Inpatient care reporting
A health insurance fund may agree with an inpatient care provider on the method of reporting and reimbursement of medicinal products used in the provision of inpatient care, for which the fund has negotiated the reimbursement amount and conditions with the marketing authorization holder or manufacturer.
For the purpose of negotiating the reimbursement amount and conditions between payers and the marketing authorization holder for medicines used exclusively in inpatient care, the State Institute for Drug Control (the Institute) will, at the request of payers or the holder, conduct an assessment of benefits and costs (analogous to HTA). All entities concerned (including marketing authorization holders) are obliged to cooperate with the Institute.
Drug lump sums, which are no longer applied in practice, are abolished.
Deductible co-payments
The conditions for recognizing co-payments for children under 4 years of age are expanded by defining selected dosage forms and by specifying the calculation method of the co-payment in these cases.
Reimbursement of expenses
Changes also apply to the reimbursement of expenses for acts performed by the Institute, which will no longer apply to applicants requesting an increase in the maximum price in the public interest or to applicants for unregistered medicinal products whose use has been authorized under the Medicines Act.
In brief: the amendment
On 12 August 2025, the amendment to the Act on Public Health Insurance was promulgated in the Collection of Laws as No. 289/2025 Coll. Its general effective date is 1 January 2026, with selected provisions taking effect during 2026 or in subsequent years.
The amendment proposes substantial changes to the regulation of public health insurance. In the area of pricing and reimbursement of medicinal products, it will affect, for example: the process of external price referencing (EPR), the rules on deemed availability, the definition of Highly Innovative Medicinal Products (VILP), proceedings on reimbursement for VILPs and orphan medicinal products (LPVOs) used in combination, contractual commitments with payers, assessment of a product as an LPVO, similar medicinal products, lis pendens (litispendence), the submission of models, and review (revision) proceedings.
The reimbursement mechanism will also change—especially for vaccines and monoclonal antibodies intended for prophylaxis—and a special procedure for immunization medicines will be introduced.
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The text was translated using ChatGPT 5.1.