Putting meat on the bone: how to fast-track innovative medicines to those who need them and generate data to justify continued use.

ABSTRACT: Regulatory agencies worldwide have taken significant steps to expedite approval and market authorization of medicines based on their potential to address areas of significant unmet medical need and severe disease burden. However, initial approval of such medicines is often accompanied by limited evidence of benefit, posing a conundrum for payers and health systems who may desire greater certainty of their value. This paper describes a system of "accelerated access" to manage these tensions and coordinate activities across stakeholders, based on discussions held at a multi-stakeholder convening in June 2023. We focus on 6 core, near-term actions that can be taken to improve the current system: clarifying criteria for expedited regulatory approval, enhancing stakeholder coordination, creatin

SUBMITTER: Ollendorf D 

PROVIDER: S-EPMC11332269 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature