The State
Institute for Drug Control (the Institute) received a joint request from medical
societies to establish increased reimbursement for medicinal products
containing a selected active substance for the treatment of paraphilic
disorders, an indication that falls outside the approved marketing
authorisation (i.e. an off-label indication). In their statement, the medical
societies explained that the request was supported by clinical experience,
scientific evidence, and safety considerations.
The
Institute concluded that the therapy represents the only available treatment
option. Consequently, it did not require the submission of a cost-effectiveness
analysis; a budget impact analysis based on the number of patients reported by
the medical societies was considered sufficient.
Based on the
submitted documentation, the Institute concluded that reimbursement in this
off-label indication is adequately supported by current scientific evidence and
that the therapy constitutes the only available treatment option. It therefore
proposed granting increased reimbursement for this indication as well.
According to
Section 39b(3) of the Public Health Insurance Act: “…The
Institute may establish reimbursement for an unregistered medicinal product
where its use is sufficiently justified by current scientific knowledge and it
represents the only available treatment option, or where its use is
cost-effective compared with available treatment, for the duration of an
approved specific treatment programme. The Institute may also establish
reimbursement for a registered medicinal product for indications not included
in the Summary of Product Characteristics, provided that the use of the
medicinal product is sufficiently justified by current scientific knowledge and
represents the only available treatment option, or where it is cost-effective
compared with existing treatment.”
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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 English translation was prepared using the latest available ChatGPT model.
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.
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 prescription voucher for a reimbursed medical device may
only be issued by a treating physician or by a healthcare professional with
specialised or special professional qualifications (e.g. a nurse, laboratory
technician, therapist, etc.). As of 1 January 2026, the use of an
electronic format (eVoucher) has become mandatory for this purpose,
subject only to specific exceptions.
On the other hand, the dispensing of medical devices
prescribed on a voucher, with subsequent reimbursement claimed from public
health insurance, may only be carried out by authorised dispensers. These
include pharmacies, medical device dispensing outlets, optical stores, or
contracted dispensing providers.
Provision of Medical Devices in a Physician’s Office
As noted above, a person authorised to issue a prescription
voucher is not authorised to dispense the prescribed medical device to the
patient and subsequently claim reimbursement from public health insurance on
the basis of that voucher.
However, certain groups of orthopaedic and prosthetic
medical devices (such as orthoses, cervical collars or crutches) are reimbursed
when prescribed on a voucher, while their intended purpose also allows their
use in the treatment of acute conditions. In such cases, and from the
perspective of appropriateness and patient safety, it is permissible for the
required medical device to be provided directly to the patient during treatment
in the physician’s office.
Several changes have been introduced since the beginning of the year in the area of prescribing and dispensing medical devices, including those related to the mandatory use of electronic...
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.
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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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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.
Exactly one year ago, the Ministry of Health of the Slovak
Republic submitted for public consultation a draft decree intended to
significantly change the rules for determining reimbursement of medicines from
public health insurance. Although the document is technical in nature, it has
attracted considerable attention. A total of 333 comments have been
submitted and published within the consultation process, including 16
classified as substantial comments.
The main purpose of the proposed decree is to define the
detailed methodology for calculating the multiplier of gross domestic product
(GDP) per capita, which is used to determine the so-called threshold value of
an assessed medicinal product. This value is a key factor in deciding whether a
medicinal product will be reimbursed from public health insurance based on its
cost-effectiveness.
The original expectation was that the decree would enter
into force on 1 June 2025. However, the timeline has been delayed, as by
15 May 2026 the Ministry had only announced the start of the comment
evaluation process.
Another draft proposal, concerning the pharmacoeconomic
evaluation of medicinal products, has already completed the public consultation
phase and is currently awaiting the Ministry’s assessment of the submitted
comments.
The purpose of this proposal is to reduce the discount rate
used in pharmacoeconomic evaluations from 5% to 3.7% per annum,
following the proposed modification of the methodology for determining the
cost-effectiveness threshold.
Here as well, 16 comments were submitted during the
consultation process, including 5 substantial comments. The comments
addressed not only the proposed level of the discount rate itself, but also the
possibility of applying lower discount rates for technologies with long-term
benefits.
