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The State Institute for Drug Control (the Institute) determined the first temporary reimbursement for a highly innovative medicinal product (HIMP) at the lower reimbursement rate under JUHR2.

When determining reimbursement for the medicinal product, the Institute proceeded in accordance with Section 39d(9) of the Public Health Insurance Act by comparing the reimbursement amount calculated using the standard method (based on price references) with reimbursement amounts previously established for the same medicinal product in other administrative proceedings and applying the lower amount.

Section 39d(9) of the Public Health Insurance Act states:

“Where proceedings are conducted to determine temporary reimbursement for a medicinal product that is already reimbursed under another therapeutic indication through public health insurance on the basis of a decision issued by the Institute pursuant to Section 39h, the Institute shall determine the temporary reimbursement amount at no more than the reimbursement amount established by the Institute's decision pursuant to Section 39h.This shall not apply where such a medicinal product has been included, by a decision of the Institute pursuant to Section 39h, in a reference group or another group of essentially therapeutically interchangeable medicinal products that already includes other medicinal products. Where another highly innovative medicinal product has also been granted temporary reimbursement and the available evidence demonstrates that it has similar clinical use and comparable or closely similar efficacy and safety, the Institute shall determine the temporary reimbursement amount for the medicinal product under assessment at no more than the temporary reimbursement amount established for the highly innovative medicinal product with similar clinical use and comparable or closely similar efficacy and safety, taking into account differences in dosage and pack size.”

In applying the above provision, the Institute verified whether the medicinal products were already reimbursed within the public health insurance system and identified their applicable reimbursement amounts. It found that, in addition to the higher JUHR1 reimbursement amount, a lower JUHR2 reimbursement amount was also in effect. As the applicable JUHR2 reimbursement amounts for the individual product codes were lower than those newly calculated on the basis of price references, the Institute determined reimbursement at the amounts previously established in proceedings concerning temporary reimbursement of the HIMP for another indication.

The application of Section 39d(9) of the Public Health Insurance Act ensured that the newly determined temporary reimbursement amount for the indication under assessment did not exceed the previously established, valid and enforceable temporary reimbursement amount for the same medicinal product in another indication.

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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 Ministry of Health (MoH) dismissed an appeal against a decision to discontinue proceedings concerning the determination of the maximum price and the amount and conditions of permanent reimbursement due to failure to pay the outstanding balance of administrative expenses. The appellant had paid the amount corresponding to the fee for an assessment without a comprehensive evaluation, whereas the State Institute for Drug Control (the Institute) required payment of the higher fee applicable to a comprehensive expert assessment. During the appeal proceedings, the MoH addressed several objections raised by the appellant.

The appellant argued that the Institute had failed to demonstrate that the conditions for applying the higher fee for a comprehensive expert assessment had been met. According to the MoH, the scope of the assessment must be determined prospectively at the beginning of the proceedings. In the case of a medicinal product with a new pharmaceutical form and intermittent dosing, entering the reimbursement system for the first time, the need for a comprehensive clinical assessment could not be ruled out.

The appellant further claimed that following the submission of additional documentation and the narrowing of its reimbursement request (acceptance of the reference group framework, withdrawal of the request for a reimbursement bonus, and reduction of the proposed reimbursement amount), a comprehensive assessment was no longer necessary. The MoH stated that even after these changes, the Institute was still required to independently assess key clinical parameters, including therapeutic interchangeability and dosing safety, to determine the product's inclusion in the reference group. Such an evaluation met the criteria for a comprehensive assessment.

The appellant also pointed to changes in the schedule of fees for administrative expenses during the proceedings. However, according to the MoH, the applicable fee is determined by the regulations in force when the payment obligation arises, i.e. on the date the application is submitted.

Finally, the appellant argued that failure to pay the outstanding balance did not constitute a material deficiency in the application and that discontinuing the proceedings was disproportionate. According to the MoH, proof of payment of the legally prescribed fee is a mandatory requirement of the application, without which the proceedings cannot continue. The Institute had also provided the appellant with the necessary assistance and sufficient time to remedy the deficiency. The MoH therefore found no procedural error on the part of the Institute.

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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 English translation was prepared using the latest available ChatGPT model.

