Objectives: This study examines the use of accelerated approval pathways by Health Canada over the period 1995 to 2016 inclusive and the relationship between the use of these pathways and the therapeutic gain offered by new products. Design: Cohort study. Data sources: Therapeutic Products Directorate, Biologics and Genetic Therapies Directorate, Notice of Compliance database, Notice of Compliance with conditions web site, Patented Medicine Prices Review Board, La revue Prescrire, World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system. Interventions: None. Primary and secondary outcomes: Percent of new drugs evaluated by Health Canada that went through an accelerated pathway between 1995 and 2016 inclusive. Kappa values comparing the review status to assessments of therapeutic value for individual drugs. Results: 438 (70.3%) drugs went through the standard pathway, 185 (29.7%) an accelerated pathway. Therapeutic evaluations were available for 509 drugs. Health Canada used an accelerated approval pathway for 159 of the 509 drugs whereas only 55 were judged to be therapeutically innovative. The Kappa value for the entire period for all 509 drugs was 0.276 (95% CI 0.194, 0.359) or fair. Conclusion: Health Canada’s use of accelerated approvals was stable over the entire time period. Its ability to predict which drugs will offer a major therapeutic gain is relatively poor. The findings in this study should provoke a discussion about whether Health Canada should continue to use these pathways and if so how their use can be improved.

Supplementary Table 2All drugs approved between 1995-2016 that did not receive therapeutic assessmentsSupplementary Table 1All drugs approved between 1995-2016 that received therapeutic assessments from Patented Medicine Prices Review Board and/or La revue Prescrire