The Czech Ministry
of Health (MoH) annulled a decision issued in an abbreviated reimbursement
review and referred the case back to the State Institute for Drug Control (the
Institute), as the Institute had failed to include in the administrative
proceedings all medicinal products that were therapeutically interchangeable at
the time the proceedings were initiated, as well as their marketing
authorisation holders.
The Institute
justified its approach by stating that it had excluded medicinal products
containing an active substance that had not yet undergone a full reimbursement
review and therefore, in its view, could not be subject to an abbreviated
review.
However, the MoH found this approach to be unlawful, pointing out that an abbreviated review is conducted as joint proceedings covering all medicinal products included in the relevant reference or pseudo-reference group. The medicinal product concerned had been included in the relevant pseudo-reference group (albeit through individual proceedings) and had been reimbursed from public health insurance since 1 May 2023, i.e. for more than a year before the reviewed proceedings were initiated. It therefore demonstrably met the statutory requirement of inclusion in the group, and the Institute should have initiated the proceedings in respect of that product as well.
The MoH further referred to a provision of the Act that expressly permits an abbreviated review to be initiated and conducted in respect of medicinal products for which reimbursement proceedings are simultaneously ongoing – and which, logically, have therefore not undergone any previous reimbursement review. If an abbreviated review may include a medicinal product whose inclusion in the relevant group is only anticipated, it must, all the more so, include a product that has already been validly and finally included in that group.
The MoH also criticised a degree of inconsistency in the Institute’s approach. On the one hand, the Institute denied that administrative proceedings could be initiated and conducted in respect of the medicinal product concerned, while on the other hand treating that same product as a reference medicinal product. Although the MoH did not generally rule out the possibility that such a situation could arise in practice and, under certain circumstances, be consistent with the applicable legislation, it concluded that this was not the case here.
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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 English translation was prepared using the latest available ChatGPT model.