary's Time atop FDA Over, Diamantas Named Acting Commissioner

(5/12, David Lim and Lauren Gardner, Politico) reports “...The embattled Food and Drug Administration commissioner is resigning from his role Tuesday after 13 months leading the federal agency, according to an administration official granted anonymity to discuss the development. Kyle Diamantas, who previously worked as the top food official at the agency, will lead the FDA in an acting capacity, the administration official said...‘It was really Secretary Kennedy himself who made this decision,’ the administration official said.” Full

Buchanan, Griffith Urge CMS to Protect ACOs While Cracking Down on Medicare Fraud

(5/12, Congressman Vern Buchanan) comments “...In their letter, the lawmakers praised CMS’s recent actions under the CRUSH initiative to address rapidly rising spending on products vulnerable to fraud, waste and abuse. They emphasized that ACOs have helped improve patient outcomes and reduce costs for taxpayers by promoting preventive care, chronic disease management and better care coordination. ‘We appreciate CMS’s leadership and its ongoing commitment to protecting the Medicare program while advancing innovative models of care,’ write Buchanan and Griffith. ‘We look forward to continued collaboration to ensure that program integrity efforts and accountable care initiatives work in tandem to strengthen Medicare for beneficiaries, providers and taxpayers alike.’” Full

EU Joint Clinical Assessments: Could Zepzleca, Imdylltra or Itvisma Be Next?

(5/12, Francesca Bruce, Pink Sheet) reports “...Some products on the list of drugs undergoing an EU-level joint clinical assessment under the Health Technology Assessment Regulation are likely to be approved by the European Commission in the near future, after which a JCA report should soon follow.” Subscription Required