• Alexander O Everhart.
• Harvard-MIT Center for Regulatory Science, Harvard Medical School, Harvard University, 200 Longwood Ave, Armenise Bldg, Room 109, Boston, MA 02115. Email: Alexander_Everhart@hms.harvard.edu.
• Am J Manag Care. 2023 May 1; 29 (5): 265268265-268.

ObjectivesAcademic 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 DesignAnalysis 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).MethodsCost-effectiveness analyses of medical devices were identified using the Tufts University Cost-Effectiveness 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.ResultsA 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).ConclusionsThere 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 cost-effectiveness when making initial decisions related to newly available medical devices.

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