Highly Innovative Medicinal Products (VILP)
The amendment changes the rules for assessing Highly Innovative Medicinal Products by defining several criteria under which medicines may be included in this group.
It changes the conditions for any application of the statutory limitation of the reimbursement amount.
Changes also occur in the cost-limitation agreements between marketing authorisation holders and payers, which will now be mandatory, with a possible sanction in the form of loss of temporary reimbursement.
Lastly, the patient’s right to complete ongoing treatment at the expense of the marketing authorisation holder has been updated.
A completely new element is a joint reimbursement proceeding for combinations with a VILP, intended to address situations where only one product in the combination has an established reimbursement.
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.