In-depth
reimbursement revision
Under the new rules, in an in-depth revision in which a significant decrease in
the basic reimbursement compared to the first in-depth revision is
demonstrated, the State Institute for Drug Control (Institute) will carry out a review or, where applicable,
cancellation of the indication restriction, and in certain cases also a
reassessment of the prescribing restriction, depending on the nature of the
medicinal product (Rx, ZULP).
A minimum interval between individual in-depth reimbursement revisions within the same reference group is introduced in order to minimise excessive administrative burden on the Institute.
Abbreviated price and reimbursement revision
The amendment introduces changes to the thresholds relevant for initiating an abbreviated reimbursement revision, depending on the type of medicinal products.
Revisions of maximum prices will newly be conducted for products included in the same reference group.
A deadline for commenting on the assessment report is introduced, excluding the possibility of submitting an obstruction appeal against the resolution setting this deadline.
The conditions for initiating a reimbursement revision due to product unavailability are updated.
As with in-depth revisions, a minimum interval between individual revisions is set, during which no new revision may be initiated. However, this time limitation does not apply to revisions initiated, for example, due to the entry of the first similar medicinal product or the need to ensure the availability of a fully reimbursed product.
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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