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Selection from Decision-Making Practice - 5

Pharmeca a.s.

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.


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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.  

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