CER Daily Newsfeed

Value Viewpoint: November 14, 2025

(11/14, Kimberly Westrich, LinkedIn) comments “A new study published in Patient Preference and Adherence surveys 46 experts across clinical research, industry, regulatory affairs, and HTA, finding that patient preference information (PPI) is widely valued but is currently inconsistently used. Most respondents reported limited availability of PPI within their organizations, and nearly three-quarters use it only occasionally or not at all. Yet, enthusiasm for future integration exists: 90% expressed a willingness to prioritize PPI moving forward, citing its potential to improve trial design, endpoint selection, and the alignment of treatments with patient needs.” Full

Study: Single-Trial FDA Approvals Often Lack Confirmatory Evidence

(11/14, Jessica Karins, Inside Health Policy) reports “A recent study published in the journal Clinical Trials found FDA is increasingly approving drugs and biologics based on a single pivotal trial and many of those approvals lack reference to confirmatory evidence of the product’s safety and efficacy, especially when the product receives designations as an orphan drug or another category that expedites review. The study also found despite FDA’s emphasis on use of real-world evidence, none of the approvals between 2015 and 2023 referenced it as a source of confirmatory evidence.” Subscription Required

GLP-1RAs Lower MACE Risk in T2D Relative to Other Antidiabetic Medications

(11/17, Jessica Nye, PhD, Endocrinology Advisor) reports “...The study authors concluded, ‘In this comparative effectiveness study of adults with T2D, MACE risk varied significantly by medication class, with the most risk reduction achieved with sustained treatment with GLP-1RAs, followed by SGLT2is, sulfonylureas, and DPP4is, in that order. The magnitude of benefit of GLP-1RAs over SGLT2is depended on patient baseline age, ASCVD, [heart failure], and kidney impairment.’” Full

Single-Tablet Bictegravir/Lenacapavir Effective After Treatment Switch

(11/16, Julia Bonavitacola, The American Journal of Managed Care) reports “Patients with HIV may be able to switch from a multi-tablet regimen to a single-tablet regimen, as a single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) was found to be equally effective when patients switched from multi-tablet regimens to treat their HIV diagnosis. These results come from the ARTISTRY-1 clinical trial, a phase 3 study.” Full

Three Ways CMMI Is Applying Evidence To Protect Patients, Providers And Taxpayers

(11/17, Gita Deo, Abe Sutton, Health Affairs Forefront) comments “...The CMS Innovation Center is tackling this challenge by testing new approaches to disincentivize low-value care that can lead to patient harm. Our WISeR (Wasteful and Inappropriate Service Reduction) Model combines enhanced technology with human clinical review to flag unnecessary and potentially harmful procedures...WISeR will run for six performance years from January 1, 2026, to December 31, 2031, in six states: New Jersey, Ohio, Oklahoma, Texas, Arizona, and Washington.” Full

GetReal Conference 2025: Advancing Data Quality and Feasibility to Deliver Decision-Grade RWE

(11/17, Katie McCool, The Evidence Base) reports “...Throughout the discussion, speakers agreed that transforming RWD into decision-grade evidence depends less on producing new frameworks than on applying existing ones with consistency and transparency. [EMA’s Catherine Cohet] underlined the value of an iterative feasibility process, advising researchers to: ‘Select your data sources, fine tune your study design based on your feasibility.’” Full