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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.
At
the beginning of April, a draft amendment to the Act on the Regulation of
Advertising and the Act on Medical Devices and In Vitro Diagnostic Medical
Devices was circulated to Members of Parliament. Among other things, it focuses
on advertising of selected sensitive commodities, including human medicinal
products and medical devices.
The
scope of the Act is not limited to B2C relationships, i.e. advertising
directed at the general public, but also extends to B2B relationships,
including advertising targeted at healthcare professionals and employees of
healthcare providers.
The
expected effective date of the amendment is 1 January 2027.
In the following article, we present selected areas of the proposal in relation to specific product categories.
Medicinal Products
The draft expands the definition of advertising, under which all forms of information, market research or incentives intended to promote prescribing, sale, dispensing or consumption will newly be considered advertising.
The amendment also sets out strict conditions under which patient programmes may be conducted so that they are not regarded as impermissible advertising.
Changes will also affect advertising targeted at healthcare professionals. Commercial representatives will newly be allowed to provide Summaries of Product Characteristics (SPC) and reimbursement information also in the form of a link to a source enabling remote access.
Conversely, stricter rules will apply to the provision of free samples, including limits related to the duration of treatment.
The amendment also introduces exemptions from regulation, particularly for incentive programmes run by health insurance funds and for educational programmes aimed at non-physician healthcare professionals.
Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD)
For medical devices and in vitro diagnostic medical devices, the definition of advertising is both expanded and clarified. Advertising will explicitly include, for example, lotteries, similar games, or consumer experience-based testing.
A more precise definition is also introduced for the recipients of comparative advertising, replacing the previously used general term “professionals”.
As with medicinal products, certain exemptions from regulation are defined.
A separate section is dedicated to patient programmes, which aim to improve awareness of diseases, diagnosis and treatment, as well as to support patient cooperation in healthcare provision and to provide training and guidance on the proper use of prescribed medical devices.
Fines
The amendment introduces new obligations and therefore significantly expands the list of actions (administrative offences) subject to penalties.
A fine of up to CZK 500,000 may newly be imposed, for example, for conducting patient programmes in breach of the law—whether due to violation of their intended purpose, content, or the provision of prohibited benefits to patients. The same fine applies to failure to meet notification obligations towards SÚKL, breaches of hospitality rules in online professional meetings, and similar cases.
Fines of up to CZK 2,000,000 are newly expressly applicable to organising prohibited competitions, lotteries and user tests for medicinal products and medical devices, for missing or outdated information in advertising directed at professionals, or for exceeding limits on the number of samples.
Fines of up to CZK 5,000,000 may be imposed for suggesting that the safety of a medicinal product is guaranteed by its natural origin, for using inappropriate depictions of bodily changes, or for providing gifts and benefits to healthcare professionals that are unrelated to their professional activities, among other violations.
Healthcare professionals themselves may newly face fines of up to CZK 100,000 if they actively request prohibited benefits or excessive hospitality, rather than merely accepting them.
Would you like to stay informed about changes in legislation? Feel free to contact us. 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.
Our knowledge, your opportunity.
The text was translated using ChatGPT 5.2.
The determination of prices and reimbursement of medicinal products is based on external price referencing, within which foreign prices denominated in foreign currencies are converted into Czech crowns.
Currently, foreign prices are converted using the quarterly average exchange rate published by the Czech National Bank for the calendar quarter preceding the calendar quarter in which the administrative proceedings were initiated (the “relevant exchange rate”).
According to the amendment to the implementing decree, where no more than three manufacturer prices of a given medicinal product are available and the relevant exchange rate differs by more than 10 % from the average exchange rates over the six quarters preceding the relevant exchange rate, the conversion for the affected medicinal product is carried out using the average exchange rate over those six quarters.
Where more than three manufacturer prices of a given medicinal product are available and the relevant exchange rate differs by more than 10 % from the average exchange rates over the six quarters preceding the relevant exchange rate, such a price is excluded from the calculation.
To make it easier to assess whether these conditions are met, we have updated a visual support tool on our website.
With a single click, you can now find not only the relevant average exchange rate for the preceding quarter but also its deviation compared to the previous six quarters.
At the beginning of December, the State Institute for Drug Control (SÚKL) held a seminar entitled Current Topics in Price and Reimbursement Regulation. The following article presents key practical information delivered at the seminar and includes SÚKL’s interpretation of selected topics previously addressed in the Dawn of the Amendment to the Public Health Insurance Act series.
This article is therefore a transcription of texts based on presentations published on the SÚKL website, where their full versions are available.
The amendment in the area of medicinal products intended for immunisation will ensure full reimbursement of more effective and more modern vaccines.
By submitting an application for the determination of reimbursement pursuant to Section 39db et seq., it is possible to request:
Types of administrative proceedings under the amendment:
Administrative proceedings are initiated only upon submission of the second application, which must be filed within 30 days of the first application. The web-based application forms have been amended to require explicit indication that the case concerns a joint proceeding with another medicinal product.
