In the proceedings, the State Institute for Drug Control (the Institute) argued that this must refer exclusively to a review of maximum prices. As only a reimbursement review—and not a price review—had been conducted in the relevant group, the Institute rejected the application as inadmissible.
The appellant, by contrast, argued that the Act does not distinguish between a price review and a reimbursement review.

In its decision, the MoH stated that the Act refers generally to “an abbreviated review under Section 39p”, which covers both price reviews and reimbursement reviews. In its view, the Institute’s interpretation was overly restrictive.
The original purpose of the reduction in price and reimbursement for the first generic was to prevent high patient co-payments upon its market entry. Once the Institute had carried out an abbreviated reimbursement review, reimbursement levels were aligned across all products within the relevant group, thereby eliminating the risk of inequality in patient co-payments.

For these reasons, the MoH concluded that the completion of an abbreviated reimbursement review is sufficient to allow the submission of an application for a price increase and, on that basis, annulled the Institute’s decision by which the proceedings had been discontinued.

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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.3. 

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.

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The text was translated using ChatGPT 5.2.  

The appellant argued that the Institute had incorrectly classified the comparator product as a generic within the meaning of a first similar medicinal product. According to the appellant, for medicinal products authorised on the basis of bibliographic data (bibliographic applications), the provisions on reimbursement reduction applicable to the entry of generic products cannot be applied automatically, as such products are not generics.
The appellant referred to a prior judgment of the Municipal Court in Prague, which annulled the Institute’s decision on reimbursement determination due to its unlawfulness, where the Institute had classified the product as a generic—although, according to the court, a product authorised on the basis of a bibliographic application does not qualify as a generic.
The appellant therefore maintained that the court’s conclusions on the unlawfulness of the Institute’s approach to the assessment of bibliographic registrations were directly applicable to the present proceedings.

The Ministry acknowledged the shift in the case law of the Municipal Court in Prague but emphasised that administrative authorities cannot arbitrarily disregard their own final decisions unless and until they are annulled by a competent court. The current situation, in which a legal action has been brought against the review decision, does not entitle the authority to depart from that decision, even if it has been challenged.
At the same time, the MoH concluded that in the present case the nature of the authorisation (bibliographic vs. generic) was not relevant, as the subject of the proceedings was limited to a technical recalculation of reimbursement.

For these reasons, the MoH upheld the Institute’s decision.

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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.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.3. 

The requirement for relevant comparators was modified in 2022 for proceedings on the reimbursement of orphan medicinal products (Section 39da), when the advisory body of the Ministry of Health introduced the following requirement for this specific type of proceedings: “…that any future application for reimbursement of an orphan medicinal product for which comparators reimbursed from public health insurance exist (whether with reimbursement determined by the Institute in administrative proceedings or under Section 16 of Act No. 48/1997 Coll.) must include a cost-effectiveness analysis against such comparators.”
As a result, in reimbursement proceedings for orphan medicinal products conducted under Section 39da, therapies reimbursed not routinely but under exceptional reimbursement pursuant to Section 16 are commonly included among comparators—even in cases where their use is off-label within the given indication.

This approach has also been identified in proceedings concerning the determination of permanent reimbursement for a non-orphan medicinal product, where SÚKL likewise accepted as a comparator a product reimbursed under Section 16.
However, in another case involving the use of a comparator reimbursed under Section 16, SÚKL argued in its assessment report, for example, as follows: “…treatment provided under Section 16 of the Public Health Insurance Act is, by its nature, exceptional and cannot be considered the least costly standard option for the purposes of general reimbursement setting…’”

It remains to be seen whether, in the future, the approach to the use of Section 16 comparators will become harmonised across different groups of medicinal products, and whether the position of Section 16–reimbursed treatments will gain greater importance even in standard reimbursement proceedings.

Section 16 of Act No. 48/1997 Coll., on Public Health Insurance
The competent health insurance fund shall reimburse, pursuant to Section 19(1)(a), in exceptional cases healthcare services otherwise not covered by health insurance, provided that the provision of such healthcare services constitutes the only option in view of the insured person’s health condition.

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Articles are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

The text was translated using ChatGPT 5.3.  

The main reasons cited were:

1. Insufficient therapeutic benefit
2. Issues related to the selection and positioning of comparators
3. Failure to meet VILP criteria across all proposed indications
4. Insufficient evidence on survival outcomes
5. Methodological concerns in comparative analyses

According to the SÚKL, unless the VILP criteria are met against all relevant comparators under assessment, the product cannot be granted temporary reimbursement, even under modified conditions.

The MoH upheld the SÚKL’s decision and additionally highlighted the inappropriateness of relying on abstracts, which are condensed summaries and do not provide sufficient detail on the underlying data. On this basis, the administrative authority cannot responsibly assess the presented evidence.
Furthermore, the MoH recommends not submitting key scientific data under confidentiality restrictions if a detailed evaluation is expected, as any public assessment of such protected data can only remain of a general nature.

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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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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.3. 

“The competent health insurance fund shall reimburse, pursuant to Section 19(1)(a), in exceptional cases healthcare services otherwise not covered by health insurance, provided that the provision of such healthcare services constitutes the only option in view of the insured person’s health condition.”

That such requests are not rare is evidenced, for example, by statistics published by the General Health Insurance Company of the Czech Republic.

Pursuant to Section 39b(5), the Institute determines the amount and conditions of reimbursement of the assessed similar medicinal product based on the amount and conditions of reimbursement of the medicinal product to which it is similar. Where more than one such reference product exists, or where an application for reimbursement has already been submitted by another marketing authorisation holder, the applicant may not request a reimbursement level higher than that established for the first similar medicinal product pursuant to Section 39b(6), or higher than that derived from the base reimbursement of the reference group pursuant to Section 39b(8).

In the first months of this year, this rule was applied in two proceedings. In both cases, the applicant selected a reference medicinal product whose reimbursement level did not correspond to the base reimbursement of the reference group (RS) within the meaning of Sections 39b(5) and (8) of the Act. In other words, the selected reference product had a base reimbursement (and thus also a core reimbursement) higher than the base reimbursement of the reference group.
As a result, one proceeding was terminated following the withdrawal of the application, while in the other case, after the modification of the submission, reimbursement was successfully determined.

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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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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.2. 

At this time, we can confirm that access to case files via the Verso application when logged in using the National Identification and Authentication Point (NIA), i.e. the so-called citizen identity, is functioning without limitations. Unfortunately, complications persist with access without login, which we are actively addressing.

We therefore recommend using login via citizen identity when accessing Verso.

Recommended Procedures for Affected Parties to Administrative Proceedings

• In-person access to the case file
  Access to the case file pursuant to Section 38 of Act No. 500/2004 Coll., the Administrative Procedure Code, remains available at the Institute’s premises.
  When: Working days, 8:00–16:00
  Where: SÚKL headquarters – Building B (Benešovská 2538/40, 101 00 Prague 10)
  Contact for appointment booking: cau_sekretariat@sukl.gov.cz

• Monitoring the Official Notice Board
  Due to the technical outage, participants in administrative proceedings are advised to pay increased attention to monitoring the Institute’s Official Notice Board. Documents published by way of public notice in proceedings under Part Six of Act No. 48/1997 Coll., on Public Health Insurance, may be posted there and may include deadlines for procedural actions.

