The Public Health Insurance Act
establishes a reimbursement cap applicable where the State Institute for Drug
Control (the Institute) decides on temporary reimbursement for a new
therapeutic indication of a highly innovative medicinal product (VILP)
that already has permanent reimbursement established for another indication.
The newly established temporary
reimbursement may not exceed the existing reimbursement granted for that
medicinal product. An exception applies where the product has been assigned to
a reference group containing other therapeutically interchangeable medicinal
products.
According to Section 39d(9) of
the Public Health Insurance Act:
“Where proceedings are conducted
to establish temporary reimbursement for a medicinal product that is already
reimbursed from public health insurance in another therapeutic indication
pursuant to a decision of the Institute under Section 39h, the Institute shall
establish temporary reimbursement at an amount not exceeding the reimbursement
determined by that decision under Section 39h. This shall not apply where,
pursuant to a decision under Section 39h, the medicinal product has been
assigned to a reference group or another group of essentially therapeutically
interchangeable medicinal products that already includes other medicinal
products. Where temporary reimbursement has also been established for another
highly innovative medicinal product and the available evidence demonstrates
that it has comparable clinical use and comparable or similar efficacy and
safety, the Institute shall establish temporary reimbursement for the assessed
medicinal product at an amount not exceeding the temporary reimbursement granted
to the highly innovative medicinal product with comparable clinical use and
comparable or similar efficacy and safety, taking into account differences in
dosage and pack size.”
The Institute verifies compliance with this statutory reimbursement cap in each proceeding concerning temporary reimbursement. In one such proceeding, where the reimbursement proposed by the applicant was equal to the permanent reimbursement already established for another indication, the Institute granted reimbursement in line with the applicant’s proposal.
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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.