The LPVO
status will newly be assessed only at the moment of issuing the first
reimbursement decision under Section 39da of the Act on Public
Health Insurance.
The amendment
introduces stricter filing requirements for applications and further
expands the rights of selected stakeholders.
The role of payers
is strengthened; they will be able to request reimbursement reviews in
additional situations.
Certain rules
for re-assessing LPVO reimbursement due to unmet assumptions are modified.
The applicant
will be required to express an active disagreement with a change opinion
issued by the Ministry of Health (MoH).
New rules
are introduced for LPVO reimbursement in combinations, whether with a
VILP (Highly Innovative Medicinal Product) or with another LPVO.
Agreements
with payers will become an important step, notably due to changes to the
rules for compensating costs.
In brief: the amendment
On 12 August 2025, the amendment to the Act on Public Health Insurance was promulgated in the Collection of Laws as No. 289/2025 Coll. Its general effective date is 1 January 2026, with selected provisions taking effect during 2026 or in subsequent years.
The amendment proposes substantial changes to the regulation of public health insurance. In the area of pricing and reimbursement of medicinal products, it will affect, for example: the process of external price referencing (EPR), the rules on deemed availability, the definition of Highly Innovative Medicinal Products (VILP), proceedings on reimbursement for VILPs and orphan medicinal products (LPVOs) used in combination, contractual commitments with payers, assessment of a product as an LPVO, similar medicinal products, lis pendens (litispendence), the submission of models, and review (revision) proceedings.
The reimbursement mechanism will also change—especially for vaccines and monoclonal antibodies intended for prophylaxis—and a special procedure for immunization medicines will be introduced.
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 part of our new article series, we briefly outline the key changes in the medicines domain linked to the amendment to the Act on Public Health Insurance. This time: orphan medicinal products.
The amendment introduces a new approach to external price referencing, expanding the options for excluding an identified external reference price from the reference set.
The concept of deemed market availability is reframed—not only by adjusting the percentage threshold, but
also, for example, by setting new conditions for deeming similar medicinal
products available; changes also concern products with an agreed maximum price.
The rules for setting the base reimbursement
according to the daily cost of an alternative therapy are completely reworked.
Several new limitations/constraints are
introduced, e.g. for filing applications to change reimbursement or for certain
applications to set reimbursement. These include, for instance, limitations on
the formulation of reimbursement conditions and time limits for re-filing.
Changes also affect applications to amend the content of filings.
Further significant changes concern, for example commercially confidential information and the submission of (pharmacoeconomic) models.
Finally, there is a breakthrough regarding lis pendens, which previously prevented a separate proceeding to
obtain reimbursement for a new indication if a proceeding was pending—at any
stage—for reimbursement of the same product code in a different indication.
This is now altered by a new special provision.
In brief: the amendment
On 12 August 2025, the amendment to the Act on Public Health Insurance was promulgated in the Collection of Laws as No. 289/2025 Coll. Its general effective date is 1 January 2026, with selected provisions taking effect during 2026 or in subsequent years.
The amendment proposes substantial changes to the regulation of public health insurance. In the area of pricing and reimbursement of medicinal products, it will affect, for example: the process of external price referencing (EPR), the rules on deemed availability, the definition of Highly Innovative Medicinal Products (VILP), proceedings on reimbursement for VILPs and orphan medicinal products (LPVOs) used in combination, contractual commitments with payers, assessment of a product as an LPVO, similar medicinal products, lis pendens (litispendence), the submission of models, and review (revision) proceedings.
The reimbursement mechanism will also change—especially for vaccines and monoclonal antibodies intended for prophylaxis—and a special procedure for immunization medicines will be introduced.
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 part of our new article series, we briefly outline the key changes in the medicines domain linked to the amendment to the Act on Public Health Insurance. This instalment focuses on reimbursement...
On 12 August 2025, the amendment was published in the
Collection of Laws as No. 289/2025 Coll. The general effective date is 1
January 2026, with certain provisions taking effect during 2026 or in
subsequent years.
The amendment proposes substantial changes to the regulation
of public health insurance. In pricing and reimbursement of medicinal products,
it will affect, for example the process of referencing
foreign prices, adjustments to the automatic
availability rule, the definition of Highly
Innovative Medicinal Products (VILP), procedures for reimbursement
of VILPs and orphan medicinal products (LPVOs) used in combination, contractual commitments
concluded with payers, assessment of a product as an
LPVO, similar medicinal products, lis pendens (litispendence), submission of
(pharmacoeconomic) models, and review (revision) proceedings. It also changes reimbursement mechanisms—especially for
vaccines and monoclonal antibodies intended for prophylaxis—and introduces a
special procedure for immunization medicines.
