PHP5 - Role Of Patient Input In The Cedac Drug Reimbursement Decision Making Process

Abstract

Since 2010, the Canadian Agency for Drugs and Technologies in Health (CADTH), via the Common Drug Review (CDR), have allowed patient groups to submit issues and outcomes important to them to inform Canadian Expert Drug Advisory Committee (CEDAC) recommendations on drug reimbursement. The objectives were to determine if the inclusion of patient input into the CDR process resulted in any change in the CEDAC positive funding recommendation (PFR) rate and to assess potential factors associated with a PFR. CEDAC recommendations (May 2004 to December 2013) were obtained from the CADTH website. “Efficacy” was defined as occurring when an outcome(s) identified as important to patients achieved statistically significant improvement versus placebo or similar/improved results versus active comparators. Trends in PFR were characterized using descriptive statistics and factors associated with a PFR were assessed using logistic regressions The PFR rate for the 153 recommendations published prior to the patient input process was 54% which was similar to the PFR rate (56%) for the 89 recommendations published after the process was established. A PFR rate of 58% was observed in the 65 submissions that included patient input and 50% in the 24 submissions without. Submissions that showed efficacy in outcomes important to patients had a similar PFR rate (60%) than the submissions that failed to demonstrate efficacy (52%). Characteristics associated with a PFR were being a biologic product, having an appropriate comparator, showing sufficient clinical evidence and being priced at a similar/lower price than the comparator. The presence of patient input was not associated with a PFR. The lack of significant association could be attributed to external factors that are not captured in CADTH’s summary reports and the limited sample size of data available. It remains unclear how patient input is integrated into the decision making process.