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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.

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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 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 (...)."

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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 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.

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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. 

A medicinal product intended for patients with acute myeloid leukaemia (AML) previously held a temporary reimbursement as a Highly Innovative Medicinal Product (VILP) under Section 39d, granted for patients with FLT3-mutated AML in first relapse, reimbursed until disease progression, transplantation, or unacceptable toxicity.

In a new application, the same product was submitted for permanent reimbursement as an orphan drug under Section 39da, this time proposing reimbursement for a broader population than previously approved. The request aimed to extend reimbursement to post-transplant AML patients and to remove the first relapse condition.

The Ministry of Health (MoH) agreed with SÚKL’s conclusion that the application must be rejected due to the overlap in indications with the original temporary reimbursement. According to Section 39da of the Public Health Insurance Act, it is not legally permissible to apply for reimbursement for an indication already covered by a previous reimbursement decision. Although the relevant medical society opposed SÚKL’s decision, citing concerns about potential negative impacts on patient care and treatment quality, the Ministry upheld the rejection, stating that rules are consistent and the perceived medical need for the drug cannot override legal requirements.
The appeal was dismissed by the Ministry of Health, and SÚKL’s original decision was confirmed.

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) has initiated its first ex officio proceeding to re-evaluate whether a Highly Innovative Medicinal Product (VILP) continues to meet the required criteria following the entry of a new comparator into the reimbursement system.

Under the Public Health Insurance Act, if, during the validity of a decision granting temporary reimbursement for a VILP, SÚKL subsequently grants reimbursement under Section 39g to another medicinal product with comparable clinical use, the Institute must promptly initiate ex officio administrative proceedings. The purpose of these proceedings is to assess whether the VILP still fulfils the criteria for a highly innovative medicinal product. This obligation does not apply if the temporary reimbursement would expire in less than 12 months.

Such a situation has now occurred. The reason for initiating the proceeding was a decision effective from 1 November 2024, which granted permanent reimbursement to a new relevant comparator for a similar indication—namely, maintenance monotherapy in adult patients with BRCA1/2-mutated (FIGO stage III or IV) advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response following first-line platinum-based chemotherapy.

SÚKL has now issued a final assessment report regarding the reimbursement of a medicinal product for patients with advanced ovarian cancer, recommending that the second temporary reimbursement of the product remain in force.
In its assessment, the Institute compared the efficacy and safety of niraparib versus olaparib in patients with and without BRCA mutations. It concluded that comparable efficacy was demonstrated only in patients with BRCA mutations, and not in BRCA wild-type (BRCAwt) or unknown-status patients. Due to a lack of clinical evidence, no efficacy comparison was possible for the BRCAwt/unknown subgroup. For this subpopulation, the Institute found that the criteria for high innovativeness continue to be met, and that the appropriate comparator remains best supportive care (i.e., watch and wait approach).

SÚKL emphasized that within the scope of this administrative proceeding, it cannot modify the existing reimbursement conditions by limiting coverage to only part of the patient population. The decision to revoke or maintain reimbursement must therefore be based on whether the VILP criteria are met overall.

Given that the VILP criteria remain fulfilled for a subpopulation of patients (BRCAwt/unknown), and that the product demonstrated at least a 30% improvement in the primary endpoint of progression-free survival (PFS) versus the relevant comparator in the overall population, SÚKL has decided to maintain the temporary reimbursement.

Timeline:

• 03/2024 – Medicinal product containing niraparib: second temporary reimbursement granted in SCAU
• 11/2024 – Medicinal product containing olaparib: permanent reimbursement granted in SCAU
• 11/2024 – Ex officio proceeding initiated to reassess fulfilment of high innovativeness criteria

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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 State Institute for Drug Control (SÚKL) has rejected a request by the marketing authorization holder (MAH) of an orphan medicinal product (OMP) to suspend the proceedings on the setting of the maximum price and reimbursement.

