PCN224 - Cancer Drug Recommendations Without Statistically Significant Overall Survival By The Pan-Canadian Oncology Drug Review

Abstract

Overall survival (OS) for cancer drugs is an important clinical endpoint to payers. This study examined oncology reimbursement recommendations by CADTH’s pan-Canadian Oncology Drug Review (pCODR) for products that that lacked statistically significant OS data and the factors that may have influenced these recommendations. All publicly available pCODR final recommendation reports were identified from 1 January 2016 to 31 December 2017 from which dates, decisions, appraisal outcomes, and clinical endpoints were extracted. Forty-one recommendations were issued by pCODR; 27 (66%) were positive (ie, with or without clinical criteria and/or conditions) and 14 (34%) were negative (ie, uncertain or insufficient clinical benefit and/or uncertain cost effectiveness). Among positive recommendations, 10 (37%) had statistically significant OS data and 17 (63%) did not report or have statistically significant OS data. Among negative recommendations, 7 (50%) had statistically significant OS data and 7 (50%) did not assess or have statistically significant OS data. Four (24%) positive recommendations without statistically significant OS data noted crossover as a potential confounder of OS. Additional reasons noted for positive recommendations without statistically significant OS data were: limited treatment options/unmet need, and demonstration of clinical benefit in progression-free survival (PFS) and/or other clinical endpoints. This study highlights that positive pCODR recommendations may be made in the absence of a clear OS benefit, likely due to crossover as a confounder and/or presence of strong PFS data. Further research may determine additional factors contributing to positive and negative pCODR recommendations despite unavailable OS data.