News from Thursday, July 24, 2025
Articles
The U.S. Drug System Strikes a Reasonable Balance Between Incentivizing Innovation and Promoting Competition
(7/23, Wayne Winegarden, Pacific Research Institute Blog) comments “...Between 2012 and 2022, the biopharmaceutical industry invested $279,000 per employee into R&D investments, which is 13 times larger than the average investment for all manufacturing industries. Further, biopharmaceutical companies invested more than $12 million for every patent issued, which was also higher than any other sector. However, the biopharmaceutical industry’s sales revenues generated per patent was $38.5 million, which is only average...The extreme gap between investment required per patent and revenue per patent illustrates the inherent risk associated with developing new medicines. The smaller revenue per patent also further undermines the accusations that market manipulation is occurring.” Full
Amy Abernethy on the New Era of Real-World Data
(7/23, Claire Rychlewski, Axios) reports “...Abernethy was the chief medical officer at Flatiron Health when it was acquired by Roche for $2.1 billion in 2018 in one of the earliest bets on real-world evidence data. She launched Highlander last year, which includes a nonprofit arm and an investment arm that acquired longitudinal data company Target RWE in January...Abernethy: ‘We have a thesis that the kinds of investments that are going to contribute to modern clinical research infrastructure fall into three categories. One is longitudinal data. The second is what we call footprint ... and the third is around trust and credibility.’” Subscription Required
Waste of the Day: “Low-Value” Medicare Treatments
(7/28, Jeremy Portnoy, RealClearInvestigations) reports “An estimated 37% of Medicare patients received a ‘low-value’ health care service in 2023, costing the federal government $5.9 billion. The numbers come from the Medicare Payment Advisory Commission’s (MedPAC) annual ‘Health Care Spending and the Medicare Program’ data book, released on July 1.” Full
RWE and HTA – A Snapshot of Recent Developments with Sreeram Ramagopalan: April–July 2025
(7/23, Sreeram Ramagopalan, The Evidence Base) comments “...The England RSV vaccination effectiveness study represents the most compelling story, showcasing how methodologically rigorous RWE generation can be performed rapidly. Using a regression discontinuity design, researchers created a natural experiment that minimized confounding while providing robust causal inference. The study's ability to demonstrate significant clinical impact (30% reduction in hospitalizations) within months of program implementation exemplifies how RWE can provide timely validation of clinical trial results and inform healthcare policy decisions in near real time.” Full
Leqembi Facing 15% Price Cut In Japan
(7/24, Lisa Takagi, Pink Sheet) reports “Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.” Subscription Required
Press Releases
Institute for Clinical and Economic Review Releases Draft Evidence Report on Treatment for Non-Cystic Fibrosis Bronchiectasis
(7/23, ICER Press Release) “The Institute for Clinical and Economic Review today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of brensocatib (Insmed Inc.) for non-cystic fibrosis bronchiectasis (NCFB). This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.” Full
Journals
Cardiovascular Events in Individuals Treated With Sulfonylureas or Dipeptidyl Peptidase 4 Inhibitors
Alexander Turchin, et al.
July 2025, JAMA Network Open
Statistical Methods to Adjust for Treatment Switching in Real-World Clinical Studies: A Scoping Review and Descriptive Comparison
Romain Jonathan Collet, et al.
July 23, 2025, Clinical Pharmacology & Therapeutics
Guiding Stakeholder Involvement in Health Technology Assessment for Medical Devices: A Novel Approach for Clarifying Stakeholders’ Roles and Contributions
Liliana Freitas, et al.
July 23, 2025, Health Policy and Technology
Transporting Trial Results to Synthetic Real-World Populations in Order to Estimate Real-World Effectiveness of Newly Marketed Medicines
Ignacio Leiva-Escobar, et al.
July 24, 2025, BMJ Open
Real-Time Continuous Glucose Monitoring vs Self-Monitoring of Blood Glucose in Distinct Multi-Ethnic Cohorts of Patients Living with Insulin-Treated Type 2 Diabetes in the United States: A Cost-Utility Analysis from a Medicare Perspective
Hamza Alshannaq, MD, MPH, et al.
July 24, 2025, Journal of Managed Care & Specialty Pharmacy