In proceedings concerning the determination of the price and reimbursement of a medicinal product intended for immunisation, the State Institute for Drug Control (the Institute) clarified its approach to handling information submitted as trade secrets to substantiate foreign price references.

The Institute stated that:

• to demonstrate the actual manufacturer's price in a reference country, supporting documents relating to the relevant period are generally submitted, primarily invoices or other similarly reliable evidence. Where such evidence is accepted and its content has been submitted as a trade secret, the Institute takes the substantiated price into account when determining the price and reimbursement, to the extent necessary to justify its approach and conclusions, and removes the price used from trade secret protection.
  
  
• Where the marketing authorisation holder intends to demonstrate only a different margin, for example by submitting a declaration from a third party (such as a distributor) specifying an amount to be deducted from the identified price, the entire declaration may be designated as a trade secret.
  
  

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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 English translation was prepared using the latest available ChatGPT model.

In administrative proceedings concerning changes to the amount and conditions of reimbursement, the State Institute for Drug Control (the Institute) assessed an extension and modification of the reimbursement conditions for an oncology medicinal product.

Before the third assessment report was issued, the applicant submitted risk-sharing agreements to the Institute. Although these agreements reduced the overall budget impact on the public health insurance system, they did not reduce the actual treatment costs sufficiently to meet the cost-effectiveness criteria. The resulting incremental cost-effectiveness ratio (ICER) exceeded the acceptable threshold of CZK 1.2 million per quality-adjusted life year (QALY). Consequently, in its third assessment report, the Institute concluded that the cost-effectiveness requirement had not been met and proposed not to grant reimbursement in subsequent lines of treatment.

In response to this conclusion, however, new cost-limitation agreements (pricing agreements ensuring cost-effectiveness) were negotiated and concluded with health insurance funds. Following the submission of these agreements, the financial requirements were addressed, resulting in a positive fourth assessment report recommending that reimbursement be granted.

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.

The State Institute for Drug Control (the Institute) discontinued reimbursement for specific variants of a medicinal product from the allergen group following an application by the manufacturer. As part of the proceedings, the Institute assessed market availability and the public interest. The analysis confirmed that discontinuing reimbursement would not put patients at risk, as fully adequate therapeutic alternatives for the treatment of allergies are available within the relevant therapeutic group.

In assessing treatment availability and the public interest in connection with the discontinuation of reimbursement, the Institute considered the following:

1. Statutory assessment criteria
The Institute may decide to discontinue the amount and conditions of reimbursement if a medicinal product has not been supplied to the Czech market for more than 12 months and, at the same time, the discontinuation of reimbursement is not contrary to the public interest in ensuring access to effective and safe healthcare. Where the application is submitted by the marketing authorisation holder, the condition requiring the product to have been absent from the market for 12 months does not have to be met; however, the assessment of the public interest remains essential.

2. Assessment of market availability
The Institute examined actual supplies of the medicinal products to the market over the preceding 12 months. For two of the three product codes, supplies to the market had been recorded during this period.

3. Therapeutic alternatives and ensuring access to care
The key argument supporting the conclusion that access to reimbursed healthcare would not be jeopardised was the availability of alternatives within the same reference group. The Institute confirmed that other reimbursed medicinal products were available to patients.
In view of this therapeutic substitutability, the Institute concluded that discontinuing reimbursement would not affect patients’ access to effective and safe healthcare.

4. Public interest
Based on the availability of therapeutic alternatives described above, the Institute concluded that the discontinuation of reimbursement was not contrary to the public interest.

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.

The State Institute for Drug Control (the Institute) received an application from the General Health Insurance Company of the Czech Republic (VZP) for a change in the amount and conditions of reimbursement from public health insurance for selected orphan medicinal products, based on the following statutory provision:
“In the event of a significant change in the price references of an orphan medicinal product, the Institute shall, upon application by a health insurance fund, initiate proceedings pursuant to Section 39i to change the amount and conditions of reimbursement of the orphan medicinal product.”
This provision has been effective since 1 January 2026 following the amendment to the Act.

