In proceedings concerning the determination or modification of the
amount and conditions of permanent reimbursement of medicinal products, where
pharmacoeconomic evidence is submitted, comparative clinical efficacy and
safety must be demonstrated against all relevant comparators. According to
the methodology of the State Institute for Drug Control (SÚKL), relevant
comparators may include therapies that are commonly or routinely used and
reimbursed from public health insurance. These are not limited to medicinal
products.
The requirement for relevant comparators was modified in 2022 for
proceedings on the reimbursement of orphan medicinal products (Section 39da),
when the advisory body of the Ministry of Health introduced the following
requirement for this specific type of proceedings: “…that any future application for reimbursement of an orphan
medicinal product for which comparators reimbursed from public health insurance
exist (whether with reimbursement determined by the Institute in administrative
proceedings or under Section 16 of Act No. 48/1997 Coll.) must include a
cost-effectiveness analysis against such comparators.” As a result, in reimbursement proceedings for orphan medicinal
products conducted under Section 39da, therapies reimbursed not routinely but
under exceptional reimbursement pursuant to Section 16 are commonly
included among comparators—even in cases where their use is off-label
within the given indication.
This approach has also been identified in proceedings concerning
the determination of permanent reimbursement for a non-orphan medicinal
product, where SÚKL likewise accepted as a comparator a product reimbursed
under Section 16. However, in another case involving the use of a comparator
reimbursed under Section 16, SÚKL argued in its assessment report, for example,
as follows: “…treatment provided under Section 16 of the Public Health
Insurance Act is, by its nature, exceptional and cannot be considered the least costly standard option for the purposes of general reimbursement
setting…’”
It remains to be seen whether, in the future, the approach to the
use of Section 16 comparators will become harmonised across different
groups of medicinal products, and whether the position of Section 16–reimbursed
treatments will gain greater importance even in standard reimbursement
proceedings.
Section 16 of Act No. 48/1997 Coll., on Public Health Insurance The competent health insurance fund shall reimburse, pursuant to
Section 19(1)(a), in exceptional cases healthcare services otherwise not
covered by health insurance, provided that the provision of such healthcare
services constitutes the only option in view of the insured person’s health
condition.
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.
In the case of rare diseases, it is not uncommon in practice that reimbursement is granted under Section 16. However, a medicinal product reimbursed in this way may also play a significant role in...
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.
The
Public Health Insurance Act No. 48/1997 Coll. provides in Section 16:
“The
competent health insurance fund shall reimburse, pursuant to Section 19(1)(a),
in exceptional cases healthcare services otherwise not covered by health
insurance, provided that the provision of such healthcare services constitutes
the only option in view of the insured person’s health condition.”
That
such requests are not rare is evidenced, for example, by statistics published
by the General Health Insurance Company of the Czech Republic.
In cases of non-reimbursed treatment, its use pursuant to Section 16—which allows reimbursement in justified cases—is not uncommon in practice. The complexity of such assessments is also reflected...
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).
Each European country approaches
the pricing and reimbursement of medicines in its own way. The common objective
is to ensure access to medicines that meet EU-wide standards of quality, safety
and efficacy. However, differences in the design of national systems have a
direct impact not only on price levels, but also on the availability of
medicines, market structure and manufacturers’ behaviour. Number of Initiated
Proceedings: The Reality of the Czech Market
According to the European
Medicines Agency Annual Report (European Medicines Agency, 2025), a total of
114 medicines were authorised through the centralised procedure in 2024,
including 46 medicines containing a new active substance (the authorisation of
one product was subsequently withdrawn).
Our analysis, conducted as of 1
March 2026, confirms that among medicines containing a new active substance
approved by the European Medicines Agency in 2024:
✅ Price and reimbursement
have been determined for only 5 of the 45 medicines,
⏳ Administrative proceedings
on price and reimbursement determination are ongoing for 20 medicines,
🛑 For 20 medicinal products, the marketing authorisation holder has not yet submitted an application for inclusion in the List of Reimbursed Medicines,
🚚 Distribution has
been initiated for 16 medicines, regardless of whether reimbursement has
been established.
These figures suggest that the
path of new innovative medicines to the Czech market is often slow and
administratively demanding, which may have a direct impact on both patients and
manufacturers. The Question: Reasons for
Delays
The 2025 study Medicines:
Regulation versus Patient Needs, conducted by the Initiative for Efficient
Healthcare (Hlávka et al., 2025), points out that the strict and long-standing
rules governing reimbursement determination are primarily focused on limiting
the budgetary impact. Typical measures include:
reimbursement limited to only part of the indicated
patient population,
prescription restrictions limited to specific
medical specialties or specialised healthcare facilities.
Such restrictions directly affect
the availability of medicines and may reduce the attractiveness of the Czech
market for manufacturers, which can lead to delayed market entry of innovative
therapies. Recommendations: Flexibility
and Modern Financing Instruments
The authors of the study
recommend:
introducing a more flexible willingness-to-pay
(WTP) threshold, better reflecting disease severity, the level of
innovation and patient needs,
using modern financing mechanisms, such as coverage
with evidence development (CED) or risk-sharing arrangements,
further developing multi-criteria decision analysis
(MCDA) for very high-cost medicines.
The study also highlights
additional factors affecting the market, including dependence on imports, the
underutilised potential of pharmacists, the need to work with real-world data,
and the importance of supporting competitiveness and self-sufficiency in the
pharmaceutical sector. The patient perspective is not
overlooked either:
“For medicines to be
effective, it is essential that patients understand their disease and therapy,
and that they know why and how to use medicines correctly and safely.”
Source:
European
Medicines Agency. (2025). Annual report 2024. Publications Office.
https://data.europa.eu/doi/10.2809/6143038
Hlávka, J., Klimková, V., Brychtová, M., Selinger, E.,
Přecechtěl, Š., Milošič, A., Chadimová, K., Decker, B., Navrátil, M., Vaniš,
K., & Kučera, M. (2025, září). IEZ_Studie_Zdravotnictvi pro
budoucnost_4-Leciva.pdf. Studie 2025: Léčiva: regulace versus potřeby
pacientů.
https://www.efektivnizdravotnictvi.cz/post/studie-2025-leciva-regulace-versus-potreby-pacientu
Each European country approaches the pricing and reimbursement of medicines in its own way. The common objective, however, is to ensure that patients have access to medicines that meet EU-wide...
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.
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...
