Pham et al. (2023) makes use of information on regulatory selections and well being expertise assessments (HTAs) in Australia, Canada, and the UK and compares them to the medication which are FDA-approved within the US. They discover that:
The FDA accepted 206 new medication in 2017 by means of 2020, of which 162 (78.6%) had been granted advertising authorization by at the very least 1 different regulatory company at a median (IQR) delay of 12.1 (17.7) months following US approval. Conversely, 5 FDA-approved medication had been refused advertising authorization by a world regulatory company because of unfavorable benefit-to-risk assessments. A further 42 FDA-approved medication acquired destructive reimbursement suggestions from HTA companies in Australia, Canada, or the UK because of uncertainty of scientific advantages or unacceptably excessive costs. The median (IQR) US value of the 47 medication refused authorization or not advisable for reimbursement by a world company was $115 281 ($166 690) per affected person per yr. Twenty medication had been for oncology indications, and 36 had been accepted by the FDA by means of expedited regulatory pathways or the Orphan Drug Act.
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