Assessment of FDA approved drugs not recommended for use or reimbursement in other countries (2017-2020)

JAMA Internal Medicine

13 February 2023 - In this cross-sectional study of all 206 new US drug approvals in 2017 through 2020, 47 drugs were refused marketing authorisation or not recommended for reimbursement in other countries due to unfavourable benefit to risk profiles, uncertain clinical benefit, or unacceptably high price. 

The median US cost for these drugs was $115, 281 per patient per year.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Market access