Conditional Funding Recommendations for Drugs in Canada: A Cross-Sectional Analysis.

BACKGROUND AND OBJECTIVE: Before listing by drug plans, new drugs that receive regulatory bodies' approval are assessed by the Health Technology Assessment agencies, including the Canadian Agency for Drugs and Technologies in Health (CADTH). Considering the impact of CADTH recommendations on payers' listing decisions, the growing number of high-cost drugs, and conditional listings, conditional recommendations have increasingly been of interest to the users of CADTH recommendations. This study aims to review the conditional reimbursement recommendations issued by CADTH and explores the reasons for those recommendations.

METHODS: All final drug reimbursement recommendations posted on the CADTH website since 1 January, 2003 were reviewed. Recommendations were included if accepted for review by 1 May, 2021 and completed before 1 January, 2022. The complete records excluding 'requests for advice' were categorized into 'reimburse,' 'do not reimburse,' and 'reimburse with criteria/condition(s)'. The identified variables were extracted and analyzed descriptively.

RESULTS: Of the 889 submissions, 785 (88.6%) completed recommendations were considered relevant to the study purpose. Of 750 recommendations, excluding 35 (4.5%) 'requests for advice,' 500 (66.6%) were 'reimburse with criteria/condition(s)'. 'Clinical criteria' at 481 (96.2%), 'cost-effectiveness improvement to an acceptable level' at 132 (26.4%), and 'the treatment cost not to exceed the cost of the alternative option(s)' at 118 (23.6%) were the most frequently reported conditions. The most frequent reasons for conditional reimbursement were 'clinical benefit and economic evaluation' at 304 (60.8%). Of conditional recommendations, 468 (93.6%) included more than one reason.

CONCLUSIONS: CADTH has facilitated patient access to innovative drugs even with limited evidence by conditional recommendations. The clinical criteria are the cornerstone of conditional recommendations. CADTH has developed the assessment process over time.