The State
Institute for Drug Control (the Institute) initiated ex officio proceedings
to change the maximum price of an orphan medicinal product pursuant to
Section 39da(10) of Act No. 48/1997 Coll., on Public Health Insurance.
According to the provision in force on the date the proceedings were initiated: “No later
than 3 years from the date on which the decision establishing the amount and
conditions of reimbursement of an orphan medicinal product becomes enforceable,
the Institute shall initiate ex officio administrative proceedings to change
the maximum price pursuant to Section 39i. Sections 39l and 39p shall apply
mutatis mutandis.”
The marketing
authorisation holder (MAH) argued that the proceedings should not have been
initiated “automatically”, but only “where necessary”. According
to the MAH, the Institute should have assessed whether the proceedings served a
meaningful purpose and would result in actual savings; otherwise, the
proceedings should have been discontinued. The Institute
stated that the law imposes an unconditional obligation to initiate
proceedings to change the maximum price within 3 years of the date on which the
orphan reimbursement decision becomes enforceable. According to the
Institute, the condition “where necessary” does not apply to the
initiation of proceedings to change the maximum price of an orphan medicinal
product itself. In this case, the three-year requirement for initiating the
proceedings was therefore met.
The MAH further
argued that the statutory requirement of annual savings of CZK 30 million,
applicable to the review proceedings referred to in Section 39da(10), had not
been demonstrated. In the MAH’s view, the Institute should have demonstrated
the expected savings to the public health insurance system; without doing so,
the proceedings were unlawful or not subject to proper review. The Institute
maintained that demonstrating such savings is not a statutory requirement
for this type of proceeding. The requirement that the relevant provisions
apply mutatis mutandis does not mean that the conditions governing the
initiation of a reimbursement review are transferred to these individual
proceedings concerning a change in the maximum price of an orphan medicinal
product. The purpose of these proceedings is not to generate reimbursement
savings, but to change the maximum price.
The MAH also
argued that the maximum price of the medicinal product concerned had already
been changed previously and that there was therefore no justification for
further ex officio proceedings. The Institute
stated that the earlier proceedings cannot be regarded as fulfilling the
obligation under Section 39da(10), as the law requires these specific
proceedings to be initiated no later than 3 years after the orphan
reimbursement decision becomes enforceable, irrespective of whether another
change in the maximum price has taken place in the meantime.
The Institute
rejected all the objections and issued a decision in the matter, against which
the MAH filed an appeal.
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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.
The English translation was prepared using the latest available ChatGPT model.
Access to reimbursement for
orphan medicinal products is subject to specific legislative procedures.
However, the procedural pathway chosen by the marketing authorisation holder
(MAH) fundamentally determines which criteria will be assessed when evaluating
clinical benefit and economic effectiveness. This is illustrated by a
comparison of two administrative proceedings concerning the same medicinal
product in the same indication. Despite this, the regulator reached different
conclusions regarding the choice of comparator, which in clinical practice is
primarily reimbursed through individual approval by a health insurance fund’s
reviewing physician under Section 16 of the Public Health Insurance Act.
Success in the “Orphan”
Pathway, Failure in the “Standard” Pathway In the earlier proceedings
specifically designed for orphan medicinal products (Section 39da), a
comparator reimbursed under Section 16 was considered relevant. However, when the same MAH
subsequently sought permanent reimbursement for the same medicinal product
through the standard reimbursement procedure, different rules applied.
According to the State Institute for Drug Control (the Institute), a medicinal
product reimbursed under Section 16 cannot be used as a legally relevant
comparator in this type of proceeding. This approach was subsequently upheld by
the Ministry of Health.
The main reason given was that
a medicinal product reimbursed under Section 16 is not considered “reimbursed”
in the context of usual therapeutic practice, as such reimbursement is limited
to exceptional, individual cases. By contrast, in the “orphan”
proceedings, the medicinal product reimbursed under Section 16 was accepted as
an appropriate comparator for demonstrating cost-effectiveness and thus became
a necessary element in establishing eligibility for reimbursement.
