Pharmeca.cz

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].

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

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

Feel free to contact us.

Our knowledge, your opportunity.

The text was translated using ChatGPT 5.2.