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The Public Health Insurance Act establishes a reimbursement cap applicable where the State Institute for Drug Control (the Institute) decides on temporary reimbursement for a new therapeutic indication of a highly innovative medicinal product (VILP) that already has permanent reimbursement established for another indication.
The newly established temporary reimbursement may not exceed the existing reimbursement granted for that medicinal product. An exception applies where the product has been assigned to a reference group containing other therapeutically interchangeable medicinal products.

According to Section 39d(9) of the Public Health Insurance Act:
“Where proceedings are conducted to establish temporary reimbursement for a medicinal product that is already reimbursed from public health insurance in another therapeutic indication pursuant to a decision of the Institute under Section 39h, the Institute shall establish temporary reimbursement at an amount not exceeding the reimbursement determined by that decision under Section 39h. This shall not apply where, pursuant to a decision under Section 39h, the medicinal product has been assigned to a reference group or another group of essentially therapeutically interchangeable medicinal products that already includes other medicinal products. Where temporary reimbursement has also been established for another highly innovative medicinal product and the available evidence demonstrates that it has comparable clinical use and comparable or similar efficacy and safety, the Institute shall establish temporary reimbursement for the assessed medicinal product at an amount not exceeding the temporary reimbursement granted to the highly innovative medicinal product with comparable clinical use and comparable or similar efficacy and safety, taking into account differences in dosage and pack size.”

The Institute verifies compliance with this statutory reimbursement cap in each proceeding concerning temporary reimbursement. In one such proceeding, where the reimbursement proposed by the applicant was equal to the permanent reimbursement already established for another indication, the Institute granted reimbursement in line with the applicant’s proposal.

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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 English translation was prepared using the latest available ChatGPT model.

The State Institute for Drug Control (the Institute) received a joint request from medical societies to establish increased reimbursement for medicinal products containing a selected active substance for the treatment of paraphilic disorders, an indication that falls outside the approved marketing authorisation (i.e. an off-label indication). In their statement, the medical societies explained that the request was supported by clinical experience, scientific evidence, and safety considerations.

The Institute concluded that the therapy represents the only available treatment option. Consequently, it did not require the submission of a cost-effectiveness analysis; a budget impact analysis based on the number of patients reported by the medical societies was considered sufficient.

Based on the submitted documentation, the Institute concluded that reimbursement in this off-label indication is adequately supported by current scientific evidence and that the therapy constitutes the only available treatment option. It therefore proposed granting increased reimbursement for this indication as well.

According to Section 39b(3) of the Public Health Insurance Act:
“…The Institute may establish reimbursement for an unregistered medicinal product where its use is sufficiently justified by current scientific knowledge and it represents the only available treatment option, or where its use is cost-effective compared with available treatment, for the duration of an approved specific treatment programme. The Institute may also establish reimbursement for a registered medicinal product for indications not included in the Summary of Product Characteristics, provided that the use of the medicinal product is sufficiently justified by current scientific knowledge and represents the only available treatment option, or where it is cost-effective compared with existing treatment.”

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 English translation was prepared using the latest available ChatGPT model.

As of 1 January 2026, an amendment to the Public Health Insurance Act has entered into force, introducing, among other changes, new rules for determining the prices of strategically important medicines. The aim is to prevent supply shortages in the Czech Republic through a more flexible approach to setting maximum prices.

For medicinal products deemed to be in the public interest, the State Institute for Drug Control (the Institute) now determines the maximum price based on:

·        the average of prices in up to seven of the lowest-priced countries within the EU reference basket;

·        if the medicinal product is not available in at least two reference basket countries, prices are compared across the entire EU, or alternatively against therapeutically comparable medicines in the Czech Republic or within the reference basket.

To prevent Czech prices from being driven down by isolated price anomalies, the Institute applies a number of exclusion rules:

·        if the lowest price in the EU is more than 20% lower than the average of the second and third lowest prices, it is excluded from the calculation;

·        prices from countries experiencing significant currency depreciation are excluded where three or more reference prices are available;

·        prices distorted by government crisis interventions in other countries are disregarded, provided that the Institute has received official information about such measures.

The Institute has already issued a number of decisions establishing maximum prices for strategically important medicines. However, a concerning trend can be observed in its decision-making practice. Although this “special regime” is intended to enhance market stability, many decisions lack sufficiently detailed reasoning clearly demonstrating that the statutory conditions for applying this approach have been met.

