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The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
The Ministry of Health (MoH) assessed whether the conditions for increasing reimbursement on the grounds of ensuring at least one fully reimbursed medicinal product within a group of substitutable products had been met in the context of a comprehensive review (Section 39c(5) of the Public Health Insurance Act).
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:
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 State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
Pharmeca a.s. provides services within the scope defined by the following legislative framework:
Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Certain Related Acts, as amended.
Implementing regulations (selected):
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):
Act No. 592/1992 Coll., on Premiums for Public Health Insurance, as amended.
Implementing Regulation:
Act No. 526/1990 Coll., on Prices, as amended.
Price regulations / price decisions – Medicinal Products (selected):
Price Decisions – Medical Devices:
Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts, as amended.
Implementing regulation (selected):
Act No 167/1998 Coll, on Addictive Substances and on Amendments to Certain Other Acts, as amended
Implementing regulation (selected):
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):
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:
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):
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.
At the beginning of December, the State Institute for Drug Control (SÚKL) held a seminar entitled Current Topics in Price and Reimbursement Regulation. The following article presents key practical information delivered at the seminar and includes SÚKL’s interpretation of selected topics previously addressed in the Dawn of the Amendment to the Public Health Insurance Act series.
This article is therefore a transcription of texts based on presentations published on the SÚKL website, where their full versions are available.
The amendment in the area of medicinal products intended for immunisation will ensure full reimbursement of more effective and more modern vaccines.
By submitting an application for the determination of reimbursement pursuant to Section 39db et seq., it is possible to request:
Types of administrative proceedings under the amendment:
Administrative proceedings are initiated only upon submission of the second application, which must be filed within 30 days of the first application. The web-based application forms have been amended to require explicit indication that the case concerns a joint proceeding with another medicinal product.
Withdrawal of one of the applications leads to termination of the
proceedings; all applicants have dispositive rights over the subject matter of
the application.
Assessment of Highly innovative medicinal product (VILP) status
Assessment of Orphan (LPVO) Status
Initiation of an abbreviated review (ZR) following entry of the first PP
Under the amendment, the abbreviated review is initiated only after verification of commercial availability (pursuant to Sections 13a and 13b of Decree No. 376/2011 Coll.) of a reimbursed similar product in relation to the originally reimbursed product.
The market share of all similar products within the relevant ATC group is assessed for a given calendar month, excluding the originally reimbursed product:
Comprehensive review (HR)
Section 39l(3): a reduction of the base reimbursement by more than 80% compared to the base reimbursement established in the first completed comprehensive review.
The justification for applying this provision is assessed either directly within the ongoing comprehensive review or after issuance of a decision in an abbreviated review in which reimbursement decreased by more than 80%.
A comprehensive review cannot be initiated if, within the last 12 months, a decision has been issued in another comprehensive review within the same group of essentially therapeutically interchangeable medicinal products.
In an individual administrative proceeding (ISŘ) concerning a
change in the amount and conditions of reimbursement (VaPÚ), it is not possible
to establish more restrictive reimbursement conditions than those set in the
most recent comprehensive review.
Abbreviated review (ZR)
Abbreviated reimbursement reviews are differentiated for groups containing ZÚLP (savings of CZK 20 million) and groups not containing ZÚLP (savings of CZK 30 million).
Removal of the statutory three-year time limit for conducting an abbreviated maximum price review.
Abbreviated reviews (cost-saving, including savings based on DNC/DoÚ) cannot be initiated if another abbreviated review decision for the same medicinal product group was issued within the last 12 months.
Abbreviated maximum price reviews are conducted for reference groups or groups of essentially therapeutically interchangeable products (the rule based on active substance and route of administration has been removed).
VILP criteria
a) The primary clinically relevant endpoint in the clinical trial demonstrated at least a 30% improvement in a quality-of-life–relevant parameter in direct comparison, or at least a 35% improvement in indirect comparison versus reimbursed therapy; in the case of progression-free survival, median PFS must be extended by at least three months; or
b) Median overall survival is prolonged by at least 30% versus reimbursed therapy, and by at least three months; where median OS is not reached, a reduction in the OS hazard ratio of at least 35% versus reimbursed therapy is demonstrated; or
c) A medicinal product with conditional marketing authorisation pursuant to Regulation (EC) No 726/2004, where no alternative with permanent or temporary reimbursement exists, or where the alternative is supportive or symptomatic treatment only, and the MAH has committed to reimbursing health insurance funds for costs incurred should the conditional authorisation expire, lapse or be withdrawn.
