Clinical Pharmacology & Therapeutics, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 19, 2025

Conducting high‐quality health technology assessments requires evidence. With evolving regulatory standards for faster approval of new pharmaceutical products, practitioners often find that the evidence base available to inform their work is lacking. This review article provides case examples how assessors have grappled with this tension, from United States and European perspective, including experiences therapies large populations, such as Alzheimer's disease, gene ultra‐rare conditions. The concludes by offering some potential policy solutions can meet goals robust generation, patient access, system affordability, reimbursement development, outcomes‐based contracts, other types managed entry agreements.

Language: Английский