News from Tuesday, May 13, 2025
Articles
Trump's Plan to Match Foreign Drug Prices Faces Familiar Hurdles
(5/13, Nyah Phensitthy, Bloomberg Law) reports “...‘There's a lot of bluster with limited meat on the bone in terms of what they're actually planning to do,’ said Zach Baron, a director of the Center for Health Policy and the Law at Georgetown University's O'Neill Institute. ‘The first time Trump tried the most favored nation approach, they lost on procedural grounds.’...‘The question, now, is what are the procedural steps and process that they're going to go through?’ Baron said. ‘They allude to some type of rulemaking plan that would come into effect, but the specifics are going to be really important.’” Subscription Required
Big Pharma Counted On a Price Negotiation Loophole. It May Be Closing
(5/13, Josh Nathan-Kazis, Barron’s) reports “...In Monday's guidance, [CMS] said it is ‘soliciting comments’ on how it ‘might consider’ grouping combination drugs where one ingredient doesn't impact the disease the drug is approved to treat together with their original version. It's a confusing paragraph, but CMS seems to be signaling it's considering a change for the negotiated prices that go into effect in 2028 that would, for example, make a combination drug like Darzelx Faspro eligible for negotiations at the same time as the original Darzalex. That's probably closer to the intent of the 2022 Inflation Reduction Act, which is the law that set up the price negotiations, according to Leerink Partners analyst Daina Graybosh.” Subscription Required
Industry On Making England’s HTA Innovation Lab A Success
(5/13, Eliza Slawther, Pink Sheet) reports “...England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.” Subscription Required
Press Releases
New Studies Recommend Inclusion of Dynamic Inputs in Cost-Effectiveness Analyses to Better Reflect Drug Value Over Time
(5/13, National Pharmaceutical Council Press Release) “Two new studies published in Value in Health underscore the importance of incorporating dynamic pricing and other evolving inputs into cost-effectiveness analyses (CEAs) to more accurately represent the value of prescription drugs across their lifecycles. ‘CEAs are comprised of both science and judgment – which is why they are a tool, not a rule,’ said NPC Chief Science Officer Jon Campbell, PhD, who was an author on both studies. ‘This research supports more useful tools that better reflect market realities.’” Full
Journals
US Drug Pricing Patterns Before Loss of Exclusivity
Ching-Hsuan Lin, MD, MPH, Jonathan D. Campbell, PhD, James Motyka, PharmD, Joshua T. Cohen, PhD
April 8, 2025, Value in Health
Identifying the Influential Dynamic Inputs in Cost-Effectiveness Analyses
Melanie D. Whittington PhD, Joshua T. Cohen PhD, Peter J. Neumann ScD, Tyler D. Wagner PhD, Jonathan D. Campbell PhD
April 12, 2025, Value in Health
Comparative Effectiveness of R-miniCOMP Versus R-miniCHOP in Older Non-Fit Patients With Diffuse Large B-Cell Lymphoma: Insights From a "Fondazione Italiana Linfomi" Cohort Study
Alberto Bavieri, et al.
May 2025, Hematological Oncoloy
Advancing the Use of Longitudinal Electronic Health Records: Tutorial for Uncovering Real-World Evidence in Chronic Disease Outcomes
Feiqing Huang, et al.
May 12, 2025, Journal of Medical Internet Research
Comparative Effectiveness of Omicron XBB 1.5-Adapted COVID-19 Vaccines: A Systematic Literature Review and Network Meta-Analysis
Kyle Fahrbach, et al.
May 13, 2025, Expert Review of Vaccines
Reports
What Proportion of the Total Value Generated by New Drugs Accrues to Manufacturers? Review of Empirical Estimates of Producer Surplus
May 14, 2025
National Pharmaceutical Council
Ongoing Accelerated Approval Trends and What It Means for Patients
May 14, 2025
National Pharmaceutical Council
Are Existing Descriptions of Unmet Medical Need Fit for Purpose in the CMS Drug Negotiation Program Context?
May 14, 2025