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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.
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].
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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.
SÚKL provides the following information regarding its year-end operations in 2025.
In connection with the new Act No. 288/2025 Coll., on the categorization of medical devices prescribed on voucher and reimbursed from public health insurance, and on the amendment of Act No. 48/1997 Coll., on public health insurance and on the amendment and supplementation of certain related acts, as amended, the State Institute for Drug Control (SÚKL) has published a set of questions and answers.
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.
Do you need to request an annual increase in the manufacturer’s price or advice on how to submit a notification through ISZP? Contact us.
Our knowledge, your opportunity.
The text was translated using ChatGPT 5.
The Advisory Board for the Reimbursement of Medicinal Products Intended for the Treatment of Rare Diseases at the Ministry of Health of the Czech Republic has published a summary report evaluating its application practice from May 2022 to March 2025.
In addition to listing the legal requirements related to orphan drugs and a comprehensive overview of all proceedings within the reviewed period, one chapter focuses on the key lessons learned from the advisory board's experience.
The full summary report is available on the Ministry of Health’s website.
Cost-Effectiveness Assessment of Pharmaceuticals: Key Questions
Cost-effectiveness assessment is a crucial element of the administrative process for determining drug reimbursement, not only in the Czech Republic. A well-prepared cost-effectiveness analysis, including budget impact assessment, not only supports the applicant's arguments but also minimizes requests for additional documentation from the State Institute for Drug Control (SÚKL/Institute) via cooperation requests, which have become standard practice.
This article presents a selection of key questions that applicants seeking drug reimbursement (where cost-effectiveness assessment is required) should be able to answer within their submitted evaluation.
The pharmaceutical market in the Czech Republic is undergoing a gradual shift in decision-making practices, which may significantly impact pricing and reimbursement regulations as well as the entire pharmaceutical sector. Section 39c(2)(b) of the Public Health Insurance Act has been in use for a long time; however, its true potential to influence reimbursement dynamics is only now becoming apparent. The uncertainty arises from the gradual convergence of differences between innovative biological molecules entering the market and those already reimbursed. The concept of comparably effective therapy thus becomes a risk factor for new medicinal products.
How Does the New Approach Work? In a recent reimbursement revision decision regarding JAK inhibitors (Ref. No. SUKLS274309/2022), SUKL determined the reimbursement for certain indications based on the daily costs of comparably effective therapy. This means that medicinal products were not necessarily placed in the same reference group as the compared therapies, yet their reimbursement was set according to cheaper alternatives from another reference group, which included, for instance, generic drugs. In the case of filgotinib, the reference product, a head-to-head clinical study (Combe, B. et al.) comparing its efficacy with the TNF-alpha inhibitor adalimumab confirmed direct clinical equivalence between these therapies.
This approach has several critical consequences:
Long-Term Impacts This new approach has not only short-term effects on the reimbursement of specific medicines but also long-term consequences for the entire pharmaceutical sector:
Open Question: Where is the Boundary Between Efficiency and Innovation Regulation? How might the domino effect manifest in non-referential indications in the future? This case represents a breakthrough in setting more than one additional increased reimbursement, meaning the barrier of "only one increased reimbursement" is eliminated. On the other hand, this new trend may lead to an intricate network of interconnected reference groups with generic-based reimbursements, discouraging marketing authorization holders from including their products in such groups.
The text was translated using ChatGPT 4o.
On February 21, 2025, the Ministry of Health of the Czech Republic published the following opinion on the procedure for assessing the financial impact on the health insurance system when determining or changing the amount and conditions of reimbursement for a medicinal product or food for special medical purposes:
"The Department of Medicinal Products and Medical Devices of the Ministry of Health of the Czech Republic (hereinafter referred to as "the Ministry"), in view of the wording of the applicable Act No. 338/2024 Coll., amending Act No. 48/1997 Coll., on Public Health Insurance and on Amendments and Supplements to Certain Related Acts, as amended, Act No. 592/1992 Coll., on Insurance Contributions for Public Health Insurance, as amended, and Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts (the Medicinal Products Act), as amended, which, with effect from January 1, 2025, changes the principles in the area of monitoring limits of deductible co-payments for partially reimbursed medicinal products and foods for special medical purposes (the protective limit) and the subsequent reimbursement of deductible co-payments exceeding the protective limit under Act No. 48/1997 Coll., on Public Health Insurance and on Amendments and Supplements to Certain Related Acts, as amended (hereinafter referred to as "the Public Health Insurance Act"), hereby issues its opinion on the procedure for assessing the financial impact on the health insurance system when determining or changing the amount and conditions of reimbursement for medicinal products or foods for special medical purposes.
