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Selection from Decision-Making Practice - 17

Pharmeca a.s. 09. 07. 2025

The Ministry of Health (MoH) has issued a binding opinion agreeing to the reimbursement of a medicinal product for rare diseases (LPVO) after the advisory board unanimously recommended approval.

Although the LPVO under assessment will be reimbursed, it will still be necessary to submit an application for an exceptional individual reimbursement under Section 16 of the Act on Public Health Insurance. This is because the LPVO is used in the given indication in combination with another medicinal product that is not covered by public health insurance. For this second product, an application for exceptional reimbursement will therefore need to be submitted, as stated by the Ministry in its opinion.

The Ministry agrees to the reimbursement terms particularly with regard to the age of the patients for whom the treatment is indicated, the seriousness of the disease, and after careful review of the evidence on the efficacy and safety of the LPVO in question.

Since the entry into force of the new legislation on pricing and reimbursement of rare disease medicines in 2023, the Ministry of Health has issued a total of 35 binding opinions. Of these, in 11 cases reimbursement was not approved, in 2 cases the Ministry proposed a change in the reimbursement conditions compared to the SUKL’s proposal, and in 1 case it proposed a change in the reimbursement amount.


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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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