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Reimbursement from public health insurance

The amendment introduces a new approach to external price referencing, expanding the options for excluding an identified external reference price from the reference set.

The concept of deemed market availability is reframed—not only by adjusting the percentage threshold, but also, for example, by setting new conditions for deeming similar medicinal products available; changes also concern products with an agreed maximum price.

The rules for setting the base reimbursement according to the daily cost of an alternative therapy are completely reworked.

Several new limitations/constraints are introduced, e.g. for filing applications to change reimbursement or for certain applications to set reimbursement. These include, for instance, limitations on the formulation of reimbursement conditions and time limits for re-filing. Changes also affect applications to amend the content of filings.

Further significant changes concern, for example commercially confidential information and the submission of (pharmacoeconomic) models.

Finally, there is a breakthrough regarding lis pendens, which previously prevented a separate proceeding to obtain reimbursement for a new indication if a proceeding was pending—at any stage—for reimbursement of the same product code in a different indication. This is now altered by a new special provision.

In brief: the amendment

On 12 August 2025, the amendment to the Act on Public Health Insurance was promulgated in the Collection of Laws as No. 289/2025 Coll. Its general effective date is 1 January 2026, with selected provisions taking effect during 2026 or in subsequent years.

The amendment proposes substantial changes to the regulation of public health insurance. In the area of pricing and reimbursement of medicinal products, it will affect, for example: the process of external price referencing (EPR), the rules on deemed availability, the definition of Highly Innovative Medicinal Products (VILP), proceedings on reimbursement for VILPs and orphan medicinal products (LPVOs) used in combination, contractual commitments with payers, assessment of a product as an LPVO, similar medicinal products, lis pendens (litispendence), the submission of models, and review (revision) proceedings.

The reimbursement mechanism will also change—especially for vaccines and monoclonal antibodies intended for prophylaxis—and a special procedure for immunization medicines will be introduced.

At Pharmeca, we help you navigate the complex landscape of pharmaceutical and medical device information. We also offer flexible services that can be tailored to your needs at any time.

Our market position and experience allow us to support you whenever you need expert guidance.

Feel free to contact us.

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The text was translated using ChatGPT 5.  

On 12 August 2025, the amendment was published in the Collection of Laws as No. 289/2025 Coll. The general effective date is 1 January 2026, with certain provisions taking effect during 2026 or in subsequent years.

The amendment proposes substantial changes to the regulation of public health insurance. In pricing and reimbursement of medicinal products, it will affect, for example the process of referencing foreign prices, adjustments to the automatic availability rule, the definition of Highly Innovative Medicinal Products (VILP), procedures for reimbursement of VILPs and orphan medicinal products (LPVOs) used in combination, contractual commitments concluded with payers, assessment of a product as an LPVO, similar medicinal products, lis pendens (litispendence), submission of (pharmacoeconomic) models, and review (revision) proceedings. It also changes reimbursement mechanisms—especially for vaccines and monoclonal antibodies intended for prophylaxis—and introduces a special procedure for immunization medicines.

We will gradually cover the key areas impacted by the amendment in this series.

Maximum Price

Beyond the existing framework, a new procedure will be introduced for important, hard-to-substitute and typically low-cost groups of medicines.

The amendment also brings a special definition of the “closest therapeutically comparable product” for medicines where availability must be ensured.

A new method of recalculating the average exchange rate will apply in cases of exchange-rate volatility for products with fewer available manufacturer prices.

The Ministry of Health will be empowered to exclude foreign manufacturer prices from referencing where there are significant currency exchange-rate differences or other exceptional, relevant circumstances affecting medicinal product prices in an EU Member State.

At Pharmeca, we help you navigate the complex landscape of pharmaceutical and medical device information. We also offer flexible services that can be tailored to your needs at any time.

Our market position and experience allow us to support you whenever you need expert guidance.

Feel free to contact us.

Our knowledge, your opportunity.

The text was translated using ChatGPT 4o.  

Fully reimbursed medicinal products play a key role in ensuring access to healthcare for patients in the Czech Republic. Their regulation is derived from Act No. 48/1997 Coll., on Public Health Insurance, which sets the conditions for their inclusion in the List of Prices and Reimbursements (SCAU). The goal is to ensure patients have access to treatment while optimizing public health insurance expenditures.

Full Reimbursement in Inpatient and Outpatient Care 

Act No. 48/1997 Coll. stipulates that, during the provision of inpatient care, the following are fully reimbursed:

·        medicinal products and foods for special medical purposes,

·        individually prepared medicinal products,

·        radiopharmaceuticals,

·        transfusion products,

·        medical devices,

·        medicinal products for advanced therapy,

·        tissues and cells.

These items are reimbursed in the least economically demanding version, and the insured person does not contribute to their payment.

In outpatient care, Annex No. 2 of the Act plays a crucial role in ensuring that at least one medicinal product in each therapeutic group is fully reimbursed by public health insurance. This guarantees patient access to treatment without co-payments, especially for chronic and severe diseases.

Full Reimbursement and Real Availability of Medicinal Products

However, full reimbursement of a medicinal product does not automatically mean its actual availability on the market. Data shows that only a portion of fully reimbursed medicines are genuinely available to patients, influenced by factors such as manufacturers’ supply decisions, demand fluctuations, and regulatory measures.

The list of medicinal products and foods for special medical purposes reimbursed by health insurance (SCAU250401) includes a total of 8,873 items, of which 987 are fully reimbursed. Out of this number, 748 products are available. The full reimbursement guarantee under Annex No. 2 of the Act applies to 467 of them, while 281 products are not included in Annex No. 2.

• Fully reimbursed products make up 11.12% of all items in the reimbursed medicines list.
• Available fully reimbursed products represent 75.79% of the total number of fully reimbursed products.
• Of the fully reimbursed items, 47.32% fall under Annex No. 2 of the Act.
• Outside Annex No. 2, 28.47% of fully reimbursed products exist.
• Available fully reimbursed products constitute only 8.43% of the total number of items in the list.
• Of the available fully reimbursed ones, 62.42% are from Annex No. 2.
• Outside Annex No. 2, 37.58% of the available fully reimbursed products remain.

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.

The European Health Data Space should lead to the empowerment of citizens and support for research and innovation.

EU residents will have more control over their health data, being able to access it electronically and share it across borders. This is particularly beneficial for cross-border healthcare, allowing individuals to access medical records and receive care seamlessly throughout the EU.

The EHDS promotes the secondary use of health data for research, innovation, and policy-making. Researchers and innovators will be able to access health data more easily and securely, which could drive the development of new treatments, medical devices, and AI applications.

The main objectives of the European Health Data Space (source: excerpt from the Communication from the Commission to the European Parliament and the Council: The European Health Data Space: Harnessing the power of health data for people, patients, and innovation):  

CTIS was established by pharmaceutical law in the Clinical Trials Regulation (Regulation (EU) No 536/2014) and will completely replace the previous system for clinical trials EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) after 30th January 2025. CTIS supports interactions between clinical trial sponsors (researchers or companies that run a clinical trial and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.

CTIS is guaranteed by European Medicines agency (EMA) and works in a secured workspace.

The important milestones for clinical trials:

• CT starts after 30^th January 2023 – the submission must be completed through CTIS
• CT ends before 30^th January 2025 – CT is maintained in EudraCT or national systems
• CT is expected to continue after 30^th January 2025 – transition from the EudraCT or national systems to the CTIS is necessary.