December 8, 2023

Pham et al. (2023) makes use of knowledge on regulatory choices and well being know-how assessments (HTAs) in Australia, Canada, and the UK and compares them to the medicine which can be FDA-approved within the US. They discover that:

The FDA authorised 206 new medicine in 2017 via 2020, of which 162 (78.6%) had been granted advertising authorization by a minimum of 1 different regulatory company at a median (IQR) delay of 12.1 (17.7) months following US approval. Conversely, 5 FDA-approved medicine had been refused advertising authorization by a global regulatory company as a result of unfavorable benefit-to-risk assessments. An extra 42 FDA-approved medicine obtained damaging reimbursement suggestions from HTA businesses in Australia, Canada, or the UK as a result of uncertainty of scientific advantages or unacceptably excessive costs. The median (IQR) US price of the 47 medicine refused authorization or not really helpful for reimbursement by a global company was $115 281 ($166 690) per affected person per yr. Twenty medicine had been for oncology indications, and 36 had been authorised by the FDA via expedited regulatory pathways or the Orphan Drug Act.

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