The Ministry of Health (MoH) rejected an application to reopen the proceedings.
The applicant argued that, following the conclusion of the original reimbursement review, previously unknown facts had emerged—namely data on the supply and consumption of medicinal products and their market shares. According to the applicant, these data called into question, or even ruled out, the correctness of the established usual daily therapeutic dose (UDTD).
According to the MoH, data on the supply and consumption of medicinal products are known to the State Institute for Drug Control (the Institute) through its official activities and are published by the Institute on a monthly basis. The applicant could therefore have had access to these data already during the original proceedings.
Moreover, specific documents containing data on the consumption of the medicinal products concerned in 2022 had formed part of the case file throughout the original reimbursement review. The statutory requirement of “previously unknown facts” was therefore not met.
The MoH further stated that potentially higher consumption of certain strengths of the medicinal products is not decisive for determining the UDTD. Other factors are key to determining the UDTD, including WHO recommendations, the SmPC, scientific literature and clinical guidelines, all of which had been duly assessed in the original proceedings. The applicant’s submission could therefore not have resulted in a different conclusion on the matter.
The MoH therefore rejected the application to reopen the proceedings and did not permit the proceedings to be reopened.
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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 English translation was prepared using the latest available ChatGPT model.