The Ministry of Health issued a binding opinion for the OMP stating that the SÚKL is not allowed to grant reimbursement for the given OMP. The MAH disagreed with the negative binding opinion and submitted a request for its review. At the same time, the MAH asked the SÚKL to suspend the reimbursement proceedings for the OMP until the review of the opinion is completed.

The SÚKL argues that it is bound by the binding opinion of the Ministry and is obliged to issue a decision. According to SÚKL, the submission of a review request is not a valid reason for suspension because the outcome of the review is not determinative for this proceeding. The SÚKL holds a binding opinion from the Ministry, which is key for the decision, and must act in accordance with it, also considering the legitimate expectations of other parties to the proceeding. Therefore, the SÚKL will not suspend the reimbursement proceedings.

Since the new legislation concerning pricing and reimbursement of orphan drugs came into effect in 2023, the Ministry of Health has issued a total of 31 binding opinions. In 10 of these cases, the Ministry did not agree with the granting of reimbursement, in 2 cases it proposed changes to the reimbursement conditions compared to SÚKL’s proposal, and in 1 case it suggested a change in the reimbursement amount compared to SÚKL’s proposal.

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 the context of administrative proceedings on the determination of reimbursement and reimbursement conditions for medicinal products, it is, under certain circumstances, possible to take into account the so-called subjective parameter. This factor allows for the reflection of specific features of a medicinal product that cannot be fully captured through standard objective criteria.
However, subjective parameters are not always relevant to the proceedings, as demonstrated by the following examples from practice. In some cases, they may even be perceived as a limitation of the submitted documentation.

Subjective Parameter in Reimbursement Indication Restriction

The Ministry of Health upheld SÚKL’s approach of including the MSWS-12 questionnaire—a subjective parameter—in the reimbursement indication restriction for a particular medicinal product.
The Ministry justified the correctness of this procedure by referencing the wording of the Summary of Product Characteristics (SmPC), which allows the prescribing physician, already at the initiation of treatment, to evaluate efficacy using the MSWS-12 questionnaire instead of the objective T25FW test.
For this reason, the Ministry dismissed the appellant’s objection, which questioned the demonstration of efficacy through a subjective questionnaire. The Ministry stated that efficacy proven by such a tool is sufficiently supported by the conditions established during the marketing authorization process.
Moreover, the Ministry emphasized that the inclusion of subjective parameters in cost-effectiveness analyses is not considered a flaw or deficiency of such analyses in general.

Subjective Parameter in Clinical Evaluation

In certain cases, the use of a subjectively assessed primary efficacy endpoint in the evaluation of therapeutic appropriateness for reimbursement purposes has been accepted by SÚKL:

The primary efficacy endpoint assessed in clinical trials was based on purely subjective patient assessment. Considering that the MG-ADL score is more sensitive to changes in condition than the QMG score, and given the observed correlation between changes in MG-ADL and QMG scores, this benefit parameter is deemed acceptable. The treatment’s efficacy compared to placebo can be considered statistically significant, even though the difference in the primary endpoint was not clinically significant.

In contrast, in other proceedings, the subjective nature of the primary study endpoint has been labeled an unacceptable limitation for the purpose of reimbursement determination:

SÚKL proposes not to grant reimbursement for the medicinal product in the indication of symptomatic treatment of myotonia. In view of the study’s limitations and other concerns (e.g., potential overestimation of efficacy, the dose used, and the subjective nature of the primary endpoint)...
The study’s primary endpoint had a subjective character (VAS scale based on patient evaluation). The secondary endpoint (chair test) was objectively measurable. Even so, variability exists between different types of NDM, with some types affecting upper limbs and facial muscles more, and others affecting the legs. EMA also stated that direct measurement of muscle strength would have been more appropriate.

These examples illustrate that the subjective nature of a study’s primary endpoint may in some cases be a limitation for reimbursement purposes. However, if the parameter is embedded in the indication restriction in accordance with the product’s SmPC, it should be accepted by SÚKL for the purpose of reimbursement determination.

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.