In its decision, the Ministry emphasised that the acceptance
of a comparator reimbursed under Section 16 in the previous “orphan”
proceedings does not establish a right to use the same comparator in standard
reimbursement proceedings, where the results of the cost-effectiveness analysis
are a key factor in the reimbursement decision.
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pharmaceutical and medical device information. We also offer flexible services
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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.
The Czech Ministry
of Health (MoH) annulled a decision issued in an abbreviated reimbursement
review and referred the case back to the State Institute for Drug Control (the
Institute), as the Institute had failed to include in the administrative
proceedings all medicinal products that were therapeutically interchangeable at
the time the proceedings were initiated, as well as their marketing
authorisation holders. The Institute
justified its approach by stating that it had excluded medicinal products
containing an active substance that had not yet undergone a full reimbursement
review and therefore, in its view, could not be subject to an abbreviated
review.
However, the MoH
found this approach to be unlawful, pointing out that an abbreviated review is
conducted as joint proceedings covering all medicinal products included in the
relevant reference or pseudo-reference group. The medicinal product concerned
had been included in the relevant pseudo-reference group (albeit through
individual proceedings) and had been reimbursed from public health insurance
since 1 May 2023, i.e. for more than a year before the reviewed proceedings
were initiated. It therefore demonstrably met the statutory requirement of
inclusion in the group, and the Institute should have initiated the proceedings
in respect of that product as well.
The MoH further
referred to a provision of the Act that expressly permits an abbreviated review
to be initiated and conducted in respect of medicinal products for which
reimbursement proceedings are simultaneously ongoing – and which, logically,
have therefore not undergone any previous reimbursement review. If an
abbreviated review may include a medicinal product whose inclusion in the
relevant group is only anticipated, it must, all the more so, include a product
that has already been validly and finally included in that group.
The MoH also
criticised a degree of inconsistency in the Institute’s approach. On the one
hand, the Institute denied that administrative proceedings could be initiated
and conducted in respect of the medicinal product concerned, while on the other
hand treating that same product as a reference medicinal product. Although the
MoH did not generally rule out the possibility that such a situation could
arise in practice and, under certain circumstances, be consistent with the
applicable legislation, it concluded that this was not the case here.
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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.
The English translation was prepared using the latest available ChatGPT model.
The Methodology sets out the procedures for including new
ZUM in the VZP Medical Devices Reimbursement Catalogue, making changes to
devices already included in the Catalogue, and increasing their price and
reimbursement.
A new version 3.0 takes effect on 1 September 2026,
introducing a major change in the assessment of innovative ZUM.
The previous distinction between moderate and substantial
innovation has been replaced by three pathways: medical device innovation
bonus, expert assessment of innovation, and economic and clinical assessment
(HTA).
📈 Medical Device
Innovation Bonus
A simplified pathway for ZUM where the clinical benefit can
be demonstrated by meeting predefined clinical criteria. If at least one of
these criteria is met, a 15% bonus may be granted compared with the
reference comparator or group of reference comparators. The criteria include,
for example, improvement in a clinically relevant outcome, shorter
hospitalisation or recovery time, or a reduced risk of reoperation or reimplantation.
🔎 Expert Assessment of
Innovation
This pathway is intended for ZUM providing a relevant
clinical, safety or organisational benefit where a full economic and clinical
assessment is not required. The assessment focuses in particular on clinical
effectiveness, safety, quality of evidence, organisational benefits,
implementation requirements, and the expected budget impact. A budget impact
analysis (BIA) must be included in the submission.
📊 Economic and
Clinical Assessment (HTA)
The most comprehensive pathway applies to innovative ZUM
with a significant impact on the public health insurance system or where it is
necessary to assess whether the additional costs are proportionate to the
claimed clinical benefit. The assessment covers clinical benefits, safety,
cost-effectiveness and budget impact. This pathway is also subject to the VZP
ČR Methodology for the Economic and Clinical Assessment of Medical Devices.
