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At the end of October, the Ministry of Health presented a draft amendment to Act No. 48/1997 Coll., which, among other changes, aims to replace the current system for determining the prices and reimbursement of medical devices covered as separately charged materials (ZUM), based on the VZP Methodology, with a new statutory framework.

🔎 New System for the Categorisation of Separately Charged Medical Devices

Under the proposal, responsibility for the Categorisation of Separately Charged Medical Devices (the proposed new designation for the ZUM category) would be transferred to the State Institute for Drug Control (SÚKL), which already manages the reimbursement system for medical devices supplied on prescription vouchers.

Through administrative proceedings, SÚKL would assign medical devices to reimbursement categories based on the European Medical Device Nomenclature (EMDN), taking into account their intended purpose, functional and technical characteristics, and mutual comparability.

The proposal introduces a base reported value per unit of measurement for each reimbursement category, which would be used to calculate the reported value and maximum reported value of individual medical devices. A device could also be granted an increased reported value through a reimbursement bonus.

For innovative medical devices, the proposal establishes three reimbursement pathways: permanent reimbursement, temporary reimbursement and a verification pathway.

💡 Reimbursement Reviews and Administrative Fees

According to the proposal, the sustainability of the system would be supported by regular reviews of the established reported values, conducted through both abbreviated and full reviews.

Communication within administrative proceedings would take place through the Medical Devices Information System (ISZP) and SÚKL's official notice board.

Applicants would be required to pay administrative fees for selected procedures.

⏱️ When Could the New Rules Take Effect?

The proposal envisages an effective date of 1 July 2027, with a gradual transition to the new system. Existing reimbursement conditions would be maintained during the transitional period until the relevant new rules are implemented.

The proposal has not yet completed the legislative process, and its final wording may change. Until then, the current VZP rules, including Methodology version 3.0 effective from 1 September 2026, remain relevant for the inclusion of ZUM in the reimbursement system.

We will continue to monitor the proposed legislative changes.

Need assistance with preparing a reimbursement application for a medical device? The quality of our services is reflected in the carefully prepared documentation that supports discussions about the future of your medical device. Please do not hesitate to contact us

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The English translation was prepared using the latest available ChatGPT model.

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. 

The General Health Insurance Fund of the Czech Republic (VZP) has published a new Methodology for the Managed Entry of Innovations, Version 1.0, effective from 21 September 2026. Its aim is to establish a uniform and structured process for assessing innovations for which their clinical or system-level value, safety, economic impact, operational feasibility and an appropriate pathway for potential future funding or reimbursement need to be evaluated.

The process is intended primarily for:

• medical devices and equipment-based technologies with a digital component,
• software as a medical device,
• digital health technologies,
• telemedicine and remote monitoring,
• AI and algorithmic tools with a clinical or operational impact.

Proposals may be prepared primarily by:

• manufacturers and suppliers of health technologies,
• research and academic institutions,
• consortia comprising multiple entities, where applicable.

VZP accepts innovation proposals through two pathways:

1. Continuous submission of innovations with exceptional benefits
   VZP has already launched continuous submission of proposals for innovations with a significant impact on the economic efficiency of the public health insurance system.
   A key requirement is a demonstrable reduction in direct public health insurance costs of at least 5% within one year compared with the current situation, while maintaining or improving clinical outcomes, safety, accessibility and quality of healthcare.
   The savings must be supported by an economic analysis conducted using the Budget Impact Analysis (BIA) methodology.
   
   
2. Thematic calls
   In addition to continuous submission, VZP will also launch calls focusing on specific areas corresponding to its strategic priorities and healthcare policy.
   The areas specified include, in particular, oncological and cardiovascular diseases, diabetes and related metabolic diseases, and neurodegenerative diseases.
   Submission of proposals will generally be open for a period of three months, after which proposals submitted under the respective call will be assessed together.

What will VZP assess?

The scope of the assessment will depend on the nature and risk associated with the particular innovation. The assessment will focus primarily on clinical value and safety, value for patients, economic impact, impact on the organisation of care, regulatory, data and security readiness, and the ability to measure the outcomes of the innovation.

