The Ministry of Health of the Czech Republic (MoH), acting as the appellate authority, examined whether the submission of two consecutive applications for a change in the reimbursement of the same medicinal product—applications concerning different therapeutic indications or reimbursement conditions—constitutes two separate proceedings or whether they relate to the same matter.
The MoH clearly concluded that the subject of the proceedings is identical and comprehensive, thereby upholding the resolution of the State Institute for Drug Control (the Institute) to discontinue the second proceeding due to litispendence.
At the same time, within the proceedings, the MoH emphasized that the subject of the procedure is not an isolated change to a single condition, but always a comprehensive assessment and determination of a new, complete set of reimbursement levels and conditions for the given product. The reimbursement level and reimbursement conditions form an inseparable and mutually interconnected pair.
In its reasoning, the MoH relied on case law of the Supreme Administrative Court (SAC), particularly on its view that even an extension of indication (and even a completely new indication) does not in itself constitute a change to the subject of the proceedings.
According to the MoH, allowing two parallel proceedings would risk the issuance of two contradictory reimbursement decisions, which would introduce absolute uncertainty into the system.
For completeness, we add that under the amendment to the Act on Public Health Insurance, from 1 January 2026 it will be possible to conduct two parallel proceedings concerning an extension of reimbursement for the same product, provided that the application for the later proceeding is submitted after a decision has been issued in the earlier proceeding, and that both proceedings are conducted for different indications.
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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 5.