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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 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.

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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.