We will gradually cover the key areas impacted by the
amendment in this series.
Maximum Price
Beyond the existing framework, a new procedure will be
introduced for important, hard-to-substitute and typically low-cost groups of
medicines.
The amendment also brings a special definition of the
“closest therapeutically comparable product” for medicines where availability
must be ensured.
A new method of recalculating the average exchange rate will
apply in cases of exchange-rate volatility for products with fewer available
manufacturer prices.
The Ministry of Health will be empowered to exclude foreign
manufacturer prices from referencing where there are significant currency
exchange-rate differences or other exceptional, relevant circumstances
affecting medicinal product prices in an EU Member State.
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 part of a new article series, we will briefly highlight the main areas that will change under the amendment to the Act on Public Health Insurance, effective 1 January 2026.
Fully
reimbursed medicinal products play a key role in ensuring access to healthcare
for patients in the Czech Republic. Their regulation is derived from Act No.
48/1997 Coll., on Public Health Insurance, which sets the conditions for their
inclusion in the List of Prices and Reimbursements (SCAU). The goal is to
ensure patients have access to treatment while optimizing public health
insurance expenditures.
Full
Reimbursement in Inpatient and Outpatient Care
Act No. 48/1997 Coll. stipulates that, during
the provision of inpatient care, the following are fully reimbursed:
·
medicinal
products and foods for special medical purposes,
·
individually
prepared medicinal products,
·
radiopharmaceuticals,
·
transfusion
products,
·
medical
devices,
·
medicinal
products for advanced therapy,
·
tissues
and cells.
These items
are reimbursed in the least economically demanding version, and the insured
person does not contribute to their payment.
In outpatient care, Annex No. 2 of the
Act plays a crucial role in ensuring that at least one medicinal product in
each therapeutic group is fully reimbursed by public health insurance. This
guarantees patient access to treatment without co-payments, especially for
chronic and severe diseases.
Full
Reimbursement and Real Availability of Medicinal Products
However,
full reimbursement of a medicinal product does not automatically mean its
actual availability on the market. Data shows that only a portion of fully
reimbursed medicines are genuinely available to patients, influenced by factors
such as manufacturers’ supply decisions, demand fluctuations, and regulatory
measures.
The list of medicinal products and foods for
special medical purposes reimbursed by health insurance (SCAU250401) includes a
total of 8,873 items, of which 987 are fully reimbursed. Out of this
number, 748 products are available. The full reimbursement guarantee
under Annex No. 2 of the Act applies to 467 of them, while 281
products are not included in Annex No. 2.
Fully
reimbursed products make up 11.12% of all items in the reimbursed medicines
list.
Available
fully reimbursed products represent 75.79% of the total number of fully
reimbursed products.
Of
the fully reimbursed items, 47.32% fall under Annex No. 2 of the Act.
Outside
Annex No. 2, 28.47% of fully reimbursed products exist.
Available
fully reimbursed products constitute only 8.43% of the total number of items in
the list.
Of
the available fully reimbursed ones, 62.42% are from Annex No. 2.
Outside
Annex No. 2, 37.58% of the available fully reimbursed products remain.
Fully reimbursed medicinal products play a key role in ensuring access to healthcare for patients in the Czech Republic. Their regulation is based on the Public Health Insurance Act, which aims to...
On February 21, 2025, the Ministry of Health of the Czech Republic published the following opinion on the procedure for assessing the financial impact on the health insurance system when determining or changing the amount and conditions of reimbursement for a medicinal product or food for special medical purposes:
"The Department of Medicinal Products and Medical Devices of
the Ministry of Health of the Czech Republic (hereinafter referred to as
"the Ministry"), in view of the wording of the applicable Act No.
338/2024 Coll., amending Act No. 48/1997 Coll., on Public Health Insurance and
on Amendments and Supplements to Certain Related Acts, as amended, Act No.
592/1992 Coll., on Insurance Contributions for Public Health Insurance, as
amended, and Act No. 378/2007 Coll., on Medicinal Products and on Amendments to
Certain Related Acts (the Medicinal Products Act), as amended, which, with
effect from January 1, 2025, changes the principles in the area of monitoring
limits of deductible co-payments for partially reimbursed medicinal products
and foods for special medical purposes (the protective limit) and the
subsequent reimbursement of deductible co-payments exceeding the protective
limit under Act No. 48/1997 Coll., on Public Health Insurance and on Amendments
and Supplements to Certain Related Acts, as amended (hereinafter referred to as
"the Public Health Insurance Act"), hereby issues its opinion on the
procedure for assessing the financial impact on the health insurance system
when determining or changing the amount and conditions of reimbursement for medicinal
products or foods for special medical purposes.
