PCN191 - Pan-Canadian Oncology Drug Review Recommendations for Cancer Products without Statistically Significant Overall Survival Data

Abstract

Overall survival (OS) for cancer products is an important clinical endpoint to payers. This analysis examined the proportion of pan-Canadian Oncology Drug Review (pCODR) recommendations that lacked statistically significant OS data and the factors that may have influenced pCODR recommendations. Final pCODR recommendations and clinical guidance reports publicly accessible at www.cadth.ca and reimbursementdecisions.com were reviewed from 13 July 2011 to 30 November 2015. Sixty-three recommendations were issued by pCODR; 48 (76%) were positive (i.e., without criteria/conditions, conditional on improved cost effectiveness, or restricted patient population) and 15 (24%) were negative (i.e., uncertain/insufficient clinical benefit and/or uncertain cost effectiveness). Among positive recommendations, 23 (48%) had statistically significant OS data and 25 (52%) did not assess or have statistically significant OS data. Among negative recommendations, 4 (27%) had statistically significant OS data and 11 (73%) did not assess or have statistically significant OS data. Ten (40%) positive recommendations without statistically significant OS data noted crossover as a potential confounder of OS, compared with only one (9%) among negative recommendations. A greater proportion of positive recommendations without statistically significant OS data (52%) had statistically significant progression-free survival (PFS) data than negative recommendations (45%). 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.