The process may result in direct inclusion in the reimbursement system, conditional entry, pilot testing, or rejection of the proposal. In the case of pilot testing or temporary reimbursement, the target population, measurable indicators (KPIs), data sources, financial framework and rules for continuation or termination, among other aspects, should be defined in advance.

The managed entry of innovations does not replace statutory pricing and reimbursement procedures, regulatory approval or conformity assessment, nor does it establish an automatic entitlement to reimbursement.

Description of the process according to the VZP website:

In practice, the reimbursement of medical devices reported as separately charged materials (ZUM) is governed by the rules established by the General Health Insurance Company of the Czech Republic (VZP ČR) in its Methodology for the Inclusion, Changes and Increases in the Price and Reimbursement of Medical Devices Reimbursed from Public Health Insurance as ZUM within the VZP Medical Devices Reimbursement Catalogue.

The Methodology sets out the procedures for including new ZUM in the VZP Medical Devices Reimbursement Catalogue, making changes to devices already included in the Catalogue, and increasing their price and reimbursement.

A new version 3.0 takes effect on 1 September 2026, introducing a major change in the assessment of innovative ZUM.

The previous distinction between moderate and substantial innovation has been replaced by three pathways: medical device innovation bonus, expert assessment of innovation, and economic and clinical assessment (HTA).

📈 Medical Device Innovation Bonus

A simplified pathway for ZUM where the clinical benefit can be demonstrated by meeting predefined clinical criteria. If at least one of these criteria is met, a 15% bonus may be granted compared with the reference comparator or group of reference comparators. The criteria include, for example, improvement in a clinically relevant outcome, shorter hospitalisation or recovery time, or a reduced risk of reoperation or reimplantation.

🔎 Expert Assessment of Innovation

This pathway is intended for ZUM providing a relevant clinical, safety or organisational benefit where a full economic and clinical assessment is not required. The assessment focuses in particular on clinical effectiveness, safety, quality of evidence, organisational benefits, implementation requirements, and the expected budget impact. A budget impact analysis (BIA) must be included in the submission.

📊 Economic and Clinical Assessment (HTA)

The most comprehensive pathway applies to innovative ZUM with a significant impact on the public health insurance system or where it is necessary to assess whether the additional costs are proportionate to the claimed clinical benefit. The assessment covers clinical benefits, safety, cost-effectiveness and budget impact. This pathway is also subject to the VZP ČR Methodology for the Economic and Clinical Assessment of Medical Devices.

The Methodology also addresses, among other matters, maximum assessment timelines for selected procedures, the possibility of increasing prices and reimbursement in accordance with the applicable Price Regulation, and the possibility of suspending the assessment process in order to obtain expert opinions.

Do you need assistance with preparing the documentation for the establishment of the price and reimbursement of your medical device by VZP? Do not hesitate to contact us.

Pharmeca a.s. has extensive experience, including in the field of economic and clinical assessment (HTA). This expertise enables us to support you in preparing a complete documentation package for the assessment of your medical device.

Our knowledge, your opportunity.

The English translation was prepared using the latest available ChatGPT model.

Reimbursed Medical Devices

A prescription voucher for a reimbursed medical device may only be issued by a treating physician or by a healthcare professional with specialised or special professional qualifications (e.g. a nurse, laboratory technician, therapist, etc.). As of 1 January 2026, the use of an electronic format (eVoucher) has become mandatory for this purpose, subject only to specific exceptions.

On the other hand, the dispensing of medical devices prescribed on a voucher, with subsequent reimbursement claimed from public health insurance, may only be carried out by authorised dispensers. These include pharmacies, medical device dispensing outlets, optical stores, or contracted dispensing providers.

Provision of Medical Devices in a Physician’s Office

As noted above, a person authorised to issue a prescription voucher is not authorised to dispense the prescribed medical device to the patient and subsequently claim reimbursement from public health insurance on the basis of that voucher.