The Methodology also addresses, among other matters, maximum
assessment timelines for selected procedures, the possibility of increasing
prices and reimbursement in accordance with the applicable Price Regulation,
and the possibility of suspending the assessment process in order to obtain
expert opinions.
Do you need assistance with preparing the documentation
for the establishment of the price and reimbursement of your medical
device by VZP? Do not hesitate to contact us.
Pharmeca a.s. has extensive experience, including in the
field of economic and clinical assessment (HTA). This expertise enables us to
support you in preparing a complete documentation package for the assessment of
your medical device.
Our knowledge, your opportunity.
The English translation was prepared using the latest available ChatGPT model.
VZP has published a new methodology governing the inclusion, changes, and increases in the price and reimbursement of separately charged materials (ZUM) within its Reimbursement Catalogue.
The first assessment reports
have been issued in proceedings concerning immunological medicinal products
conducted under the new rules introduced by the amendment to the Public Health
Insurance Act.
As part of these proceedings,
the importance of vaccination was assessed from several key perspectives:
Societal and social benefits –
the assessment considered not only the impact of vaccination on reducing the
number of infections, but also, for example, the deterioration in children’s
school performance associated with illness and protection against permanent
functional impairment, which in adult patients may affect independence, family
life and overall quality of life.
Economic benefits – the
assessment focused on direct costs, including savings resulting from a reduced
need for treatment and a lower burden on healthcare facilities, as well as
indirect costs, such as loss of household income, productivity losses and reduced
government expenditure on sickness benefits, disability pensions and similar
social benefits.
In these specific cases, prevention through vaccination was
found to be a more economically favourable strategy than the subsequent
treatment of complicated cases of disease.
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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.
The English translation was prepared using the latest available ChatGPT model.
The Ministry of Health (MoH) rejected an application to reopen the proceedings.
The applicant argued that, following the conclusion of the original reimbursement review, previously unknown facts had emerged—namely data on the supply and consumption of medicinal products and their market shares. According to the applicant, these data called into question, or even ruled out, the correctness of the established usual daily therapeutic dose (UDTD).
According to the MoH, data on the supply and consumption of medicinal products are known to the State Institute for Drug Control (the Institute) through its official activities and are published by the Institute on a monthly basis. The applicant could therefore have had access to these data already during the original proceedings. Moreover, specific documents containing data on the consumption of the medicinal products concerned in 2022 had formed part of the case file throughout the original reimbursement review. The statutory requirement of “previously unknown facts” was therefore not met.
The MoH further stated that potentially higher consumption of certain strengths of the medicinal products is not decisive for determining the UDTD. Other factors are key to determining the UDTD, including WHO recommendations, the SmPC, scientific literature and clinical guidelines, all of which had been duly assessed in the original proceedings. The applicant’s submission could therefore not have resulted in a different conclusion on the matter.
The MoH therefore rejected the application to reopen the proceedings and did not permit the proceedings to be reopened.
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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.
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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.
In an abbreviated
reimbursement review triggered by the market entry of the first similar
medicinal product (generic), the State Institute for Drug Control (the
Institute) reduced the base reimbursement for a group of medicinal products
stimulating platelet production following the launch of the first generic
product. One of the
parties to the proceedings, the marketing authorisation holder of a
medicinal product included in the same group but containing a different active
substance than the newly introduced first similar medicinal product, challenged
the therapeutic interchangeability of the individual active substances. The
party submitted new scientific evidence and raised objections regarding safety.
However, the Institute rejected these arguments, referring to previous
administrative proceedings and the legislation governing abbreviated
reimbursement reviews.
In its response,
the Institute stated that the purpose of an abbreviated review is not to
reassess the therapeutic interchangeability of medicinal products. That issue
is addressed within full reimbursement reviews. In the present proceedings, the
Institute relied on conclusions that had already become final in previous full
reimbursement reviews and individual administrative proceedings.
