Rozhodnutí SÚKL | Pharmeca a.s.

Selection from Decision-Making Practice - 2

The State Institute for Drug Control questioned the cost-effectiveness presented in the administrative proceedings.

Pharmeca a.s. 03/12/2025

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:

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.
Impact on patients – lower reimbursements may lead to reduced availability of innovative therapies and fewer treatment options for both patients and physicians.
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.

Rozhodnutí SÚKL Rozhodovací praxe State Institute for Drug Control Medicines Information for MAH

Impacts of the New SUKL Decision-Making Practice on the Reimbursement of Innovative Medicines

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...

03/07/2025

SÚKL, in the reimbursement review, assessed the expansion of JAK inhibitors reimbursement for rheumatoid arthritis ("RA") with moderate disease activity as sufficiently supported by clinical data and desirable for clinical practice in the Czech Republic.

Given that such an expansion of reimbursement conditions would result in an increase in the number of treated patients, it is necessary to evaluate the cost-effectiveness and the budget impact. Since SÚKL did not receive a pharmacoeconomic evaluation from the participants in the required scope, the expansion of reimbursement for rheumatoid arthritis with moderate disease activity was carried out by setting the reimbursement for JAKi at the cost level of another therapy that is (at least) equally effective and already reimbursed for the target group of patients with RA and moderate disease activity. The approach chosen by SÚKL in the ongoing reimbursement review, therefore, by setting two reimbursement levels, ensures that JAKi remain reimbursed for RA with high disease activity in the second and subsequent lines of treatment with higher reimbursement, while JAKi are also newly reimbursed for moderate disease activity, though at a lower reimbursement amount.

The participant argued that a medicinal product may only have one additional increased reimbursement level set, alongside the basic reimbursement (not multiple increased reimbursement levels, as SÚKL did). SÚKL refers to Section 39b, paragraph 11 of the Health Insurance Act, which does not exclude the possibility of applying it based on the evaluation of a medicinal substance, product, or pharmaceutical form for several selected indications or for multiple patient groups.

SÚKL also states that during the ongoing reimbursement review, no statements were received from payers regarding any difficulties in reporting healthcare when establishing multiple reimbursement levels.

Articles from decision-making practice are based on publicly available texts from decisions by the Ministry of Health of the Czech Republic and decisions by SÚKL.

On the website of Pharmeca a.s., you can continuously follow an overview of the pricing and reimbursement decisions issued by SÚKL and the Ministry of Health of the Czech Republic.

Articles on decision-making practice are based on publicly available texts of the Ministry of Health and SÚKL decisions.

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Information for MAH Medicines Pharmeca info Rozhodovací praxe Rozhodnutí SÚKL

Selection from Decision-Making Practice

Multiple reimbursement levels for JAKi in reimbursement review.

Pharmeca a.s. 03/05/2025

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Selection from Decision-Making Practice - 2

Impacts of the New SUKL Decision-Making Practice on the Reimbursement of Innovative Medicines

Selection from Decision-Making Practice