• Procedural Deadlines and Applications
  If a technical obstacle on the part of the Institute objectively prevents a party from performing a procedural act within the prescribed time limit, the following instruments under the Administrative Procedure Code may be used:
        Extension of a deadline / suspension of proceedings:
  This may be requested if there is a risk of missing a deadline due to the unavailability of remote access. The request must be submitted sufficiently in advance.
        Waiver of missed deadline:
  If a deadline has already expired, the party may request a waiver pursuant to Section 41(2) of the Administrative Procedure Code. Each such request will be assessed individually, taking into account the current technical situation.

Note: Information on the restoration of the Verso system will be published on this page without delay. We apologise for the inconvenience caused and thank you for your understanding.

FAQ

1) Is it currently possible to access a case file?
Yes, in person at the Institute’s premises, Monday–Friday, 8:00–16:00. The Verso service may be temporarily unavailable.

2) What is DSŘ and can it be used instead of case file access?
DSŘ is an automated method for downloading selected documents (system-to-system communication). It is not an alternative to access to the case file under Section 38 of the Administrative Procedure Code and cannot replace it. DSŘ availability may be limited.

3) I am unable to meet a deadline due to the outage — what should I do?
Submit a timely request for an extension of the deadline or suspension of proceedings; after the deadline has expired, you may request a waiver pursuant to Section 41(2) of the Administrative Procedure Code.

4) How should I proceed if I need a specific document?
Book an in-person file inspection; for general orientation in the proceedings, continuously monitor the Official Notice Board.

The text of this article was taken in full from the SÚKL website.

The text was translated using ChatGPT 5.2. 

According to the European Medicines Agency Annual Report (European Medicines Agency, 2025), a total of 114 medicines were authorised through the centralised procedure in 2024, including 46 medicines containing a new active substance (the authorisation of one product was subsequently withdrawn).

Our analysis, conducted as of 1 March 2026, confirms that among medicines containing a new active substance approved by the European Medicines Agency in 2024:

• ✅ Price and reimbursement have been determined for only 5 of the 45 medicines,
• ⏳ Administrative proceedings on price and reimbursement determination are ongoing for 20 medicines,
• 🛑 For 20 medicinal products, the marketing authorisation holder has not yet submitted an application for inclusion in the List of Reimbursed Medicines,
• 🚚 Distribution has been initiated for 16 medicines, regardless of whether reimbursement has been established.

These figures suggest that the path of new innovative medicines to the Czech market is often slow and administratively demanding, which may have a direct impact on both patients and manufacturers.

The Question: Reasons for Delays

The 2025 study Medicines: Regulation versus Patient Needs, conducted by the Initiative for Efficient Healthcare (Hlávka et al., 2025), points out that the strict and long-standing rules governing reimbursement determination are primarily focused on limiting the budgetary impact. Typical measures include:

• reimbursement limited to only part of the indicated patient population,
• prescription restrictions limited to specific medical specialties or specialised healthcare facilities.

Such restrictions directly affect the availability of medicines and may reduce the attractiveness of the Czech market for manufacturers, which can lead to delayed market entry of innovative therapies.

Recommendations: Flexibility and Modern Financing Instruments

The authors of the study recommend:

• introducing a more flexible willingness-to-pay (WTP) threshold, better reflecting disease severity, the level of innovation and patient needs,
• using modern financing mechanisms, such as coverage with evidence development (CED) or risk-sharing arrangements,
• further developing multi-criteria decision analysis (MCDA) for very high-cost medicines.

The study also highlights additional factors affecting the market, including dependence on imports, the underutilised potential of pharmacists, the need to work with real-world data, and the importance of supporting competitiveness and self-sufficiency in the pharmaceutical sector. The patient perspective is not overlooked either:

“For medicines to be effective, it is essential that patients understand their disease and therapy, and that they know why and how to use medicines correctly and safely.”

Source:

European Medicines Agency. (2025). Annual report 2024. Publications Office. https://data.europa.eu/doi/10.2809/6143038

Hlávka, J., Klimková, V., Brychtová, M., Selinger, E., Přecechtěl, Š., Milošič, A., Chadimová, K., Decker, B., Navrátil, M., Vaniš, K., & Kučera, M. (2025, září). IEZ_Studie_Zdravotnictvi pro budoucnost_4-Leciva.pdf. Studie 2025: Léčiva: regulace versus potřeby pacientů. https://www.efektivnizdravotnictvi.cz/post/studie-2025-leciva-regulace-versus-potreby-pacientu

The text was translated using ChatGPT 5.2.  

In administrative proceedings concerning the determination of price and reimbursement initiated from 1 January 2026, it is possible, beyond the previously existing options, to exclude the manufacturer price in an EU Member State where that state has introduced a market-wide measure affecting the manufacturer price of the medicinal product. In such cases, however, SÚKL must receive official information from the relevant foreign authority or from the Ministry of Health.

In the determination of the maximum manufacturer price, a foreign price is also excluded in cases where the lowest price deviates by more than 20% from the average of the second and third lowest prices, or where more than three prices are identified and the price associated with an exchange rate deviating by more than 10% from the average exchange rate over the previous six calendar quarters is excluded.

When determining the base reimbursement, a foreign price may also be excluded if it is at least 20% lower than the average of the second and third lowest prices. However, this rule does not apply to highly innovative and orphan medicinal products.

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? 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.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.2. 

A simplified process scheme follows:

The primary reason for the decision was to ensure continued treatment availability for oncology patients, as supply of the previously registered medicinal products containing the above active substance had been interrupted for manufacturing reasons. 
As no other registered alternative for oral administration was available within the relevant group, the Ministry of Health approved a specific treatment programme for an unregistered medicinal product. The Institute subsequently determined its maximum price and reimbursement level, adopting the reimbursement conditions of the originally reimbursed product that had become unavailable.
The decision on the determination of price and reimbursement was issued 24 days after submission of the application. 

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? 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.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.2. 

At this time, we can confirm that access to case files via the Verso application when logged in using the National Identification and Authentication Point (NIA), i.e. the so-called citizen identity, is functioning without limitations. Unfortunately, complications persist with access without login, which we are actively addressing.

We therefore recommend using login via citizen identity when accessing Verso.

Recommended Procedures for Affected Parties to Administrative Proceedings

• In-person access to the case file
  Access to the case file pursuant to Section 38 of Act No. 500/2004 Coll., the Administrative Procedure Code, remains available at the Institute’s premises.
  When: Working days, 8:00–16:00
  Where: SÚKL headquarters – Building B (Benešovská 2538/40, 101 00 Prague 10)
  Contact for appointment booking: cau_sekretariat@sukl.gov.cz

• Monitoring the Official Notice Board
  Due to the technical outage, participants in administrative proceedings are advised to pay increased attention to monitoring the Institute’s Official Notice Board. Documents published by way of public notice in proceedings under Part Six of Act No. 48/1997 Coll., on Public Health Insurance, may be posted there and may include deadlines for procedural actions.