Comments were also submitted by the Slovak Ministry of
Finance, which fundamentally disagrees with the method used to assess the
financial burden. According to the Ministry, the expected positive budget
impact is not sufficiently transparent, and it is unclear to what extent this
impact results specifically from the proposed change in the discount rate as
opposed to other measures, such as the above-mentioned proposal concerning
changes to medicinal product threshold values. The interconnection between both draft proposals has also
been highlighted by the Slovak Antimonopoly Office, which recommended
withdrawing the proposal from the legislative process until broader
professional consensus is reached within the wider framework of medicinal
product categorisation.
We will continue monitoring the outcome of the consultation
process and keep you informed.
The article is based on publicly available information relating to Slovak legislation.
Current developments surrounding draft decrees of the Ministry of Health of the Slovak Republic concern both the calculation of the GDP multiplier used to determine the threshold value of assessed...
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.
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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.
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.
At
the beginning of April, a draft amendment to the Act on the Regulation of
Advertising and the Act on Medical Devices and In Vitro Diagnostic Medical
Devices was circulated to Members of Parliament. Among other things, it focuses
on advertising of selected sensitive commodities, including human medicinal
products and medical devices. The
scope of the Act is not limited to B2C relationships, i.e. advertising
directed at the general public, but also extends to B2B relationships,
including advertising targeted at healthcare professionals and employees of
healthcare providers. The
expected effective date of the amendment is 1 January 2027.
In
the following article, we present selected areas of the proposal in relation to
specific product categories.
Medicinal
Products
The
draft expands the definition of advertising, under which all forms of
information, market research or incentives intended to promote prescribing,
sale, dispensing or consumption will newly be considered advertising.
The
amendment also sets out strict conditions under which patient programmesmay be conducted so that they are not regarded as impermissible advertising.
Changes
will also affect advertising targeted at healthcare professionals. Commercial
representatives will newly be allowed to provideSummaries of Product
Characteristics (SPC) and reimbursement information also in the form of a
link to a source enabling remote access.
Conversely,
stricter rules will apply to the provision offree samples, including
limits related to the duration of treatment.
The
amendment also introduces exemptions from regulation, particularly for
incentive programmes run by health insurance funds and for educational
programmes aimed at non-physician healthcare professionals.
Medical
Devices (MD) and In Vitro Diagnostic Medical Devices (IVD)
For
medical devices and in vitro diagnostic medical devices, the definition of
advertising is both expanded and clarified. Advertising will explicitly
include, for example, lotteries, similar games, or consumer experience-based
testing.
A
more precise definition is also introduced for therecipients of comparative
advertising, replacing the previously used general term “professionals”.
As
with medicinal products, certain exemptions from regulation are defined.
A
separate section is dedicated to patient programmes, which aim to
improve awareness of diseases, diagnosis and treatment, as well as to support
patient cooperation in healthcare provision and to provide training and
guidance on the proper use of prescribed medical devices.
Fines
The
amendment introduces new obligations and therefore significantly expands the
list of actions(administrative offences) subject to penalties.
A fine of
up to CZK 500,000 may newly be imposed, for example, for conducting
patient programmes in breach of the law—whether due to violation of their
intended purpose, content, or the provision of prohibited benefits to
patients. The same fine applies to failure to meet notification
obligations towards SÚKL, breaches of hospitality rules in online
professional meetings, and similar cases.
Fines of
up to CZK 2,000,000 are newly expressly applicable to organising
prohibited competitions, lotteries and user tests for medicinal products
and medical devices, for missing or outdated information in advertising
directed at professionals, or for exceeding limits on the number of
samples.
Fines of
up to CZK 5,000,000 may be imposed for suggesting that the safety
of a medicinal product is guaranteed by its natural origin, for using
inappropriate depictions of bodily changes, or for providing gifts and
benefits to healthcare professionals that are unrelated to their professional
activities, among other violations.
Healthcare
professionals themselves may newly face fines of up to CZK 100,000 if
they actively request prohibited benefits or excessive hospitality, rather than
merely accepting them.
Would you like to stay informed about changes in legislation? 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.
As of January next year, the currently discussed draft amendment to the Act on the Regulation of Advertising may come into force. It introduces a number of new regulatory requirements and...
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.
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.
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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.
