CER Daily Newsfeed

New MSU Project Works to Increase Stakeholder Involvement in Psychosis Research

(5/19, Shelly DeJong, Michigan State University) reports “We are pleased to announce that Michigan State University has been approved for a funding award through the Eugene Washington PCORI Engagement Award Program, an initiative of the Patient-Centered Outcomes Research Institute (PCORI). The funds will support a project to increase stakeholder involvement in psychosis research...The project aims to increase stakeholder involvement in research, generate a research agenda based on stakeholder priorities, and develop tools to support meaningful collaboration with stakeholders.” Full

The FDA's New Leaders Can Unleash Innovation

(5/18, Tomas J. Philipson, The Wall Street Journal) comments “...Because of FDA delays, patients don’t have access to products they are willing to use, and future patients won’t benefit from innovations the agency makes prohibitively costly to pursue. In our analysis, we find that speeding up development by one to six years for FDA-approved medical products (small-molecule drugs, biologics and medical devices) would unlock between $10 trillion and $49 trillion in economic value.” Subscription Required

MFN Payment Models 'Legally Defensible' As CMMI Tests, CMS Advisor Says

(5/18, Cathy Kelly, Pink Sheet) reports “...The Trump Administration's Most Favored Nation drug pricing payment models have been designed to avoid the legal challenges that bedeviled them during the first Trump Administration, US Centers for Medicare and Medicaid Services senior advisor for drug pricing Inmaculada Hernandez said....[Hernandez] said May 18 at the ISPOR annual meeting that the metrics chosen for the models, including the plan to implement MFN prices in specific, randomly selected geographic areas representing 25% of the Parts B and D populations, are evidence they are truly designed as a test.” Subscription Required

SCOTUS Rejects Pharma Companies' Petitions To Review IRA Drug Program

(5/18, Donna Haseley, Inside Health Policy) reports “...It's still possible one of the remaining IRA drug negotiation lawsuits might result in a ruling different from those of all the other courts. A D.C. district judge still needs to rule on cases filed by AbbVie and Merck, the D.C. Circuit Court of Appeals needs to rule on a case brought in by Teva Pharmaceuticals and the Fifth Circuit has yet to rule in a case brought by the Pharmaceutical Research and Manufacturers of America (PhRMA).” Subscription Required

German Pharma Industry Calls For National Changes To Accommodate EU-Level JCAs

(5/18, Francesca Bruce, Pink Sheet) reports “...Germany’s AMNOG benefit assessment process for Ipsen’s Ojemda, the first drug to be the subject of an EU-level joint clinical assessment (JCA) report under the Health Technology Assessment regulation, has begun in Germany before the report’s publication.” Subscription Required