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The Ministry of Health of the Czech Republic agreed to grant reimbursement for an orphan medicinal product (LPVO) in the indication treatment of advanced gastrointestinal stromal tumour (GIST). The medicine is intended for a small patient population and, although the expected duration of therapy is measured in months and its effect is not curative, it enables a significant prolongation of progression-free survival while maintaining a good quality of life.

The advisory board unanimously supported inclusion of this product in reimbursement, as the evidence in the file demonstrated its efficacy in fourth-line treatment of a rare malignancy for which no therapeutic alternative exists and where there is a clear unmet medical need.

The Ministry’s approval was justified, inter alia, by the fact that patients’ conditions require rapid treatment initiation, which individual exceptional reimbursement applications under Section 16 do not accommodate with sufficient flexibility.

According to the reasoning, contractual arrangements with health insurance companies also contributed to the positive opinion, resulting in a more favourable projected budget impact—not only compared with the findings of the assessment report, but also relative to current Section 16 practice.

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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. 

VZP informs applicants about the option to keep non-traded medical devices without EMDN in the Reimbursement Catalogue.

As part of the ongoing refinement of the VZP Reimbursement Catalogue – Medical Devices (ÚK VZP – ZP) and following a request from the Ministry of Health in connection with forthcoming legislation, all medical devices that were included in the ÚK VZP – ZP (ZUM) by 31 December 2023 and that, according to VZP ČR and SZP ČR data, were not traded (no recorded sales) between 1 January 2024 and 30 June 2025, and for which no EMDN category was submitted by 31 August 2025, and for which VZP ČR does not receive the relevant proposal, will be removed from the ÚK VZP – ZP (ZUM) as of 1 March 2026.

VZP hereby informs applicants of the possibility to keep non-traded ZUMs without EMDN in the Reimbursement Catalogue.

Applicants may, by 31 December 2025, submit the proposal “2. CH NÁVRH NA PONECHÁNÍ NEOBCHODOVANÝCH ZUM V ÚK VZP – ZP – VZP ČR” (Proposal to Retain Non-Traded medical devices in the ÚK VZP – ZP – VZP ČR) if they wish to keep non-traded medical devices without EMDN in the catalogue.

If the proposal is not submitted or is rejected, the ZUMs concerned will be removed from the ÚK VZP – ZP.

List of non-traded medical devices

The text of the opinion was translated using ChatGPT 5.  

For medicinal products included in a reference group that are not granted a reimbursement amount or conditions beyond those of interchangeable products, a cost-effectiveness analysis is not required. Newly, however, a budget impact analysis (BIA) must be submitted including a calculation of deductible co-payments. 

According to the State Institute for Drug Control (SÚKL), the BIA should consider all medicinal products included in the relevant reference group.
On the other hand, for example in proceedings on price and reimbursement in reference group No. 104/7 – therapeutic allergen extracts – standardised, depot injectable, the calculation of deductible co-payments must reflect actual practice: a product containing dust-mite allergens will in practice be replaced exclusively by products containing only these allergens. For this reason, including other interchangeable products (from the same reference group) in the BIA should not affect the result, because their costs would be the same in the world with and without the assessed intervention and therefore cancel out.

The analysis works with costs of deductible co-payments that would accrue to health insurance companies when the annual out-of-pocket cap is exceeded.
Excluding the CZK 1,000 insured person’s cap from the analysis was accepted by SÚKL in the above-mentioned case as a conservative setting. SÚKL found that including a CZK 5,000 cap per insured person would lead to higher deductions in the world with the assessed intervention (CZK 5,000 per patient) than in the world without it (less than CZK 5,000 per patient), thus lowering the resulting budget impact.
If the CZK 1,000 cap were applied, the patient in the world without the assessed intervention would exceed this cap in the first year only, not in subsequent years. Even when accounting for this lower cap, the resulting budget impact would remain lower.

The analysis should include separate results for the budget impact without deductible co-payments and with deductible co-payments.

Previously published SÚKL guidance also states that the analysis must reflect co-payments actually applied in practice.
To calculate real deductible co-payments, SÚKL uses average pharmacy prices per pack, obtained from reports under guideline LEK-13.

Costs of deductible co-payments relate to prescription-dispensed products; therefore, products billed on requisition forms are not included in the consumption analysis.

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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. 

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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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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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.

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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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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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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.

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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. 

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.  

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.

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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. 

Position of the Ministry of Health of the Czech Republic on Administrative Proceedings for Reimbursement Applications for Indications of Diseases Meeting the Definition of a Rare Disease, Involving Medicinal Products Not Designated as Orphan Medicines under Regulation (EC) No 141/2000

Act No. 48/1997 Coll., on Public Health Insurance and on Amendments and Supplements to Certain Related Acts, as amended (hereinafter referred to as the "Act"), does not regulate a special procedure for the entry into the reimbursement system for a medicinal product intended for the treatment of a rare disease that has not been granted so-called orphan designation under the relevant Regulation. Such a medicinal product cannot be classified as an orphan medicinal product (LPVO) under the Act, as the second sentence of Section 39da(1) stipulates: “An orphan medicinal product shall mean a medicinal product designated as such under directly applicable EU legislation on orphan medicinal products.” This means that a medicinal product not designated as an orphan under Regulation (EC) No 141/2000 cannot apply for reimbursement under Section 39da, even if it is authorized for a rare disease.

It is worth noting that submitting a reimbursement application under Section 39da is a right, not an obligation, of the marketing authorization holder. Entry into the reimbursement system is also possible via the procedures set out in Sections 39g or 39d of the Act.

