As of 1 January
2026, an amendment to the Public Health Insurance Act has entered into force,
introducing, among other changes, new rules for determining the prices of
strategically important medicines. The aim is to prevent supply shortages
in the Czech Republic through a more flexible approach to setting maximum
prices.
For medicinal
products deemed to be in the public interest, the State Institute for
Drug Control (the Institute) now determines the maximum price based on:
·
the average of prices in up to seven of the
lowest-priced countries within the EU reference basket;
·
if the medicinal product is not available in at
least two reference basket countries, prices are compared across the entire EU,
or alternatively against therapeutically comparable medicines in the Czech
Republic or within the reference basket.
To prevent Czech
prices from being driven down by isolated price anomalies, the Institute applies
a number of exclusion rules:
·
if the lowest price in the EU is more than
20% lower than the average of the second and third lowest prices, it is
excluded from the calculation;
·
prices from countries experiencing significant
currency depreciation are excluded where three or more reference prices are
available;
·
prices distorted by government crisis
interventions in other countries are disregarded, provided that the Institute
has received official information about such measures.
The Institute
has already issued a number of decisions establishing maximum prices for
strategically important medicines. However, a concerning trend can be
observed in its decision-making practice. Although this “special regime” is
intended to enhance market stability, many decisions lack sufficiently
detailed reasoning clearly demonstrating that the statutory conditions for
applying this approach have been met.
The new framework
provides the state with a powerful tool for safeguarding the availability of
medicines. Its effectiveness, however, will depend on the transparency and
reviewability of decisions, ensuring that marketing authorisation holders
clearly understand how and why the final price was determined.
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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.
In
administrative proceedings concerning a change in the amount and conditions of
reimbursement, the marketing authorisation holder applied for an extension of
the prescribing restriction to one additional medical specialty. Together with
the application, the holder paid only the administrative fee applicable to
cases that do not require a full clinical and pharmacoeconomic assessment. However,
during the proceedings, the State Institute for Drug Control (the Institute)
subsequently requested payment of an additional amount, taking the view that
the case required a comprehensive expert assessment. The
applicant appealed against this approach.
In the
appeal proceedings, the Ministry of Health (MoH) upheld the Institute’s
position, confirming that the administrative fee applicable to proceedings
involving a full expert assessment was appropriate. According to
the MoH, any relaxation of prescribing restrictions facilitates patient access
to treatment, which in itself creates the potential for increased expenditure
from the public health insurance system. This applies even where the absolute
number of patients in the indication does not increase, as treatment patterns
may shift internally in favour of the medicinal product concerned. From the
Ministry’s perspective, such shifts may also result in increased expenditure
from the system. The MoH
therefore concluded that the Institute has a legitimate obligation to properly
assess any potential impact on public health insurance funds and that the
requested administrative fee corresponds to the scope of the assessment being
carried out.
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.
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 Supreme Administrative Court (SAC) confirmed that a
current cost-effectiveness analysis (CEA) must be submitted in cases where the
requested reimbursement corresponds to the base reimbursement of the
reference group, but exceeds the reimbursement granted to other
therapeutically interchangeable medicinal products. According to the Court, the
decisive factor is whether the proposed change will generate savings for the
system or, conversely, increase expenditure.
In the administrative proceedings, the marketing
authorisation holder applied for an increase in the reimbursement of its
medicinal product. In its view, the request merely sought to align
reimbursement with the level of the base reimbursement established for the
relevant group in a previous review and therefore did not require new economic
evidence. However, both SÚKL and the Ministry of Health insisted on
the submission of supporting analyses and discontinued the proceedings due to
their absence.
According to the administrative authorities, the Public
Health Insurance Act requires a cost-effectiveness assessment and budget
impact analysis whenever the proposed change in reimbursement is expected
to increase expenditure from the public health insurance system and the
requested reimbursement exceeds that of other medicinal products that are
essentially therapeutically interchangeable.
The SAC stated that such analyses are not required where a
medicinal product generates savings for the public health insurance system.
However, where no savings are expected and the proposal results in a negative
budget impact, their submission is necessary. In the case at hand, the proposed reimbursement increase
demonstrably showed signs of an expected negative budget impact (higher costs),
while the requested reimbursement exceeded that of the only therapeutically
interchangeable medicinal product. Since both statutory conditions were met,
the applicant was required to submit a cost-effectiveness analysis.
