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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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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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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.

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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 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. 

The Ministry of Health of the Czech Republic (MoH) has issued a decision confirming the classification of medicinal products containing gliflozins as a group of essentially therapeutically interchangeable medicinal products for the treatment of type 2 diabetes mellitus (T2DM). This decision upheld the original contested ruling of the State Institute for Drug Control (SÚKL).

Gliflozins are used in the treatment of T2DM, contributing to improved glycaemic control and offering additional benefits for comorbidities such as heart failure and chronic kidney disease.
The proceeding evaluated medicinal products containing the following active substances from the group of sodium-glucose co-transporter 2 (SGLT2) inhibitors: dapagliflozin, empagliflozin, and ertugliflozin.

The core question was whether gliflozin-containing products can be deemed essentially therapeutically interchangeable within the reference indication "treatment of type 2 diabetes mellitus."
In its objections to the therapeutic interchangeability of dapagliflozin-containing products, the appellant presented the following key arguments:

1. Different Approved Indications – The company claimed that dapagliflozin has broader approved indications (e.g., heart failure with reduced and preserved ejection fraction) that are not approved for all other gliflozins.
2. Differences in Efficacy and Safety – The argument was based on variations in clinical study outcomes and differences in dapagliflozin’s safety profile compared to other gliflozins.
3. Varying Availability of Clinical Data – More robust clinical evidence is available for dapagliflozin in multiple indications, whereas for other gliflozins data is either incomplete or lacking.
4. Irreplaceability in Specific Indications – In clinical practice, dapagliflozin is irreplaceable in certain indications due to the lack of alternative treatments with comparable efficacy and safety evidence.

Despite the objections, the MoH confirmed that SÚKL correctly assessed gliflozins as essentially therapeutically interchangeable based on similar efficacy, safety, and clinical use in the reference indication. The rationale was that while individual gliflozins may offer different benefits for specific patient subpopulations, their overall effects in T2DM treatment are comparable.

The MoH also confirmed that classification into a group of essentially therapeutically interchangeable medicines is not based on market share or prevalence of use, but rather on expert considerations such as efficacy, safety, and clinical application. Therefore, the limited use of one substance in T2DM therapy was not a valid reason to exclude it from the group.

The MoH cited a judgment of the Prague Municipal Court dated 22 May 2015, Case No. 5 Ad 11/2010-164, which concluded that terms such as "essentially therapeutically interchangeable," "similar or close efficacy and safety," and "similar clinical use" under Section 39c(1) of Act No. 48/1997 Coll. should not be interpreted narrowly. The law deliberately uses modifiers such as "similar," "close," and "essentially" to indicate that products do not need to be completely identical in all aspects, including safety profiles.
This interpretation was subsequently reaffirmed by the same court in its judgment dated 23 September 2015, Case No. 7 Ad 19/2011-98. Further support comes from the Supreme Administrative Court’s ruling (Case No. 2 As 388/2017–66, para. 24), which stated: "There is no reason to equate the terms 'essentially therapeutically interchangeable with similar or close efficacy and safety and similar clinical use' for reimbursement purposes with 'interchangeability' of medicinal products for healthcare provision purposes. The objectives of these administrative proceedings differ, and the criteria considered cannot be compared with those evaluated by physicians in selecting appropriate 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. 

The State Institute for Drug Control (SÚKL) assessed the objections raised by the Health Insurance Association (“the Association”) and the General Health Insurance Company (VZP) concerning the allegedly unacceptable budget impact of the evaluated treatment on the public health insurance system.

The Association’s calculations were based on a comparison of per-patient treatment costs – CZK 1,509,429 for the evaluated intervention versus CZK 151,503 for the reimbursed comparator, representing nearly a tenfold increase. However, SÚKL concluded that this merely reflects a multiple increase in unit costs, not the total budget impact. According to SÚKL, such an argument does not sufficiently reflect the capacity or planning of the public health insurance system.

Both the Association’s and VZP’s calculations were based on internal data from the years 2017–2023 (Association) and 2014–2023 (VZP), and in both cases the projected budget impacts were compared against figures from the first (older) version of the assessment report.
SÚKL considered the projected cost increase presented by the insurers to be irrelevant, as the conclusions were based on outdated data. Current costs are lower due to updated external reference pricing and cost-capping agreements submitted by the applicant in cooperation with health insurance companies. Therefore, SÚKL did not accept the insurers’ conclusions as valid for the present decision-making process.

What Should a Statement on Unacceptable Budget Impact Look Like?

In an updated 2023 article, SÚKL based on a decision by the Ministry of Health outlined new requirements regarding how health insurance funds should submit statements concerning the unacceptability of budget impact.

SÚKL emphasized, among other things, that it is not acceptable to apply a universal threshold for all therapies that would automatically indicate the boundary between acceptable and unacceptable budget impact.
Furthermore, it stated that budget impact assessments must not be limited to pharmaceutical costs alone, but must reflect the overall budget impact, including other non-pharmaceutical segments of healthcare provision.

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. 

At the end of 2024, the City Court issued a ruling concerning the classification of a medicinal product as the first similar product or generic. The court reviewed several claims raised against decisions of the Ministry of Health (MoH) and the State Institute for Drug Control (SÚKL).

A similar product is, in simplified terms, a medicinal product with the same active substance(s) and an identical or similar pharmaceutical form as the reimbursed product (similarly applicable to biological products).

The court addressed the question of whether an application could be considered first in line, even if another product had already been granted reimbursement under legislation valid until 31 December 2007.
The court held that the definition of a “first similar product” does not require the application to have been submitted after the effective date of the amendment to the Public Health Insurance Act.

Furthermore, the court assessed whether an application for reimbursement modification is equivalent to an application for reimbursement determination.
In the case of a first similar product, the applicant is required to submit a commitment to market the product. However, this obligation does not apply to applications for reimbursement of the second or subsequent similar products.
SÚKL had interpreted the law in such a way that, for determining the order of applications (i.e. whether the product is the first or not), only the existence of a previous reimbursement determination application for a similar product was relevant, while applications for modification of reimbursement were not considered.
The court disagreed, accepting the plaintiff’s argument that both types of applications (determination and modification) are materially equivalent and should be taken into account when assessing the order. Thus, if an application for reimbursement modification for a similar product was submitted before the application for reimbursement determination, the latter cannot be considered an application for the first similar product, and therefore the marketing commitment does not need to be submitted.

The court also considered whether the medicinal product in question could be regarded as a generic.
The court stated that in order to deny reimbursement due to non-submission of the marketing commitment for 12 months, it is not sufficient for the product to be the first similar product—the law also requires that the product must be registered as either a biological medicinal product or a generic. Since the product under review was not registered as a generic, it cannot be considered one.

Following the City Court’s ruling, SÚKL re-evaluated the application for the maximum price and reimbursement determination of the medicinal product in question and did not classify it as the first similar product. Instead, it recognized another product as the first similar one.

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.