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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 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.

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

The Pharmeca team

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.

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.

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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.