News from Thursday, May 22, 2025
Articles
Podcast: Chief Science Officer, National Pharmaceutical Council, Jon Campbell, PhD
(5/21, Perspectives by the Leerink Center for Pharmacoeconomics) reports “Melanie Whittington, Head of the Leerink Center for Pharmacoeconomics interviews Jon Campbell, PhD, Chief Science Officer, National Pharmaceutical Council, where they discuss the distinctions between comparing drug pricing to consumer goods, the importance of evaluating different biopharmaceutical innovations, and solving puzzles for the common good.” Full | Apple Podcast | Spotify
How To Effectively Integrate Patient Perspectives Into Payer Coverage Decisions
(5/21, Elisabeth M. Oehrlein, Leah McCormick Howard, Joe Vandigo, and Kimberly Westrich, Health Affairs Forefront) comments “...This commentary explores moving beyond token patient inclusion, drawing on lessons from patient advocacy, patient-centered research, and value assessment initiatives...[C]ommittee leaders could look to the Comparative Effectiveness Research Collaborative created by the National Pharmaceutical Council, AMCP, and the International Society for Pharmacoeconomics and Outcomes Research, which offered educational resources on real-world data and other emerging methodologies.” Full
MHRA Drafting Guidance for RW Clinical Studies Control Arm
(5/21, Mark McCarty, BioWorld) reports “The U.K. Medicines and Health Care Products Regulatory Agency posted a draft guidance on the use of real-world evidence to serve as a control arm for clinical trials.” Subscription Required
Verana Health Launches Real-World Dataset on Cataract Surgery
(5/21, Anthony DeFino, Healio) reports “...‘Qdata Cataracts is a unique real-world dataset that enables precise analysis of patients undergoing cataract surgery while also tracking their outcomes through structured codes and unstructured clinical notes of electronic health records,’ Sujay Jadhav, CEO of Verana Health, told Healio. ‘Variations in surgical techniques, IOL models and patient characteristics can impact outcomes, making real-world data essential for understanding long-term effectiveness and optimizing patient care.’” Full
‘Ill-Conceived’: Proposed Bill Would Require Medicare Advantage to Pay for Hospice Care
(5/21, Jim Parker, Skilled Nursing News) reports “Rep. David Schweikert (R-Ariz.) has introduced the Medicare Advantage Reform Act, which among other provisions would require health plans to pay for hospice care...This is not the government’s first attempt to work hospice into Medicare Advantage. The highest profile example was the hospice component of the Value-Based Insurance Design model (VBID), which ended Dec. 31, 2024.” Full
Press Releases
IGBA Welcomes ICH New Topic for Harmonisation: Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs
(5/21, IGBA) “The International Generic and Biosimilar medicines Association (IGBA) commends the General Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonisation of ‘Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs.’” Full
Journals
Comparative Effectiveness of Long-Acting Lipoglycopeptides vs Standard-of-Care Antibiotics in Serious Bacterial Infections
David Goodman-Meza, et al.
May 21, 2025, JAMA Network Open
Effect of Chemotherapy Timing in Triple-Negative Breast Cancer: A Real-World Evidence Study
Noiver Graciano, et al.
May 21, 2025, Breast Cancer Research and Treatment