Similar medicinal product
The amendment introduces the concept of an “original reimbursed product” and clarifies the definition of the “first similar product,” for which a marketing commitment will no longer be submitted; instead, its actual market availability will trigger an abbreviated revision due to its entry into the reimbursement system.
The Institute will newly assess the appropriateness of therapeutic intervention for similar products originating from the same marketing authorization holder, with the aim of preventing circumvention of contractual arrangements.
The conditions for the automatic recognition of an appropriate therapeutic
intervention are defined.
The assessment of market availability of a similar product will now be governed by criteria focused on the total quantity of all supplied similar products and by calculating the average monthly volume.
Combination
product
The amendment introduces a significant change in the calculation of reimbursement for combination products, taking into account situations where all included active substances are reimbursed individually on the one hand, and situations where one of the substances is not reimbursed on the other.
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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