OBJECTIVES: New drugs that receive regulatory bodies' approval are assessed by the Health Technology Assessment agencies, including the CADTH, before listing by drug plans in Canada. Considering the impact of CADTH recommendations on the listing decisions, the growing number of high-cost drugs and conditional listings, conditional recommendations have always been of interest to the users of CADTH recommendations. This study explores the conditions of recommendations and their reasons.

METHODS: All final reviews of drug reimbursement recommendations posted on the CADTH website since 1 January 2003 were reviewed. Submissions 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/conditions’. The conditions of the recommendation, and reasons for the recommendation, were extracted and analyzed descriptively.

RESULTS: Of the 889 submissions, 785 (88.6%) completed recommendations were reviewed. After excluding 35 (4.5%) “requests for advice” the remaining 750 recommendations consisted of 27 (3.5%) ‘reimburse’, 223 (29.7%) ‘do not reimburse’, and 500 (66.6%) ‘reimburse with criteria/conditions’.

‘Clinical criteria’ 481 (96.2%), ‘cost-effectiveness improvement to an acceptable level’ 132 (26.4%), and ‘price reduction’ 106 (21.1%) are the most frequently reported conditions. Among the reasons for conditional reimbursement, ‘clinical benefit & economic evaluation’ 304 (60.8%) and ‘clinical benefit & economic evaluation & patient-based values’ 91 (18.2%) were the most frequent one. Of conditional recommendations, 468 (93.6%) included more than one reason and only 32 (6.4%) of the recommendations were due to one reason, ‘clinical criteria’ or ‘economic evaluation’.

CONCLUSIONS: CADTH has provided the patient timely access to innovative drugs even with limited evidence by conditional recommendations rather than rejecting the new drugs. The clinical criteria is the cornerstone of conditional recommendations. CADTH has developed the assessment process and added patients’ engagement to ensure meeting their values.