In proceedings concerning Highly Innovative Medicinal Products (VILP), the Institute concluded that no publications are currently available that would sufficiently demonstrate comparable efficacy in terms of the parameter of objective response rate (ORR). On this basis, it did not reduce the reimbursement amount pursuant to Section 39d(9) of the Act on Public Health Insurance to the level of other products with similar clinical use.
The Act, in the referenced paragraph, requires the Institute—in cases where another Highly Innovative Medicinal Product with similar clinical use and comparable or close efficacy has already been granted temporary reimbursement—to set the temporary reimbursement amount of the assessed product at most to the level of that other product, taking into account differences in dosing and pack size.
The Institute is responsible for demonstrating the existence of another VILP with similar clinical use and comparable or close efficacy, which is temporarily reimbursed under public health insurance. In particular, it must prove the condition of comparable or close efficacy. If it fails to gather the necessary evidence, it is not authorized to reduce the reimbursement on these grounds.
The Institute also examines the possibility of reducing
reimbursement for a Highly Innovative Medicinal Product in cases where the
product is reimbursed in a different therapeutic indication and is not included
in a group of interchangeable products together with other medicinal products.
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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.