CER Daily Newsfeed

Value Viewpoint: November 7, 2025

(11/7, Kimberly Westrich, LinkedIn) comments “A new perspective published in the Journal of Comparative Effectiveness Research explores the highly technical language of HTA reports as a persistent barrier to meaningful patient involvement. Although patient and public engagement in HTA is a growing area of focus, dense scientific and methodological jargon often limits comprehension and reinforces inequities...The article stresses that responsible use requires ‘human-in-the-loop’ oversight, standardized templates, ethical guardrails, and co-governance with HTA agencies and patient groups. Generative AI could become a powerful enabler of equitable participation, but only if implemented with strong oversight, transparency, and a commitment to patient-centeredness.” Full

Real-World Data Shows AUSTEDO Improves Life for Patients with Tardive Dyskinesia

(11/11, John Pinching, PharmaTimes) reports “...The interim analysis from part B of the phase 4 IMPACT-TD Registry evaluated 27 adults with TD over a three-month period. Patients reported improvements in speech and communication (77%), eating (75%), psychosocial impact (65%), activities of daily living (59%) and sleep or pain (50%). Stacy Finkbeiner, Senior Medical Director, Movement Disorders & Psychiatry at Teva, said: ‘The silent struggle of tardive dyskinesia, with its relentless, involuntary movements, can deprive patients of their quality of life and independence – real-world findings are so critical to inform how we innovate and improve the everyday lives of individuals living with this disease.’” Full

Risk-Based Contracts May Not Cut Low-Value Care in Medicare Advantage

(11/10, Maggie L. Shaw, The American Journal of Managed Care) reports “...Despite making a voluntary switch to risk-based payment contracts, either upside only or 2-sided, there was no measurable impact on low-value service use or health care utilization overall, according to Medicare Advantage data published online today in JAMA Internal Medicine. An upside-only plan has potential for financial bonuses, and 2-sided plans include possible bonuses and penalties, the authors wrote.

‘The growth of risk-based payments raises key questions for government institutions, private insurers, and health care organizations,’ they added.” Full

New Resources Will Support Representativeness of PCORnet® Studies

(11/11, PCORnet Blog) comments “...Over the last year, the PCORnet Representativeness Project team has been working through the nuances of how to help clinical researchers optimize their use of PCORnet to enhance and evaluate the representativeness of a clinical study. The project will culminate in early 2026 with new resources for guiding researchers in their use of the PCORnet infrastructure...Helping investigators get as close a match as possible is the goal of the representativeness project, said [Laine Thomas, Professor of Biostatistics and Bioinformatics at Duke]. ‘Through this work we hope to show that PCORnet is not only a data network but a design tool to make research more representative from the start.’” Full

ISPOR Europe 2025 – Inside the Second Plenary: Pragmatic Trials and the Future of Clinical Evidence

(11/11, Laura Dormer, The Evidence Base) reports “...The speakers, representing patient advocacy, regulatory, HTA, industry and public health viewpoints, agreed that pragmatic clinical trials are essential to bridge the gap between research and real-world care. By combining the scientific rigor of randomized trials with the flexibility and relevance of real-world data, pragmatic clinical trials can generate the evidence needed to inform better decisions, faster. The challenge now lies in aligning regulatory and HTA frameworks, fostering early collaboration and ensuring that pragmatic design principles become a routine part of evidence generation.” Full

How Regulatory Horizon Scanning Works In The EU, UK & Switzerland

(11/10, Eliza Slawther, Pink Sheet) reports “...Horizon scanning is a tool used by regulators to prepare for forthcoming medicines that might challenge existing processes. Senior figures from the European Medicines Agency, Swissmedic and the UK MHRA explain how they conduct horizon scanning activities in their respective jurisdictions.” Subscription Required