The State Institute for Drug Control (SÚKL) has rejected a request by the marketing authorization holder (MAH) of an orphan medicinal product (OMP) to suspend the proceedings on the setting of the maximum price and reimbursement.
The Ministry of Health issued a binding opinion for the OMP stating that the SÚKL is not allowed to grant reimbursement for the given OMP. The MAH disagreed with the negative binding opinion and submitted a request for its review. At the same time, the MAH asked the SÚKL to suspend the reimbursement proceedings for the OMP until the review of the opinion is completed.
The SÚKL argues that it is bound by the binding opinion of the Ministry and is obliged to issue a decision. According to SÚKL, the submission of a review request is not a valid reason for suspension because the outcome of the review is not determinative for this proceeding. The SÚKL holds a binding opinion from the Ministry, which is key for the decision, and must act in accordance with it, also considering the legitimate expectations of other parties to the proceeding. Therefore, the SÚKL will not suspend the reimbursement proceedings.
Since the new legislation concerning pricing and reimbursement of orphan drugs came into effect in 2023, the Ministry of Health has issued a total of 31 binding opinions. In 10 of these cases, the Ministry did not agree with the granting of reimbursement, in 2 cases it proposed changes to the reimbursement conditions compared to SÚKL’s proposal, and in 1 case it suggested a change in the reimbursement amount compared to SÚKL’s proposal.
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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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