Abstract

A cost-effective medicine has been defined by the Act on Public Health Insurance as a medicine dominating its relevant comparator, being cost-minimizing, or generating an incremental cost-effectiveness ratio (ICER) similar to those shown in already reimbursed medicines. The primary aim of this study was to review, for the first time, the ICERs already accepted for reimbursement within administrative proceedings by the State Institute for Drug Control (SUKL). The secondary aim was to report the ratio of cost-minimization analysis relative to cost-utility analysis. We analyzed all proceedings of the SUKL since 2013 and selected those where the pharmacoeconomic analysis fulfilled our prespecified selection criteria. We considered only applications for permanent reimbursement having acceptable quality of the submission without any confidential agreement on price and excluded proceedings where additional criteria were considered since these represent exceptional cases. In the case that the submitting company requested reimbursement for more than one indication or presented results for different subgroups of patients and, therefore, more ICERs were available, only the highest value was used in the base case analysis. The exchange rate considered was 27 CZK = 1 EUR. Out of 355 proceedings in which economic evaluations have been required, we identified 35 in which the medicine under review was either dominant or cost-minimizing and 30 proceedings where ICERs were shown. The mean positive ICER value was 22,712 EUR per QALY, the maximum was 57,407 EUR per QALY. In 57% of proceedings, the ICERs were lower than 22,200 EUR per QALY and in 97% of proceedings, they were lower than 44,400 EUR per QALY. The results prove long-term consistency of SUKL’s judgments in standard proceedings and can be used as basis for future decisions in compliance with the legislative requirements on evaluating cost-effectiveness in the Czech Republic.

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