OBJECTIVES : Health Canada has proposed major reforms to current health technology assessment (HTA) practices including consideration of economic factors, revision of countries for reference pricing, relaxed rules on generic drugs, updated reporting requirements, and the disclosure of third-party discounts and rebates. However, these reforms may prolong review of HTA submissions, increase chances of negative recommendations and/or delay reimbursement decisions. These expected unintended consequences are concerning as they may adversely affect Canadian’s access to much needed innovative medicines. In this study, we examined the impact of indicated reforms on the duration of review and outcomes of HTA submissions to CADTH.

METHODS : We reviewed reports on HTA submissions for lung cancer and multiple myeloma drugs to CADTH and several other HTA agencies (i.e., NICE [UK], SMC [Scotland], AMNOG [Germany] and HAS [France] between 2012 and 2019. We examined and compared number of reimbursement submissions, duration of review, recommendation status/decision, percentages of negative recommendations, reimbursement decisions and implementation of reimbursement. We also examined trends in these outcomes over time.

RESULTS : The number of indicated HTA submissions were similar across HTA agencies. CADTH had a higher percentage of negative recommendations (28%) compared to other agencies (5-10%), and trends in percentage of negative recommendations remained level over the study period. NICE had the longest HTA review times (median of 329 days for lung cancer drugs), followed by CADTH and SMC. However, CADTH’s time to final recommendation progressively increased over time. Other findings were similar across all HTA agency reports reviewed.

CONCLUSIONS : Health Canada’s HTA reforms have been associated with a higher percentage of negative recommendations and may adversely patient impact access to novel drugs in Canada. A study limitation is that HTA comparator agencies reviewed may have independently implemented similar HTA reforms as Health Canada’s thus confounding the observed unadjusted policy impact.