• Procedural Deadlines and Applications
  If a technical obstacle on the part of the Institute objectively prevents a party from performing a procedural act within the prescribed time limit, the following instruments under the Administrative Procedure Code may be used:
        Extension of a deadline / suspension of proceedings:
  This may be requested if there is a risk of missing a deadline due to the unavailability of remote access. The request must be submitted sufficiently in advance.
        Waiver of missed deadline:
  If a deadline has already expired, the party may request a waiver pursuant to Section 41(2) of the Administrative Procedure Code. Each such request will be assessed individually, taking into account the current technical situation.

Note: Information on the restoration of the Verso system will be published on this page without delay. We apologise for the inconvenience caused and thank you for your understanding.

FAQ

1) Is it currently possible to access a case file?
Yes, in person at the Institute’s premises, Monday–Friday, 8:00–16:00. The Verso service may be temporarily unavailable.

2) What is DSŘ and can it be used instead of case file access?
DSŘ is an automated method for downloading selected documents (system-to-system communication). It is not an alternative to access to the case file under Section 38 of the Administrative Procedure Code and cannot replace it. DSŘ availability may be limited.

3) I am unable to meet a deadline due to the outage — what should I do?
Submit a timely request for an extension of the deadline or suspension of proceedings; after the deadline has expired, you may request a waiver pursuant to Section 41(2) of the Administrative Procedure Code.

4) How should I proceed if I need a specific document?
Book an in-person file inspection; for general orientation in the proceedings, continuously monitor the Official Notice Board.

The text of this article was taken in full from the SÚKL website.

The text was translated using ChatGPT 5.2. 

However, one of the affected marketing authorisation holders appealed against the initiation of the proceedings, arguing that the entering product was not the first similar medicinal product and referring to earlier proceedings in which the newly entering product had not been assessed as similar.

The Ministry of Health (MoH) rejected this objection, stating that although in the referenced proceedings the assessed product and the reference (originator) product contained the same active substance, they differed in dosage, standardisation units and pharmaceutical forms. At the same time, the products were assessed against additional criteria—such as therapeutic indications or pharmacological properties—and, on that basis as well, were not considered similar.

In the present case, however, the MoH considers the medicinal product concerned to be a generic within the meaning of the Act on Medicinal Products. The products involved in the proceedings contain the same active substance and a comparable pharmaceutical form as the reference product, and the appellant repeatedly failed to demonstrate otherwise.

In the case under review, the conditions for initiating a review on the grounds of the entry of the first similar medicinal product were therefore met.

The MoH further notes that although, under the legislation applicable at the time, SÚKL could have initiated the proceedings earlier, the appellate authority considers the approach whereby SÚKL waited for the first actual supply of the medicinal product concerned to be appropriate and well justified. This prevented a reduction in reimbursement for similar products based on a first similar medicinal product that was not yet commercially available.

Pursuant to the amendment to the Public Health Insurance Act, in abbreviated reviews initiated after 1 January 2026, there is now an obligation to verify market availability at a minimum level of 5%, or 2% for ZÚLP.

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? 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.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.2. 

The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.

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.

Our new online overview provides:
✔ The required average exchange rate from the previous quarter
✔ The exchange rate development in the current quarter
✔ A monitoring focus on the 6 most commonly used European exchange rates in administrative proceedings

And all of this at a click!

The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.

The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.

According to the MoH, it was not possible to designate the product referenced in the proceedings as a relevant fully reimbursed medicinal product for two main reasons:

• the referenced product had reported an interruption of its placing on the domestic market effective as of 25 December 2023, i.e. prior to the date on which the contested decision (issued on 27 November 2023) became enforceable. In the case of a product with a notified interruption, a temporary supply disruption may reasonably be assumed, and consequently the practical impossibility of its full reimbursement;
• the referenced product is also reimbursed for the treatment of bladder cancer. The products for which the reimbursement increase was assessed are reimbursed exclusively for patients with renal cancer and soft tissue sarcoma. Although bladder cancer and renal cancer both fall under carcinomas of the urogenital tract, the MoH does not consider them to constitute diseases of the same type within the meaning of the legal opinion of the Constitutional Court.

Full reimbursement for the group of patients with the indication of bladder cancer could therefore not be ensured through the assessed product but was secured through other medicinal products.

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? 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.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.2. 

The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.

The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.

The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.

The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.

Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Certain Related Acts, as amended.  

Implementing regulations (selected):

• Decree No. 376/2011 Coll., implementing certain provisions of the Public Health Insurance Act, as amended,
• Notice of the Ministry of Health No. 529/2025 Coll., on the antigenic composition of vaccines against pneumococcal infections for vaccination of insured persons over 65 years of age
• Notice of the Ministry of Health No. 23/2024 Coll., on the antigenic composition of vaccines against pneumococcal infections for childhood vaccination and for insured persons with health risk factors
• Notice of the Ministry of Health No. 273/2024 Coll., on the antigenic composition of reimbursed vaccines for influenza vaccination of persons over 65 years of age
• Notice of the Ministry of Health No. 474/2021 Coll., on the antigenic composition of reimbursed vaccines against human papillomavirus
• Decree No. 432/2025 Coll., on the determination of the value of a point, reimbursement levels for reimbursed services, advance payments, and regulatory limitations for 2026
• Notice of the Czech Statistical Office No. 159/2018 Coll., introducing the CZ-DRG classification of hospitalized patients
• Decree No  384/2007 Coll., on the list of reference groups, as amended,
• Decree No  385/2007 Coll., on the list of medicinal substances intended for supportive or adjunctive treatment, as amended,
• Decree No. 63/2007 Coll., on reimbursement of medicinal products and foods for special medical purposes, as amended.
• Decree No. 618/2006 Coll., issuing framework contracts, as amended,
• Decree No. 134/1998 Coll., issuing the list of healthcare procedures with point values, as amended,
• Decree No. 527/2021 Coll., on the determination of the amount of reimbursement of expenses for expert acts and the method for determining the amount of reimbursement of expenses for expert consultations carried out by the State Institute for Drug Control pursuant to the Act on Public Health Insurance, as amended,
• Decree on the determination of the value of a point, reimbursement levels for reimbursed services and regulatory limitations – issued annually for the relevant period,
• Government Regulation No. 307/2012 Coll., on local and temporal availability of healthcare services, as amended.

Act No. 551/1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended.

Act No. 280/1992 Coll., on sectoral, professional, company and other health insurance companies, as amended.

