CER Daily Newsfeed

Video: Steps to Strengthen Patient Representation in Managed Care Decision-Making: Kimberly Westrich, MA

(4/3, Pearl Steinzor, Kimberly Westrich, MA, The American Journal of Managed Care) “New Centers for Medicare & Medicaid Services (CMS) rules requiring patient representation on pharmacy-and-therapeutics (P&T) and Medicaid committees mark important progress, but their success hinges on thoughtful implementation, said Kimberly Westrich, MA, chief strategy officer at the National Pharmaceutical Council.” View Video

Video: Evidence Suggests IRA is a ‘Poorly Designed Policy' | AMCP Annual 2025

(4/3, Pearl Steinzor, Briana Contreras, Managed Healthcare Executive) “While the intent of the Inflation Reduction Act (IRA) was to lower prescription drug costs, its unintended consequences may be leading to higher patient expenses at the pharmacy counter, according to Julie Patterson, Pharm.D., Ph.D., senior director of research at the National Pharmaceutical Council...Evidence suggests the IRA is a ‘poorly designed policy with unintended consequences on clinical research, uncertain impact on patients and it’s costing more than originally anticipated.’ Patterson highlighted NPC research showing that the policy could lead to delayed drug launches, fewer additional indications for existing drugs and a ‘chilling effect’ on post-approval clinical research.” View Video

Video: Impact of IRA Drug Negotiation on Part D Formularies and PBMs | AMCP Annual 2025

(4/3, Pearl Steinzor, Briana Contreras, Managed Healthcare Executive) “...[NPC’s Julie Patterson, Pharm.D., Ph.D.] highlighted how early research shows that access to selected drugs has been strong in recent years but warned of potential challenges ahead. ‘What we found was that coverage and access were high in 2019 and increasing through 2023, including few utilization management barriers for most of the drugs,’ Patterson said. However, she noted that while Medicare Part D plans must now cover negotiated drugs, there are no firm restrictions on formulary tiering or utilization management.” View Video

New Report Explores Health Technology Assessment Body and Regulator Collaborations to Address Evidence Challenges and Uncertainty for Timely Patient Access

(4/3, Katie McCool, The Evidence Base) reports “...While real-world data (RWD) can provide valuable context, such as understanding treatment patterns or informing trial design, the report highlights significant concerns when RWD is used for effect estimation in indirect comparisons. These analyses are often conducted post hoc, without sufficient planning or adjustment for confounding, and are not considered suitable as confirmatory evidence. Reliable use of RWD requires a well-designed approach and access to high-quality, granular data.” Full

Navigating the Use of Real-World Evidence for Drug Assessment in Germany: An Interview with Eva Susanne Dietrich, Institute for Evidence-Based Positioning in the Health Care Sector

(4/3, The Evidence Base) reports “...In this interview, we hear from Eva Susanne Dietrich (Founder and Head of Institute, Institute for Evidence-Based Positioning in the Health Care Sector) about the current role of RWE in Germany, the challenges facing industry, and the opportunities to strengthen its acceptance in regulatory and reimbursement decisions.” Subscription Required

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

(4/3, Neena Brizmohun, Pink Sheet) reports “...Drug companies should consider randomizing as early as possible in their clinical development program to improve their chances of producing evidence that will be relevant to both regulators and health technology assessment (HTA) bodies.” Subscription Required