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One in five cancer drugs reviewed for public funding in Canada from 2010 to 2017 had a conditional licence based on early data; none received an unconditional funding recommendation, and Health Canada never revoked a conditional licence for unmet conditions.
Health Canada and pan-Canadian Oncology Drug Review databases for 2010 to 2017 were analysed for conditional authorisations of cancer drugs, the post-authorisation follow-up of their conditions, and the funding recommendations that followed.
Of 105 unique drug and indication pairs reviewed by pCODR, 22 (21 per cent) had conditional authorisation, in every case on preliminary surrogate-endpoint data. 36 per cent had no updated data, 36 per cent had updated data meeting Health Canada's conditions and 27 per cent met some but not all. None received an unconditional positive funding recommendation; 11 (50 per cent) were conditionally recommended and 6 (27 per cent) not recommended for insufficient evidence. Health Canada never revoked a conditional authorisation for failure to meet its conditions in the period.
A conditional Canadian licence means the evidence was early; the confirmatory evidence may never arrive, and the licence is not withdrawn when it does not.
Shares Canada's Drug Agency (CDA-AMC), Current oncology, Health Canada.
Shares Canada's Drug Agency (CDA-AMC), Current oncology, Health Canada.
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