Implementing regulations to the Health Insurance Acts (selected):

• Decree No. 421/2025 Coll., on the determination of certain contributions from the fund of generally beneficial activities of the General Health Insurance Company of the Czech Republic and sectoral, professional, company and other health insurance companies for 2026, as amended
• Decree No. 125/2018 Coll., on information contained in health insurance plans and outlooks and on the method of their submission by health insurance companies, as amended
• Decree No. 362/2010 Coll., on the method of providing information on the financial management of health insurance companies and its scope, as amended
• Decree No. 418/2003 Coll., laying down more detailed specification of the scope and amount of income and expenditure of public health insurance funds of health insurance companies, the conditions for their creation, use, permissibility of mutual transfers of financial resources and their management, the limit of operating costs of health insurance companies covered from the resources of the basic fund including the method of calculation of this limit, as amended
• Decree No. 41/2000 Coll., laying down detailed conditions for the creation and use of financial resources of the funds of the Military Health Insurance Company of the Czech Republic for reimbursement of healthcare provided beyond the scope of public health insurance from the state budget resources of the Ministry of Defence, as amended
• Measure of the Ministry of Health determining financial performance indicators of health insurance companies for the relevant year

Act No. 592/1992 Coll., on Premiums for Public Health Insurance, as amended.

Implementing Regulation:

• Government Regulation No. 357/2025 Coll., on the assessment base for public health insurance premiums paid by the state for 2026
• Decree No. 107/2025 Coll., on adjustable parameters of redistribution of public health insurance premiums for 2026 and on the content, structure and format of data for calculation of the calculated redistribution parameters
• Decree No. 65/2025 Coll., on the method of valuation of costs of healthcare services for the purposes of redistribution of public health insurance premiums
• Decree No. 351/2022 Coll., on the transfer of data on consumption of medicinal products by insured persons of public health insurance when changing a health insurance company, as amended

Act No. 526/1990  Coll., on Prices, as amended.

Price regulations / price decisions – Medicinal Products (selected):

• Price Decision of the Ministry of Health No. 1/2026/OLZP, on price regulation of medicinal products and foods for special medical purposes
• Price Decision of the Ministry of Health No. 2/2026/OLZP, establishing the list of ATC groups of medicinal products significant for the provision of healthcare, for which the maximum manufacturer price is determined in the public interest of ensuring availability
• Price Decision No. 2/2025/OLZP, on price regulation of individually prepared medicinal products containing cannabis for medical use
• Price Regulation of the Ministry of Health No. 4/2024/OLZP, on the determination of a special distribution margin for medicinal products released from reserve stock system,

Price Decisions – Medical Devices:

• Price Decision of the Ministry of Health No. 3/2026/OLZP of 24 October 2025, on price regulation of medical devices and in vitro diagnostic medical devices

 Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts, as amended.

 Implementing regulation (selected):

• Government Regulation No. 552/2025 Coll., on conditions for prescribing, dispensing and use of individually prepared medicinal products containing psilocybin for medical use
• Decree No. 457/2023 Coll., laying down the list of human medicinal products to which the obligation of the marketing authorisation holder to ensure their supply after the notified date of interruption or termination of supplies does not apply, as amended.
• Decree No. 84/2008 Coll., on Good Pharmacy Practice, on detailed conditions for handling medicinal products in pharmacies, healthcare facilities and by other operators and establishments dispensing medicinal products, as amended,
• Decree No. 85/2008 Coll., laying down the list of medicinal substances and excipients that may be used for the preparation of medicinal products, as amended,
• Decree No. 86/2008 Coll., laying down the principles of Good Laboratory Practice in the field of medicinal products, as amended
• Decree No. 106/2008 Coll., on Good Practice for sellers of restricted medicinal products and on the professional training course for sellers of restricted medicinal products, as amended
• Decree No. 143/2008 Coll., on human blood, as amended
• Decree No. 228/2008 Coll., on registration of medicinal products, as amended,
• Decree No. 229/2008 Coll., on the manufacture and distribution of medicinal products, as amended,
• Decree No. 236/2015 Coll., laying down the conditions for prescribing, preparation, distribution, dispensing and use of individually prepared medicinal products containing cannabis for medical use, as amended,
• Decree No. 329/2019 Coll., on prescribing medicinal products in the provision of healthcare services, as amended,
• Decree No. 463/2021 Coll., on the detailed conditions for conduct of clinical trials of human medicinal products, as amended.

Act No 167/1998 Coll, on Addictive Substances and on Amendments to Certain Other Acts, as amended

Implementing regulation (selected):

• Government Regulation No. 552/2025 Coll., on the conditions for prescribing, dispensing and use of individually prepared medicinal products containing psilocybin for medical use, as amended
• Government Regulation No. 456/2025 Coll., on the list of psychomodulatory substances, as amended
• Decree No. 448/2025 Coll., on psychomodulatory substances, as amended
• Decree No. 349/2025 Coll., on the requirements for notifications submitted by persons cultivating opium poppy and technical hemp, as amended
• Decree No. 147/2025 Coll., on specimen forms and records of psychomodulatory substances and classified psychoactive substances, as amended
• Government Regulation No. 11/2025 Coll., on the list of classified psychoactive substances, as amended
• Decree No. 53/2014 Coll., on official forms pursuant to the Act on Addictive Substances, as amended,
• Decree No. 123/2006 Coll., on records and documentation of addictive substances and preparations containing them, as amended,
• Decree No. 243/2009 Coll., laying down the list of persons, including specification of their workplaces, for whose activities no permit for handling addictive substances or preparations containing them is required, as amended,
• Government Regulation No. 463/2013 Coll., on the lists of addictive substances, as amended,
• Decree No. 235/2022 Coll., on the cultivation and processing of cannabis plants for medicinal use, as amended,
• Decree No 53/2022 Coll., on the determination of the amount of reimbursement of expenses for expert acts carried out by the State Institute for Drug Control pursuant to the Act on Addictive Substances, as amended.
• Decree No. 329/2019 Coll., on prescribing medicinal products in the provision of healthcare services, as amended by Decree No. 53/2020 Coll., as amended

Act No. 288/2025 Coll., on the Categorisation of Medical Devices Prescribed on Vouchers Reimbursed from Public Health Insurance and on Amendments to Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Certain Related Acts (the Medical Devices Categorisation Act), as amended

Act No. 375/2022 Coll., on Medical Devices and In Vitro Diagnostic Medical Devices, as amended. 

Implementing regulation (selected):

• Decree No 377/2022 Coll., implementing certain provisions of the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended, 
• Decree No. 378/2022 Coll., on the specimen inspector identification card of the State Institute for Drug Control pursuant to the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended.
• Decree No 379/2022 Coll., on the determination of the amount of reimbursement of expenses for expert acts carried out by the State Institute for Drug Control pursuant to the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended. 

Act No 376/2022 Coll., amending certain Acts in connection with the adoption of the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended.

Act No. 268/2014 Coll., In Vitro Diagnostic Medical Devices, as amended.

Act No. 89/2021 Coll., on Medical Devices and on Amendments to Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts (the Medicinal Products Act), as amended.

