The Ministry of Health of the Czech Republic agreed to grant reimbursement for an orphan medicinal product (LPVO) in the indication treatment of advanced gastrointestinal stromal tumour (GIST). The medicine is intended for a small patient population and, although the expected duration of therapy is measured in months and its effect is not curative, it enables a significant prolongation of progression-free survival while maintaining a good quality of life.
The advisory board unanimously supported inclusion of this product in reimbursement, as the evidence in the file demonstrated its efficacy in fourth-line treatment of a rare malignancy for which no therapeutic alternative exists and where there is a clear unmet medical need.
The Ministry’s approval was justified, inter alia, by the fact that patients’ conditions require rapid treatment initiation, which individual exceptional reimbursement applications under Section 16 do not accommodate with sufficient flexibility.
According to the reasoning, contractual arrangements with health insurance companies also contributed to the positive opinion, resulting in a more favourable projected budget impact—not only compared with the findings of the assessment report, but also relative to current Section 16 practice.
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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.