However, certain groups of orthopaedic and prosthetic medical devices (such as orthoses, cervical collars or crutches) are reimbursed when prescribed on a voucher, while their intended purpose also allows their use in the treatment of acute conditions. In such cases, and from the perspective of appropriateness and patient safety, it is permissible for the required medical device to be provided directly to the patient during treatment in the physician’s office.

The Supreme Administrative Court (SAC) confirmed that a current cost-effectiveness analysis (CEA) must be submitted in cases where the requested reimbursement corresponds to the base reimbursement of the reference group, but exceeds the reimbursement granted to other therapeutically interchangeable medicinal products. According to the Court, the decisive factor is whether the proposed change will generate savings for the system or, conversely, increase expenditure.

In the administrative proceedings, the marketing authorisation holder applied for an increase in the reimbursement of its medicinal product. In its view, the request merely sought to align reimbursement with the level of the base reimbursement established for the relevant group in a previous review and therefore did not require new economic evidence.
However, both SÚKL and the Ministry of Health insisted on the submission of supporting analyses and discontinued the proceedings due to their absence.

According to the administrative authorities, the Public Health Insurance Act requires a cost-effectiveness assessment and budget impact analysis whenever the proposed change in reimbursement is expected to increase expenditure from the public health insurance system and the requested reimbursement exceeds that of other medicinal products that are essentially therapeutically interchangeable.

The SAC stated that such analyses are not required where a medicinal product generates savings for the public health insurance system. However, where no savings are expected and the proposal results in a negative budget impact, their submission is necessary.
In the case at hand, the proposed reimbursement increase demonstrably showed signs of an expected negative budget impact (higher costs), while the requested reimbursement exceeded that of the only therapeutically interchangeable medicinal product. Since both statutory conditions were met, the applicant was required to submit a cost-effectiveness analysis.

The Court therefore definitively confirmed the approach established under the legislation effective since 2022: whenever the requested reimbursement exceeds that of other therapeutically interchangeable medicines on the market, its cost-effectiveness must be demonstrated through updated evidence.

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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.

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Our knowledge, your opportunity.

The article is based on publicly available court decisions published on official judicial websites.  

The text was translated using ChatGPT 5.3.  

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. 

The amendment introduced a new type of reimbursement procedure for products intended for immunisation (vaccines), designed primarily for non-mandatory vaccination. As of 1 May 2026, according to information from the State Institute for Drug Control (the Institute), 10 administrative proceedings had been initiated and are currently at various stages of progress.

This type of procedure is intended to apply the principle of multi-criteria assessment, placing emphasis not only on economic but primarily on non-economic criteria reflecting broader societal needs and interests.
In addition to the standard reimbursement criteria (safety, efficacy and, in the case of vaccines, immunogenicity), the criteria assessed also include, for example:

• the severity of the disease targeted by the vaccine,
• the broader societal importance of prevention,
• the public health benefit, including increased herd immunity, prevention of threats to public health, and support for and improvement of population health,
• recommendations issued by professional societies and institutions.

A different approach also applies to budget impact, where a high budget impact may reflect high vaccination uptake, which is desirable in this context. Budget impact is therefore assessed as the difference between the costs of prevention and the costs of treatment, diagnostics and broader societal costs that would arise in the absence of immunisation.

The Institute’s assessment report will also include an opinion of the National Institute of Public Health (SZÚ). SZÚ has already provided opinions in the first two administrative proceedings, focusing in detail on the epidemiology of the diseases concerned. It also addresses the health, societal and economic impacts of the diseases and the extent to which these may be mitigated through vaccination. The opinion further includes a recommended time horizon for the budget impact analysis, taking into account the characteristics of the disease, as well as an overview of currently applicable vaccination recommendations.

As in the case of orphans, the assessment report will subsequently be reviewed by the advisory body of the Ministry of Health (MoH) during a closed session, in which a conciliation procedure will take place.

The subsequently issued binding opinion of the MoH will then be incorporated into the final decision issued by the Institute. 

Our knowledge, your opportunity.

The article is based on publicly available information concerning administrative proceedings conducted by SÚKL in the area of pricing and reimbursement.

The text was translated using ChatGPT 5.2.