CER Daily Newsfeed

Value Viewpoint May – June 2025: Recent Developments in US Healthcare Value and Access with Kimberly Westrich

(6/24, Kimberly Westrich, The Evidence Base) comments “...Employers, in particular, can play a significant role in removing barriers to high-value care. Through the decisions they make – such as selecting benefits consultants and PBMs aligned with their fiduciary responsibilities and requiring access to their data – they can reshape the market and push PBMs toward a more transparent, patient-centered model. Moreover, employers who insist on accountability and data access can help curb excessive or clinically inappropriate UM practices, thereby improving care access not only for their employees but also across the broader healthcare system.” Full

FDA and NIH Publish Unified Glossary to Strengthen Real-World Evidence Research

(6/24, Katie McCool, The Evidence Base) reports “...Titled ‘Modernizing Research and Evidence Consensus Definitions: A Food and Drug Administration–National Institutes of Health Collaboration’, the glossary reflects a shared effort to modernize scientific communication and improve the consistent use of terminology in both interventional and noninterventional research. It was developed by the FDA-NIH Modernizing Research and Evidence (MoRE) Glossary Working Group, a multidisciplinary team of epidemiologists, clinicians, statisticians, pharmacologists, engineers, and policy experts from both agencies.” Full

FDA, NIH Create Common Vocabulary for Real-World Evidence

(6/23, Emily Hayes, Regulatory Focus) reports “...The glossary also defines pragmatic trials, noninterventional studies, observational studies, cluster randomized trials, N-of-1 trials, sequential multiple assignment randomized trials (SMART), stepped-wedge cluster-randomized trials, and umbrella trials. ‘Due to the complexities of describing these designs, misperceptions are common in the clinical research community, and the consensus definitions are intended to bring clarity,’ [Donna Rivera, associate director of pharmacoepidemiology, RWD, and RWE at the FDA Oncology Center of Excellence,] and colleagues explained. ‘For example, the definitions clarify that pragmatic trial designs include elements along a continuum that often also incorporate randomization, and that RWD denotes a data source rather than a study design, which can be prospectively or retrospectively collected.’” Full

IRA Poised To Raise Drug Costs For Most Seniors, USC Study Finds

(6/23, Gabrielle Wanneh, Inside Health Policy) reports "The prescription drug price controls in the Inflation Reduction Act were intended to reduce out-of-pocket spending for Medicare beneficiaries, but health policy experts at the University of Southern California Schaeffer Center for Health Policy& Economics say the impact of higher annual deductibles and a shift from fixed copayments to often more expensive coinsurance requirements may leave seniors -- the majority of whom are not expected to reach the new annual drug spending cap before a year's end -- paying more for their medications in the long run." Subscription Required

Oz Pushes Drug Middlemen to End Rebates Before Washington Acts

(6/24, Rachel Cohrs Zhang, John Tozzi, Bloomberg) reports “...‘There’s a possibility that we have a window now where the three big PBMs might actually consider doing away with the rebate-slash-kickback system,’ Oz told a meeting hosted by Transparency-Rx, a coalition of smaller PBMs committed to more open pricing...Oz suggested regulators and lawmakers could revamp the system ‘fairly expeditiously, because there’s a motivated group of people who want to do that.’” Subscription Required

From Red Tape to Relief: Rewriting the Rules of Prior Authorization

(6/23, Maggie L. Shaw, The American Journal of Managed Care) reports “...[Congressman Greg Murphy, MD], a practicing urologist, continued the string of criticisms, emphasizing how the drawn-out PA process even goes so far as to undermine the doctor-patient relationship, but also noting that physicians are not completely blameless in this regard. There are some, he explained, who prioritize profit over care and ‘game the system.’ Is peer-to-peer review necessary then, he wondered, and should specialists evaluate denials, he asked, all the while expressing cautious optimism about the insurers’ reform pledges. Doctors must guide patient care, not the bureaucracy, the ‘opaque people in cubicles.’ Accountability is key, he stressed.” Full

How Is Cochrane Advancing Responsible AI for Evidence Synthesis?

(6/24, Cochrane) comments “...We are primed to use AI and automation, thanks to our wealth of high-quality, structured data from systematic reviews and included studies. Recent innovations include: dynamic analysis reporting in RevMan, which allows authors to insert live results directly into their reviews while they’re writing and updating them; a new feature in CENTRAL, our clinical trials database, that flags retracted publications to authors.” Full