Implementing regulation:

• Notification of the Ministry of Health No. 54/2022 Coll., on the commissioning of the central repository of electronic vouchers.

Act No. 22/1997 Coll., on Technical Requirements for Products and on Amendments to Certain Related Acts, as amended.  

Act No. 90/2016 Coll., on Conformity Assessment of Specified Products when Supplied on the Market, as amended.

Act No. 325/2021 Coll., on Healthcare Digitalisation, as amended, and other related acts, as amended

Act No. 372/2011 Coll., on Health Services and Conditions for Their Provision (the Health Services Act), as amended.  

Implementing regulations (selected):

• Decree No. 380/2025 Coll., on emergency medical on-call services, as amended
• Decree No. 30/2025 Coll., on telemedicine health services, as amended
• Decree No. 444/2024 Coll., on healthcare documentation, as amended
• Decree No. 373/2016 Coll., on the transfer of data to the National Health Information System, as amended
• Decree No. 70/2012 Coll., on preventive medical examinations, as amended
• Decree No. 39/2012 Coll., on dispensary care, as amended

Act No. 40/1995 Coll., on Regulation of Advertising and on Amendments to Act No. 468/1991 Coll., on the Operation of Radio and Television Broadcasting, as amended.

Act No 242/2022 Coll., on Video-sharing Platform Services and on Amendments to Certain Related Acts (the Video-Sharing Platform Services Act), as amended.

Act No. 387/2024 Coll., on General Product Safety and on Amendments to Certain Related Acts, as amended.

Act No. 500/2004 Coll., the Administrative Procedure Code, as amended.

Current price decisions, opinions and methodological gudelines or regulations of the Ministry of Health of the Czech Republic.

Instructions and guidelines of SÚKL.

The Pharmeca team

This article is therefore a transcription of texts based on presentations published on the SÚKL website, where their full versions are available.

Vaccine Reimbursement as of 2026

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:

• reimbursement of new indications of an already reimbursed vaccine, resulting in the determination of an additional reimbursement entry in the List of Reimbursed Medicinal Products (SCAU);
• reimbursement in an indication already reimbursed under the previous legislation, resulting in the revocation of the existing reimbursement and the determination of a new one.
  In the event of a partial overlap between the newly proposed reimbursement conditions and an existing reimbursed indication, the Institute will revoke the existing reimbursement only in the overlapping part and determine a new reimbursement for that part.
• reimbursement of a vaccine not previously reimbursed, by submitting an application for the determination of the maximum price and the amount and conditions of reimbursement (MC and VaPÚ).

Joint Proceedings Concerning Combinations of Medicinal Products

Types of administrative proceedings under the amendment:

• VILP + VILP combination – procedure pursuant to Section 39d et seq. of the Public Health Insurance Act (ZoVZP);
• LPVO + VILP combination – procedure pursuant to Section 39da et seq. ZoVZP;
• LPVO + LPVO combination – procedure pursuant to Section 39da et seq. ZoVZP.

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

• In VILP + VILP applications, VILP status is not assessed separately for each medicinal product used in combination; the combination as a whole must meet the VILP criteria.
• In LPVO + VILP applications, VILP criteria are not assessed in any orphan indication. The VILP already has temporary reimbursement established in another indication.
  
  

Assessment of Orphan (LPVO) Status

• In LPVO + LPVO applications, both products have active orphan status; at least one of them has orphan status in the given indication.
• In LPVO + non-reimbursed medicinal product without orphan status, the non-orphan product must have the relevant orphan indication included in its SPC.

Similar Medicinal Products (PP)

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:

• PP in a reference group containing prescription-only medicines: at least a 5% share of the average monthly volume (DIS-13);
• PP in a reference group containing only separately reimbursed medicinal products (ZÚLP): at least a 2% share of the average monthly volume (REG-13).

Comprehensive and Abbreviated Reviews

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.

• For reference groups containing prescription medicines, SÚKL will remove indication restrictions (except for off-label indications) and reassess prescribing restrictions.
• For reference groups containing ZÚLP, SÚKL will reassess indication restrictions, with possible removal following BIA assessment.

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).

Changes Affecting VILP and LPVO

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.

Assessment of Benefits and Costs of Hospital Medicinal Products

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.

• This is not a formalised process (i.e. not administrative proceedings or an OOP).
• A non-public file is established; access pursuant to Section 38 of the Administrative Procedure Code.
• SÚKL does not act as a regulator issuing a substantive decision.
• SÚKL does not decide on the amount and conditions of reimbursement of hospital medicinal products listed in SCUP.
• SÚKL processes submitted documentation from health insurance companies, marketing authorisation holders, and professional societies in an impartial manner.
• Assessment compares costs and benefits of the hospital medicinal product versus alternative treatment options.

Submission of Pharmacoeconomic Models

Models – general requirements

• Preferred format: Excel or TreeAge.
• Fully functional, allowing parameter adjustments with automatic recalculation of results.
• Non-functional models, incorrect formulas or source codes trigger a request for correction.
• Technical documentation must be submitted (does not replace structured submission).
• Maximum recalculation time: 10 seconds; justified cases 30–60 seconds.
• Required for all types of administrative proceedings (determination/change, VILP §39d, LPVO §39da, immunisation products §39db ZoVZP).

Determination of the Maximum Manufacturer Price of Medicinal Products  

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:

• where no more than three medicinal product prices are identified, conversion is carried out using the average exchange rate for the preceding six calendar quarters prior to the relevant exchange rate (Section 3(2) of the Decree);
• where more than three medicinal product prices are identified, any price whose relevant exchange rate deviates by more than 10% from the average quarterly exchange rates over the preceding six calendar quarters is excluded (Section 7(2) of the Decree).
  
  

Exclusion of a Foreign Price from External Reference Pricing

• The deviation of the lowest identified price exceeds 20% compared to the average of the second and third lowest prices, the average of the second and third lowest prices or the DNCV is applied (Section 7(1) of the Decree);
• More than three prices are identified, SÚKL excludes the price associated with an exchange rate that deviates by more than 10% from the average exchange rate over the preceding six calendar quarters (Section 7(2) of the Decree);
• Market-wide regulatory measures affecting the market have been introduced in an EU Member State and SÚKL has received official information from the competent authority of that Member State or from the Ministry of Health (Section 7(3) of the Decree).

Determination of Reimbursement for Medicinal Products

Determination of the base reimbursement amount (Section 39c(2)(a) of the Public Health Insurance Act)

Manufacturer price / ODTD in the EU:

• where it is demonstrated in administrative proceedings that the medicinal product is not present on the market in a given EU country, such price reference is excluded;
• availability requirements:
  • medicinal products within substitutability on the Czech market ≥ 5%;
  • a similar product for six months from the date on which the decision determining its reimbursement amount and conditions becomes enforceable, at the latest until another reimbursed similar product becomes available pursuant to Section 39b(4), first sentence, excluding the originally reimbursed product;
  • a medicinal product with a concluded DNCV (maximum manufacturer price agreement) or DoÚ (reimbursement agreement) for six months from the effective date of the written agreement.
  