The method of assessing the financial impact on the health insurance system (hereinafter referred to as "budget impact") is expressed in the third and fourth sentences of Section 15(8) of the Public Health Insurance Act, which state that "The budget impact is determined as the difference between the costs of treating a given disease associated with the use of a medicinal product or food for special medical purposes that would be reimbursed from health insurance funds, and the costs of treatment using another medicinal product, food for special medical purposes, or treatment method that is already reimbursed from health insurance funds. The budget impact must be in accordance with the public interest pursuant to Section 17(2)."
If, under Section 15(9) of the Public Health Insurance Act, the anticipated budget impact associated with determining reimbursement for a medicinal product or food for special medical purposes shows an increase in expenditures from the health insurance system, the budget impact assessment must be conducted through a budget impact analysis submitted by the applicant, which the State Institute for Drug Control assesses during the proceedings [see Section 39b(2)(c) of the Public Health Insurance Act].
The requirements of the third and fourth sentences of Section 15(8) of the Public Health Insurance Act for the applicant-submitted budget impact analysis and the procedure of the State Institute for Drug Control in its assessment are elaborated in the methodology SP-CAU-27 (hereinafter referred to as "the methodology") as of the date of this opinion. For the purpose of quantifying the budget impact, the methodology allows only the perspective of health insurance expenditures (for completeness, it should be noted that this applies outside of proceedings conducted under Section 39da of the Public Health Insurance Act).
The Ministry is aware from its own official activities that the State Institute for Drug Control currently considers only direct costs (both pharmaceutical and non-pharmaceutical) demonstrably incurred from health insurance in connection with the therapy of the given disease as relevant costs in the budget impact assessment, whereby the State Institute for Drug Control considers only the costs at the level of reimbursement from health insurance, or costs corresponding to the maximum consumer price if this price is lower than the reimbursement amount, as direct pharmaceutical costs for both the evaluated intervention and the comparator.
However, as the Public Health Insurance Act stipulates that the budget impact is determined as the difference in treatment costs for the given disease (from the perspective of health insurance) associated with the use of medicinal products, the Ministry considers it necessary to include in the relevant direct costs for the evaluated intervention and the comparator also the amounts of deductible co-payments reimbursed by health insurance funds above the protective limit of the insured, which, in connection with the amendment to the Public Health Insurance Act, will be a direct expenditure of health insurance funds paid to pharmacy service providers related to the treatment of the given disease.
For this reason, it is necessary that the applicant, within the submitted application, consider the anticipated budget impact, taking into account any deductible co-payments for the evaluated and comparator intervention.
If, in the assessment of the anticipated budget impact under Section 39b(2)(j) of the Public Health Insurance Act in proceedings on determining or changing the amount and conditions of reimbursement for a medicinal product, it becomes apparent that this anticipated reimbursement impact on health insurance funds, taking into account the anticipated amount of deductible co-payments (representing the cost of treating the given disease), shows an increase in expenditures from the health insurance system, in such a case, the applicant must submit a budget impact analysis that also considers the amount of the anticipated deductible co-payment.
According to the Ministry, in order to fulfill the purpose of the aforementioned legal provisions concerning the new protective limit rules, it is necessary that, in the budget impact assessment by the applicant and the budget impact evaluation by the State Institute for Drug Control, the deductible co-payment amounts applied in practice are considered, rather than the highest possible deductible co-payment amounts calculated according to the second sentence of Section 16b(1) of the Public Health Insurance Act.
The Ministry further emphasizes that the deductible co-payments for partially reimbursed medicinal products and foods for special medical purposes, which count towards the insured person's protective limit, are known to the State Institute for Drug Control from its own official activities, as well as to health insurance funds, and marketing authorization holders can also determine the actually applied amounts of deductible co-payments from the publicly available data on the website of the State Institute for Drug Control at https://prehledy.sukl.cz/prehled_leciv.html#/ or calculate them from data on already reimbursed medicinal products (comparators) published at regular intervals on https://opendata.sukl.cz/?q=katalog/lek-13 (note: link valid as of the date of this opinion).
For practical implementation, the Ministry believes that the above-mentioned change in the procedure for budget impact assessment can be realized as follows. The budget impact analysis will, in addition to the currently expressed budget impact, also include a separately calculated budget impact incorporating the costs of deductible co-payments for partially reimbursed medicinal products and foods for special medical purposes that would arise for health insurance funds when exceeding the annual protective limit. However, presenting a separately calculated budget impact with applied deductible co-payments will not be entirely necessary (or would be redundant) in cases where no deductible co-payment arises in the determination or change of the reimbursement amount and conditions for the evaluated intervention.
In conclusion, the Ministry states that this opinion does not interfere with the current practice of assessing cost-effectiveness analyses."
The original document is available on the website of the Ministry of Health of the Czech Republic.
This is an unofficial translation generated with the assistance of ChatGPT-4o. It is provided for informational purposes only and does not constitute an official or legally binding translation.
