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.
Are you interested in reading regular commentaries on decisions by
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.
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.
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.
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 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.
The Ministry of Health (MoH)
assessed whether the medicinal product under review met the criteria for being
designated as a highly innovative medicinal product (VILP). In the proceedings
on the determination of the amount and conditions of price and reimbursement,
the Institute for Drug Control (SÚKL) had refused to grant initial temporary reimbursement, as it
concluded that the product did not meet the VILP criteria.
The main reasons cited were:
Insufficient therapeutic benefit
Issues related to the selection and positioning of
comparators
Failure to meet VILP criteria across all proposed indications
Insufficient evidence on survival outcomes
Methodological concerns in comparative analyses
According to the SÚKL,
unless the VILP criteria are met against all relevant comparators under
assessment, the product cannot be granted temporary reimbursement, even under
modified conditions.
The MoH upheld the SÚKL’s
decision and additionally highlighted the inappropriateness of relying on
abstracts, which are condensed summaries and do not provide sufficient detail
on the underlying data. On this basis, the administrative authority cannot
responsibly assess the presented evidence. Furthermore, the MoH recommends not submitting key scientific
data under confidentialityrestrictions if a detailed evaluation
is expected, as any public assessment of such protected data can only remain of
a general nature.
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.
Under the previous wording of
the Public Health Insurance Act, abbreviated proceedings for similar medicinal
products allowed the selection of even the most expensive product in the group
as the reference product, which led to inequalities within the reference group
and disadvantaged other medicinal products. As of 1 January 2026, it now
applies that the applicant may not request a reimbursement level higher than
that established for the first similar medicinal product or higher than that
derived from the base reimbursement of the reference group.
Pursuant to Section 39b(5),
the Institute determines the amount and conditions of reimbursement of the
assessed similar medicinal product based on the amount and conditions of
reimbursement of the medicinal product to which it is similar. Where more than
one such reference product exists, or where an application for reimbursement
has already been submitted by another marketing authorisation holder, the
applicant may not request a reimbursement level higher than that established
for the first similar medicinal product pursuant to Section 39b(6), or higher
than that derived from the base reimbursement of the reference group pursuant
to Section 39b(8).
In the first months of this
year, this rule was applied in two proceedings. In both cases, the applicant
selected a reference medicinal product whose reimbursement level did not
correspond to the base reimbursement of the reference group (RS) within the meaning
of Sections 39b(5) and (8) of the Act. In other words, the selected reference
product had a base reimbursement (and thus also a core reimbursement) higher
than the base reimbursement of the reference group. As a result, one proceeding was terminated following the
withdrawal of the application, while in the other case, after the modification
of the submission, reimbursement was successfully determined.
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.
