PP59 Evaluating Reimbursement Applications With Decision-Oriented Evidence

Abstract

Introduction:Our research group recently evaluated a minimally invasive surgical procedure in order to inform a reimbursement decision. The application for funding was designed around the study selection criteria from a single pivotal randomized controlled trial (RCT). The aim of this study review was to evaluate the safety and effectiveness of this minimally invasive surgical procedure, and document challenges faced in evaluating a technology based on a highly targeted population.Methods:A systematic literature search of four biomedical databases was conducted (PubMed, Embase, Cochrane library, York CRD) up to 8 August 2017. Specific elements related to the population were patient age, together with level and duration of pain. Primary effectiveness outcomes included pain, patient reported quality of life, mortality and adverse events. The included RCTs were critically appraised against the Cochrane risk of bias tool. Meta-analysis was not possible due to the limited availability of evidence with consistent outcomes.Results:From 4,718 search results, only one pivotal RCT specifically met the inclusion criteria, which demonstrated favorable safety and effectiveness of the procedure; however, the sample population in the trial had limited external validity to the proposed reimbursement population and follow-up was limited to six months. As a result, the selection criteria were broadened to better reflect the manner in which the service may be provided in clinical practice, and capture longer-term safety concerns. Four additional RCTs were included, which provided contradictory results.Conclusions:The results of this review identified two important issues in evaluating a health technology where the assessment has been focused to the results of a single trial. In particular, the generalizability of a trial is defined by the demographic distribution of the sample, not the selection criteria. Designing the review selection criteria around the selection criteria for a single trial can have consequences for a funding decision.