If an applicant has previously submitted and succeeded in a different type of administrative proceeding to determine the amount and conditions of reimbursement for a medicinal product in a certain indication, they cannot subsequently apply for reimbursement under Section 39da of the Act on Public Health Insurance (Rules for the Reimbursement of Medicinal Products for Rare Diseases) for the same medicinal product and the same indication—even if the product holds orphan medicinal product (LPVO) status.
According to the Ministry of Health, this condition follows from Section 39da(1): “If it is in the public interest under Section 17(2) and no application has been submitted for the same indication for temporary reimbursement under Section 39d or for determination of the amount and conditions of reimbursement in proceedings under Section 39g, the Institute shall decide on the amount and conditions of reimbursement for a medicinal product intended for the treatment of a rare disease…”
The Ministry stated that this provision must be applied not only to parallel administrative proceedings concerning the same indication but also to proceedings that have already taken place and have been lawfully concluded for the same indication of the given medicinal product.
An amendment to the Act on Public Health Insurance, scheduled to enter into force on 1 January 2026, explicitly establishes the rule that reimbursement for an LPVO cannot be requested if the product already has temporary reimbursement set for the same 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).
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The text was translated using ChatGPT 4o.