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Slovakia has adopted a major amendment to Act No. 363/2011 Coll., on the Scope and Conditions of Reimbursement of Medicinal Products, Medical Devices and Dietary Foods under Public Health Insurance, introducing significant changes to reimbursement rules, among other areas. The main provisions of the amendment will take effect on 1 November 2026, while the related implementing decrees will not enter into force before 1 December 2026.

The following article highlights selected changes introduced by this legislative amendment.

QALY Thresholds and Clinical Criteria

The amendment introduces standard and increased cost-effectiveness thresholds per QALY, with the increased threshold applying to orphan, innovative and paediatric medicinal products.

Even if a medicinal product does not meet the GDP-based requirements, it may still exceptionally be included in the reimbursement system (in the case of orphan drugs, paediatric indications, innovative treatments or medicinal products for serious diseases), provided that strict clinical criteria are met.

Managed Entry Agreements (MEAs) and Applicants' Financial Obligations

Concluding a Managed Entry Agreement (MEA) is mandatory for the inclusion of a medicinal product in the reimbursement system if its expected budget impact exceeds EUR 1,500,000 over 12 months or if the product is included under a threshold exemption.

The agreement must cover at least three reference periods (36 months) and include obligations for the marketing authorisation holder if the annual reimbursement cap is exceeded or if a conditional marketing authorisation ceases to be valid. The marketing authorisation holder must bear the costs of continuing treatment if it unilaterally terminates the agreement or if the medicinal product is removed from the reimbursement list due to failure to meet the applicable conditions.

Price Caps and the Entry of Generics and Biosimilars

The proposed officially determined price must not exceed the arithmetic mean of the three lowest prices in EU Member States. For the first generic or biosimilar medicinal product, mandatory price reductions (percentage discounts) from the lowest applicable prices are established.

Existing decisions on special price regulation will expire on 31 December 2026, and prices will be adjusted to the European reference price level unless an application for a price adjustment under the new rules has been submitted.

Procedural Rules and Distribution Regulation

All submissions must be made exclusively through an electronic portal.

The Ministry of Health will be authorised to prevent the export of a reimbursed medicinal product if there is a risk of a critical shortage on the Slovak market.

The main provisions of the amendment will take effect on 1 November 2026. However, deferred effective dates apply to certain related pricing and reimbursement mechanisms. Additional implementing regulations are currently undergoing public consultation. These address, among other matters, the detailed calculation of the applicable multiple of gross domestic product (GDP) used to determine the cost-effectiveness threshold for an assessed medicinal product, as well as the requirements for pharmacoeconomic evaluations of medicinal products. Their adoption can be expected in the coming period.

The new rules introduce changes to pricing and reimbursement requirements for medicinal products in Slovakia. If you are planning to enter the Slovak market or need support with pharmacoeconomic analyses and reimbursement submissions, we will be happy to assist you. Please do not hesitate to contact us.

Our knowledge, your opportunity. 

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. 

From January 1, 2025, Slovakia will include medicines and medical devices in the reduced VAT rate of 5%. This move is part of a broader tax reform aimed at improving access to essential goods for the population while reducing the financial burden on patients. The changes are likely a response to the European Commission’s assessment of public finances and an effort to reduce the budget deficit.

This change contrasts with developments in the Czech Republic, where, as of January 1, 2024, the VAT rate on medicines increased from the original 10% to 12%, as we mentioned in our previous article Changes in VAT Rate for Pharmaceuticals.

What Impact Will the Reduced VAT Rate Have in Slovakia?

The lower VAT rate is expected to significantly reduce costs for patients in Slovakia for medical devices and medicines, both in outpatient and hospital care. The direct financial impact on individuals will depend on specific measures and pricing policies. For comparison, Slovakia’s VAT on medicines has dropped from 10% to 5%, which could lead to a more noticeable impact on final prices than in the Czech Republic, where the rate was increased.

Impact on External Price Referencing for Medicines

The reduced VAT rate in Slovakia, however, will not affect the external price referencing (EPR) of medicines, used by some countries to set maximum prices and reimbursement levels in their markets. The VAT change does not reflect in EPR because the reference price is almost universally based on the manufacturer’s price.

At the same time, this change offers an opportunity to compare tax policies across the EU, where VAT rates on medicines and medical devices vary significantly. For example, according to data from EFPIA (European Federation of Pharmaceutical Industries and Associations) as of January 1, 2024, Spain applies a 4% VAT rate on medicines, while Denmark has a standard rate of 25%.

Stay tuned to our website for more updates on legislative changes and their impact on healthcare in the EU.