Program Type: ICER

Strengthening the FDA’s Accelerated Approval Pathway

Apr 2021 | Policy Paper

This paper aims to create a clearer understanding of both the opportunities and challenges inherent in the FDA’s accelerated approval pathway (AAP), and to present an analysis of the potential risks and benefits of a range of reform options that policymakers may consider in efforts to strengthen the AAP moving forward.    Date of publication: […]

Unsupported Price Increases Occurring in 2020

Nov 2021 | Policy Paper

The price of many existing drugs, both brand and generic, can increase substantially over time, and questions are frequently raised regarding whether these price increases are justified. State policymakers have been particularly active in seeking measures to address this issue. For example, both California and Vermont now have laws tracking substantial drug price increases, requiring drug manufacturers […]

Unsupported Price Increases Occurring in 2017-2018

Oct 2019 | Policy Paper

ICER evaluated selected high-impact drugs with substantial price increases. ICER reviewed changes in the evidence base for each of these drugs and assess whether or not new clinical data exists that could suggest that the drugs could be significantly more beneficial for patients than what was previously understood. ICER published the final draft of its […]