Withdrawal of one of the applications leads to termination of the
proceedings; all applicants have dispositive rights over the subject matter of
the application.
Assessment of Highly innovative medicinal product (VILP) status
Assessment of Orphan (LPVO) Status
Initiation of an abbreviated review (ZR) following entry of the first PP
Under the amendment, the abbreviated review is initiated only after verification of commercial availability (pursuant to Sections 13a and 13b of Decree No. 376/2011 Coll.) of a reimbursed similar product in relation to the originally reimbursed product.
The market share of all similar products within the relevant ATC group is assessed for a given calendar month, excluding the originally reimbursed product:
Comprehensive review (HR)
Section 39l(3): a reduction of the base reimbursement by more than 80% compared to the base reimbursement established in the first completed comprehensive review.
The justification for applying this provision is assessed either directly within the ongoing comprehensive review or after issuance of a decision in an abbreviated review in which reimbursement decreased by more than 80%.
A comprehensive review cannot be initiated if, within the last 12 months, a decision has been issued in another comprehensive review within the same group of essentially therapeutically interchangeable medicinal products.
In an individual administrative proceeding (ISŘ) concerning a
change in the amount and conditions of reimbursement (VaPÚ), it is not possible
to establish more restrictive reimbursement conditions than those set in the
most recent comprehensive review.
Abbreviated review (ZR)
Abbreviated reimbursement reviews are differentiated for groups containing ZÚLP (savings of CZK 20 million) and groups not containing ZÚLP (savings of CZK 30 million).
Removal of the statutory three-year time limit for conducting an abbreviated maximum price review.
Abbreviated reviews (cost-saving, including savings based on DNC/DoÚ) cannot be initiated if another abbreviated review decision for the same medicinal product group was issued within the last 12 months.
Abbreviated maximum price reviews are conducted for reference groups or groups of essentially therapeutically interchangeable products (the rule based on active substance and route of administration has been removed).
VILP criteria
a) The primary clinically relevant endpoint in the clinical trial demonstrated at least a 30% improvement in a quality-of-life–relevant parameter in direct comparison, or at least a 35% improvement in indirect comparison versus reimbursed therapy; in the case of progression-free survival, median PFS must be extended by at least three months; or
b) Median overall survival is prolonged by at least 30% versus reimbursed therapy, and by at least three months; where median OS is not reached, a reduction in the OS hazard ratio of at least 35% versus reimbursed therapy is demonstrated; or
c) A medicinal product with conditional marketing authorisation pursuant to Regulation (EC) No 726/2004, where no alternative with permanent or temporary reimbursement exists, or where the alternative is supportive or symptomatic treatment only, and the MAH has committed to reimbursing health insurance funds for costs incurred should the conditional authorisation expire, lapse or be withdrawn.
For medicinal products with conditional marketing authorisation applying for VILP status under point (c), criteria under points (a) and (b) are not assessed. The sole condition is the absence of causal treatment within the reimbursement system and the conclusion of an agreement.
Section 17(6): ...upon request of a health insurance fund or MAH, the Institute assesses the benefits and costs associated with the use of such medicinal products. MAHs, health insurance funds and relevant professional societies provide cooperation.
Models – general requirements
The procedure for determining the maximum price (MC) for medicinal products that are significant for the provision of healthcare and which the Ministry of Health, with regard to the public interest in maintaining their availability, designates in a special price measure (Section 39a(3)) is as follows:
a) the average of prices in up to seven reference basket countries, provided that the medicinal product is present in at least two reference basket countries;
b) the average of identified prices within the EU, where point (a) cannot be applied;
c) a therapeutically comparable medicinal product (TPLP) in the Czech Republic, where points (a) and (b) cannot be applied
(i.e. the lowest price of a medicinal product containing the same active substance, pharmaceutical form and strength; where more than one TPLP exists, the lowest price of the medicinal product with the same or the closest pack size is used);
d) the average price of TPLP in the reference basket, where points (a) to (c) cannot be applied
(from each reference basket country, the lowest price of a medicinal product containing the same active substance, pharmaceutical form and strength is used; where more than one such product exists, the lowest price of the medicinal product with the same or the closest pack size is applied).
Determination of MC / Price Referencing
Pursuant to the amendment to Decree No. 376/2011 Coll., new rules apply concerning the relevant exchange rate and exceptions in situations where, during price referencing for the purpose of MC determination, the exchange rate deviation exceeds 10% compared to the average quarterly exchange rates over the preceding six calendar months:
Exclusion of a Foreign Price from External Reference Pricing
Determination of the base reimbursement amount (Section 39c(2)(a) of the Public Health Insurance Act)
Manufacturer price / ODTD in the EU:
Determination of Reimbursement / Price Referencing
Where the relevant exchange rate deviates by more than 10% compared to the average quarterly exchange rates of the foreign exchange market published by the Czech National Bank over the preceding six calendar quarters, conversion into Czech currency is carried out using the average exchange rate published by the Czech National Bank over the preceding six calendar quarters (Section 11(2) of the Decree).
