{"entity":{"id":"paper-andersen-conditional-approval-cancer-drugs-canada-curr-oncol-2019","kind":"paper","name":"Conditional approval of cancer drugs in Canada: accountability and impact on public funding","aka":[],"tldr":"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.","summary":"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.\n\nOf 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.","asOf":"2026-11-03","links":[{"label":"Curr Oncol 2019","url":"https://doi.org/10.3747/co.26.4397"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/30853815/"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["health-canada","cda-amc"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["current-oncology-mdpi"],"dependsOn":[],"notes":[],"journal":"Current Oncology","year":2019,"doi":"10.3747/co.26.4397","pmid":"30853815","authors":"Andersen SK, Penner N, Chambers A, et al.","paperType":"observational","findings":["22 of 105 drug and indication pairs reviewed by pCODR (21 per cent) had conditional authorisation, all on surrogate endpoints.","Of those 22: 36 per cent no updated data, 36 per cent conditions met, 27 per cent partly met.","No conditional authorisation was revoked for unmet conditions, 2010 to 2017."],"whatItMeans":"A conditional Canadian licence means the evidence was early; the confirmatory evidence may never arrive, and the licence is not withdrawn when it does not.","caveats":["Covers 2010 to 2017, before the time-limited recommendation route of 2023."]},"route":"/key-papers/paper-andersen-conditional-approval-cancer-drugs-canada-curr-oncol-2019/","neighbours":{"institution":[{"id":"cda-amc","kind":"institution","name":"Canada's Drug Agency (CDA-AMC)","route":"/institutions/cda-amc/"},{"id":"health-canada","kind":"institution","name":"Health Canada","route":"/institutions/health-canada/"}],"journal":[{"id":"current-oncology-mdpi","kind":"journal","name":"Current oncology","route":"/journals/current-oncology-mdpi/"}]}}