Pham et al. (2023) Data on regulatory decisions and Health Technology Assessments (HTAs) in Australia, Canada and the United Kingdom were used and compared with US FDA-approved drugs. They found:
Of the 206 new drugs approved by the FDA between 2017 and 2020, 162 (78.6%) received marketing approval from at least 1 other regulatory agency, with a median (IQR) delay of 12.1 (17.7) post-approval in the US moon. In contrast, 5 FDA-approved drugs were rejected by international regulatory agencies due to unfavorable benefit-risk assessments. An additional 42 FDA-approved drugs received negative reimbursement recommendations from Australian, Canadian, or British HTA agencies due to uncertain clinical benefit or unacceptably high prices. The average (IQR) cost in the United States of 47 drugs that were denied authorization or not recommended for reimbursement by international agencies was $115 281 ($166 690) per patient year. Twenty drugs are for oncology indications and 36 drugs have FDA approval through accelerated regulatory pathways or the Orphan Drug Act.
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