In
2025, 12 decisions of the State Institute for Drug Control(SÚKL) became
legally effective in administrative proceedings relating to the determination
of price and reimbursement for orphan medicinal products. Although the system
introduced in 2022 is formally structured around SÚKL decisions, the Institute
may not deviate from the binding opinion of the Ministry of Health of the Czech Republic.
In 2025, SÚKL issued a total of 12 final decisions in proceedings concerning the determination of price and reimbursement for orphan medicinal products, based on binding opinions of the Ministry of...
The State Institute for Drug Control questioned the cost-effectiveness of the medicinal product from the group of drugs used for the treatment of functional gastrointestinal disorders, as presented in the administrative proceedings. The reason was significant uncertainties in the submitted analysis.
Upon reviewing the
documentation, the Institute identified several problematic aspects. Pharmaceutical
costs had increased compared to the originally submitted data. Uncertainties
regarding dosage—the method of dose determination was unverifiable, and it was
impossible to clearly establish the considered dosage for individual patients. Serious
discrepancies in total cost presentation—different values appeared in various
sections of the documentation.
All these
inconsistencies prevented a proper assessment of cost-effectiveness.
Given these
findings, the Institute concluded that the submitted analysis did not meet the
minimum quality requirements, and therefore, the medicinal product could not be
considered a cost-effective intervention.
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 4o.
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.
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 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...
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.
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.
