CER Daily Newsfeed

Real-World Evidence: Shaping Obesity Treatment Beyond Clinical Trials

(6/4, Amgen Stories) comments “...[Paul Dluzniewski, Amgen’s executive director of Observational Research:] As more long-term longitudinal real-world data becomes available, we’ll gain a better understanding of treatment patterns, unmet needs and long-term outcomes, including the experience of patients who may not have been well-studied in the clinical trials. We’ll also better understand the impact of patients not remaining on therapy, and build the foundation for conducting comparative effectiveness studies.” Full

AcademyHealth Opposes House Bill that Defunds AHRQ and Smothers Health Research

(6/5, Aaron E. Carroll, M.D., M.S., Josh Caplan, M.A., M.P.P., AcademyHealth Blog) comments “...Disturbingly, [the House Appropriations Committee’s FY27 bill] not only eliminates AHRQ, it also rescinds funding necessary to support the Patient Centered Outcomes Research Institute...The elimination of mandatory funding for the Patient Centered Outcomes Research Trust Fund (PCORTF) also eliminates PCORI and would end research into substance abuse disorders, telehealth, patient safety, chronic conditions, maternal morbidity, behavioral care access, and more.” Full

Opinion: The Next FDA Commissioner Must Be a Champion for Gene Therapies

(6/5, Erik Paulsen, BioSpace) comments “...We need a commissioner who is fluent in the evidence tools available for rare disease: adaptive and innovative trial designs, natural history data, real-world evidence, patient-reported outcomes and biomarker science. These are not shortcuts. They are the legitimate evidentiary methods appropriate to diseases where randomized controlled trials of traditional scale are simply not possible.” Full

Unconstitutional Drug Pricing Demands Fifth Circuit Intervention

(6/5, Alice LaCour, Bloomberg Law) comments “...At issue in National Infusion Center Association  is the Inflation Reduction Act’s Medicare drug negotiation program. Despite being titled the ‘Drug Price Negotiation Program,’ it isn’t a negotiation in any real sense. Negotiation requires parties who can walk away; the Inflation Reduction Act denies manufacturers that option...A law that enables the government to force manufacturers to accept its preferred pricing or face extinction doesn’t foster negotiation; it destroys it.” Full

Evaluating RWE Use in Health Technology Assessments Submitted to Canada’s Drug Agency

(6/4, The Evidence Base) reports “Real-world evidence (RWE) is increasingly discussed as an important component of health technology assessment (HTA), but what does the evidence actually show about how it is being used in practice? This question formed the basis of a new study published in Value in Health Regional Issues titled ‘Real-World Evidence in Action: A Comprehensive Environmental Scan of Real-World Evidence Use in Health Technology Assessments Submitted to Canada’s Drug Agency From 2020 to 2024.’ In this interview, we speak with Paul Arora (Inka Health and Dalla Lana School of Public Health, University of Toronto) about the study’s findings, the evolving role of RWE within Canadian HTA, and the implications for evidence generation and reimbursement decision-making.” Full