PHP182 - Number of Submissions Needed to Reach a Positive Reimbursement Decision from SMC, CADTH, and PBAC

Abstract

Often positive reimbursement decisions are only achieved after multiple submissions. Multiple submissions can delay patient access to necessary therapies and be costly for the manufacturer. This study analyzes the number of submissions needed to gain a positive decision and determines the lag time between the first submission and the positive decision. The data covered three agencies: SMC, PBAC, and CADTH’s Common Drug Review. The reviews spanned 23 disease conditions and included 396 Health Technology Assessments (HTAs). A positive decision was achieved after the first submission in 50% of the HTAs analyzed. At 1.57 submissions, PBAC had the highest average number of submissions needed to achieve a positive decision. PBAC’s average was statistically higher than that of both CADTH and SMC (p<0.001). On average, CADTH and SMC needed 1.17 and 1.16 submissions, respectively, to obtain a positive decision. Also, for drugs that were resubmitted, it took on average 430, 924 and 1,189 days to gain a positive decision from SMC, CADTH, and PBAC. For CADTH and SMC, there appears to be a modest linear relationship between the number of resubmissions needed to obtain a positive decision and the number of unique drugs reviewed within the disease condition (r= .46 and .41, respectively). This relationship was not observed for PBAC (r=0.01). PBAC required a greater number of submissions to gain a positive decision and the lag time to a positive decision is longer compared to SMC and CADTH. The number of submissions needed to gain a positive decision by CADTH and SMC were similar, but CADTH’s lag time was double that of SMC. For both SMC and CADTH, the number of drugs reviewed in a disease condition was positively correlated with the number of times a drug had to be submitted in order to gain a positive decision.