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In a previously conducted in-depth reimbursement review, the medicine containing budesonide in tablet form was assessed as generally therapeutically interchangeable with rectal formulations in the reference indication of treatment of acute ulcerative colitis affecting the rectum and sigmoid colon. This conclusion was primarily based on the results of the CORE I and CORE II studies in a subgroup of patients with proctosigmoiditis.

However, following the entry of another budesonide-based medicine in suppository form into the reimbursement system during an ongoing review procedure, the Institute (SÚKL) decided to narrow the reference indication to the treatment of acute ulcerative colitis affecting the rectum only.

In the issued assessment report, the Institute responded to objections raised by one of the parties, pointing out that patients with ulcerative colitis limited to the rectum were not included in the registration studies for the tablet formulation. Therefore, it is not possible to draw conclusions regarding the efficacy and safety of the tablet form for this specific patient group based on those studies, nor to conduct a direct comparison with rectal formulations of budesonide.

Given the different clinical uses, the Institute proposes dividing the assessed medicines into two separate groups:

• a) Budesonide for the treatment of ulcerative colitis affecting the rectum (rectal formulations) – reference indication: treatment of acute ulcerative colitis affecting the rectum.
• b) Budesonide for the treatment of ulcerative colitis (oral formulations) – reference indication: treatment of acute ulcerative colitis affecting the rectum and sigmoid colon.

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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 4o. 

In reimbursement and pricing administrative proceedings, the State Institute for Drug Control (the Institute) determines not only the reimbursement amount but also the reimbursement conditions. These include reporting and prescribing restrictions that define which medical specialties or certified centers are authorized to prescribe specific medicines and report them to health insurance companies for reimbursement.

In one such proceeding, the Ministry of Health (MoH) expressed the legal opinion that replacing the symbol “S” with a prescribing restriction “E/DER” (i.e., extending prescribing rights from a limited number of specialized centers to all physicians with defined specializations) generally presumes an increase in the budget impact.

Specifically, the MoH stated in its decision: “The reimbursed medicinal products in question will now be dispensed to insured persons at pharmacies—potentially without any link to a specialized center—based on a prescription, and the dispensing pharmacy will routinely invoice the relevant health insurance company the amount corresponding to the set reimbursement. This change has certain economic consequences—at a minimum, in terms of co-payments and pharmacy markups. These are not the only economic implications: medicinal products with the ‘S’ symbol are reimbursed by the health insurance fund only to providers with whom they have a special agreement to ensure the economical use of such products, whereas no such legal obligation applies to products without the ‘S’ symbol.”

For these reasons, the MoH concluded that a cost-effectiveness and budget impact analysis was necessary, which the Institute failed to conduct during the procedure.
Although the Czech Dermatovenerology Society, when consulted by the Institute, confirmed the Institute’s assumption that the number of patients would not increase, the MoH noted that budget impact can still rise even without an increase in patient numbers. It also highlighted that the medical society did not comment at all on the actual budget impact.
As a result, the MoH annulled the Institute’s decision.

Definitions of the Symbols:

• Symbol “S” – Used for medicinal products that, in the public interest, should be concentrated in specialized centers (as per Section 15(10) of the Act). Only these specialized centers may invoice such products to health insurance companies, and only based on a special agreement between the provider and the insurance company.
• Symbol “E“ – Used when, due to the medicine’s efficacy and safety profile, prescribing should remain limited to physicians with a specific specialty qualification listed in the prescribing restriction.
• Symbol “DER” – Refers to the specialties of dermatovenerology, pediatric dermatovenerology, and corrective dermatology.

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 4o. 

Dne 4. 9. 2025 od 9:00 do 16:30 hod. se uskuteční seminář SÚKL na téma: ICH E6 R3 Good Clinical Practice.

Okruh semináře: Revize 3 pokynu ICH R6 R3 správné klinické praxe

Podrobný program semináře bude k dispozici nejpozději den před konáním semináře.

Cílovou skupinou jsou monitoři, zkoušející, členové studijních týmů (studijní sestra, koordinátoři,… ), zástupci zadavatelů, CRO, výzkumníci.

Dne 4. 9. 2025 od 9:00 do 16:30 hod. se uskuteční seminář SÚKL na téma: ICH E6 R3 Good Clinical Practice.

Okruh semináře: Revize 3 pokynu ICH R6 R3 správné klinické praxe

Podrobný program semináře bude k dispozici nejpozději den před konáním semináře.