The method of assessing the financial impact on the health
insurance system (hereinafter referred to as "budget impact") is
expressed in the third and fourth sentences of Section 15(8) of the Public
Health Insurance Act, which state that "The budget impact is determined
as the difference between the costs of treating a given disease associated with
the use of a medicinal product or food for special medical purposes that would
be reimbursed from health insurance funds, and the costs of treatment using
another medicinal product, food for special medical purposes, or treatment
method that is already reimbursed from health insurance funds. The budget
impact must be in accordance with the public interest pursuant to Section
17(2)."
If, under Section 15(9) of the Public Health Insurance Act,
the anticipated budget impact associated with determining reimbursement for a
medicinal product or food for special medical purposes shows an increase in
expenditures from the health insurance system, the budget impact assessment
must be conducted through a budget impact analysis submitted by the applicant,
which the State Institute for Drug Control assesses during the proceedings [see
Section 39b(2)(c) of the Public Health Insurance Act].
The requirements of the third and fourth sentences of
Section 15(8) of the Public Health Insurance Act for the applicant-submitted
budget impact analysis and the procedure of the State Institute for Drug
Control in its assessment are elaborated in the methodology SP-CAU-27
(hereinafter referred to as "the methodology") as of the date of this
opinion. For the purpose of quantifying the budget impact, the methodology
allows only the perspective of health insurance expenditures (for completeness,
it should be noted that this applies outside of proceedings conducted under
Section 39da of the Public Health Insurance Act).
The Ministry is aware from its own official activities that
the State Institute for Drug Control currently considers only direct costs
(both pharmaceutical and non-pharmaceutical) demonstrably incurred from health
insurance in connection with the therapy of the given disease as relevant costs
in the budget impact assessment, whereby the State Institute for Drug Control
considers only the costs at the level of reimbursement from health insurance,
or costs corresponding to the maximum consumer price if this price is lower
than the reimbursement amount, as direct pharmaceutical costs for both the
evaluated intervention and the comparator.
However, as the Public Health Insurance Act stipulates
that the budget impact is determined as the difference in treatment costs for
the given disease (from the perspective of health insurance) associated with
the use of medicinal products, the Ministry considers it necessary to include
in the relevant direct costs for the evaluated intervention and the comparator
also the amounts of deductible co-payments reimbursed by health insurance funds
above the protective limit of the insured, which, in connection with the
amendment to the Public Health Insurance Act, will be a direct expenditure of
health insurance funds paid to pharmacy service providers related to the
treatment of the given disease.
For this reason, it is necessary that the applicant, within
the submitted application, consider the anticipated budget impact, taking into
account any deductible co-payments for the evaluated and comparator
intervention.
If, in the assessment of the anticipated budget impact under
Section 39b(2)(j) of the Public Health Insurance Act in proceedings on
determining or changing the amount and conditions of reimbursement for a
medicinal product, it becomes apparent that this anticipated reimbursement
impact on health insurance funds, taking into account the anticipated amount of
deductible co-payments (representing the cost of treating the given disease),
shows an increase in expenditures from the health insurance system, in such a
case, the applicant must submit a budget impact analysis that also considers
the amount of the anticipated deductible co-payment.
According to the Ministry, in order to fulfill the purpose
of the aforementioned legal provisions concerning the new protective limit
rules, it is necessary that, in the budget impact assessment by the applicant
and the budget impact evaluation by the State Institute for Drug Control, the
deductible co-payment amounts applied in practice are considered, rather than
the highest possible deductible co-payment amounts calculated according to the
second sentence of Section 16b(1) of the Public Health Insurance Act.
The Ministry further emphasizes that the deductible
co-payments for partially reimbursed medicinal products and foods for special
medical purposes, which count towards the insured person's protective limit,
are known to the State Institute for Drug Control from its own official
activities, as well as to health insurance funds, and marketing authorization
holders can also determine the actually applied amounts of deductible
co-payments from the publicly available data on the website of the State
Institute for Drug Control at https://prehledy.sukl.cz/prehled_leciv.html#/ or
calculate them from data on already reimbursed medicinal products (comparators)
published at regular intervals on https://opendata.sukl.cz/?q=katalog/lek-13
(note: link valid as of the date of this opinion).
