Pham et al. 2023) Uses data from regulatory decisions and health tech assessments (HTAs), in Australia, Canada and the UK, and compares them with FDA-approved drugs in the US. They discover that:
In 2017, the FDA approved 206 new medicines. 162 (78.6%), however, were denied marketing authorization by at most 1 other regulatory agency with a median (IQR delay) of 12.1 (17.7) month after US approval. 5 FDA-approved medicines were denied marketing authorization by an international regulatory body due to unfavorable benefits-to-risk analyses. HTA agencies in Australia, Canada and the UK also recommended negative reimbursements for 42 FDA approved drugs. These were due to uncertainty regarding clinical benefits or unacceptable prices. The median (IQR) US cost of the 47 drugs refused authorization or not recommended for reimbursement by an international agency was $115 281 ($166 690) per patient per year. Twenty-six drugs were approved for use in oncology. 36 of these drugs were approved by FDA via expedited regulatory processes or the Orphan Drug Act.
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