Time to Publication of Cost-effectiveness Analyses for Medical Devices

OBJECTIVES: Academic researchers and physicians have called for greater use of cost-effectiveness analyses in informing treatment and reimbursement decisions. This study examines the availability of cost-effectiveness analyses for medical devices, in terms of both the number of studies and when studies are published. STUDY DESIGN: Analysis of the number of years between FDA approval/clearance and publication for cost-effectiveness analyses of medical devices in the United States published between 2002 and 2020 (n = 86). METHODS: Cost-effectiveness analyses of medical devices were identified using the Tufts University CostEffectiveness Analysis Registry. Studies in which the model and manufacturer of the medical device used in the intervention were identifiable were linked to FDA databases. Years between FDA approval/clearance and publication of cost-effectiveness analyses were calculated. RESULTS: A total of 218 cost-effectiveness analyses of medical devices in the United States published between 2002 and 2020 were identified. Of these studies, 86 (39.4%) were linked to FDA databases. Studies examining devices approved via premarket approval were published a mean of 6.0 years after the device received FDA approval (median, 4 years), whereas studies examining devices that were cleared via the 510(k) process were published a mean of 6.5 years after the device received FDA clearance (median, 5 years). CONCLUSIONS: There are few studies describing the cost-effectiveness of medical devices. Most of these studies' findings are not published until several years after the studied devices received FDA approval/clearance, meaning that decision makers will likely not have evidence of costeffectiveness when making initial decisions related to newly available medical devices.