Pharmeca info | Pharmeca a.s.

Medicinal products intended for immunization

The amendment introduces a special reimbursement procedure for certain selected vaccines, particularly those that are non-mandatory.

Participants in the proceedings will newly include not only marketing authorization holders and health insurance companies, but also the Czech Medical Association of J. E. Purkyně.

For the purpose of determining the amount and conditions of reimbursement, the State Institute for Drug Control (Institute) will assess vaccines with regard to medical, social, economic, and ethical aspects, as well as their impact on public health.

The Institute’s assessment report will newly include a statement from the National Institute of Public Health, which is issued after the initiation of the procedure and may differ from the Institute’s own position.
As in the case of orphan medicines, the assessment report will be reviewed by the advisory body of the Ministry of Health in a non-public session, during which a conciliation procedure will take place.

The Institute will then issue a decision in accordance with the binding opinion of the Ministry of Health, which may, among other things, differ from the original proposal of the assessment report — for example, in the amount or conditions of reimbursement.

The amendment abandons the “economically least demanding variant” (ENNV) regime for vaccines, which previously favored older vaccines at the expense of modern ones. Vaccines that are already reimbursed will retain their current reimbursement after the amendment, with the possibility of individual changes in selected cases.

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.

Dawn of the Amendment to the Act on Public Health Insurance – Part 5

As part of our new article series, we briefly outline the key changes in the medicines domain linked to the amendment to the Act on Public Health Insurance. This time: products Intended for...

Pharmeca a.s. 11/12/2025

Section 39i(2) of the Act on Public Health Insurance stipulates the obligation of the State Institute for Drug Control (hereinafter “the Institute”) to immediately initiate ex officio proceedings to amend the determined amount and conditions of reimbursement of a medicinal product in cases where the current reimbursement or reimbursement conditions do not correspond to the basic reimbursement of the reference group or to the reimbursement conditions established in a revision procedure.

Within the ongoing proceedings initiated by the Institute pursuant to the cited provision, the Institute addressed issues related to the amount of the usual daily therapeutic dose (ODTD) and its binding nature.

According to the Institute, the purpose of this type of proceeding is not to establish a new ODTD, but to harmonize the reimbursement levels with the latest enforceable decision issued in the revision procedure.

The incorporation of the ODTD from the revision decision into individual administrative proceedings is in accordance with the law, the decree, and established administrative practice, even if the ODTD is not explicitly stated in the operative part of the decision. It constitutes an inherent component of the operative part concerning the amount of the basic reimbursement, as confirmed by relevant decisions of the Ministry of Health of the Czech Republic.

The Institute further emphasized that the ODTD forms the technical basis for calculating the basic reimbursement, and its value is legally binding for all subsequent administrative proceedings concerning changes to the amount and conditions of reimbursement until the next in-depth reimbursement revision.

The Institute therefore considered objections regarding the absence of the ODTD in the operative part of the revision decision or the request for a new determination of the ODTD within the ongoing proceedings to be unfounded.

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? Feel free to contact us.

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.

Our knowledge, your opportunity.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.

Information for MAH Medicines Pharmeca info Decision making

Selection from Decision-Making Practice - 25

Inclusion of the ODTD in the operative part of the decision.

Pharmeca a.s. 11/05/2025

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.

Information for MAH Legislation Medicines Pharmeca info Amendment_2026

Dawn of the Amendment to the Act on Public Health Insurance – Part 4

As part of our new article series, we briefly outline the key changes in the medicines domain linked to the amendment to the Act on Public Health Insurance. This time: highly Innovative Medicinal...

Pharmeca a.s. 10/29/2025

The Act on Public Health Insurance provides that the amount and conditions of temporary reimbursement for Highly Innovative Medicinal Products (VILP) are set for a period of 3 years, with the possibility of re-setting the reimbursement for no more than an additional 2 years.

In an ongoing administrative proceeding on the first temporary reimbursement for a VILP in tablet form, the State Institute for Drug Control (the Institute) proposes to limit the duration of the first temporary reimbursement so that it expires at the same time as the first temporary reimbursement of a therapeutically interchangeable medicine with the same active substance in capsule form for the same indication. Accordingly, in this case, the first temporary reimbursement for the tablets will be granted for a period shorter than 3 years.

The Institute also states that the public health insurance expenditure on reimbursement of the product in tablet form, supplied to insured persons during the validity of the temporary reimbursement decision, must not exceed the amount specified in the budget impact analysis that served as the basis for the decision in the previous administrative proceeding on the first temporary reimbursement of the therapeutically interchangeable capsule formulation.

