In an abbreviated reimbursement review triggered by the market entry of the first similar medicinal product (generic), the State Institute for Drug Control (the Institute) reduced the base reimbursement for a group of medicinal products stimulating platelet production following the launch of the first generic product. One of the parties to the proceedings, the marketing authorisation holder of a medicinal product included in the same group but containing a different active substance than the newly introduced first similar medicinal product, challenged the therapeutic interchangeability of the individual active substances. The party submitted new scientific evidence and raised objections regarding safety. However, the Institute rejected these arguments, referring to previous administrative proceedings and the legislation governing abbreviated reimbursement reviews.
In its response, the Institute stated that the purpose of an abbreviated review is not to reassess the therapeutic interchangeability of medicinal products. That issue is addressed within full reimbursement reviews. In the present proceedings, the Institute relied on conclusions that had already become final in previous full reimbursement reviews and individual administrative proceedings.
According to the Institute, the purpose of an abbreviated review under the Act is to ensure a swift procedure, avoiding extensive scientific debate with the parties in order to achieve timely savings for the public health insurance system.
Its role is limited to recalculating reimbursement levels on the basis of the current external price reference.
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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.