Pharmeca.cz

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:

• the referenced product had reported an interruption of its placing on the domestic market effective as of 25 December 2023, i.e. prior to the date on which the contested decision (issued on 27 November 2023) became enforceable. In the case of a product with a notified interruption, a temporary supply disruption may reasonably be assumed, and consequently the practical impossibility of its full reimbursement;
• the referenced product is also reimbursed for the treatment of bladder cancer. The products for which the reimbursement increase was assessed are reimbursed exclusively for patients with renal cancer and soft tissue sarcoma. Although bladder cancer and renal cancer both fall under carcinomas of the urogenital tract, the MoH does not consider them to constitute diseases of the same type within the meaning of the legal opinion of the Constitutional Court.

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.

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.