Orphan Medicinal Products (LPVOs)
The LPVO status will newly be assessed only at the moment of issuing the first reimbursement decision under Section 39da of the Act on Public Health Insurance.
The amendment
introduces stricter filing requirements for applications and further
expands the rights of selected stakeholders.
The role of payers
is strengthened; they will be able to request reimbursement reviews in
additional situations.
Certain rules
for re-assessing LPVO reimbursement due to unmet assumptions are modified.
The applicant will be required to express an active disagreement with a change opinion issued by the Ministry of Health (MoH).
New rules are introduced for LPVO reimbursement in combinations, whether with a VILP (Highly Innovative Medicinal Product) or with another LPVO.
Agreements
with payers will become an important step, notably due to changes to the
rules for compensating costs.
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.