For medicinal products with conditional marketing authorisation applying for VILP status under point (c), criteria under points (a) and (b) are not assessed. The sole condition is the absence of causal treatment within the reimbursement system and the conclusion of an agreement.
Section 17(6): ...upon request of a health insurance fund or MAH, the Institute assesses the benefits and costs associated with the use of such medicinal products. MAHs, health insurance funds and relevant professional societies provide cooperation.
Models – general requirements
The procedure for determining the maximum price (MC) for medicinal products that are significant for the provision of healthcare and which the Ministry of Health, with regard to the public interest in maintaining their availability, designates in a special price measure (Section 39a(3)) is as follows:
a) the average of prices in up to seven reference basket countries, provided that the medicinal product is present in at least two reference basket countries;
b) the average of identified prices within the EU, where point (a) cannot be applied;
c) a therapeutically comparable medicinal product (TPLP) in the Czech Republic, where points (a) and (b) cannot be applied
(i.e. the lowest price of a medicinal product containing the same active substance, pharmaceutical form and strength; where more than one TPLP exists, the lowest price of the medicinal product with the same or the closest pack size is used);
d) the average price of TPLP in the reference basket, where points (a) to (c) cannot be applied
(from each reference basket country, the lowest price of a medicinal product containing the same active substance, pharmaceutical form and strength is used; where more than one such product exists, the lowest price of the medicinal product with the same or the closest pack size is applied).
Determination of MC / Price Referencing
Pursuant to the amendment to Decree No. 376/2011 Coll., new rules apply concerning the relevant exchange rate and exceptions in situations where, during price referencing for the purpose of MC determination, the exchange rate deviation exceeds 10% compared to the average quarterly exchange rates over the preceding six calendar months:
Exclusion of a Foreign Price from External Reference Pricing
Determination of the base reimbursement amount (Section 39c(2)(a) of the Public Health Insurance Act)
Manufacturer price / ODTD in the EU:
Determination of Reimbursement / Price Referencing
Where the relevant exchange rate deviates by more than 10% compared to the average quarterly exchange rates of the foreign exchange market published by the Czech National Bank over the preceding six calendar quarters, conversion into Czech currency is carried out using the average exchange rate published by the Czech National Bank over the preceding six calendar quarters (Section 11(2) of the Decree).
Determination of Base Reimbursement / Price Referencing
In the event of the introduction of market-wide measures, the Institute excludes the identified foreign manufacturer price in the EU Member State analogously pursuant to Section 7(3) (Section 12(4) of the Decree).
Where the deviation of the lowest identified price is ≥ 20% compared to the average of the second and third lowest prices, the price extreme is excluded. This does not apply to VILP and LPVO (Section 16(2) of the Decree).
Source:
YOUNG, Michaela; ŽÁČKOVÁ, Kristýna a CHYTILOVÁ, Petra. Seminář SÚKL č. 19 – Sekce cenové a úhradové regulace: Úhrada vakcín 2026. Online. In: . 2025. Dostupné z: https://sukl.gov.cz/wp-content/uploads/2025/10/5.-Uhrada-vakcin-2026.pdf. [cit. 2025-12-18].
ŠVORCOVÁ, Tatiana; CHYTILOVÁ, Petra a VYSEKALOVÁ, Eva. Seminář
SÚKL č. 19 – Sekce cenové a úhradové regulace: Novela ZoVZP - další změny.
Online. In: . 2025. Dostupné z: https://sukl.gov.cz/wp-content/uploads/2025/10/6.-Novela-ZoVZP-%E2%80%93-dalsi-zmeny.pdf. [cit.
2025-12-18].
At Pharmeca, we help you navigate the complex landscape of pharmaceutical and medical device information. We also offer flexible services that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you need expert guidance.
Feel free to contact us.
Our knowledge, your opportunity.
The text was translated using ChatGPT 5.2.