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Fully reimbursed medicinal products play a key role in ensuring access to healthcare for patients in the Czech Republic. Their regulation is derived from Act No. 48/1997 Coll., on Public Health Insurance, which sets the conditions for their inclusion in the List of Prices and Reimbursements (SCAU). The goal is to ensure patients have access to treatment while optimizing public health insurance expenditures.

Full Reimbursement in Inpatient and Outpatient Care 

Act No. 48/1997 Coll. stipulates that, during the provision of inpatient care, the following are fully reimbursed:

·        medicinal products and foods for special medical purposes,

·        individually prepared medicinal products,

·        radiopharmaceuticals,

·        transfusion products,

·        medical devices,

·        medicinal products for advanced therapy,

·        tissues and cells.

These items are reimbursed in the least economically demanding version, and the insured person does not contribute to their payment.

In outpatient care, Annex No. 2 of the Act plays a crucial role in ensuring that at least one medicinal product in each therapeutic group is fully reimbursed by public health insurance. This guarantees patient access to treatment without co-payments, especially for chronic and severe diseases.

Full Reimbursement and Real Availability of Medicinal Products

However, full reimbursement of a medicinal product does not automatically mean its actual availability on the market. Data shows that only a portion of fully reimbursed medicines are genuinely available to patients, influenced by factors such as manufacturers’ supply decisions, demand fluctuations, and regulatory measures.

The list of medicinal products and foods for special medical purposes reimbursed by health insurance (SCAU250401) includes a total of 8,873 items, of which 987 are fully reimbursed. Out of this number, 748 products are available. The full reimbursement guarantee under Annex No. 2 of the Act applies to 467 of them, while 281 products are not included in Annex No. 2.

• Fully reimbursed products make up 11.12% of all items in the reimbursed medicines list.
• Available fully reimbursed products represent 75.79% of the total number of fully reimbursed products.
• Of the fully reimbursed items, 47.32% fall under Annex No. 2 of the Act.
• Outside Annex No. 2, 28.47% of fully reimbursed products exist.
• Available fully reimbursed products constitute only 8.43% of the total number of items in the list.
• Of the available fully reimbursed ones, 62.42% are from Annex No. 2.
• Outside Annex No. 2, 37.58% of the available fully reimbursed products remain.

The process of determining the reimbursement of medicinal products in the Czech Republic is complex and involves several key stakeholders who collectively influence the final decision. In our recent post on decision-making practices, we highlighted the role of health insurance companies in the reimbursement process. Now, let’s take a closer look at the entities involved and how the entire mechanism works.

Cost-Effectiveness Assessment of Pharmaceuticals: Key Questions

Cost-effectiveness assessment is a crucial element of the administrative process for determining drug reimbursement, not only in the Czech Republic. A well-prepared cost-effectiveness analysis, including budget impact assessment, not only supports the applicant's arguments but also minimizes requests for additional documentation from the State Institute for Drug Control (SÚKL/Institute) via cooperation requests, which have become standard practice.

This article presents a selection of key questions that applicants seeking drug reimbursement (where cost-effectiveness assessment is required) should be able to answer within their submitted evaluation.

The pharmaceutical market in the Czech Republic is undergoing a gradual shift in decision-making practices, which may significantly impact pricing and reimbursement regulations as well as the entire pharmaceutical sector. Section 39c(2)(b) of the Public Health Insurance Act has been in use for a long time; however, its true potential to influence reimbursement dynamics is only now becoming apparent. The uncertainty arises from the gradual convergence of differences between innovative biological molecules entering the market and those already reimbursed. The concept of comparably effective therapy thus becomes a risk factor for new medicinal products.

How Does the New Approach Work? In a recent reimbursement revision decision regarding JAK inhibitors (Ref. No. SUKLS274309/2022), SUKL determined the reimbursement for certain indications based on the daily costs of comparably effective therapy. This means that medicinal products were not necessarily placed in the same reference group as the compared therapies, yet their reimbursement was set according to cheaper alternatives from another reference group, which included, for instance, generic drugs. In the case of filgotinib, the reference product, a head-to-head clinical study (Combe, B. et al.) comparing its efficacy with the TNF-alpha inhibitor adalimumab confirmed direct clinical equivalence between these therapies.

This approach has several critical consequences:

• Reduction in the reimbursement of innovative medicines – if the reimbursement of a medicinal product is set according to another reference group that includes generics, it automatically decreases regardless of the original therapeutic value.
• Domino effect on other groups – once reimbursement is lowered in one group, this decrease can reflect in reimbursement revisions across other reference groups, leading to a gradual overall reduction in reimbursements.
• Unpredictability for pharmaceutical manufacturers – companies bringing new medicinal products to market lack certainty about how their reimbursement will be determined, as it may be derived from different reference groups without formal inclusion in them.

