Information for MAH | Pharmeca a.s.

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.

Selection from Decision-Making Practice - 23

Flexible Approach to Treatment.

Pharmeca a.s. 10/08/2025

Information for MAH Medical devices

VZP on Non-Traded Medical Devices without EMDN

VZP informs applicants about the option to keep non-traded medical devices without EMDN in the Reimbursement Catalogue.

VZP 10/02/2025

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

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

Information for MAH State Institute for Drug Control Medicines

Seminář SÚKL 15/2025 - DAN

Seminář SÚKL na téma - Dostupnost léčiv krok za krokem pro začátečníky: od legislativy k praxi.

SÚKL 09/22/2025

Information for MAH State Institute for Drug Control Medical devices

Seminář SÚKL 16/2025 - ZP

Seminář SÚKL na téma - Povinnosti distributorů a dovozců zdravotnických prostředků.

SÚKL 09/22/2025

Information for MAH State Institute for Drug Control Medicines

Seminář SÚKL 17/2025 - DAN

Seminář SÚKL na téma - Dostupnost léčiv v praxi: data, nástroje a souvislosti pro pokročilé.

SÚKL 09/22/2025

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.

Information for MAH Legislation Medicines Pharmeca info

Dawn of the Amendment to the Act on Public Health Insurance – Part 1

As part of a new article series, we will briefly highlight the main areas that will change under the amendment to the Act on Public Health Insurance, effective 1 January 2026.

Pharmeca a.s. 09/17/2025

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