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A third of FDA cancer approvals from 2019 to 2023 went through Project Orbis, but the drugs offered no more benefit than other approvals and faster licensing did not bring faster funding: in Canada the review agency's median time to a decision rose to 202 days by 2023.
A retrospective comparative analysis of cancer drug approvals reviewed through Project Orbis in the USA, Canada and the UK between 1 May 2019 and 1 November 2023, comparing regulatory review times, time from approval to health technology assessment in England, Scotland and Canada, reimbursement outcomes, clinical benefit and monthly prices with other FDA approvals of the same period.
81 of 244 FDA cancer approvals (33 per cent) went through Orbis. Median overall survival gain was 4.1 months against 2.7 for other approvals and progression-free survival gain 2.6 months in both, neither difference significant. Of 49 Orbis approvals reviewed by CADTH, 44 (90 per cent) were conditionally recommended; CADTH's median time from approval to decision rose from 97 days (one drug, 2020) to 202 days in 2023, while NICE's rose to 302 days and the SMC's to 368. The median monthly price was US$20,000.
Shared regulatory review gets cancer drugs licensed in Canada sooner, but licensing is only the first step; access depends on the value review and price negotiation that follow.
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