Determination of Base Reimbursement / Price Referencing
In the event of the introduction of market-wide measures, the Institute excludes the identified foreign manufacturer price in the EU Member State analogously pursuant to Section 7(3) (Section 12(4) of the Decree).
Where the deviation of the lowest identified price is ≥ 20% compared to the average of the second and third lowest prices, the price extreme is excluded. This does not apply to VILP and LPVO (Section 16(2) of the Decree).
Source:
YOUNG, Michaela; ŽÁČKOVÁ, Kristýna a CHYTILOVÁ, Petra. Seminář SÚKL č. 19 – Sekce cenové a úhradové regulace: Úhrada vakcín 2026. Online. In: . 2025. Dostupné z: https://sukl.gov.cz/wp-content/uploads/2025/10/5.-Uhrada-vakcin-2026.pdf. [cit. 2025-12-18].
ŠVORCOVÁ, Tatiana; CHYTILOVÁ, Petra a VYSEKALOVÁ, Eva. Seminář
SÚKL č. 19 – Sekce cenové a úhradové regulace: Novela ZoVZP - další změny.
Online. In: . 2025. Dostupné z: https://sukl.gov.cz/wp-content/uploads/2025/10/6.-Novela-ZoVZP-%E2%80%93-dalsi-zmeny.pdf. [cit.
2025-12-18].
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 5.2.
In the field of reimbursement and regulation of foods for special medical purposes (FSMP) reimbursed from public health insurance within outpatient care, significant changes will take effect from 1 January 2026 based on the amendment to the Public Health Insurance Act.
New rules for FSMP reimbursement
Transitional period
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The text was translated using ChatGPT 5.1.
Inpatient care reporting
A health insurance fund may agree with an inpatient care provider on the method of reporting and reimbursement of medicinal products used in the provision of inpatient care, for which the fund has negotiated the reimbursement amount and conditions with the marketing authorization holder or manufacturer.
For the purpose of negotiating the reimbursement amount and conditions between payers and the marketing authorization holder for medicines used exclusively in inpatient care, the State Institute for Drug Control (the Institute) will, at the request of payers or the holder, conduct an assessment of benefits and costs (analogous to HTA). All entities concerned (including marketing authorization holders) are obliged to cooperate with the Institute.
Drug lump sums, which are no longer applied in practice, are abolished.
Deductible co-payments
The conditions for recognizing co-payments for children under 4 years of age are expanded by defining selected dosage forms and by specifying the calculation method of the co-payment in these cases.
Reimbursement of expenses
Changes also apply to the reimbursement of expenses for acts performed by the Institute, which will no longer apply to applicants requesting an increase in the maximum price in the public interest or to applicants for unregistered medicinal products whose use has been authorized under the Medicines Act.
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.
Our knowledge, your opportunity.
The text was translated using ChatGPT 5.1.
Similar medicinal product
The amendment introduces the concept of an “original reimbursed product” and clarifies the definition of the “first similar product,” for which a marketing commitment will no longer be submitted; instead, its actual market availability will trigger an abbreviated revision due to its entry into the reimbursement system.
The Institute will newly assess the appropriateness of therapeutic intervention for similar products originating from the same marketing authorization holder, with the aim of preventing circumvention of contractual arrangements.
The conditions for the automatic recognition of an appropriate therapeutic
intervention are defined.
The assessment of market availability of a similar product will now be governed by criteria focused on the total quantity of all supplied similar products and by calculating the average monthly volume.
Combination
product
The amendment introduces a significant change in the calculation of reimbursement for combination products, taking into account situations where all included active substances are reimbursed individually on the one hand, and situations where one of the substances is not reimbursed on the other.
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.
Our knowledge, your opportunity.
The text was translated using ChatGPT 5.1.
In-depth
reimbursement revision
Under the new rules, in an in-depth revision in which a significant decrease in
the basic reimbursement compared to the first in-depth revision is
demonstrated, the State Institute for Drug Control (Institute) will carry out a review or, where applicable,
cancellation of the indication restriction, and in certain cases also a
reassessment of the prescribing restriction, depending on the nature of the
medicinal product (Rx, ZULP).
A minimum interval between individual in-depth reimbursement revisions within the same reference group is introduced in order to minimise excessive administrative burden on the Institute.
Abbreviated price and reimbursement revision
The amendment introduces changes to the thresholds relevant for initiating an abbreviated reimbursement revision, depending on the type of medicinal products.
Revisions of maximum prices will newly be conducted for products included in the same reference group.
A deadline for commenting on the assessment report is introduced, excluding the possibility of submitting an obstruction appeal against the resolution setting this deadline.
The conditions for initiating a reimbursement revision due to product unavailability are updated.
As with in-depth revisions, a minimum interval between individual revisions is set, during which no new revision may be initiated. However, this time limitation does not apply to revisions initiated, for example, due to the entry of the first similar medicinal product or the need to ensure the availability of a fully reimbursed product.
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.
Our knowledge, your opportunity.
The text was translated using ChatGPT 5.1.