Pharmeca.cz

The State Institute for Drug Control decided on the determination of the maximum price and reimbursement for a medicinal product containing the active substance tamoxifen citrate.
The proceedings were initiated upon the company’s application pursuant to Section 32d of the Public Health Insurance Act. The purpose of this specific procedure is to ensure the availability of irreplaceable medicinal products in situations where a supply disruption in the Czech Republic is imminent or has already occurred. 

The primary reason for the decision was to ensure continued treatment availability for oncology patients, as supply of the previously registered medicinal products containing the above active substance had been interrupted for manufacturing reasons. 
As no other registered alternative for oral administration was available within the relevant group, the Ministry of Health approved a specific treatment programme for an unregistered medicinal product. The Institute subsequently determined its maximum price and reimbursement level, adopting the reimbursement conditions of the originally reimbursed product that had become unavailable.
The decision on the determination of price and reimbursement was issued 24 days after submission of the application. 

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 (hereinafter the “Institute”) informs about current service outages of Verso and DSŘ (documents of CAU administrative proceedings). The reason for these outages is unforeseen technical issues on the side of an external supplier. Intensive work is underway to resolve the problem with the aim of restoring full system functionality as soon as possible. System adjustments have been implemented to eliminate the causes of the issues, along with improved monitoring and control of errors arising from this situation.

At this time, we can confirm that access to case files via the Verso application when logged in using the National Identification and Authentication Point (NIA), i.e. the so-called citizen identity, is functioning without limitations. Unfortunately, complications persist with access without login, which we are actively addressing.

We therefore recommend using login via citizen identity when accessing Verso.

Recommended Procedures for Affected Parties to Administrative Proceedings

• In-person access to the case file
  Access to the case file pursuant to Section 38 of Act No. 500/2004 Coll., the Administrative Procedure Code, remains available at the Institute’s premises.
  When: Working days, 8:00–16:00
  Where: SÚKL headquarters – Building B (Benešovská 2538/40, 101 00 Prague 10)
  Contact for appointment booking: cau_sekretariat@sukl.gov.cz

• Monitoring the Official Notice Board
  Due to the technical outage, participants in administrative proceedings are advised to pay increased attention to monitoring the Institute’s Official Notice Board. Documents published by way of public notice in proceedings under Part Six of Act No. 48/1997 Coll., on Public Health Insurance, may be posted there and may include deadlines for procedural actions.

• Procedural Deadlines and Applications
  If a technical obstacle on the part of the Institute objectively prevents a party from performing a procedural act within the prescribed time limit, the following instruments under the Administrative Procedure Code may be used:
        Extension of a deadline / suspension of proceedings:
  This may be requested if there is a risk of missing a deadline due to the unavailability of remote access. The request must be submitted sufficiently in advance.
        Waiver of missed deadline:
  If a deadline has already expired, the party may request a waiver pursuant to Section 41(2) of the Administrative Procedure Code. Each such request will be assessed individually, taking into account the current technical situation.

Note: Information on the restoration of the Verso system will be published on this page without delay. We apologise for the inconvenience caused and thank you for your understanding.

FAQ

1) Is it currently possible to access a case file?
Yes, in person at the Institute’s premises, Monday–Friday, 8:00–16:00. The Verso service may be temporarily unavailable.

2) What is DSŘ and can it be used instead of case file access?
DSŘ is an automated method for downloading selected documents (system-to-system communication). It is not an alternative to access to the case file under Section 38 of the Administrative Procedure Code and cannot replace it. DSŘ availability may be limited.

3) I am unable to meet a deadline due to the outage — what should I do?
Submit a timely request for an extension of the deadline or suspension of proceedings; after the deadline has expired, you may request a waiver pursuant to Section 41(2) of the Administrative Procedure Code.

4) How should I proceed if I need a specific document?
Book an in-person file inspection; for general orientation in the proceedings, continuously monitor the Official Notice Board.

The text of this article was taken in full from the SÚKL website.

The text was translated using ChatGPT 5.2. 

The Institute initiated an ex officio abbreviated reimbursement review on the grounds of the entry of the first similar medicinal product into the reimbursement system, without undue delay after verifying that the product concerned had been placed on the Czech market.

However, one of the affected marketing authorisation holders appealed against the initiation of the proceedings, arguing that the entering product was not the first similar medicinal product and referring to earlier proceedings in which the newly entering product had not been assessed as similar.

The Ministry of Health (MoH) rejected this objection, stating that although in the referenced proceedings the assessed product and the reference (originator) product contained the same active substance, they differed in dosage, standardisation units and pharmaceutical forms. At the same time, the products were assessed against additional criteria—such as therapeutic indications or pharmacological properties—and, on that basis as well, were not considered similar.

In the present case, however, the MoH considers the medicinal product concerned to be a generic within the meaning of the Act on Medicinal Products. The products involved in the proceedings contain the same active substance and a comparable pharmaceutical form as the reference product, and the appellant repeatedly failed to demonstrate otherwise.

In the case under review, the conditions for initiating a review on the grounds of the entry of the first similar medicinal product were therefore met.

The MoH further notes that although, under the legislation applicable at the time, SÚKL could have initiated the proceedings earlier, the appellate authority considers the approach whereby SÚKL waited for the first actual supply of the medicinal product concerned to be appropriate and well justified. This prevented a reduction in reimbursement for similar products based on a first similar medicinal product that was not yet commercially available.

Pursuant to the amendment to the Public Health Insurance Act, in abbreviated reviews initiated after 1 January 2026, there is now an obligation to verify market availability at a minimum level of 5%, or 2% for ZÚLP.

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 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