According to the
Institute, the purpose of an abbreviated review under the Act is to ensure a swift
procedure, avoiding extensive scientific debate with the parties in order to
achieve timely savings for the public health insurance system.
Its role is
limited to recalculating reimbursement levels on the basis of the current
external price reference.
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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 English translation was prepared using the latest available ChatGPT model.
The Public Health Insurance Act
establishes a reimbursement cap applicable where the State Institute for Drug
Control (the Institute) decides on temporary reimbursementfor a new
therapeutic indication of a highly innovative medicinal product (VILP)
that already has permanent reimbursement established for another indication. The newly established temporary
reimbursement may not exceed the existing reimbursement granted for that
medicinal product. An exception applies where the product has been assigned to
a reference group containing other therapeutically interchangeable medicinal
products.
According to Section 39d(9) of
the Public Health Insurance Act: “Where proceedings are conducted
to establish temporary reimbursement for a medicinal product that is already
reimbursed from public health insurance in another therapeutic indication
pursuant to a decision of the Institute under Section 39h, the Institute shall
establish temporary reimbursement at an amount not exceeding the reimbursement
determined by that decision under Section 39h. This shall not apply where,
pursuant to a decision under Section 39h, the medicinal product has been
assigned to a reference group or another group of essentially therapeutically
interchangeable medicinal products that already includes other medicinal
products. Where temporary reimbursement has also been established for another
highly innovative medicinal product and the available evidence demonstrates
that it has comparable clinical use and comparable or similar efficacy and
safety, the Institute shall establish temporary reimbursement for the assessed
medicinal product at an amount not exceeding the temporary reimbursement granted
to the highly innovative medicinal product with comparable clinical use and
comparable or similar efficacy and safety, taking into account differences in
dosage and pack size.”
The Institute verifies compliance
with this statutory reimbursement cap in each proceeding concerning
temporary reimbursement. In one such proceeding, where the reimbursement
proposed by the applicant was equal to the permanent reimbursement already
established for another indication, the Institute granted reimbursement in line
with the applicant’s proposal.
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Pharmeca a.s.? Feel free to contact us.
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pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
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need expert guidance.
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.
The State Institute for Drug Control (SÚKL) has launched the Innovation Office for Medical Devices, a new service designed to support innovation in the Czech healthcare sector.
The Innovation Office for Medical Devices will provide expert consultations to entities developing innovative medical devices, in vitro diagnostic medical devices (IVDs), and medical software.
The new service has been established in cooperation with the Ministry of Health as part of broader initiatives aimed at fostering innovation in the healthcare sector and creating a predictable regulatory environment for the development of new medical technologies.
The objective of the Innovation Office is to help developers gain an early understanding of regulatory requirements and identify, at an early stage of their projects, any issues or risks that may affect further product development. Early consultation can contribute to more efficient development planning, an appropriate regulatory strategy, and a smoother route to market.
Expert consultations may cover topics such as the intended purpose of a medical device, its regulatory status, qualification and classification, clinical evaluation or performance evaluation, conformity assessment procedures, and the need to involve a notified body.
At the same time, SÚKL has published the Guidance of the Innovation Office for Medical Devices, which sets out the conditions for submitting applications, the scope of expert consultations, and the procedures for providing them. The guidance also includes a triage form, which serves as the basis for the preliminary assessment of applications and the preparation of expert consultations.
In its initial phase, the Innovation Office is being implemented as a pilot project. Its purpose is to validate the established processes in practice and to gather feedback from both applicants and SÚKL experts. Based on the experience gained during the pilot phase, both the methodology and the scope of consultations may be further refined to better meet the needs of innovators and regulatory practice.
This article is based on information published on the SÚKL website, where the full version is available.
The English translation was prepared using the latest available ChatGPT model.
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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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 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.
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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.
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.
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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.
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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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.”
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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.
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...
