OBJECTIVES : Clinical outcome assessments (COAs) are of growing importance in health technology assessments (HTAs). While their most common place in HTA is in the evidence package, HTA agencies can also decide to include COAs as a condition in their recommendations. The objective of this analysis was to evaluate trends in the inclusion of COAs as condition in Canadian HTA recommendations.

METHODS : HTA recommendation from January 2017 through May 2019 for Canada’s HTA body CADTH were identified. Single drug assessment recommendations for both oncology (pCODR) and non-oncology (CDR) were evaluated for their inclusion of COAs. Trends based type of COA were analysed (patient-reported [PRO], clinician-reported [ClinRO], or performance outcome [PerfO]). Additionally, trends in indication and condition type were explored.

RESULTS : In nearly 2.5 years, the Canadian national agency published 57 oncology and 85 non-oncology final recommendations. The majority of oncology reviews (45/57) had a positive recommendation. Of these, only one included a physician-assessed criterium (‘patient deemed fit’). Additionally, the majority specified ‘good performance status’ as condition in the recommendation (33/45; 73%). Similarly, the majority of non-oncology reviews (73/85) had a positive recommendation. Of these, thirteen (18%) included a COA as a condition in their recommendation. The COA-inclusion rate increased over the years, with 2/28 (7%) in 2017 (one PRO, one ClinRO), 3/32 (9%) in 2018 (one PRO, two ClinROs), and 8/14 (57%) in the first five months of 2019 (three PROs, two ClinROs and two PerfOs). Most COAs were included in autoimmune diseases and asthma. Examples of COA conditions include the requirement to meet baseline criteria, and the requirement to demonstrate improvement or lack of deterioration post baseline.

CONCLUSIONS : COAs currently do not play a crucial role in Canadian oncology reviews, but appear to have a growing role in recommendations for non-oncology treatments.