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Abstract
Objectives: The aim of this study was to review the impact of new reimbursement requirements for medicines in the Slovak Republic based on legislation that came into force in January 2018. Methods: The new legislation was reviewed. The reimbursement dossiers for medicines and health technology assessments and appraisals, justifications for reimbursement decisions, final reimbursement decisions, and all aspects of the appeal mechanisms have been transparently published on the website of the Slovak Ministry of Health and were used for this analysis. Results: Based on the new legislation, there was no need to submit information about relative effectiveness and cost-effectiveness of medicines with less than 1:50,000 eligible patients prior to reimbursement decisions, and the cost-effectiveness threshold has been increased for all other medicines. The estimated impact of the 2-year budget for the 59 medicines submitted for reimbursement without relative effectiveness and cost-effectiveness analysis was €181,273,698, based on the published submission dossiers. The estimated impact of the 2-year budget for the 45 medicines with evidence of relative effectiveness and cost-effectiveness was €178,566,634. In contrast to the easier market access criteria for new original medicines, the new legislation enforces stricter price erosion criteria for generic and biosimilar medicines. Consequently, the number of generic and biosimilar entries was reduced from 242 in 2017 to 224 in 2018. Conclusions: Although some of the new reimbursement applications were not approved by the Ministry of Health, many new medicines were added to the Slovak pharmaceutical reimbursement list based on “balanced assessment” requirements; hence, the system became financially unsustainable. It was necessary to change the legislation from January 2019.
Highlights
This article reports on selected legislative initiatives and their implementation, focusing on the consequences for financial sustainability of the Slovak health care system
We reviewed the legislation, including updated Act 363/2011 regarding the scope and conditions of payments for medicines, medical devices, and dietetic foods from public health insurance, and Decree 93/2018 regarding the criteria for determining the significance of the effect of a medication on the public health insurance funds budget; the evaluation criteria for the calculation of the threshold value coefficient; and details of the calculation of the threshold value coefficient
Even if increased market access for new medicines is prioritized by healthcare policymakers, it is questionable whether an increased cost-effectiveness threshold and a simpler market access pathway based on a “balanced assessment” are appropriate tools to achieve this objective
Summary
This article reports on selected legislative initiatives and their implementation, focusing on the consequences for financial sustainability of the Slovak health care system. The strategic pricing of innovative medicinal products is not based on the needs of small markets with low purchasing power (such as Slovakia), as pharmaceutical companies adjust the price level of their new drugs to the requirements of wealthier countries with a greater willingness to pay for one unit of health gain (Kaló et al, 2013). Calculation of the threshold value coefficient was determined by Act 363/2011, and the lower (λ1) and upper (λ2) cost-effectiveness thresholds were defined as 24 and 35 times the average monthly salary, respectively. This meant that the threshold could be increased automatically in positive economic periods.
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