VZP’s application specified price references indicating a change in the price references and, consequently, a change in the reimbursement amount.
The Institute subsequently issued a decision in the proceedings changing the reimbursement of the medicinal product concerned.
During the proceedings, price references were identified that could potentially support the conclusion that a significant change in price references had occurred. However, in its decision, the Institute did not address whether it actually considered the identified change in price references to be significant, nor did it indicate the percentage change in price references that would be required for a change to be considered significant.
Although the Institute granted VZP’s application in full, VZP appealed against the decision after it had been issued in order to withdraw its application in its entirety. Following the withdrawal of the application, the proceedings were discontinued.

The Institute addressed the interpretation of the term “significant change in price references” in another proceeding concerning a change in the reimbursement of an orphan medicinal product on the same grounds. A party to the proceedings argued that, according to the explanatory memorandum, a significant change in price references should be in the range of tens of percent, which was not the case in the proceedings concerned, and that the Institute had failed to address whether or not a significant change in price references had occurred.
The Institute stated that the term “significant change in price references” is not defined by law and that the law does not require the Institute to define this term in abstract terms beyond the wording of the Act. Although the Institute acknowledged the reference to the explanatory memorandum, it emphasised that the explanatory memorandum is not a legally binding document for decision-making purposes and cannot substitute for the law. According to the Institute, the fact that the explanatory memorandum mentioned a potential decrease in the range of tens of percent does not mean that only a price reduction of such magnitude can constitute grounds for initiating proceedings.
The Institute also pointed out that proceedings in the event of a significant change in price references are initiated upon application by a health insurance fund. According to the Institute, it is the health insurance fund that, by submitting its application, implies that the change in price references in the particular case is sufficiently relevant to warrant consideration by the Institute in administrative proceedings.

The Institute entirely refrained from assessing whether the statutory condition of a significant change in price references had been met, even though this condition is essential for the initiation of the proceedings.

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.

The State Institute for Drug Control (the Institute) initiated ex officio proceedings to change the maximum price of an orphan medicinal product pursuant to Section 39da(10) of Act No. 48/1997 Coll., on Public Health Insurance. According to the provision in force on the date the proceedings were initiated:
“No later than 3 years from the date on which the decision establishing the amount and conditions of reimbursement of an orphan medicinal product becomes enforceable, the Institute shall initiate ex officio administrative proceedings to change the maximum price pursuant to Section 39i. Sections 39l and 39p shall apply mutatis mutandis.”

The marketing authorisation holder (MAH) argued that the proceedings should not have been initiated “automatically”, but only “where necessary”. According to the MAH, the Institute should have assessed whether the proceedings served a meaningful purpose and would result in actual savings; otherwise, the proceedings should have been discontinued.
The Institute stated that the law imposes an unconditional obligation to initiate proceedings to change the maximum price within 3 years of the date on which the orphan reimbursement decision becomes enforceable. According to the Institute, the condition “where necessary” does not apply to the initiation of proceedings to change the maximum price of an orphan medicinal product itself. In this case, the three-year requirement for initiating the proceedings was therefore met.

The MAH further argued that the statutory requirement of annual savings of CZK 30 million, applicable to the review proceedings referred to in Section 39da(10), had not been demonstrated. In the MAH’s view, the Institute should have demonstrated the expected savings to the public health insurance system; without doing so, the proceedings were unlawful or not subject to proper review.
The Institute maintained that demonstrating such savings is not a statutory requirement for this type of proceeding. The requirement that the relevant provisions apply mutatis mutandis does not mean that the conditions governing the initiation of a reimbursement review are transferred to these individual proceedings concerning a change in the maximum price of an orphan medicinal product. The purpose of these proceedings is not to generate reimbursement savings, but to change the maximum price.

The MAH also argued that the maximum price of the medicinal product concerned had already been changed previously and that there was therefore no justification for further ex officio proceedings.
The Institute stated that the earlier proceedings cannot be regarded as fulfilling the obligation under Section 39da(10), as the law requires these specific proceedings to be initiated no later than 3 years after the orphan reimbursement decision becomes enforceable, irrespective of whether another change in the maximum price has taken place in the meantime.

The Institute rejected all the objections and issued a decision in the matter, against which the MAH filed an appeal.

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.