CER Daily Newsfeed

Employer-Driven Health Care: Opportunities for Change

(10/2025, F. Randy Vogenberg, PhD, FASHP, Journal of Clinical Pathways) comments “...All parties need to get involved with health care reform, as the government has become engaged in market change...Commercial employer insurance plans will require a lot of education. Established business groups have been active in education with their members, but that is a small percentage of plans. In January, the National Pharmaceutical Council produced the open-source publication Patient & Caregiver Odyssey to illustrate challenges patients face in therapeutic care for cell and gene therapy (CAGT). Care guidelines and pathways, while informative clinically, can go awry with the presence of multiple financial adaptations in the market. These adaptations, used by both government and commercial plan administrators, often conflict, ultimately preventing optimal care for a patient.” Full

Gene Therapy Tops Nusinersen in Spinal Muscular Atrophy

(10/16, Damian McNamara, MA, Medscape) reports “Treatment with onasemnogene abeparvovec gene therapy for spinal muscular atrophy (SMA) type 1 was associated with less need for nutritional support or nighttime ventilation compared to recommended first-line nusinersen, new data showed. Those treated with gene therapy also had lower rates of unsatisfactory clinical responses (UCRs), a composite of death, treatment change due to inadequate response, initiation of feeding support, and/or failure to achieve independent sitting.” Full

Biosimilar Stivant Shows Noninferior Efficacy and Comparable Safety to Reference Bevacizumab

(10/16, Gillian McGovern, Pharmacy Times) reports “...When treating premature infants with prethreshold type 1 retinopathy of prematurity (ROP), Stivant (CinnaGen), a biosimilar to originator bevacizumab (Avastin; Genentech), exhibited noninferior efficacy to its reference product. The study results, published in the Journal of Current Ophthalmology. also showed that the biosimilar has a comparable safety profile to its reference product.” Full

FDA Outlines Future Directions for Real-World Evidence

(10/16, Katie McCool, The Evidence Base) reports “...Mallika Mundkur (FDA) described the current landscape for RWE as transformative, emphasizing a fundamental shift toward interagency collaboration. ‘One thing that I think is very unique to this time is this move towards sort of a whole government approach,’ she said, highlighting how RWE and AI have become ‘so prominent as a national as well as Department of Health and Human Services (HHS) priority.’” Subscription Required

Inside The Race To Harness Real-World Data: Who Will Build Healthcare’s Most Powerful Platform?

(10/16, Seth Joseph, Forbes) comments “...The competitive implications for real-world data (RWD) platforms are profound. Epic holds a structural advantage: it is the incumbent EHR supplier for more than 40% of hospital systems. That means Epic already ‘owns the pipes’ - it can natively collect, normalize, and operationalize clinical data at scale, and push models or agents directly into the workflows of its customers. Compared to independent RWD players like Briya, OMNY Health, or the Mayo Clinic Platform, which must negotiate data access, ingest heterogeneous sources, and integrate with non-Epic systems, Epic’s advantage is not just technical but institutional.” Full

340B Abuses Are Fueling Higher Medicare Costs, New BRG Report Shows

(10/15, Molly Jenkins, PhRMA Blog) comments “The hidden cost of 340B: The 340B hospital markup program is costing taxpayers an estimated $13.4 billion a year in lost Medicare rebates, according to a new report from Berkeley Research Group (BRG). When hospitals purchase medicines at the 340B price, Medicare cannot collect rebates intended to reduce federal spending. This means that as more tax-exempt hospitals exploit the 340B program as a profit center, Medicare costs also rise. This number is expected to continue to increase due to program growth and additional lost inflation rebates.” Full

AcademyHealth Warns of "Collapse in the Nation's Health Evidence Infrastructure" Following Cuts to the National Center for Health Statistics

(10/15, AcademyHealth Blog) comments “...‘There is nothing partisan about collecting, maintaining, and disseminating health statistics,’ said Aaron Carroll, president and CEO of AcademyHealth. ‘When we don’t have evidence for policy, policymakers are flying blind. We trade sight for conjecture. The capacity to collect, analyze, and share high-quality, nonpartisan data is essential to good governance, accountability, and the health of every community in this country.’” Full