OBJECTIVES: The Food and Drug Administration (FDA) have approved 28 oncologics across 37 indications on the basis of a clinical trial package lacking comparative Phase III data (Macaulay, ISPOR Toronto 2014). Approval was typically granted for indications with no therapeutic alternative where a response rate ≥10% was demonstrated. This research aims to define the circumstances under which oncologics can obtain both regulatory approval and public reimbursement in Canada on this basis. METHODS: All pan-Canadian Oncology Drug (pCODR) final recommendations and Provincial Funding Summaries were analysed up to 26^th November 2014 and the supportive trial package and key rationale were extracted. RESULTS: CONCLUSIONS: pCODR will recommend oncologics based on single-arm Phase II data for indications where RCTs are not deemed feasible but discounting at a provincial level may be required to offset the inherent uncertainty in the resulting ICER estimation.