Comparing manufacturer submitted analysis and Common Drug Review reanalysis of results: A review of health technology assessment reports for non-oncology medications from 2018 to 2019

Abstract

Introduction Identifying key differences between the manufacturer's submitted analysis and the Canada's Common Drug Review (CDR) economic reanalysis is a crucial step toward creating more appropriate models by manufacturers. We compared manufacturers’ submitted analysis to CDR reanalysis in order to identify any variations in incremental costs utility ratio (ICUR) and 3-year Budget impact analysis (BIA). We assessed the willingness to pay (WTP) threshold and CDR critiques on manufacturers’ clinical and economic reports. Method A pair of reviewers extracted data regarding therapeutic category, percent price reduction requested by CDR, WTP, and the critiques on the manufacturers' clinical and economic reports in publicly available CDR reports from 2018 to 2022. We used Wilcoxon rank test to assess the difference between mean incremental QALY, ICUR, and BIA in manufacturers and CDR reanalysis reports and chi-square tests and logistic regression to assess the relationship between the variables and the final CDR recommendation. Results Of 178 reports assessed, 31 received "do not reimburse" recommendation and 147 received "reimburse with criteria or conditions". The median ICUR in manufacturer's analysis was $138,658/QALY and significantly lower than ICUR reanalyses by CDR of $380,251/QALY. The ICUR in manufacturers' submitted reports was 2.5-fold lower than in the CDR reanalysis ($138,658/QALY versus $380,251/QALY). The CDR reanalysis median for 3-year BIA was $4,575,102 which was 27% higher than the manufacturers submitted 3-year BIA (p value<0.001). The most frequent CDR critiques were clinical effectiveness and the uncertainty of evidence in cost-effectiveness analysis and miscalculations in the population of patients and the percentage of market share in BIA. From 2018 to 2020, $100,000 was the most frequent WTP threshold followed by a $50,000 threshold, but during 2021 and 2022, the CDR only used $50,000 as a WTP threshold. Conclusion Manufacturers may tend to underestimate the costs or overestimate the effect of their medications.