The State Institute for Drug Control decided on the determination of the maximum price and reimbursement for a medicinal product containing the active substance tamoxifen citrate.
The proceedings were initiated upon the company’s application pursuant to Section 32d of the Public Health Insurance Act. The purpose of this specific procedure is to ensure the availability of irreplaceable medicinal products in situations where a supply disruption in the Czech Republic is imminent or has already occurred.
The primary reason for the decision was to ensure continued treatment availability for oncology patients, as supply of the previously registered medicinal products containing the above active substance had been interrupted for manufacturing reasons.
As no other registered alternative for oral administration was available within the relevant group, the Ministry of Health approved a specific treatment programme for an unregistered medicinal product. The Institute subsequently determined its maximum price and reimbursement level, adopting the reimbursement conditions of the originally reimbursed product that had become unavailable.
The decision on the determination of price and reimbursement was issued 24 days after submission of the application.
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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.
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