In administrative proceedings concerning changes to the amount and conditions of reimbursement, the State Institute for Drug Control (the Institute) assessed an extension and modification of the reimbursement conditions for an oncology medicinal product.
Before the third assessment report was issued, the applicant submitted risk-sharing agreements to the Institute. Although these agreements reduced the overall budget impact on the public health insurance system, they did not reduce the actual treatment costs sufficiently to meet the cost-effectiveness criteria. The resulting incremental cost-effectiveness ratio (ICER) exceeded the acceptable threshold of CZK 1.2 million per quality-adjusted life year (QALY). Consequently, in its third assessment report, the Institute concluded that the cost-effectiveness requirement had not been met and proposed not to grant reimbursement in subsequent lines of treatment.
In response to this conclusion, however, new cost-limitation agreements (pricing agreements ensuring cost-effectiveness) were negotiated and concluded with health insurance funds. Following the submission of these agreements, the financial requirements were addressed, resulting in a positive fourth assessment report recommending that reimbursement be granted.
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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.