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.
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