OBJECTIVES:

Medical devices are increasingly relying on economic evaluations whether through peer-reviewed publications or reimbursement dossiers for HTA bodies. This research aims to comprehend the key aspects of economic evaluation of medical devices following a previous publication from the EU MedtecHTA Project (Health Economics 2017; 26:S1).

METHODS:

We conducted a systematic literature review in MEDLINE (Pubmed) on cost-benefit/utility/effectiveness/minimization and budget impact analyses for medical devices published since January 1, 2017. Our review focused on cardiovascular disease as it was the predominant disease area. No further restrictions were applied.

RESULTS:

A total of 1,294 citations were identified and assessed with title and abstract screening. Further, 92 full-text publications were then screened leading to the inclusion of 86 economic evaluation studies. Cost-utility analysis was the type of economic evaluation predominantly used (86%), followed by budget impact analysis (6%). Other types of analysis included cost-effectiveness (5%), cost-benefit (2%), and cost-minimization analyses (1%). The three most prevalent types of models were (semi-)Markov (51%), decision-tree (19%), and combined decision-tree + Markov models (14%). A lifetime horizon was used in most of the studies (51%), whereas the second most used time horizon was 5 years (15%). Various sources were used for efficacy outcomes including randomized clinical trials, observational studies, and KOLs. In terms of geographical scope, the USA was the most common country of interest (31%) followed by European Union countries (26%), the UK (17%), and Canada (10%).

CONCLUSIONS:

The results of our study showed that even though cost-utility was the dominant type of analysis conducted, there was heterogeneity in modeling approaches chosen to better reflect the different decision problems. These results together with current updates of HTA guidelines can guide the health economists in the development of economic evaluations for medical devices.