The Act on Public Health Insurance provides that the amount and conditions of temporary reimbursement for Highly Innovative Medicinal Products (VILP) are set for a period of 3 years, with the possibility of re-setting the reimbursement for no more than an additional 2 years.
In an ongoing administrative proceeding on the first temporary reimbursement for a VILP in tablet form, the State Institute for Drug Control (the Institute) proposes to limit the duration of the first temporary reimbursement so that it expires at the same time as the first temporary reimbursement of a therapeutically interchangeable medicine with the same active substance in capsule form for the same indication. Accordingly, in this case, the first temporary reimbursement for the tablets will be granted for a period shorter than 3 years.
The Institute also states that the public health insurance expenditure on reimbursement of the product in tablet form, supplied to insured persons during the validity of the temporary reimbursement decision, must not exceed the amount specified in the budget impact analysis that served as the basis for the decision in the previous administrative proceeding on the first temporary reimbursement of the therapeutically interchangeable capsule formulation.
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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.