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? Feel free to contact us.

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.

Our knowledge, your opportunity.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.

Information for MAH Medicines Pharmeca info Decision making

Selection from Decision-Making Practice - 24

Shortening the Validity of Temporary Reimbursement.

Pharmeca a.s. 10/29/2025

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.

Information for MAH Legislation Medicines Pharmeca info Amendment_2026

Dawn of the Amendment to the Act on Public Health Insurance – Part 3

As part of our new article series, we briefly outline the key changes in the medicines domain linked to the amendment to the Act on Public Health Insurance. This time: orphan medicinal products.

Pharmeca a.s. 10/15/2025

The Ministry of Health of the Czech Republic agreed to grant reimbursement for an orphan medicinal product (LPVO) in the indication treatment of advanced gastrointestinal stromal tumour (GIST). The medicine is intended for a small patient population and, although the expected duration of therapy is measured in months and its effect is not curative, it enables a significant prolongation of progression-free survival while maintaining a good quality of life.

The advisory board unanimously supported inclusion of this product in reimbursement, as the evidence in the file demonstrated its efficacy in fourth-line treatment of a rare malignancy for which no therapeutic alternative exists and where there is a clear unmet medical need.

The Ministry’s approval was justified, inter alia, by the fact that patients’ conditions require rapid treatment initiation, which individual exceptional reimbursement applications under Section 16 do not accommodate with sufficient flexibility.

According to the reasoning, contractual arrangements with health insurance companies also contributed to the positive opinion, resulting in a more favourable projected budget impact—not only compared with the findings of the assessment report, but also relative to current Section 16 practice.

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? Feel free to contact us.

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.

Our knowledge, your opportunity.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.

Information for MAH Medicines Pharmeca info Decision making

Selection from Decision-Making Practice - 23

Flexible Approach to Treatment.

Pharmeca a.s. 10/08/2025

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.

Information for MAH Legislation Medicines Pharmeca info Amendment_2026

Dawn of the Amendment to the Act on Public Health Insurance – Part 2

As part of our new article series, we briefly outline the key changes in the medicines domain linked to the amendment to the Act on Public Health Insurance. This instalment focuses on reimbursement...

Pharmeca a.s. 10/01/2025

For medicinal products included in a reference group that are not granted a reimbursement amount or conditions beyond those of interchangeable products, a cost-effectiveness analysis is not required. Newly, however, a budget impact analysis (BIA) must be submitted including a calculation of deductible co-payments.

According to the State Institute for Drug Control (SÚKL), the BIA should consider all medicinal products included in the relevant reference group.
On the other hand, for example in proceedings on price and reimbursement in reference group No. 104/7 – therapeutic allergen extracts – standardised, depot injectable, the calculation of deductible co-payments must reflect actual practice: a product containing dust-mite allergens will in practice be replaced exclusively by products containing only these allergens. For this reason, including other interchangeable products (from the same reference group) in the BIA should not affect the result, because their costs would be the same in the world with and without the assessed intervention and therefore cancel out.

The analysis works with costs of deductible co-payments that would accrue to health insurance companies when the annual out-of-pocket cap is exceeded.
Excluding the CZK 1,000 insured person’s cap from the analysis was accepted by SÚKL in the above-mentioned case as a conservative setting. SÚKL found that including a CZK 5,000 cap per insured person would lead to higher deductions in the world with the assessed intervention (CZK 5,000 per patient) than in the world without it (less than CZK 5,000 per patient), thus lowering the resulting budget impact.
If the CZK 1,000 cap were applied, the patient in the world without the assessed intervention would exceed this cap in the first year only, not in subsequent years. Even when accounting for this lower cap, the resulting budget impact would remain lower.

The analysis should include separate results for the budget impact without deductible co-payments and with deductible co-payments.

Previously published SÚKL guidance also states that the analysis must reflect co-payments actually applied in practice.
To calculate real deductible co-payments, SÚKL uses average pharmacy prices per pack, obtained from reports under guideline LEK-13.

Costs of deductible co-payments relate to prescription-dispensed products; therefore, products billed on requisition forms are not included in the consumption analysis.

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? Feel free to contact us.

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.

Our knowledge, your opportunity.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.

The text was translated using ChatGPT 5.

Information for MAH Medicines Pharmeca info Decision making

Selection from Decision-Making Practice - 22

Snippets from Analyses Incorporating Deductible Co-payments

Pharmeca a.s. 09/26/2025

Subscribe to our newsletter