The Court therefore definitively confirmed the approach
established under the legislation effective since 2022: whenever the requested
reimbursement exceeds that of other therapeutically interchangeable medicines
on the market, its cost-effectiveness must be demonstrated through updated
evidence.
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Pharmeca a.s.? Feel free to contact us.
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pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
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need expert guidance.
Our knowledge, your opportunity.
The article is based on publicly available court decisions published on official judicial websites.
The requirement to submit up-to-date cost-effectiveness analyses (CEA) when applying for a reimbursement increase has been confirmed by the Supreme Administrative Court.
A medicinal
product entered the reimbursement system as the first similar medicinal product
to the reference product, even without submitting the confidential agreements
that ensure the cost-effectiveness of the reference product.
During the
proceedings, health insurance funds pointed out that, in practice, a situation
may arise where, even after the statutory 40% price reduction of the first
similar medicinal product, its price would still remain higher than the actual
(contractual) price of the originator product. According to the insurers, such
a situation would result in a breach of the requirement for an efficient
therapeutic intervention. From the payer’s
perspective, this approach is considered unacceptable in terms of budget
stability and contrary to the public interest.
The State
Institute for Drug Control rejected the insurers’ objections
with reference to the amendment to the Public Health Insurance Act effective
from 1 January 2026. Under this amendment, a similar medicinal product is
deemed cost-effective even where the reimbursement of the reference medicinal
product of another marketing authorisation holder was influenced by an
agreement concluded between that holder and health insurance funds, while no
comparable agreement was concluded for the assessed medicinal product.
Part of the
amended statutory provision states: “Similar medicinal
products shall be deemed to fulfil the conditions of an efficient therapeutic
intervention pursuant to Section 15(6)(d), and the Institute shall not assess
them, except for similar medicinal products of the same marketing authorisation
holder who concluded an agreement with health insurance funds, where such
agreement was decisive for granting reimbursement to the originally reimbursed
medicinal product.”
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.
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 Ministry of
Health (MoH) upheld an appeal against the rejection of an application for the
abolition of the maximum price after the case had been remitted for further
proceedings by the Supreme Administrative Court.
In its decision,
the State Institute for Drug Control (Institute) took the view that an application for abolition of the maximum
price could only be submitted on the grounds of 12 months of non-marketing. It
further stated that, according to its findings, the medicinal products
concerned were used only during hospitalisation and, in outpatient settings,
solely as substances for individual preparation rather than as finished
products.
The appellant’s
principal argument, by contrast, was that the medicinal product had become
newly usable in outpatient care. According to the appellant, the maximum price
should therefore be abolished, since under the applicable pricing regulations
medicinal products usable in outpatient care and without established
reimbursement are not subject to price regulation. Although the Act
does not explicitly list a change in the segment of use as a ground for
abolishing the maximum price, the appellant argued that this constituted an
unintended gap in the legislation that should be bridged by analogy.
In line with the
binding opinion of the court, the MoH acknowledged the existence of an
“unintentional gap” in the legislation. If, in the further course of the
proceedings, the participant demonstrates outpatient use of the medicinal
product, this constitutes a legitimate reason for abolishing the maximum price,
even though the Act does not expressly provide for it. At the same time,
the MoH held that the Institute must reassess the issue of the product’s actual
usability in outpatient care in a more thorough manner.
The contested
decision of the Institute was therefore annulled and the case was remitted for
reconsideration.
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.
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 amendment
introduced a new type of reimbursement procedure for products intended for
immunisation (vaccines), designed primarily for non-mandatory vaccination. As
of 1 May 2026, according to information from the State Institute for
Drug Control (the Institute), 10 administrative proceedings had been
initiated and are currently at various stages of progress.
This type of
procedure is intended to apply the principle of multi-criteria assessment,
placing emphasis not only on economic but primarily on non-economic criteria
reflecting broader societal needs and interests. In addition to
the standard reimbursement criteria (safety, efficacy and, in the case of
vaccines, immunogenicity), the criteria assessed also include, for example:
the severity of the disease targeted by the
vaccine,
the broader societal importance of prevention,
the public health benefit, including increased herd
immunity, prevention of threats to public health, and support for and
improvement of population health,
recommendations issued by professional societies
and institutions.