The new framework provides the state with a powerful tool for safeguarding the availability of medicines. Its effectiveness, however, will depend on the transparency and reviewability of decisions, ensuring that marketing authorisation holders clearly understand how and why the final price was determined.

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 5.3

In administrative proceedings concerning a change in the amount and conditions of reimbursement, the marketing authorisation holder applied for an extension of the prescribing restriction to one additional medical specialty. Together with the application, the holder paid only the administrative fee applicable to cases that do not require a full clinical and pharmacoeconomic assessment.
However, during the proceedings, the State Institute for Drug Control (the Institute) subsequently requested payment of an additional amount, taking the view that the case required a comprehensive expert assessment.
The applicant appealed against this approach.

In the appeal proceedings, the Ministry of Health (MoH) upheld the Institute’s position, confirming that the administrative fee applicable to proceedings involving a full expert assessment was appropriate.
According to the MoH, any relaxation of prescribing restrictions facilitates patient access to treatment, which in itself creates the potential for increased expenditure from the public health insurance system. This applies even where the absolute number of patients in the indication does not increase, as treatment patterns may shift internally in favour of the medicinal product concerned. From the Ministry’s perspective, such shifts may also result in increased expenditure from the system.
The MoH therefore concluded that the Institute has a legitimate obligation to properly assess any potential impact on public health insurance funds and that the requested administrative fee corresponds to the scope of the assessment being carried out.

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 5.3.  

A medicinal product entered the reimbursement system as the first similar medicinal product to the reference product, even without submitting the confidential agreements that ensure the cost-effectiveness of the reference product.

During the proceedings, health insurance funds pointed out that, in practice, a situation may arise where, even after the statutory 40% price reduction of the first similar medicinal product, its price would still remain higher than the actual (contractual) price of the originator product. According to the insurers, such a situation would result in a breach of the requirement for an efficient therapeutic intervention.
From the payer’s perspective, this approach is considered unacceptable in terms of budget stability and contrary to the public interest.

The State Institute for Drug Control rejected the insurers’ objections with reference to the amendment to the Public Health Insurance Act effective from 1 January 2026. Under this amendment, a similar medicinal product is deemed cost-effective even where the reimbursement of the reference medicinal product of another marketing authorisation holder was influenced by an agreement concluded between that holder and health insurance funds, while no comparable agreement was concluded for the assessed medicinal product.

Part of the amended statutory provision states:
“Similar medicinal products shall be deemed to fulfil the conditions of an efficient therapeutic intervention pursuant to Section 15(6)(d), and the Institute shall not assess them, except for similar medicinal products of the same marketing authorisation holder who concluded an agreement with health insurance funds, where such agreement was decisive for granting reimbursement to the originally reimbursed medicinal product.”

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 5.3.  

The Ministry of Health (MoH) upheld an appeal against the rejection of an application for the abolition of the maximum price after the case had been remitted for further proceedings by the Supreme Administrative Court.

In its decision, the State Institute for Drug Control (Institute) took the view that an application for abolition of the maximum price could only be submitted on the grounds of 12 months of non-marketing. It further stated that, according to its findings, the medicinal products concerned were used only during hospitalisation and, in outpatient settings, solely as substances for individual preparation rather than as finished products.

The appellant’s principal argument, by contrast, was that the medicinal product had become newly usable in outpatient care. According to the appellant, the maximum price should therefore be abolished, since under the applicable pricing regulations medicinal products usable in outpatient care and without established reimbursement are not subject to price regulation.
Although the Act does not explicitly list a change in the segment of use as a ground for abolishing the maximum price, the appellant argued that this constituted an unintended gap in the legislation that should be bridged by analogy.

In line with the binding opinion of the court, the MoH acknowledged the existence of an “unintentional gap” in the legislation. If, in the further course of the proceedings, the participant demonstrates outpatient use of the medicinal product, this constitutes a legitimate reason for abolishing the maximum price, even though the Act does not expressly provide for it.
At the same time, the MoH held that the Institute must reassess the issue of the product’s actual usability in outpatient care in a more thorough manner.

The contested decision of the Institute was therefore annulled and the case was remitted for reconsideration.

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 5.5.