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At the beginning of December, the State Institute for Drug Control (SÚKL) held a seminar entitled Current Topics in Price and Reimbursement Regulation. The following article presents key practical information delivered at the seminar and includes SÚKL’s interpretation of selected topics previously addressed in the Dawn of the Amendment to the Public Health Insurance Act series.

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

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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In the field of reimbursement and regulation of foods for special medical purposes (FSMP) reimbursed from public health insurance within outpatient care, significant changes will take effect from 1 January 2026 based on the amendment to the Public Health Insurance Act.

New rules for FSMP reimbursement

• 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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Inpatient care reporting

A health insurance fund may agree with an inpatient care provider on the method of reporting and reimbursement of medicinal products used in the provision of inpatient care, for which the fund has negotiated the reimbursement amount and conditions with the marketing authorization holder or manufacturer.

For the purpose of negotiating the reimbursement amount and conditions between payers and the marketing authorization holder for medicines used exclusively in inpatient care, the State Institute for Drug Control (the Institute) will, at the request of payers or the holder, conduct an assessment of benefits and costs (analogous to HTA). All entities concerned (including marketing authorization holders) are obliged to cooperate with the Institute.

Drug lump sums, which are no longer applied in practice, are abolished.

Deductible co-payments

The conditions for recognizing co-payments for children under 4 years of age are expanded by defining selected dosage forms and by specifying the calculation method of the co-payment in these cases.

Reimbursement of expenses

Changes also apply to the reimbursement of expenses for acts performed by the Institute, which will no longer apply to applicants requesting an increase in the maximum price in the public interest or to applicants for unregistered medicinal products whose use has been authorized under the Medicines Act.

In brief: the amendment

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

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

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

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

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

Feel free to contact us.

Our knowledge, your opportunity.

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Similar medicinal product

The amendment introduces the concept of an “original reimbursed product” and clarifies the definition of the “first similar product,” for which a marketing commitment will no longer be submitted; instead, its actual market availability will trigger an abbreviated revision due to its entry into the reimbursement system.

The Institute will newly assess the appropriateness of therapeutic intervention for similar products originating from the same marketing authorization holder, with the aim of preventing circumvention of contractual arrangements.

The conditions for the automatic recognition of an appropriate therapeutic intervention are defined.

The assessment of market availability of a similar product will now be governed by criteria focused on the total quantity of all supplied similar products and by calculating the average monthly volume.

Combination product

The amendment introduces a significant change in the calculation of reimbursement for combination products, taking into account situations where all included active substances are reimbursed individually on the one hand, and situations where one of the substances is not reimbursed on the other.

In brief: the amendment

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

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

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

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

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

Feel free to contact us.

Our knowledge, your opportunity.

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In-depth reimbursement revision
Under the new rules, in an in-depth revision in which a significant decrease in the basic reimbursement compared to the first in-depth revision is demonstrated, the State Institute for Drug Control (Institute) will carry out a review or, where applicable, cancellation of the indication restriction, and in certain cases also a reassessment of the prescribing restriction, depending on the nature of the medicinal product (Rx, ZULP).

A minimum interval between individual in-depth reimbursement revisions within the same reference group is introduced in order to minimise excessive administrative burden on the Institute.

Abbreviated price and reimbursement revision

The amendment introduces changes to the thresholds relevant for initiating an abbreviated reimbursement revision, depending on the type of medicinal products.

Revisions of maximum prices will newly be conducted for products included in the same reference group.

A deadline for commenting on the assessment report is introduced, excluding the possibility of submitting an obstruction appeal against the resolution setting this deadline.

The conditions for initiating a reimbursement revision due to product unavailability are updated.

As with in-depth revisions, a minimum interval between individual revisions is set, during which no new revision may be initiated. However, this time limitation does not apply to revisions initiated, for example, due to the entry of the first similar medicinal product or the need to ensure the availability of a fully reimbursed product.

In brief: the amendment

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

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

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

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

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

Feel free to contact us.

Our knowledge, your opportunity.

The text was translated using ChatGPT 5.1.  

Medicinal products intended for immunization

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.

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

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

Feel free to contact us.

Our knowledge, your opportunity.

The text was translated using ChatGPT 5.