OBJECTIVES: The pan-Canadian Oncology Drug Review (pCODR) provides national level reimbursement recommendations on oncology regimens (excluding Quebec). A positive recommendation is typically only provided if a regimen has demonstrated a net-clinical benefit. The objective of this research is to explore pCODR recommendations of regimens without a documented overall survival (OS) advantage, to describe what drove the HTA conclusion.

METHODS: Available pCODR reports from Jan 2012 to Nov 2017 were considered. Primary and secondary study outcomes, in addition to patient-based factors, were extracted for assessment. Descriptive statistics were completed, as well inferential statistics performed using a χ2 test.

RESULTS: Of 71 pCODR submission reviewed, 73% received a positive recommendation (conditional or non-conditional), and 27% received a negative recommendation. 58% of submissions did not include OS as an outcome or did not meet median OS. There was no significant difference in the proportion of reports receiving a positive recommendation between submissions that had OS discussed and those that did not (p=0.99). This finding held true in a subgroup analysis of reports regarding hematologic cancers, where no significant difference was found (p=0.83). In 18% of reports, pCODR explicitly stated an unmet need in their discussion, for which no significant difference was found (p=0.31) in the proportion of reports receiving a positive recommendation between submissions with/without OS discussion. Positive recommendations in absence of OS consideration were mostly driven by improvements in progression free survival (PFS), as well as the treatment aligning with patient values.

CONCLUSIONS: pCODR has provided positive recommendations for oncology regimens submitted without a documented advantage in OS, as there was no significant change in the proportion of reports obtaining a positive recommendation. This suggests that pCODR considers a broader view of the clinical data and patient-based outcomes when considering if a regimen should be recommended for funding.