[Eleven years of economic evaluations of medical devices by the Spanish Network of Assessment Agencies. Methodological quality and cost-utility impact].

Objective: To analyse the quality and impact of cost-utility evaluations of medical devices carried out by the Spanish Network of Assessment Agencies (RedETS).

Method: The cost-utility evaluations of medical devices were identified by searching the evaluation reports of the RedETS website database (2006-2016). Quality and its impact were evaluated with a RedETS quality checklist, comparing cost-utility results and inclusion in the portfolio of common services of the National Health System. The portfolio inclusion status was analysed considering whether the cost-effectiveness incremental ratio was or was not less than €25,000/quality adjusted life years.

Results: 25 cost-utility evaluations of medical devices were found (12 cost-utility, 10 cost-effectiveness and 3 both). Fifteen selected cost-utility studies with 19 cost-utility ratios met at least 18 of 25 verification criteria. Also, 12 of the 15 studies met 19 of the 25 criteria. On the impact, in 6 out of the 19 results, the product was included in the portfolio even though the ratio exceeded €25,000/quality adjusted life years. There are three cases undergoing a re-evaluation process, another case being reconsidered once the efficacy-safety of new devices has been reported and in two cases the portfolio states that protocols are required.

Conclusions: Most of the cost-utility evaluations of medical devices published by RedETS fulfil most of the items on the checklist and, therefore, were thorough. These cost-utility evaluations of medical devices are consistent with the decision-making framework to efficiently manage the National Health System portfolio.