Thus, medicinal products that cannot be considered LPVOs under the Act can only enter the reimbursement system via procedures under Sections 39g, 39i, or 39d. In proceedings under Sections 39g or 39i, resulting in permanent reimbursement of a non-orphan medicinal product for a rare disease indication, it is necessary, among other things, to meet the condition of a purposeful therapeutic intervention under the second sentence of Section 15(7) of the Act. However, during cost-effectiveness assessment in such procedures, it is not appropriate to use LPVOs reimbursed under Section 39da as comparators in the base-case scenario, as clarified in the Ministry's statement from 7 April 2025.

Therefore, the more suitable route for non-orphan designated products for rare diseases is through temporary reimbursement under Section 39d, as the features of this procedure are better suited to the nature of such medicinal products than the process for permanent reimbursement.

The first specific feature of the Section 39d procedure is the requirement to demonstrate at least one criterion for granting Highly Innovative Medicinal Product (VILP) status under Section 39d(2), which ensures that the product brings a degree of innovation that significantly impacts the treatment of a serious disease and plays a role in recommended treatment guidelines either in the Czech Republic or abroad. The applicant should specify in the submission, based on the principle of disposition, under which paragraph of Section 39d(2) the product fulfills the VILP criteria.

Fulfilment of at least one criterion for granting VILP status to a non-orphan designated medicinal product for which the first or second temporary reimbursement is requested in therapeutic indications for a condition meeting the definition of a rare disease is then assessed in comparison to therapies with reimbursement established under Section 39g of the Act, i.e., in a manner analogous to the procedure before 1 January 2022, when the amendment introducing the legal framework for the third reimbursement pathway under Section 39da for LPVOs entered into force. Given that the procedure under Section 39da is intended solely for a clearly defined group of LPVOs and applies specific requirements and criteria, where an LPVO reimbursed under Section 39da already exists in the reimbursement system at the time of the application for temporary reimbursement of a non-orphan medicinal product for a rare disease indication, the VILP criteria for such a product should not be assessed in comparison to the LPVO. This preserves the principle of assessing VILP criteria against therapies reimbursed under Section 39g, as is also the case when a temporary reimbursement is requested and a VILP is already reimbursed for the same indication. Otherwise, it would lead to an unjustified cumulative increase in entry requirements for newly entering medicinal products.

The relevant comparator for assessing the VILP criteria under Section 39d(2) and comparative effectiveness should thus be a reimbursed therapeutic intervention with reimbursement under Section 39g or Section 39i, or, if unavailable, another treatment alternative such as best supportive care (BSC). Nonetheless, even a reimbursed LPVO under Section 39da constitutes a therapeutic option, and thus in the clinical evaluation submitted by the applicant, a comparison with the LPVO in the given indication should be made. The entering VILP must meet the requirement of comparable or superior efficacy versus the LPVO in the assessed therapeutic indication—since setting reimbursement for a product with lower efficacy than a reimbursed LPVO cannot be considered in the public interest. Such a product would likely not bring patient benefit over the existing LPVO treatment. Regarding the evaluation of the VILP criterion for the non-orphan designated product, it is appropriate to note that where direct evidence is insufficient, indirect evidence or methodologically appropriate indirect comparisons may be accepted.

The second specific feature of the Section 39d procedure is the approach to assessing the purposefulness of therapeutic intervention, as under the third sentence of Section 39d(3) of the Act, “For temporary reimbursement, it is not required to fulfil the cost-effectiveness condition as one of the conditions for purposeful therapeutic intervention under Section 15(7).” This addresses cases where highly innovative medicines are not cost-effective due, for example, to a lack of sufficient data for a methodologically acceptable cost-effectiveness analysis, yet are reasonably expected to become cost-effective over time and clearly provide innovation.

Although failure to meet the cost-effectiveness condition under Section 15(7), second sentence, is not grounds to reject temporary reimbursement for a product eligible for VILP status, pharmacoeconomic evaluations—cost-effectiveness and budget impact analyses—must still be submitted. As per Section 15(8), fourth sentence, “The budget impact must align with the public interest under Section 17(2),” meaning an unacceptable budget impact may justify denial of temporary reimbursement.

Since the relevant clinical comparator for VILP assessment of a non-orphan medicinal product in a rare disease indication is therapy reimbursed under Section 39g or Section 39i or other alternatives, these should be used in the base-case scenario of the pharmacoeconomic assessment.

However, the alternative cost-effectiveness analysis scenario should include a comparator consisting of the LPVO reimbursed under Section 39da, provided that the analysis is methodologically sound and reviewable. Conversely, the LPVO must be used as the base-case comparator in the budget impact analysis under Section 39d(6), to ensure that estimated budget impacts reflect actual clinical practice and do not overestimate costs by omitting the LPVO as a comparator.

A product not designated as an orphan under Regulation (EC) No 141/2000 but intended for a rare disease indication may enter the reimbursement system under Section 39d if it demonstrates at least one VILP criterion compared to therapies reimbursed under Sections 39g or 39i and shows comparable efficacy to an LPVO reimbursed under Section 39da. The pharmacoeconomic base-case analysis should be performed using comparators reimbursed under Sections 39g or 39i, and the LPVO reimbursed under Section 39da must be included as a comparator in the base-case budget impact analysis and the alternative cost-effectiveness analysis.

This text was fully taken from the website of the Ministry of Health of the Czech Republic.

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.

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 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.