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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.

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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.

Selection from Decision-Making Practice - 8

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...

Pharmeca a.s. 04/23/2025

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.

Information for MAH Medicines Pharmeca info Decision making

Selection from Decision-Making Practice - 7

Use of Subjective Parameters in Administrative Proceedings

Pharmeca a.s. 04/17/2025

As part of a streamlined reimbursement review for cost-saving purposes (§ 39p(1)), the State Institute for Drug Control unified reimbursement conditions by removing the “A” symbol (indicating use in ambulatory care) for products that can be self-administered by patients after prior training.

The Institute argued that if all products in a given group serve the same purpose and can be administered by patients, there is no reason for them to be subject to different reimbursement conditions. Previously, some products required immediate administration by a physician (marked with the “A” symbol), while others—therapeutically interchangeable—were not subject to such restriction.

The appeal body agreed with this reasoning and described the previous arrangement as inefficient.

The Institute had already reached the same conclusion in 2022, stating that if the accompanying texts (SPC/PIL) allow for patient self-administration after proper training instead of administration in ambulatory care, the “A” prescription restriction (ZULP for ambulatory care) may be removed without requiring a pharmacoeconomic assessment, as no expansion in the number of treated patients occurs.

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.

Information for MAH Medicines Pharmeca info Decision making

Selection from Decision-Making Practice - 6

Removal of the Prescription Symbol “A”

Pharmeca a.s. 04/09/2025

Fully reimbursed medicinal products play a key role in ensuring access to healthcare for patients in the Czech Republic. Their regulation is derived from Act No. 48/1997 Coll., on Public Health Insurance, which sets the conditions for their inclusion in the List of Prices and Reimbursements (SCAU). The goal is to ensure patients have access to treatment while optimizing public health insurance expenditures.

Full Reimbursement in Inpatient and Outpatient Care

Act No. 48/1997 Coll. stipulates that, during the provision of inpatient care, the following are fully reimbursed:

· medicinal products and foods for special medical purposes,

· individually prepared medicinal products,

· radiopharmaceuticals,

· transfusion products,

· medical devices,

· medicinal products for advanced therapy,

· tissues and cells.

These items are reimbursed in the least economically demanding version, and the insured person does not contribute to their payment.

In outpatient care, Annex No. 2 of the Act plays a crucial role in ensuring that at least one medicinal product in each therapeutic group is fully reimbursed by public health insurance. This guarantees patient access to treatment without co-payments, especially for chronic and severe diseases.

Full Reimbursement and Real Availability of Medicinal Products

However, full reimbursement of a medicinal product does not automatically mean its actual availability on the market. Data shows that only a portion of fully reimbursed medicines are genuinely available to patients, influenced by factors such as manufacturers’ supply decisions, demand fluctuations, and regulatory measures.

The list of medicinal products and foods for special medical purposes reimbursed by health insurance (SCAU250401) includes a total of 8,873 items, of which 987 are fully reimbursed. Out of this number, 748 products are available. The full reimbursement guarantee under Annex No. 2 of the Act applies to 467 of them, while 281 products are not included in Annex No. 2.

Fully reimbursed products make up 11.12% of all items in the reimbursed medicines list.
Available fully reimbursed products represent 75.79% of the total number of fully reimbursed products.
Of the fully reimbursed items, 47.32% fall under Annex No. 2 of the Act.
Outside Annex No. 2, 28.47% of fully reimbursed products exist.
Available fully reimbursed products constitute only 8.43% of the total number of items in the list.
Of the available fully reimbursed ones, 62.42% are from Annex No. 2.
Outside Annex No. 2, 37.58% of the available fully reimbursed products remain.

Information for MAH Legislation Medicines Decision making Pharmeca info

Fully Reimbursed Medicinal Products in the Czech Health Insurance System

Fully reimbursed medicinal products play a key role in ensuring access to healthcare for patients in the Czech Republic. Their regulation is based on the Public Health Insurance Act, which aims to...

Pharmeca a.s. 04/02/2025

The Ministry of Health annulled the decision of the State Institute for Drug Control (SÚKL) on the grounds that the Institute had failed to respect the Ministry’s previous binding legal opinion, as set out in its earlier decision — which we reported in our regular 2021 newsletter.

In 2021, the Association of Health Insurance Companies (Svaz ZP) appealed against the extension of reimbursement conditions for products containing inosine pranobex as part of a comprehensive reimbursement review. The Institute had approved the extension without assessing the cost-effectiveness and budget impact of the proposed change.

The Ministry stated that the removal of reimbursement conditions, such as prescription and indication restrictions, constitutes an expansion of reimbursement that leads to an increase in the number of treated patients. Following the change, all medical specialists could prescribe these products for reimbursement from public health insurance within the approved therapeutic indications listed in the SPC. However, the Ministry emphasized that the prevalence of the relevant conditions in the general Czech population was likely much higher than the number of patients covered under the prior reimbursement restrictions. The contested decision would thus logically lead to increased use and higher reimbursement costs.

By extending reimbursement without a proper assessment of cost-effectiveness and budget impact, the Institute acted unlawfully.

In the further course of the administrative proceedings, the Institute was not allowed to change the reimbursement conditions in a way that would increase the number of treated patients without the submission and assessment of the relevant pharmacoeconomic analyses from the parties to the proceedings. However, after the participants failed to provide the requested analyses, the Institute performed its own calculations and again extended the reimbursement conditions. This decision was again challenged — all payers filed an appeal.

Following further review, the Ministry of Health reiterated that the Institute may not create its own pharmacoeconomic analyses for the purpose of changing reimbursement conditions in the absence of such analyses submitted by the parties. The Institute is only authorized to perform corrective recalculations or similar adjustments within the scope of analyses provided by the parties.

For these reasons, the Ministry annulled the Institute’s decision once again.

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.

Information for MAH Medicines Pharmeca info Decision making

Selection from Decision-Making Practice - 5

The Institute may not conduct its own pharmacoeconomic analyses

Pharmeca a.s. 04/02/2025

In its decision, the Ministry of Health confirms the possibility of ensuring patients’ right to free (i.e., fully reimbursed) medicinal products from the groups listed in Annex No. 2 to Act No. 48/1997 Coll., even through products that are not available on the Czech market at the time of the SÚKL decision, as long as it is certain that such products will be available in sufficient quantities at the time the administrative decision becomes enforceable.

This typically applies to contractual arrangements between marketing authorization holders and health insurance companies, which include a binding commitment to ensure availability of the respective medicinal products.

On the other hand, the right to free medicinal products cannot be ensured through products that are not present on the Czech market or are available only in negligible quantities.

Furthermore, according to the Ministry of Health of the Czech Republic, SÚKL is not obliged to verify whether a product has been reported as temporarily unavailable on the domestic market, since such a temporary unavailability concerns only a transitional period, unlike permanent discontinuation of supply.

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.

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.

Information for MAH Medicines Pharmeca info Decision making Decision of Ministry of Health CZ

Selection from Decision-Making Practice - 4

Ensuring the Right to Full Reimbursement for Medicinal Products Listed in Annex No. 2

Pharmeca a.s. 03/26/2025

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Selection from Decision-Making Practice - 3

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