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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.

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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 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.

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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. 

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.

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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 4o. 

The Ministry of Health (MoH) has issued a binding opinion agreeing to the reimbursement of a medicinal product for rare diseases (LPVO) after the advisory board unanimously recommended approval.

Although the LPVO under assessment will be reimbursed, it will still be necessary to submit an application for an exceptional individual reimbursement under Section 16 of the Act on Public Health Insurance. This is because the LPVO is used in the given indication in combination with another medicinal product that is not covered by public health insurance. For this second product, an application for exceptional reimbursement will therefore need to be submitted, as stated by the Ministry in its opinion.

The Ministry agrees to the reimbursement terms particularly with regard to the age of the patients for whom the treatment is indicated, the seriousness of the disease, and after careful review of the evidence on the efficacy and safety of the LPVO in question.

Since the entry into force of the new legislation on pricing and reimbursement of rare disease medicines in 2023, the Ministry of Health has issued a total of 35 binding opinions. Of these, in 11 cases reimbursement was not approved, in 2 cases the Ministry proposed a change in the reimbursement conditions compared to the SUKL’s proposal, and in 1 case it proposed a change in the reimbursement amount.

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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 4o. 

The conditions for reimbursement of off-label indications are governed by Section 39b(3) of the Act on Public Health Insurance. To establish reimbursement, it is necessary to demonstrate that the use of the assessed medicinal product in the given off-label indication is sufficiently justified by current scientific knowledge and that its use represents the only available treatment option.
If it is not the only treatment option, reimbursement can still be granted provided that the applicant demonstrates cost-effectiveness compared to existing therapies.
If the condition of sufficient scientific justification is not met during the procedure, the Institute does not assess compliance with the remaining conditions.

Sufficient scientific knowledge is evaluated based on the evidence related to the specific indication. Recently, the State Institute for Drug Control (SÚKL) reached different conclusions on this condition for two indications of the same product: the treatment of high-grade squamous intraepithelial lesions of the vulva (HSIL) and extramammary Paget’s disease of the vulva (EMPD). Both proposed indications, HSIL and EMPD, are off-label.
The Institute determined that, based on available evidence, the use of the product in the treatment of vulvar HSIL is sufficiently supported by current scientific knowledge. Additionally, the product was found to be cost-effective, and therefore the reimbursement conditions for this off-label indication can be established.
In contrast, for EMPD, the use of the product was deemed insufficiently justified. The studies provided exhibited several methodological limitations, such as small patient samples, lack of a control arm, and observational design. As a result, the Institute proposes not to grant reimbursement for the EMPD indication.

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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.

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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. 

In the course of the administrative proceedings, the appellant argued that the State Institute for Drug Control (SÚKL) failed to proceed in accordance with Section 39c(5) of the Act on Public Health Insurance by not increasing the reimbursement of products containing the selected active substance to ensure full reimbursement.
This provision stipulates that if, during the process of determining reimbursement, no fully reimbursed medicinal product is available in any of the substance groups listed in Annex No. 2—regardless of therapeutic interchangeability—SÚKL shall adjust the reimbursement so that the least costly product from the assessed group is fully reimbursed.

The appellant maintained that under the provision in question, full reimbursement must be increased within the group of interchangeable products. According to the appellant, it is not sufficient that a fully reimbursed product exists within the same Annex No. 2 group if it is not therapeutically interchangeable and cannot be used in patients requiring the evaluated active substance under the established reimbursement conditions. Therefore, the appellant argued that the requirement for full reimbursement of at least one product under Section 39c(5) of the Act had not been met.

The Ministry of Health (MoH) responded by stating that the assessed active substances fall under the cytostatic tyrosine kinase inhibitors group—Group No. 116 of Annex No. 2. The medicinal products under review, as well as the fully reimbursed product within the same group, are used and reimbursed for the same disease type—chronic myeloid leukemia (CML). The Ministry noted that the condition of ensuring full reimbursement for at least one product within Annex No. 2 must be assessed in relation to the reference indication (i.e., the broader patient population), not to a specific subpopulation of CML patients. For these reasons, the MoH confirmed that SÚKL had acted correctly, as a reimbursed product was ensured for patients with CML within Group 116 of Annex No. 2 of the Act on Public Health Insurance.

The issue of fully reimbursed medicinal products under Annex No. 2 has also been addressed by the Constitutional Court of the Czech Republic. A landmark ruling concerned the full reimbursement of therapy for prostate and breast cancer.
In decision ref. no. III. ÚS 2332/16, the Court focused on whether it is constitutionally acceptable for no fully reimbursed product to be available for patients with prostate cancer, while such a product exists for breast cancer—even though the relevant products are categorized in the same Annex No. 2 group under the Act on Public Health Insurance.
The Constitutional Court held that interpreting the law in a way that denies full reimbursement of a medicinal product simply because another fully reimbursed product exists for a different disease (in this case, breast cancer) undermines the essence of the constitutionally guaranteed right to health protection under Article 31 of the Charter of Fundamental Rights and Freedoms. The Court emphasized that the administrative courts had acted too formalistically and failed to consider the merits of the claimant’s argument that no fully reimbursed treatment existed for prostate cancer.
As a result, it followed that if products contain active substances listed in the same Annex No. 2 group but are intended to treat categorically different diseases (e.g., one for breast cancer and another for prostate cancer), then full reimbursement must be ensured not only within the Annex No. 2 group but also specifically for each individual disease (i.e., for both breast and prostate cancer).
In a recent appeal review concerning the expedited reassessment of a reference group, the Ministry interpreted the Constitutional Court’s ruling to mean that if full reimbursement is ensured for a product from Annex No. 2 for the treatment of a specific disease type, and other products from the same group are indicated for entirely different diseases, then it is not necessary to ensure full reimbursement for those other products—provided that treatment for the different disease type is already fully reimbursed by a product outside the same Annex No. 2 group. No court has yet ruled on this interpretation.

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. 

In an administrative procedure conducted by the State Institute for Drug Control (SÚKL), objections raised by payers regarding cost-effectiveness were not upheld. The payers argued that the evaluated therapy could not be considered cost-effective due to the existence of cost-reducing agreements concluded between insurers and the marketing authorization holders of comparably effective medicinal products.
SÚKL, in its first-instance decision, did not take these cost-limiting agreements into account, reasoning that the agreements were not decisive for the reimbursement of the comparably effective therapies, which were cost-effective even without such arrangements.
The correctness of this approach was confirmed by the Ministry of Health (MoH) during the appeals process, stating that administrative proceedings must be based on verifiable data. SÚKL cannot rely on claimed cost levels of comparably effective therapies if such data is not available to it. Therefore, SÚKL rightly based its assessment on publicly available reimbursement data listed in the Price and Reimbursement List.

Following this MoH decision, another ministerial ruling was issued concerning the reimbursement of a product included in the same reimbursement group as in the aforementioned case.
Again, SÚKL justified its decision not to consider the existence of agreements in setting the reimbursement for the comparably effective therapy in a similar manner to the previous case.
The MoH confirmed this approach as well, reasoning that essential parts of the agreements—specifically the agreed manufacturer’s maximum price—were confidential. As such, these agreements could not be taken into consideration during the procedure.

The Ministry of Health’s reasoning may influence SÚKL’s approach in cases involving confidential agreements affecting the reimbursement of a comparator/reference product/comparably effective therapy.

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.