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.”
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Pharmeca a.s.? Feel free to contact us.
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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.
The State Institute for Drug Control (hereinafter the “Institute”) informs about current service outages of Verso and DSŘ (documents of CAU administrative proceedings). The reason for these outages is unforeseen technical issues on the side of an external supplier. Intensive work is underway to resolve the problem with the aim of restoring full system functionality as soon as possible. System adjustments have been implemented to eliminate the causes of the issues, along with improved monitoring and control of errors arising from this situation.
At this time, we can confirm that access to case files via the Verso application when logged in using the National Identification and Authentication Point (NIA), i.e. the so-called citizen identity, is functioning without limitations. Unfortunately, complications persist with access without login, which we are actively addressing.
We therefore recommend using login via citizen identity when accessing Verso.
Recommended Procedures for Affected Parties to Administrative Proceedings
In-person access to the case file Access to the case file pursuant to Section 38 of Act No. 500/2004 Coll., the Administrative Procedure Code, remains available at the Institute’s premises. When: Working days, 8:00–16:00 Where: SÚKL headquarters – Building B (Benešovská 2538/40, 101 00 Prague 10) Contact for appointment booking: cau_sekretariat@sukl.gov.cz
Monitoring the Official Notice Board Due to the technical outage, participants in administrative proceedings are advised to pay increased attention to monitoring the Institute’sOfficial Notice Board. Documents published by way of public notice in proceedings under Part Six of Act No. 48/1997 Coll., on Public Health Insurance, may be posted there and may include deadlines for procedural actions.
Procedural Deadlines and Applications If a technical obstacle on the part of the Institute objectively prevents a party from performing a procedural act within the prescribed time limit, the following instruments under the Administrative Procedure Code may be used: Extension of a deadline / suspension of proceedings: This may be requested if there is a risk of missing a deadline due to the unavailability of remote access. The request must be submitted sufficiently in advance. Waiver of missed deadline: If a deadline has already expired, the party may request a waiver pursuant to Section 41(2) of the Administrative Procedure Code. Each such request will be assessed individually, taking into account the current technical situation.
Note: Information on the restoration of the Verso system will be published on this page without delay. We apologise for the inconvenience caused and thank you for your understanding.
FAQ
1) Is it currently possible to access a case file?
Yes, in person at the Institute’s premises, Monday–Friday, 8:00–16:00. The Verso service may be temporarily unavailable.
2) What is DSŘ and can it be used instead of case file access?
DSŘ is an automated method for downloading selected documents (system-to-system communication). It is not an alternative to access to the case file under Section 38 of the Administrative Procedure Code and cannot replace it. DSŘ availability may be limited.
3) I am unable to meet a deadline due to the outage — what should I do?
Submit a timely request for an extension of the deadline or suspension of proceedings; after the deadline has expired, you may request a waiver pursuant to Section 41(2) of the Administrative Procedure Code.
4) How should I proceed if I need a specific document?
Book an in-person file inspection; for general orientation in the proceedings, continuously monitor the Official Notice Board.
The text of this article was taken in full from the SÚKL website.
SÚKL warns of possible limitations affecting remote access to case files via the Verso application and automated access to documents of administrative proceedings in CAU (DSŘ).
There is no
legal basis in the Public Health Insurance Act for excluding a medicinal
product from price
referencing on the grounds that its price is a tender price, nor does any other
legal provision allow such a procedure.
In
administrative proceedings concerning the determination of price and
reimbursement initiated from 1 January 2026, it is possible, beyond the
previously existing options, to exclude the manufacturer price in an EU Member
State where that state has introduced a market-wide measure affecting the
manufacturer price of the medicinal product. In such cases, however, SÚKL must
receive official information from the relevant foreign authorityor from the
Ministry of Health.
In the
determination of the maximum manufacturer price, a foreign price is also
excluded in cases where the lowest price deviates by more than 20% from the
average of the second and third lowest prices, or where more than three prices
are identified and the price associated with an exchange rate deviating by more
than 10% from the average exchange rate over the previous six calendar quarters
is excluded.
When determining the base reimbursement, a
foreign price may also be excluded if it is at least 20% lower than the average
of the second and third lowest prices. However, this rule does not apply to highly innovative and orphan medicinal products.
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.
