CER Daily Newsfeed

Value Viewpoint: September 12, 2025

(9/12, Kimberly Westrich, LinkedIn) comments “In Patient Experience Dossiers: Connecting Decision Makers With Patient-Centered Evidence, co-authors Elisabeth Oehrlein, Omar Escontrias, Hayley Chapman, and Joe Vandigo propose a Patient Experience Dossier as a transparent, standardized method to share patient experience data (PED) and patient-centered evidence (PCE) with decision-makers. The authors conclude: ‘The PE Dossier template is currently being used to develop disease-specific dossiers. In the future, we envision that disease-specific PE Dossiers will be created and used by various decision-makers. Uptake of PE Dossiers can lead to more targeted, informed discussions among the patient community and biopharmaceutical companies, academic researchers, regulatory bodies, value/health technology assessment (HTA) bodies, and payers.’” Full

A New Patent Fee Could Upend American Innovation

(9/15, Hans Sauer, The Washington Post) comments "The Commerce Department is mulling a change to the 235-year-old patent system that would impair American start-ups...In biotech, for instance, more than 90 percent of candidate medicines fail to make it past clinical trials. A gene-editing start-up in early clinical trials might hold three patents and employ a dozen researchers but generate no income for years. Under this proposal, the company could owe hundreds of thousands of dollars in taxes just to retain patents. In quantum computing, patent filings surged by an average of 49 percent annually from 2019 to 2023, yet total industry revenue stalled under $1.5 billion last year. Many analysts predict commercial viability for those innovations won't arrive until the 2030s. " Full

How IRA and JCA are Influencing HTA in Asia: Insights from China, Japan, and South Korea

(9/15, Katie McCool, The Evidence Base) reports “A recent ISPOR Asia Consortium webinar explored how indication-specific real-world evidence (RWE) under the US Inflation Reduction Act (IRA) and the EU Joint Clinical Assessment (JCA) could reshape health technology assessment (HTA) in Asia, with perspectives from China, Japan, and South Korea...Moderator Hong Li (University of Cincinnati) outlined the discussion’s focus: ‘We need to think ahead, even if indication specific is relatively new in our mind, especially in Asia, it will become influential in drug price negotiation in the other parts of the world. So we need to get prepared now.’” Subscription Required