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...
The process
of determining the reimbursement of medicinal products in the Czech Republic is
complex and involves several key stakeholders who collectively influence the
final decision. In our recent post on decision-making practices, we highlighted
the role of health insurance companies in the reimbursement process. Now, let’s
take a closer look at the entities involved and how the entire mechanism works.
The process of determining the reimbursement of medicinal products in the Czech Republic is complex and involves several key stakeholders who collectively influence the final decision. In our...
Cost-Effectiveness Assessment of
Pharmaceuticals: Key Questions
Cost-effectiveness assessment is a crucial
element of the administrative process for determining drug reimbursement, not
only in the Czech Republic. A well-prepared cost-effectiveness analysis,
including budget impact assessment, not only supports the applicant's arguments
but also minimizes requests for additional documentation from the State
Institute for Drug Control (SÚKL/Institute) via cooperation requests, which
have become standard practice.
This article presents a selection of key
questions that applicants seeking drug reimbursement (where cost-effectiveness
assessment is required) should be able to answer within their submitted
evaluation.
Cost-effectiveness assessment is a crucial element of the administrative process for determining drug reimbursement, not only in the Czech Republic. A well-prepared cost-effectiveness analysis,...
The pharmaceutical market in the Czech Republic
is undergoing a gradual shift in decision-making practices, which may
significantly impact pricing and reimbursement regulations as well as the
entire pharmaceutical sector. Section 39c(2)(b) of the Public Health Insurance
Act has been in use for a long time; however, its true potential to influence
reimbursement dynamics is only now becoming apparent. The uncertainty arises
from the gradual convergence of differences between innovative biological
molecules entering the market and those already reimbursed. The concept of
comparably effective therapy thus becomes a risk factor for new medicinal
products.
How Does the New Approach Work? In a recent reimbursement revision
decision regarding JAK inhibitors (Ref. No. SUKLS274309/2022), SUKL determined
the reimbursement for certain indications based on the daily costs of
comparably effective therapy. This means that medicinal products were not
necessarily placed in the same reference group as the compared therapies, yet
their reimbursement was set according to cheaper alternatives from another
reference group, which included, for instance, generic drugs. In the case of
filgotinib, the reference product, a head-to-head clinical study (Combe, B. et
al.) comparing its efficacy with the TNF-alpha inhibitor adalimumab confirmed
direct clinical equivalence between these therapies.
This approach has several critical
consequences:
Reduction
in the reimbursement of innovative medicines – if the reimbursement of a medicinal
product is set according to another reference group that includes
generics, it automatically decreases regardless of the original
therapeutic value.
Domino
effect on other groups – once reimbursement is lowered in one group, this decrease can
reflect in reimbursement revisions across other reference groups, leading
to a gradual overall reduction in reimbursements.
Unpredictability
for pharmaceutical manufacturers – companies bringing new medicinal
products to market lack certainty about how their reimbursement will be
determined, as it may be derived from different reference groups without
formal inclusion in them.
Long-Term Impacts This new approach has not only short-term
effects on the reimbursement of specific medicines but also long-term
consequences for the entire pharmaceutical sector:
Reduced
attractiveness of the Czech market – if innovative medicines are
systematically undervalued, pharmaceutical companies may be discouraged
from introducing new medicines to the Czech market.
Impact
on patients –
lower reimbursements may lead to reduced availability of innovative
therapies and fewer treatment options for both patients and physicians.
Disruption
of reimbursement policy transparency – linking reimbursements across different
reference groups may complicate predictability and planning in the field
of pharmaco-economics.
Open Question: Where is the Boundary Between
Efficiency and Innovation Regulation? How might the domino effect manifest in
non-referential indications in the future? This case represents a breakthrough
in setting more than one additional increased reimbursement, meaning the
barrier of "only one increased reimbursement" is eliminated. On the
other hand, this new trend may lead to an intricate network of interconnected
reference groups with generic-based reimbursements, discouraging marketing
authorization holders from including their products in such groups.
The pharmaceutical market in the Czech Republic is undergoing a gradual shift in decision-making practices, which may significantly impact pricing and reimbursement regulations as well as the...
The European Medicines Agency (EMA) has
announced the launch of a new platform designed to routinely monitor shortages
of centrally authorized medicines. This platform is a direct result of Regulation
(EU) 2022/123, which aims to improve preparedness for and mitigation of
medicine shortages across EU member states.
Key Points:
Platform
Availability:
The European Shortages Monitoring Platform (ESMP) is now accessible
online.
Mandatory
Usage:
Starting from February 2, 2025, all Marketing Authorization Holders (MAHs)
with centrally authorized products will be required to use the ESMP.
Early
Familiarity:
EMA encourages MAHs to familiarize themselves with the platform before the
mandatory deadline.
Data
Submission:
Until February 2, 2025, MAHs and National Competent Authorities (NCAs) can
submit data on supply, demand, and availability of both centrally and
nationally authorized medicines to the EMA's Executive Steering Group on
Shortages and Safety of Medicinal Products (MSSG).
Medicine
Monitoring:
The platform will be used for routine monitoring of all centrally
authorized medicines and may also be used for monitoring nationally
authorized medicines under special circumstances.
The European Medicines Agency (EMA) has announced the launch of a new platform designed to routinely monitor shortages of centrally authorized medicines.