  

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].

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The text was translated using ChatGPT 5.2.  

Although, in proceedings under Section 39da initiated at the request of a health insurance fund, the marketing authorisation holder is not formally subject to an enforceable obligation to submit pharmacoeconomic analyses of a defined quality, the assessment of clinical benefit, cost-effectiveness and budget impact remains a key prerequisite for determining the appropriateness of reimbursement from public health insurance. The absence of a cost-effectiveness analysis is therefore considered a material deficiency.

While the results of the cost-effectiveness analysis (ICER) are not formally applied as a decision-making threshold, budget impact and value for money considerations remain implicitly present in the assessment of the public interest.

A declared intention to conclude budget cap agreements does not constitute a binding basis for a reimbursement decision unless such arrangements have been incorporated into SÚKL’s assessment report prior to the issuance of the opinion of the Ministry of Health.

Individual reimbursement granted under Section 16 for exceptional cases does not establish an automatic entitlement to system-wide reimbursement under Section 39da, where the existence of a public interest constitutes the primary statutory condition.

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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.

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

Our knowledge, your opportunity.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.2. 

New rules for FSMP reimbursement

• FSMP will newly be classified into reimbursement groups listed in the categorisation tree attached to the Act, based on their composition and intended use (similarly to medical devices).

• The rules for price and reimbursement regulation are also changing, the new system will take into account whether a product is categorised (i.e., can be included in the categorisation tree and is substitutable with reimbursed FSMP) or non-categorised (i.e., cannot be included in the categorisation tree and is not substitutable with reimbursed FSMP).

• The reimbursement amount for specific FSMP will be derived from the base reimbursement set by a measure of general nature for the respective reimbursement group.

• A new obligation is introduced to notify the actual placing on the market and to maintain detailed records of FSMP.

Transitional period

• FSMP reimbursed at the end of 2025 will continue to be reimbursed under the same conditions and at the same reimbursement level.
  This applies until the State Institute for Drug Control (SÚKL) publishes their new reimbursement within the new system.

• The manufacturer/importer (notifier) of FSMP reimbursed in 2025 must submit a notification to SÚKL by the end of September 2026, otherwise, the respective FSMP will cease to be reimbursed.

• All administrative proceedings concerning FSMP that have not been concluded under the previous legislation will be discontinued as of 1 January 2026.

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The text was translated using ChatGPT 5.1.  

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.

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

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The text was translated using ChatGPT 5.1.  

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.

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The text was translated using ChatGPT 5.1.  

The MoH clearly concluded that the subject of the proceedings is identical and comprehensive, thereby upholding the resolution of the State Institute for Drug Control (the Institute) to discontinue the second proceeding due to litispendence.

At the same time, within the proceedings, the MoH emphasized that the subject of the procedure is not an isolated change to a single condition, but always a comprehensive assessment and determination of a new, complete set of reimbursement levels and conditions for the given product. The reimbursement level and reimbursement conditions form an inseparable and mutually interconnected pair.

In its reasoning, the MoH relied on case law of the Supreme Administrative Court (SAC), particularly on its view that even an extension of indication (and even a completely new indication) does not in itself constitute a change to the subject of the proceedings.

According to the MoH, allowing two parallel proceedings would risk the issuance of two contradictory reimbursement decisions, which would introduce absolute uncertainty into the system.

For completeness, we add that under the amendment to the Act on Public Health Insurance, from 1 January 2026 it will be possible to conduct two parallel proceedings concerning an extension of reimbursement for the same product, provided that the application for the later proceeding is submitted after a decision has been issued in the earlier proceeding, and that both proceedings are conducted for different indications.

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? 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.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5. 

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.

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• The SÚKL registry office will be open on 23 December 2025 and 31 December 2025 from 8:00 a.m. to 12:00 p.m.
• The SÚKL cash desk will be open on 23 December 2025 from 9:30 a.m. to 11:00 a.m. From 27 December to 31 December 2025, the SÚKL cash desk will be closed.

The following text highlights selected points that focus not only on the new obligations for the entities concerned.

Is it possible to submit a notification of an annual increase in the manufacturer’s price already in November, effective from 1 January 2026?

Yes. Under the currently valid price regulation, an annual increase in the manufacturer’s price may be submitted from 1 November 2025. These notifications are processed into lists published in December, effective from 1 January 2026.

Will the change of reimbursement group be carried out automatically based on the current classification of the medical device, or must the authorization holder (manufacturer/authorized representative) actively submit a new notification in the ISZP system?
The Institute cannot automatically reclassify products into a newly established reimbursement group. It is necessary to submit a notification of the change of the reimbursement group (UHS) pursuant to Section 39s(7) of the Act on Public Health Insurance, as amended and effective from 1 January 2026.

When and how will it be possible to notify a change in the reimbursement group according to the new Act on the Categorization of Medical Devices?
The change of the reimbursement group must be submitted between 1 January 2026 and 31 January 2026 via the ISZP system.

Which date is decisive for assessing the reimbursement amount and the correct classification of a medical device – the date of the voucher being issued by the physician or the date of actual dispensing of the medical device by the pharmacy/distributor?
If a medical device is prescribed under the Act on Public Health Insurance (ZoVZP) and redeemed before the new Act on the Categorization of Medical Devices (ZoKaZP) takes effect, it is reimbursed under the original conditions of ZoVZP (see Section 3(1) of ZoKaZP).

If the device is prescribed under ZoVZP but redeemed after ZoKaZP takes effect, it is reimbursed under the new conditions of ZoKaZP (see Section 3(2) of ZoKaZP).

In the case of a voucher issued by 30 April 2026 for an elastoviscous solution in reimbursement group UHS 11 — i.e. for a medical device reimbursed under the transitional provisions of Section 3(4) of ZoKaZP — and if the voucher is redeemed (the patient collects it) in the following month (May 2026), such a medical device is reimbursed under the conditions of UHS 07.07.01.01 ZoKaZP.

Can an existing power of attorney still be recognized if it does not include the newly established reimbursement group 07.07.01.01, provided it is clear from its content that it applies to the categorization and reimbursement of medical devices in general?
If the power of attorney covers all medical devices of a manufacturer, it may continue to be used as an approved valid authorization. However, if the power of attorney lists specific reimbursement groups or specific medical devices and does not include the new reimbursement group or the related devices, it cannot be used for medical devices in the new reimbursement group.

Is it possible to submit an application now using the existing power of attorney, and later provide an updated version including the new group (for example, as an amendment to the power of attorney) after it is issued?
SÚKL does not and has not accepted any amendments, supplements, or declarations to existing powers of attorney. In assessing powers of attorney, the Institute must act consistently for both medicinal products and medical devices.

Do you recommend any alternative formal way to ensure timely submission of the application during the period when the new reimbursement group is not yet included in the issued authorization or in public lists?
If the new reimbursement group is not included in the approved power of attorney, it is necessary to submit a new application with a new power of attorney containing the respective group or devices, or a power of attorney covering all the manufacturer’s medical devices.