A different
approach also applies tobudget impact, where a high budget impact may
reflect high vaccination uptake, which is desirable in this context. Budget
impact is therefore assessed as the difference between the costs of prevention
and the costs of treatment, diagnostics and broader societal costs that would
arise in the absence of immunisation.
The Institute’s
assessment report will also include an opinion of theNational Institute of
Public Health (SZÚ). SZÚ has already provided opinions in the first two
administrative proceedings, focusing in detail on the epidemiology of the
diseases concerned. It also addresses the health, societal and economic impacts
of the diseases and the extent to which these may be mitigated through
vaccination. The opinion further includes a recommended time horizon for the
budget impact analysis, taking into account the characteristics of the disease,
as well as an overview of currently applicable vaccination recommendations.
As in the case
of orphans, the assessment report will subsequently be reviewed by the advisory
body of the Ministry of Health (MoH) during a closed session, in which a
conciliation procedure will take place.
The
subsequently issued binding opinion of the MoH will then be incorporated into
the final decision issued by the Institute.
Our knowledge, your opportunity.
The article is based on publicly available information concerning administrative proceedings conducted by SÚKL in the area of pricing and reimbursement.
The amendment to the Public Health Insurance Act, effective from the beginning of 2026, introduced a dedicated reimbursement procedure for selected vaccines. The first proceedings are already...
The Ministry of Health (MoH)
assessed whether the maximum price of the so-called “first similar medicinal
product” may be increased after an abbreviated reimbursement review, or only
after an abbreviated review of maximum prices. The key issue in dispute was
therefore the interpretation of the term “the first subsequent abbreviated
review”, which is set out in the Public Health Insurance Act as a condition for
a potential increase in the maximum price.
In the proceedings, the State
Institute for Drug Control (the Institute) argued that this must refer
exclusively to a review of maximum prices. As only a reimbursement review—and
not a price review—had been conducted in the relevant group, the Institute rejected
the application as inadmissible. The appellant, by contrast,
argued that the Act does not distinguish between a price review and a
reimbursement review.
In its decision, the MoH
stated that the Act refers generally to “an abbreviated review under Section
39p”, which covers both price reviews and reimbursement reviews. In its view,
the Institute’s interpretation was overly restrictive. The original purpose of the
reduction in price and reimbursement for the first generic was to prevent high
patient co-payments upon its market entry. Once the Institute had carried out
an abbreviated reimbursement review, reimbursement levels were aligned across
all products within the relevant group, thereby eliminating the risk of
inequality in patient co-payments.
For these reasons, the MoH concluded that the completion of
an abbreviated reimbursement review is sufficient to allow the submission of an
application for a price increase and, on that basis, annulled the Institute’s
decision by which the proceedings had been discontinued.
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.
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 Ministry of Health (MoH)
assessed an appeal against a decision on a change in reimbursement based on the
fixed base reimbursement established in a review.
The appellant argued that the
Institute had incorrectly classified the comparator product as a generic within
the meaning of a first similar medicinal product. According to the appellant,
for medicinal products authorised on the basis of bibliographic data
(bibliographic applications), the provisions on reimbursement reduction
applicable to the entry of generic products cannot be applied automatically, as
such products are not generics. The appellant referred to a
prior judgment of the Municipal Court in Prague, which annulled the Institute’s
decision on reimbursement determination due to its unlawfulness, where the
Institute had classified the product as a generic—although, according to the
court, a product authorised on the basis of a bibliographic application does
not qualify as a generic. The appellant therefore
maintained that the court’s conclusions on the unlawfulness of the Institute’s
approach to the assessment of bibliographic registrations were directly
applicable to the present proceedings.
The Ministry acknowledged the
shift in the case law of the Municipal Court in Prague but emphasised that
administrative authorities cannot arbitrarily disregard their own final
decisions unless and until they are annulled by a competent court. The current
situation, in which a legal action has been brought against the review
decision, does not entitle the authority to depart from that decision, even if
it has been challenged. At the same time, the MoH
concluded that in the present case the nature of the authorisation
(bibliographic vs. generic) was not relevant, as the subject of the proceedings
was limited to a technical recalculation of reimbursement.
For these reasons, the MoH upheld the Institute’s decision.
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.
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.
