Exactly one year ago, the Ministry of Health of the Slovak Republic submitted for public consultation a draft decree intended to significantly change the rules for determining reimbursement of medicines from public health insurance. Although the document is technical in nature, it has attracted considerable attention. A total of 333 comments have been submitted and published within the consultation process, including 16 classified as substantial comments.
The main purpose of the proposed decree is to define the detailed methodology for calculating the multiplier of gross domestic product (GDP) per capita, which is used to determine the so-called threshold value of an assessed medicinal product. This value is a key factor in deciding whether a medicinal product will be reimbursed from public health insurance based on its cost-effectiveness.
The original expectation was that the decree would enter into force on 1 June 2025. However, the timeline has been delayed, as by 15 May 2026 the Ministry had only announced the start of the comment evaluation process.
Another draft proposal, concerning the pharmacoeconomic evaluation of medicinal products, has already completed the public consultation phase and is currently awaiting the Ministry’s assessment of the submitted comments.
The purpose of this proposal is to reduce the discount rate used in pharmacoeconomic evaluations from 5% to 3.7% per annum, following the proposed modification of the methodology for determining the cost-effectiveness threshold.
Here as well, 16 comments were submitted during the consultation process, including 5 substantial comments. The comments addressed not only the proposed level of the discount rate itself, but also the possibility of applying lower discount rates for technologies with long-term benefits.
Comments were also submitted by the Slovak Ministry of
Finance, which fundamentally disagrees with the method used to assess the
financial burden. According to the Ministry, the expected positive budget
impact is not sufficiently transparent, and it is unclear to what extent this
impact results specifically from the proposed change in the discount rate as
opposed to other measures, such as the above-mentioned proposal concerning
changes to medicinal product threshold values.
The interconnection between both draft proposals has also
been highlighted by the Slovak Antimonopoly Office, which recommended
withdrawing the proposal from the legislative process until broader
professional consensus is reached within the wider framework of medicinal
product categorisation.
We will continue monitoring the outcome of the consultation
process and keep you informed.
The article is based on publicly available information relating to Slovak legislation.
The text was translated using ChatGPT 5.5.