Potential therapeutic value of new drugs approved in Australia: a retrospective cohort study
Joel Lexchin
A B *
A School of Health Policy and Management, York University, 4700 Keele Street, Toronto, ON M3J 1P3, Canada.
B Faculty of Medicine, University of Toronto, Toronto, Canada.
Australian Health Review 47(2) 203-207 https://doi.org/10.1071/AH22280
Submitted: 1 December 2022 Accepted: 6 January 2023 Published: 27 January 2023
© 2023 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of AHHA.
Abstract
Objective To examine the potential therapeutic value of new medicines approved in the US and both approved and not approved in Australia.
Methods A list of new medicines approved by the US Food and Drug Administration (FDA) between 1 January 2015 and 31 December 2020 was assembled and it was determined which of these medicines were also approved in Australia. Three metrics – first in class, priority review and therapeutic rating by two independent organisations – were used to determine the potential therapeutic value of the medicines. The percent of medicines with and without potential significant therapeutic value was compared using each of the three metrics.
Results A total of 273 drugs were approved by the FDA, of which 147 (53.8%) were approved by the Therapeutic Goods Administration, the Australian regulator. For each of these three metrics, the percent of medicines with and without potential significant therapeutic value approved in Australia was the same: first in class (yes vs no: Chi-squared P = 0.8562), priority review (yes vs no: Chi-squared P = 0.4593), therapeutic rating (major/moderate vs little/no: Chi-squared P = 0.9006). Some of the 126 drugs not approved may be therapeutically important.
Conclusions New medicines approved in the US between 2015 and 2020 without potential significant therapeutic value are as likely to be introduced into Australia as drugs with potential significant therapeutic value. Some potentially valuable drugs may not have been submitted for approval in Australia by the companies making them.
Keywords: Australia, drug approval, FDA, prescription medicines, TGA, therapeutic group, therapeutic value, United States.
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