News from Monday, September 8, 2025
Articles
Value Viewpoint: September 5, 2025
(9/5, Kimberly Westrich, LinkedIn) comments “New NPC research published in Health Affairs Scholar finds that post-approval cancer trials fell after the Inflation Reduction Act (IRA) passage, with a disproportionate impact on small molecule drugs...The authors found that after the IRA’s passage: Overall, monthly post-approval oncology trials fell by 40.0%, with sharper declines for small molecule drugs (45.3%) than for biologics (32.5%). The disproportionate decline for small molecule drugs translated into an additional reduction of 4.5 trials/month, when compared to biologics. The disproportionate decline for small molecule drugs was robust to a sensitivity analysis that limited the pre-IRA period to the post-COVID-19 era.” Full
Cemiplimab Shows 5-Year Survival Benefit in Advanced NSCLC With High PD-L1 Expression
(9/8, Skylar Jeremias, The American Journal of Managed Care) reports “...Cemiplimab significantly improved overall survival and progression-free survival compared to chemotherapy in advanced NSCLC with high PD-L1 expression. The EMPOWER-Lung 1 trial showed a median OS of 26.1 months for cemiplimab versus 13.3 months for chemotherapy.” Full
Real-World Data Show 12-Month Drug Survival Rates Among Anti-TNF Biosimilars in Psoriasis, PsA
(9/8, Deana Ferreri, PhD, The American Journal of Managed Care) reports “...Anti-TNF-α biosimilars showed a 91% drug survival rate at 12 months, with no significant differences between infliximab, etanercept, and adalimumab. Long-term effectiveness and safety of anti-TNF-α biosimilars were emphasized, despite the availability of newer biologics.” Full
It's Time to Rewire Organizations to Meet RWE’s Strategic and Operational Demands: An Interview with Jeff Trotter
(9/8, The Evidence Base) reports “...[Jeff Trotter:] Ultimately, it will require (re-)education about the value of science and the importance of unbiased facts. For those of us working in RWE – acknowledging both its benefits and limitations – the responsibility is to be as transparent as possible about our methods, to remain humble in how we frame our findings, and, more than ever, to be open about our affiliations and potential biases. If we cast light on our own limitations first, it becomes much harder for outsiders to dismiss the credibility of our work. And above all, we must keep patients at the center – including speaking out against poorly researched products that put them at risk.” Full
A Patient-Centered Pathway For Biomedical Innovation And Access
(9/8, June Cha, Health Affairs Forefront) comments “...By bringing patients to the center of value assessment and policy decisions, we make health care smarter, more just, and more effective. Precision medicine may provide the tools to target diseases, but patient engagement ensures we aim at the outcomes that truly matter. Realizing this vision of patient-informed, precision health care will yield a system that delivers value as patients define it: health, dignity, and quality of life.” Full
Joint Clinical Assessment in Europe: Progress, Challenges, and What’s Next
(9/8, Joanne Walker, The Evidence Base) comments “...The first wave of JCAs will provide valuable insight into how the new system functions in practice and how Member States integrate joint reports into their national HTA processes. These early experiences will be closely watched as the framework broadens, covering orphan medicines from 2028 and all centrally authorized medicines by 2030.” Full
Press Releases
Study Links 340B Expansion With Higher ACA Premiums
(9/8, National Pharmaceutical Council Press Release) “...‘The Association of the 340B Program With Affordable Care Act (ACA) Premiums: A Longitudinal Analysis From 2018-2022' provides evidence of the impact of the 340B program on ACA premiums and the corresponding burden it places on taxpayers and enrollees. The study is authored by Neal Masia, PhD, of Health Capital Group; and James Motyka, PharmD, Kimberly Westrich, MA, and Jon D. Campbell, MS, PhD, of the National Pharmaceutical Council...‘It's important to understand the impact of the significant expansion of covered entities and child sites in the 340B program, given that most 340B covered entities sell these discounted drugs at higher rates to insurers,’ explained Dr. Motyka, NPC Research Manager. ‘This research captures how the growth in the 340B program is associated with increases in ACA premiums.’” Full
New Tool Tackles Unreliable Research Trials
(9/8, The University of Manchester) “An international group of researchers has developed a new tool which can help identify problematic randomised controlled trials (RCTs), including fraudulent studies, where there are serious concerns about trustworthiness...INSPECT-SR is designed to root out problematic RCTs which publish faked or manipulated data or have Inadvertently made critical errors.” Full
Journals
Impact of Acid Suppressants on the Development of Clostridioides difficile Infection and Possible Preventive Effects of Probiotic Formulations
Chihiro Shiraishi, et al.
August 31, 2025, Infection and Drug Resistance
Comparative Effectiveness of Opioids and Opioid Substitutes on Pain and Health Related Quality of Life Among Cancer Survivors
Shirley K Chan Sanchez, et al.
September 2025, Cancer Medicine
The Association of the 340B Program with Affordable Care Act (ACA) Premiums: A Longitudinal Analysis from 2018 to 2022
Neal Masia, Ph.D, James D. Motyka, PharmD, Kimberly Westrich, MA, Jon D. Campbell, Ph.D
September 4, 2025, INQUIRY: The Journal of Health Care Organization, Provision, and Financing
INQUIRY: The Journal of Health Care Organization, Provision, and Financing
Efficacy and Safety of IL-23 Inhibitors in the Treatment of Crohn's Disease and Ulcerative Colitis: Systemic Review and Network Meta-Analysis
Ritik Kaste, et al.
September 5, 2025, medRxiv
INSPECT-SR: A Tool for Assessing Trustworthiness of Randomised Controlled Trials
Jack D Wilkinson, et al.
September 5, 2025, medRxiv