Please note that if several powers of attorney are submitted for all medical devices of the same manufacturer, a problem may arise where previous powers of attorney for other representatives of the same manufacturer will be terminated due to multiple authorizations. Therefore, if you represent only certain medical devices of a manufacturer, please carefully consider the scope of your power of attorney.

In case of any uncertainties or other questions regarding powers of attorney, please use the email address plne_moci@sukl.gov.cz, or consult your company’s legal representative.

The complete article is available on the SÚKL website.

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The amendment introduces a special reimbursement procedure for certain selected vaccines, particularly those that are non-mandatory.

Participants in the proceedings will newly include not only marketing authorization holders and health insurance companies, but also the Czech Medical Association of J. E. Purkyně.

For the purpose of determining the amount and conditions of reimbursement, the State Institute for Drug Control (Institute) will assess vaccines with regard to medical, social, economic, and ethical aspects, as well as their impact on public health.

The Institute’s assessment report will newly include a statement from the National Institute of Public Health, which is issued after the initiation of the procedure and may differ from the Institute’s own position.
As in the case of orphan medicines, the assessment report will be reviewed by the advisory body of the Ministry of Health in a non-public session, during which a conciliation procedure will take place.

The Institute will then issue a decision in accordance with the binding opinion of the Ministry of Health, which may, among other things, differ from the original proposal of the assessment report — for example, in the amount or conditions of reimbursement.

The amendment abandons the “economically least demanding variant” (ENNV) regime for vaccines, which previously favored older vaccines at the expense of modern ones. Vaccines that are already reimbursed will retain their current reimbursement after the amendment, with the possibility of individual changes in selected cases.

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.

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Within the ongoing proceedings initiated by the Institute pursuant to the cited provision, the Institute addressed issues related to the amount of the usual daily therapeutic dose (ODTD) and its binding nature.

According to the Institute, the purpose of this type of proceeding is not to establish a new ODTD, but to harmonize the reimbursement levels with the latest enforceable decision issued in the revision procedure.

The incorporation of the ODTD from the revision decision into individual administrative proceedings is in accordance with the law, the decree, and established administrative practice, even if the ODTD is not explicitly stated in the operative part of the decision. It constitutes an inherent component of the operative part concerning the amount of the basic reimbursement, as confirmed by relevant decisions of the Ministry of Health of the Czech Republic.

The Institute further emphasized that the ODTD forms the technical basis for calculating the basic reimbursement, and its value is legally binding for all subsequent administrative proceedings concerning changes to the amount and conditions of reimbursement until the next in-depth reimbursement revision.

The Institute therefore considered objections regarding the absence of the ODTD in the operative part of the revision decision or the request for a new determination of the ODTD within the ongoing proceedings to be unfounded.

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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

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The amendment changes the rules for assessing Highly Innovative Medicinal Products by defining several criteria under which medicines may be included in this group. 

It changes the conditions for any application of the statutory limitation of the reimbursement amount.

Changes also occur in the cost-limitation agreements between marketing authorisation holders and payers, which will now be mandatory, with a possible sanction in the form of loss of temporary reimbursement.

Lastly, the patient’s right to complete ongoing treatment at the expense of the marketing authorisation holder has been updated.

A completely new element is a joint reimbursement proceeding for combinations with a VILP, intended to address situations where only one product in the combination has an established reimbursement.

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.

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In an ongoing administrative proceeding on the first temporary reimbursement for a VILP in tablet form, the State Institute for Drug Control (the Institute) proposes to limit the duration of the first temporary reimbursement so that it expires at the same time as the first temporary reimbursement of a therapeutically interchangeable medicine with the same active substance in capsule form for the same indication. Accordingly, in this case, the first temporary reimbursement for the tablets will be granted for a period shorter than 3 years.

The Institute also states that the public health insurance expenditure on reimbursement of the product in tablet form, supplied to insured persons during the validity of the temporary reimbursement decision, must not exceed the amount specified in the budget impact analysis that served as the basis for the decision in the previous administrative proceeding on the first temporary reimbursement of the therapeutically interchangeable capsule formulation.

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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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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

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In response to requests from applicants (manufacturers/suppliers of ZUM) whose devices are listed in the ÚK VZP – ZP, VZP has also published a list of VZP codes for which, as of 7 October 2025, it records terminal EMDN branches; see List of ZUM with a Terminal EMDN Branch.

At the same time, VZP notes that the proposal “2.CH NÁVRH NA PONECHÁNÍ NEOBCHODOVANÝCH ZUM V ÚK VZP – ZP” has also been published for non-traded items for which no EMDN category has been provided.

After the above deadline, VZP will assign an EMDN code to any ZUM for which no EMDN category has been submitted.

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The LPVO status will newly be assessed only at the moment of issuing the first reimbursement decision under Section 39da of the Act on Public Health Insurance.

The amendment introduces stricter filing requirements for applications and further expands the rights of selected stakeholders.

The role of payers is strengthened; they will be able to request reimbursement reviews in additional situations.

Certain rules for re-assessing LPVO reimbursement due to unmet assumptions are modified.

The applicant will be required to express an active disagreement with a change opinion issued by the Ministry of Health (MoH).

New rules are introduced for LPVO reimbursement in combinations, whether with a VILP (Highly Innovative Medicinal Product) or with another LPVO.

Agreements with payers will become an important step, notably due to changes to the rules for compensating costs.

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.

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The advisory board unanimously supported inclusion of this product in reimbursement, as the evidence in the file demonstrated its efficacy in fourth-line treatment of a rare malignancy for which no therapeutic alternative exists and where there is a clear unmet medical need.

The Ministry’s approval was justified, inter alia, by the fact that patients’ conditions require rapid treatment initiation, which individual exceptional reimbursement applications under Section 16 do not accommodate with sufficient flexibility.

According to the reasoning, contractual arrangements with health insurance companies also contributed to the positive opinion, resulting in a more favourable projected budget impact—not only compared with the findings of the assessment report, but also relative to current Section 16 practice.

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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.

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

Our knowledge, your opportunity.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

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As part of the ongoing refinement of the VZP Reimbursement Catalogue – Medical Devices (ÚK VZP – ZP) and following a request from the Ministry of Health in connection with forthcoming legislation, all medical devices that were included in the ÚK VZP – ZP (ZUM) by 31 December 2023 and that, according to VZP ČR and SZP ČR data, were not traded (no recorded sales) between 1 January 2024 and 30 June 2025, and for which no EMDN category was submitted by 31 August 2025, and for which VZP ČR does not receive the relevant proposal, will be removed from the ÚK VZP – ZP (ZUM) as of 1 March 2026.

VZP hereby informs applicants of the possibility to keep non-traded ZUMs without EMDN in the Reimbursement Catalogue.

