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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.

Wishing you a Merry Christmas and a successful 2026 filled with further cooperation,

The Pharmeca team

In proceedings concerning orphan medicinal products, State Institue for Drug Controla (SÚKL) is authorised to assess the pharmacoeconomic analyses submitted by the parties but does not have the competence to generate such analyses itself.

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.

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 Ministry of Health of the Czech Republic (MoH), acting as the appellate authority, examined whether the submission of two consecutive applications for a change in the reimbursement of the same medicinal product—applications concerning different therapeutic indications or reimbursement conditions—constitutes two separate proceedings or whether they relate to the same matter.

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. 

SÚKL provides the following information regarding its year-end operations in 2025.

• 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.

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.  

Section 39i(2) of the Act on Public Health Insurance stipulates the obligation of the State Institute for Drug Control (hereinafter “the Institute”) to immediately initiate ex officio proceedings to amend the determined amount and conditions of reimbursement of a medicinal product in cases where the current reimbursement or reimbursement conditions do not correspond to the basic reimbursement of the reference group or to the reimbursement conditions established in a revision procedure.

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.

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. 

The Act on Public Health Insurance provides that the amount and conditions of temporary reimbursement for Highly Innovative Medicinal Products (VILP) are set for a period of 3 years, with the possibility of re-setting the reimbursement for no more than an additional 2 years.

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.

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.