CER Daily Newsfeed

Evidence Generation Shouldn't End with Publication: Why Every HEOR and RWE Publication Needs a Plain Language Strategy

(7/20, Joanne Walker, Laura Dormer, The Evidence Base) comments “...As HEOR and RWE continue to inform increasingly important healthcare decisions, every publication should have a plain language strategy. That starts with including a PLS as part of the primary publication and, where appropriate, extends to developing a standalone, peer-reviewed PLSP. Communicating evidence clearly should no longer be viewed as an optional enhancement to publication planning – it should be considered an integral part of evidence generation itself.” Full

Better Access to Local Pharmacies Lowers Racial Disparities in Medication Use

(7/20, The Journal of Blacks in Higher Education) reports “...According to their analysis, the authors found a 1 percent increase in people living within 10 minutes of a pharmacy was associated with a 0.7 percent higher use of medications. This association was strongest among Black residents, as well as Asian/Pacific Islander and Hispanic populations. Additionally, a 1 percent increase in 10-minute community pharmacy access was associated with a 0.52 percent decrease in racial and ethnic disparities in medication use. Based on their findings, the authors conclude that disparities in local pharmacy access may exacerbate existing racial inequities in healthcare. Thus, the research team urges policymakers to consider targeted interventions to expand pharmacy access to underserved communities.” Full

Video: Evaluating Real-World Evidence and Clinical Endpoints in mCSPC

(7/20, Greg McMahon, DO, Alicia Morgans, MD, MPH, Gordon Brown, DO, FACOS, Caroline Branch, NP-C, Urology Times) “As real-world evidence (RWE) becomes increasingly integrated into oncology research, the expert faculty discuss both the strengths and limitations of these analyses and how they complement findings from prospective clinical trials.” View Video

Is Evidence-Based Medicine Quietly Failing Physicians?

(7/18, Vaishali Popat, MD, MPH, KevinMD.com) comments “...Evidence-based medicine was supposed to improve judgment, not replace it. But in practice, it has often been operationalized in ways that make care look more standardized, more protocol-driven, and more interchangeable. Once that happens, the system starts asking a dangerous question: If medicine is mostly following guidelines, why does it require so much physician training? And that question has consequences. If a less-trained clinician can follow the same algorithm, check the same boxes, and prescribe according to the same protocol, then from the perspective of private equity or a cost-cutting health system, the physician starts to look expensive rather than essential.” Full

Step Therapy Requirements Drive up Time, Costs in DME Patients | ASRS 2026

(7/18, Denise Myshko, Managed Healthcare Executive) comments “...Mathematical modeling of a one-year retina practice workflow linked two additional step-therapy requirements to 8 extra staff hours, scaling to >8,000 hours and $380,000 for 1,000 DME patients...‘In the worst-case scenario, if everyone had a double-step edit, the impact would be nearly half a billion dollars of increased retina overhead,’ [Sabin Dang, M.D.] said. ‘We further stratified to differentiate Medicare Advantage, and we found increases in both time and money.’” Full

Midsize Biotechs Take Case Against CMS' GLOBE and GUARD Models to White House

(7/17, Max Bayer, Endpoints News) reports “...Representatives of the trade group PhRMA met with more than a dozen officials across HHS and OMB on Monday, the government disclosed. In a written memo accompanying the meeting, the group laid out multiple legal and operational concerns with the rules, further teasing a legal battle if they are finalized. PhRMA argues that GLOBE and GUARD, which would test pricing models in the Medicare Part B and Part D system, would act as a mandatory funding mechanism and that each unlawfully extends CMS' authority on multiple fronts.” Subscription Required

European Commission Sets Expectations On Joint Clinical Assessment AI Use

(7/20, Francesca Bruce, Pink Sheet) reports “...Artificial intelligence has the potential to make joint clinical assessments carried out under the EU Health Technology Assessment Regulation more efficient, but companies must not jeopardize the quality and integrity of the assessments by not being accountable or transparent.” Subscription Required

Ireland’s NCPE Applies EU Joint Clinical Assessment in First National HTA Review

(7/20, Joanne Walker, The Evidence Base) reports “...The JCA concerns Novartis’ Itvisma® (onasemnogene abeparvovec intrathecal), an advanced therapy medicinal product for the treatment of spinal muscular atrophy...At the same time, Ireland’s health technology assessment (HTA) body, the NCPE, has completed a Rapid Review for the therapy...The use of the JCA report within the Rapid Review process is notable given that the EU-level report has not yet been published.” Full