For practical implementation, the Ministry believes that the
above-mentioned change in the procedure for budget impact assessment can be
realized as follows. The budget impact analysis will, in addition to the
currently expressed budget impact, also include a separately calculated budget
impact incorporating the costs of deductible co-payments for partially
reimbursed medicinal products and foods for special medical purposes that would
arise for health insurance funds when exceeding the annual protective limit.
However, presenting a separately calculated budget impact with applied
deductible co-payments will not be entirely necessary (or would be redundant)
in cases where no deductible co-payment arises in the determination or change
of the reimbursement amount and conditions for the evaluated intervention.
In conclusion, the Ministry states that this opinion does
not interfere with the current practice of assessing cost-effectiveness
analyses."
The original document is available on the website of the Ministry of Health of the Czech Republic.
This is an unofficial translation generated with the assistance of ChatGPT-4o. It is provided for informational purposes only and does not constitute an official or legally binding translation.
The Ministry of Health of the Czech Republic has published an opinion on the procedure for assessing the financial impact on the health insurance system when determining or changing the amount and...
From January 1, 2025, Slovakia will include medicines
and medical devices in the reduced VAT rate of 5%. This move is part of a
broader tax reform aimed at improving access to essential goods for the
population while reducing the financial burden on patients. The changes are
likely a response to the European Commission’s assessment of public finances
and an effort to reduce the budget deficit.
This change contrasts with developments in the Czech
Republic, where, as of January 1, 2024, the VAT rate on medicines increased
from the original 10% to 12%, as we mentioned in our previous article Changes
in VAT Rate for Pharmaceuticals.
What Impact Will the Reduced VAT Rate Have in
Slovakia?
The lower VAT rate is expected to significantly reduce
costs for patients in Slovakia for medical devices and medicines, both in
outpatient and hospital care. The direct financial impact on individuals will
depend on specific measures and pricing policies. For comparison, Slovakia’s
VAT on medicines has dropped from 10% to 5%, which could lead to a more
noticeable impact on final prices than in the Czech Republic, where the rate
was increased.
Impact on External Price Referencing for Medicines
The reduced VAT rate in Slovakia, however, will not
affect the external price referencing (EPR) of medicines, used by some
countries to set maximum prices and reimbursement levels in their markets. The
VAT change does not reflect in EPR because the reference price is almost
universally based on the manufacturer’s price.
At the same time, this change offers an opportunity to
compare tax policies across the EU, where VAT rates on medicines and medical
devices vary significantly. For example, according to data
from EFPIA (European Federation of Pharmaceutical Industries and
Associations) as of January 1, 2024, Spain applies a 4% VAT rate on medicines,
while Denmark has a standard rate of 25%.
Stay tuned to our website for more updates on
legislative changes and their impact on healthcare in the EU.
From January 1, 2025, Slovakia will introduce a significant change in its tax policy. This step is part of a broader tax reform aimed at improving access to essential goods for the population while...
The European Health Data Space should lead to the empowerment of citizens and support for research and innovation.
EU residents will have more control over their health data,
being able to access it electronically and share it across borders. This
is particularly beneficial for cross-border healthcare, allowing
individuals to access medical records and receive care seamlessly
throughout the EU.
The EHDS promotes the secondary
use of health data for research, innovation, and policy-making.
Researchers and innovators will be able to access health data more easily
and securely, which could drive the development of new treatments, medical
devices, and AI applications.
The main objectives of the European Health Data Space (source: excerpt from the Communication from the Commission to the European Parliament and the Council: The European Health Data Space: Harnessing the power of health data for people, patients, and innovation):
The European Health Data Space (EHDS) has advanced significantly since the initial concept of a digital transformation in healthcare across all EU member states.
CTIS was established by pharmaceutical law in the Clinical Trials Regulation (Regulation (EU) No 536/2014) and will completely replace the previous system for clinical trials EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) after 30th January 2025. CTIS supports interactions between clinical trial sponsors (researchers or companies that run a clinical trial and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.
CTIS is guaranteed by European Medicines
agency (EMA) and works in a secured workspace.
The important milestones for clinical trials:
CT starts after
30th January 2023 – the submission must be completed through CTIS
CT ends before
30th January 2025 – CT is maintained in EudraCT or national
systems
CT is expected
to continue after 30th January 2025 – transition from the EudraCT or
national systems to the CTIS is necessary.
CTIS podporuje interakce mezi sponzory klinických studií (výzkumníky nebo společnostmi, které provádějí klinickou studii a shromažďují a analyzují data) a regulačními orgány v členských státech EU...