Applicants may, by 31 December 2025, submit the proposal “2. CH NÁVRH NA PONECHÁNÍ NEOBCHODOVANÝCH ZUM V ÚK VZP – ZP – VZP ČR” (Proposal to Retain Non-Traded medical devices in the ÚK VZP – ZP – VZP ČR) if they wish to keep non-traded medical devices without EMDN in the catalogue.

If the proposal is not submitted or is rejected, the ZUMs concerned will be removed from the ÚK VZP – ZP.

List of non-traded medical devices

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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.

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According to the State Institute for Drug Control (SÚKL), the BIA should consider all medicinal products included in the relevant reference group.
On the other hand, for example in proceedings on price and reimbursement in reference group No. 104/7 – therapeutic allergen extracts – standardised, depot injectable, the calculation of deductible co-payments must reflect actual practice: a product containing dust-mite allergens will in practice be replaced exclusively by products containing only these allergens. For this reason, including other interchangeable products (from the same reference group) in the BIA should not affect the result, because their costs would be the same in the world with and without the assessed intervention and therefore cancel out.

The analysis works with costs of deductible co-payments that would accrue to health insurance companies when the annual out-of-pocket cap is exceeded.
Excluding the CZK 1,000 insured person’s cap from the analysis was accepted by SÚKL in the above-mentioned case as a conservative setting. SÚKL found that including a CZK 5,000 cap per insured person would lead to higher deductions in the world with the assessed intervention (CZK 5,000 per patient) than in the world without it (less than CZK 5,000 per patient), thus lowering the resulting budget impact.
If the CZK 1,000 cap were applied, the patient in the world without the assessed intervention would exceed this cap in the first year only, not in subsequent years. Even when accounting for this lower cap, the resulting budget impact would remain lower.

The analysis should include separate results for the budget impact without deductible co-payments and with deductible co-payments.

Previously published SÚKL guidance also states that the analysis must reflect co-payments actually applied in practice.
To calculate real deductible co-payments, SÚKL uses average pharmacy prices per pack, obtained from reports under guideline LEK-13.

Costs of deductible co-payments relate to prescription-dispensed products; therefore, products billed on requisition forms are not included in the consumption analysis.

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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.

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

Our knowledge, your opportunity.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

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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.

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In a previously conducted in-depth reimbursement review, the medicine containing budesonide in tablet form was assessed as generally therapeutically interchangeable with rectal formulations in the reference indication of treatment of acute ulcerative colitis affecting the rectum and sigmoid colon. This conclusion was primarily based on the results of the CORE I and CORE II studies in a subgroup of patients with proctosigmoiditis.

However, following the entry of another budesonide-based medicine in suppository form into the reimbursement system during an ongoing review procedure, the Institute (SÚKL) decided to narrow the reference indication to the treatment of acute ulcerative colitis affecting the rectum only.

In the issued assessment report, the Institute responded to objections raised by one of the parties, pointing out that patients with ulcerative colitis limited to the rectum were not included in the registration studies for the tablet formulation. Therefore, it is not possible to draw conclusions regarding the efficacy and safety of the tablet form for this specific patient group based on those studies, nor to conduct a direct comparison with rectal formulations of budesonide.

Given the different clinical uses, the Institute proposes dividing the assessed medicines into two separate groups:

• a) Budesonide for the treatment of ulcerative colitis affecting the rectum (rectal formulations) – reference indication: treatment of acute ulcerative colitis affecting the rectum.
• b) Budesonide for the treatment of ulcerative colitis (oral formulations) – reference indication: treatment of acute ulcerative colitis affecting the rectum and sigmoid colon.

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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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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

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In one such proceeding, the Ministry of Health (MoH) expressed the legal opinion that replacing the symbol “S” with a prescribing restriction “E/DER” (i.e., extending prescribing rights from a limited number of specialized centers to all physicians with defined specializations) generally presumes an increase in the budget impact.

Specifically, the MoH stated in its decision: “The reimbursed medicinal products in question will now be dispensed to insured persons at pharmacies—potentially without any link to a specialized center—based on a prescription, and the dispensing pharmacy will routinely invoice the relevant health insurance company the amount corresponding to the set reimbursement. This change has certain economic consequences—at a minimum, in terms of co-payments and pharmacy markups. These are not the only economic implications: medicinal products with the ‘S’ symbol are reimbursed by the health insurance fund only to providers with whom they have a special agreement to ensure the economical use of such products, whereas no such legal obligation applies to products without the ‘S’ symbol.”

For these reasons, the MoH concluded that a cost-effectiveness and budget impact analysis was necessary, which the Institute failed to conduct during the procedure.
Although the Czech Dermatovenerology Society, when consulted by the Institute, confirmed the Institute’s assumption that the number of patients would not increase, the MoH noted that budget impact can still rise even without an increase in patient numbers. It also highlighted that the medical society did not comment at all on the actual budget impact.
As a result, the MoH annulled the Institute’s decision.

Definitions of the Symbols:

• Symbol “S” – Used for medicinal products that, in the public interest, should be concentrated in specialized centers (as per Section 15(10) of the Act). Only these specialized centers may invoice such products to health insurance companies, and only based on a special agreement between the provider and the insurance company.
• Symbol “E“ – Used when, due to the medicine’s efficacy and safety profile, prescribing should remain limited to physicians with a specific specialty qualification listed in the prescribing restriction.
• Symbol “DER” – Refers to the specialties of dermatovenerology, pediatric dermatovenerology, and corrective dermatology.

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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

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The Act, in the referenced paragraph, requires the Institute—in cases where another Highly Innovative Medicinal Product with similar clinical use and comparable or close efficacy has already been granted temporary reimbursement—to set the temporary reimbursement amount of the assessed product at most to the level of that other product, taking into account differences in dosing and pack size.

The Institute is responsible for demonstrating the existence of another VILP with similar clinical use and comparable or close efficacy, which is temporarily reimbursed under public health insurance. In particular, it must prove the condition of comparable or close efficacy. If it fails to gather the necessary evidence, it is not authorized to reduce the reimbursement on these grounds.

The Institute also examines the possibility of reducing reimbursement for a Highly Innovative Medicinal Product in cases where the product is reimbursed in a different therapeutic indication and is not included in a group of interchangeable products together with other medicinal products.

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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.

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

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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

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According to the Ministry of Health, this condition follows from Section 39da(1): “If it is in the public interest under Section 17(2) and no application has been submitted for the same indication for temporary reimbursement under Section 39d or for determination of the amount and conditions of reimbursement in proceedings under Section 39g, the Institute shall decide on the amount and conditions of reimbursement for a medicinal product intended for the treatment of a rare disease…”

The Ministry stated that this provision must be applied not only to parallel administrative proceedings concerning the same indication but also to proceedings that have already taken place and have been lawfully concluded for the same indication of the given medicinal product.

An amendment to the Act on Public Health Insurance, scheduled to enter into force on 1 January 2026, explicitly establishes the rule that reimbursement for an LPVO cannot be requested if the product already has temporary reimbursement set for the same indication.

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? 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.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 4o.