Long-Term Impacts This new approach has not only short-term effects on the reimbursement of specific medicines but also long-term consequences for the entire pharmaceutical sector:

1. Reduced attractiveness of the Czech market – if innovative medicines are systematically undervalued, pharmaceutical companies may be discouraged from introducing new medicines to the Czech market.
2. Impact on patients – lower reimbursements may lead to reduced availability of innovative therapies and fewer treatment options for both patients and physicians.
3. Disruption of reimbursement policy transparency – linking reimbursements across different reference groups may complicate predictability and planning in the field of pharmaco-economics.

Open Question: Where is the Boundary Between Efficiency and Innovation Regulation? How might the domino effect manifest in non-referential indications in the future? This case represents a breakthrough in setting more than one additional increased reimbursement, meaning the barrier of "only one increased reimbursement" is eliminated. On the other hand, this new trend may lead to an intricate network of interconnected reference groups with generic-based reimbursements, discouraging marketing authorization holders from including their products in such groups.

The text was translated using ChatGPT 4o.

The European Medicines Agency (EMA) has announced the launch of a new platform designed to routinely monitor shortages of centrally authorized medicines. This platform is a direct result of Regulation (EU) 2022/123, which aims to improve preparedness for and mitigation of medicine shortages across EU member states.

Key Points:

• Platform Availability: The European Shortages Monitoring Platform (ESMP) is now accessible online.
• Mandatory Usage: Starting from February 2, 2025, all Marketing Authorization Holders (MAHs) with centrally authorized products will be required to use the ESMP.
• Early Familiarity: EMA encourages MAHs to familiarize themselves with the platform before the mandatory deadline.
• Data Submission: Until February 2, 2025, MAHs and National Competent Authorities (NCAs) can submit data on supply, demand, and availability of both centrally and nationally authorized medicines to the EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).
• Medicine Monitoring: The platform will be used for routine monitoring of all centrally authorized medicines and may also be used for monitoring nationally authorized medicines under special circumstances.

Additional Resources:

• Frequently Asked Questions

From January 1, 2025, Slovakia will include medicines and medical devices in the reduced VAT rate of 5%. This move is part of a broader tax reform aimed at improving access to essential goods for the population while reducing the financial burden on patients. The changes are likely a response to the European Commission’s assessment of public finances and an effort to reduce the budget deficit.

This change contrasts with developments in the Czech Republic, where, as of January 1, 2024, the VAT rate on medicines increased from the original 10% to 12%, as we mentioned in our previous article Changes in VAT Rate for Pharmaceuticals.

What Impact Will the Reduced VAT Rate Have in Slovakia?

The lower VAT rate is expected to significantly reduce costs for patients in Slovakia for medical devices and medicines, both in outpatient and hospital care. The direct financial impact on individuals will depend on specific measures and pricing policies. For comparison, Slovakia’s VAT on medicines has dropped from 10% to 5%, which could lead to a more noticeable impact on final prices than in the Czech Republic, where the rate was increased.

Impact on External Price Referencing for Medicines

The reduced VAT rate in Slovakia, however, will not affect the external price referencing (EPR) of medicines, used by some countries to set maximum prices and reimbursement levels in their markets. The VAT change does not reflect in EPR because the reference price is almost universally based on the manufacturer’s price.

At the same time, this change offers an opportunity to compare tax policies across the EU, where VAT rates on medicines and medical devices vary significantly. For example, according to data from EFPIA (European Federation of Pharmaceutical Industries and Associations) as of January 1, 2024, Spain applies a 4% VAT rate on medicines, while Denmark has a standard rate of 25%.

Stay tuned to our website for more updates on legislative changes and their impact on healthcare in the EU.

The European Health Data Space should lead to the empowerment of citizens and support for research and innovation.

EU residents will have more control over their health data, being able to access it electronically and share it across borders. This is particularly beneficial for cross-border healthcare, allowing individuals to access medical records and receive care seamlessly throughout the EU.

The EHDS promotes the secondary use of health data for research, innovation, and policy-making. Researchers and innovators will be able to access health data more easily and securely, which could drive the development of new treatments, medical devices, and AI applications.

The main objectives of the European Health Data Space (source: excerpt from the Communication from the Commission to the European Parliament and the Council: The European Health Data Space: Harnessing the power of health data for people, patients, and innovation):  

CTIS byl zřízen farmaceutickým zákonem v rámci Nařízení o klinických studiích (Nařízení (EU) č. 536/2014) a po 30. lednu 2025 kompletně nahradí původní systém pro klinické studie EudraCT (Databáze klinických studií orgánů pro regulaci léčiv Evropské unie).

Evropská léková agentura (EMA) průběžně publikuje zprávy, jak proces přechodu na nový systém pokračuje.

V předchozím článku jsme ukazovali, jaká byla situace v únoru 2024, v tomto článku jsme informace o počtu podání a rozhodnutí o přechodu aktualizovali ke konci srpna 2024.

Obr. č. 1 – Změny v počtu podaných žádostí, resp. v počtu podání, kde již bylo rozhodnuto, v porovnání s předchozím měsícem