In a previously conducted in-depth reimbursement review, the medicine containing budesonide in tablet form was assessed as generally therapeutically interchangeable with rectal formulations in the reference indication of treatment of acute ulcerative colitis affecting the rectum and sigmoid colon. This conclusion was primarily based on the results of the CORE I and CORE II studies in a subgroup of patients with proctosigmoiditis.
However, following the entry of another budesonide-based medicine in suppository form into the reimbursement system during an ongoing review procedure, the Institute (SÚKL) decided to narrow the reference indication to the treatment of acute ulcerative colitis affecting the rectum only.
In the issued assessment report, the Institute responded to objections raised by one of the parties, pointing out that patients with ulcerative colitis limited to the rectum were not included in the registration studies for the tablet formulation. Therefore, it is not possible to draw conclusions regarding the efficacy and safety of the tablet form for this specific patient group based on those studies, nor to conduct a direct comparison with rectal formulations of budesonide.
Given the different clinical uses, the Institute proposes dividing the assessed medicines into two separate groups:
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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 4o.