CER Daily Newsfeed

FDA's Accelerated Approval Pathway Needs Stronger Transparency, Evidence Standards: ICER

(4/17, Kevin Dunleavy, Fierce Pharma) reports “...The National Pharmaceutical Council...pointed out that ICER’s white paper emphasizes the risks associated with the pathway while ‘downplaying its current benefits.’ ‘The evidence tells a different story. Despite its challenges, research shows the pathway is largely working as intended, is delivering value to patients, and overall, its benefits outweigh its risks,’ the NPC added in a statement. ‘As healthcare stakeholders consider additional reforms to the pathway, it’s worth examining what the evidence shows about how the program is performing and the vital role it plays in earlier patient access to innovative medicines.’” Full

Value Viewpoint: April 17, 2026

(4/17, Kimberly Westrich, LinkedIn) comments “Tomas Philipson’s latest report, ‘Estimating the Full Value of Medical Innovation,’ aligns with prior NPC research. NPC’s body of research shows that health spending delivers high value for many conditions, biopharmaceutical innovation has been a key driver of that value creation, and years of life lost would have been significantly higher without biopharmaceutical innovations.” Full

Video: Evaluating IL-23 Inhibitors with Long-Term Data and Real-World Evidence

(4/20, Linda Stein Gold, MD, Eingun James Song, MD, FAAD, Jeffrey Crowley, MD, MS, HCPLive) “...The panel emphasizes that real world data is critical because clinical trials represent a best case scenario, with carefully screened patients, controlled comorbidities, and a high level of clinical support including dedicated nursing staff, medication delivery, and appointment reminders that do not reflect everyday practice. In contrast, real world patients may have uncontrolled comorbidities, complex medication regimens, and limited support, making adherence more challenging. When comparing drug classes in real world analyses, IL-23 inhibitors are noted to generally outperform IL-17 inhibitors, TNF inhibitors, and newer oral agents in keeping patients on therapy over time.” View Video

Video: GLP-1 Coverage Gaps and Real-World Evidence Shape Access Trends: Ben Urick, PharmD, PhD

(4/17, Sabrina McCrear, Benjamin Y. Urick, PharmD, PhD, The American Journal of Managed Care) “Ben Urick, PharmD, PhD, examines GLP-1 coverage gaps and real-world evidence challenges shaping payer decisions and obesity treatment access.” View Video