OBJECTIVES: To characterize the oncology outcomes in Canada’s Drug Agency (CDA-AMC) reviews from 2022-2023 and to understand the rationale for positive recommendations.

METHODS: The CDA-AMC Reimbursement Review Reports database was used to identify all oncology reviews with final recommendations dated 2022 to 2023. The following data were extracted: indication, line of therapy, clinical trial and pharmacoeconomic information, and reasons for recommendation. Data were extracted by a single reviewer and validated by a second reviewer. Characteristics of the reviews were qualitatively analyzed.

RESULTS: A total of 61 reviews (45 unique drugs) were identified for data extraction including five chimeric antigen receptor T-cell (CAR-T) therapies (six review reports). Most reviews (92%) were for indications approved for adults. There were 49%, 23%, and 11% reviews for relapsed/refractory, front-line, and line-agnostic indications. The remaining reviews (16%) were for neo-adjuvant and adjuvant therapies. More than half of the clinical trials were comparative (randomized or non-randomized) with 66% Phase III or IV trials.

There were a total of 85% positive recommendations (52/61). Of these positive recommendations, overall survival (OS) was the primary or co-primary outcome in only 11 reviews. The most common outcomes were progression free survival (PFS, 29 reviews) and response rate (17 reviews). In the comparative trials, OS and PFS results were statistically significant in 12 and 23 reviews. In contrast, none of the reviews with negative recommendations included OS as the primary outcome or had statistically significant OS or PFS results.

In the absence of significant OS improvements, CDA-AMC considered patient needs, delays to disease progression, safety, and economic value to the healthcare system.

CONCLUSIONS: Most reviews were for adults, and more than half submitted comparative clinical data from Phase III trials. Although OS is the most important outcome for oncology drugs, CDA-AMC also evaluates additional efficacy results, patient needs, and cost-effectiveness when issuing a positive recommendation.