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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.

At Pharmeca, we help you navigate the complex landscape of pharmaceutical and medical device information. We also offer flexible services that can be tailored to your needs at any time.

Our market position and experience allow us to support you whenever you need expert guidance.

Feel free to contact us.

Our knowledge, your opportunity.

The text was translated using ChatGPT 5.  

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.

At Pharmeca, we help you navigate the complex landscape of pharmaceutical and medical device information. We also offer flexible services that can be tailored to your needs at any time.

Our market position and experience allow us to support you whenever you need expert guidance.

Feel free to contact us.

Our knowledge, your opportunity.

The text was translated using ChatGPT 5.  

Reimbursement from public health insurance

The amendment introduces a new approach to external price referencing, expanding the options for excluding an identified external reference price from the reference set.

The concept of deemed market availability is reframed—not only by adjusting the percentage threshold, but also, for example, by setting new conditions for deeming similar medicinal products available; changes also concern products with an agreed maximum price.

The rules for setting the base reimbursement according to the daily cost of an alternative therapy are completely reworked.

Several new limitations/constraints are introduced, e.g. for filing applications to change reimbursement or for certain applications to set reimbursement. These include, for instance, limitations on the formulation of reimbursement conditions and time limits for re-filing. Changes also affect applications to amend the content of filings.

Further significant changes concern, for example commercially confidential information and the submission of (pharmacoeconomic) models.

Finally, there is a breakthrough regarding lis pendens, which previously prevented a separate proceeding to obtain reimbursement for a new indication if a proceeding was pending—at any stage—for reimbursement of the same product code in a different indication. This is now altered by a new special provision.

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.

At Pharmeca, we help you navigate the complex landscape of pharmaceutical and medical device information. We also offer flexible services that can be tailored to your needs at any time.

Our market position and experience allow us to support you whenever you need expert guidance.

Feel free to contact us.

Our knowledge, your opportunity.

The text was translated using ChatGPT 5.  

On 12 August 2025, the amendment was published in the Collection of Laws as No. 289/2025 Coll. The general effective date is 1 January 2026, with certain provisions taking effect during 2026 or in subsequent years.

The amendment proposes substantial changes to the regulation of public health insurance. In pricing and reimbursement of medicinal products, it will affect, for example the process of referencing foreign prices, adjustments to the automatic availability rule, the definition of Highly Innovative Medicinal Products (VILP), procedures for reimbursement of VILPs and orphan medicinal products (LPVOs) used in combination, contractual commitments concluded with payers, assessment of a product as an LPVO, similar medicinal products, lis pendens (litispendence), submission of (pharmacoeconomic) models, and review (revision) proceedings. It also changes reimbursement mechanisms—especially for vaccines and monoclonal antibodies intended for prophylaxis—and introduces a special procedure for immunization medicines.

We will gradually cover the key areas impacted by the amendment in this series.

Maximum Price

Beyond the existing framework, a new procedure will be introduced for important, hard-to-substitute and typically low-cost groups of medicines.

The amendment also brings a special definition of the “closest therapeutically comparable product” for medicines where availability must be ensured.

A new method of recalculating the average exchange rate will apply in cases of exchange-rate volatility for products with fewer available manufacturer prices.

The Ministry of Health will be empowered to exclude foreign manufacturer prices from referencing where there are significant currency exchange-rate differences or other exceptional, relevant circumstances affecting medicinal product prices in an EU Member State.

At Pharmeca, we help you navigate the complex landscape of pharmaceutical and medical device information. We also offer flexible services that can be tailored to your needs at any time.

Our market position and experience allow us to support you whenever you need expert guidance.

Feel free to contact us.

Our knowledge, your opportunity.

The text was translated using ChatGPT 4o.