Cílovou skupinou jsou monitoři, zkoušející, členové studijních týmů (studijní sestra, koordinátoři,… ), zástupci zadavatelů, CRO, výzkumníci.

Dne 4. 9. 2025 od 9:00 do 16:30 hod. se uskuteční seminář SÚKL na téma: ICH E6 R3 Good Clinical Practice.

Okruh semináře: Revize 3 pokynu ICH R6 R3 správné klinické praxe

Podrobný program semináře bude k dispozici nejpozději den před konáním semináře.

Cílovou skupinou jsou monitoři, zkoušející, členové studijních týmů (studijní sestra, koordinátoři,… ), zástupci zadavatelů, CRO, výzkumníci.

In proceedings concerning Highly Innovative Medicinal Products (VILP), the Institute concluded that no publications are currently available that would sufficiently demonstrate comparable efficacy in terms of the parameter of objective response rate (ORR). On this basis, it did not reduce the reimbursement amount pursuant to Section 39d(9) of the Act on Public Health Insurance to the level of other products with similar clinical use.

The Act, in the referenced paragraph, requires the Institute—in cases where another Highly Innovative Medicinal Product with similar clinical use and comparable or close efficacy has already been granted temporary reimbursement—to set the temporary reimbursement amount of the assessed product at most to the level of that other product, taking into account differences in dosing and pack size.

The Institute is responsible for demonstrating the existence of another VILP with similar clinical use and comparable or close efficacy, which is temporarily reimbursed under public health insurance. In particular, it must prove the condition of comparable or close efficacy. If it fails to gather the necessary evidence, it is not authorized to reduce the reimbursement on these grounds.

The Institute also examines the possibility of reducing reimbursement for a Highly Innovative Medicinal Product in cases where the product is reimbursed in a different therapeutic indication and is not included in a group of interchangeable products together with 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 4o. 

If an applicant has previously submitted and succeeded in a different type of administrative proceeding to determine the amount and conditions of reimbursement for a medicinal product in a certain indication, they cannot subsequently apply for reimbursement under Section 39da of the Act on Public Health Insurance (Rules for the Reimbursement of Medicinal Products for Rare Diseases) for the same medicinal product and the same indication—even if the product holds orphan medicinal product (LPVO) status.

According to the Ministry of Health, this condition follows from Section 39da(1): “If it is in the public interest under Section 17(2) and no application has been submitted for the same indication for temporary reimbursement under Section 39d or for determination of the amount and conditions of reimbursement in proceedings under Section 39g, the Institute shall decide on the amount and conditions of reimbursement for a medicinal product intended for the treatment of a rare disease…”

The Ministry stated that this provision must be applied not only to parallel administrative proceedings concerning the same indication but also to proceedings that have already taken place and have been lawfully concluded for the same indication of the given medicinal product.

An amendment to the Act on Public Health Insurance, scheduled to enter into force on 1 January 2026, explicitly establishes the rule that reimbursement for an LPVO cannot be requested if the product already has temporary reimbursement set for the same indication.

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 4o. 

VZP is requesting that all applicants submit EMDN codes (European Medical Device Nomenclature) for all medical devices (ZÚM) listed in the VZP Reimbursement Catalogue – Medical Devices (ÚK VZP – ZP) by 30 June 2025.

This requirement follows a request from the Ministry of Health in connection with forthcoming legislation. The inclusion of EMDN codes, in accordance with Article 26 of the MDR / Article 23 of the IVDR, is essential for setting clear, transparent, and predictable rules, both within the legislative process and for the inclusion, modification, or price/reimbursement adjustment of medical devices in the ÚK VZP – ZP.

According to the current wording of the MDR / IVDR, manufacturers must assign an EMDN code to their device, which will be used for registration in the EUDAMED database and linked to the device’s Unique Device Identifier (UDI-DI).

Using the EMDN hierarchical structure, manufacturers must always assign the code at the lowest applicable level available (i.e., the most specific level of the categorisation tree).

If one ZÚM item includes multiple devices (catalogue numbers) with different EMDN codes, list each EMDN code in the corresponding “EMDN” column.

If a single device (catalogue number) has multiple intended purposes and therefore multiple potential EMDN codes, select and submit only one EMDN code.

A single submission may contain up to 5,000 ZÚM items.

The template and submission instructions are available on the VZP website.

The text of the opinion was translated using ChatGPT 4o.