In the field of reimbursement and regulation of foods for special
medical purposes (FSMP) reimbursed from public health insurancewithin
outpatient care, significant changes will take effect from 1 January 2026 based
on the amendment to the Public Health Insurance Act.
New rules for FSMP reimbursement
FSMP will newly
be classified into reimbursement groups listed in the categorisation tree
attached to the Act, based on their composition and intended use (similarly to
medical devices).
The rules for
price and reimbursement regulation are also changing, the new system will take
into account whether a product is categorised (i.e., can be included in the
categorisation tree and is substitutable with reimbursed FSMP) or
non-categorised (i.e., cannot be included in the categorisation tree and is not
substitutable with reimbursed FSMP).
The reimbursement
amount for specific FSMP will be derived from the base reimbursement set by a
measure of general nature for the respective reimbursement group.
A new obligation
is introduced to notify the actual placing on the market and to maintain
detailed records of FSMP.
Transitional period
FSMP reimbursed
at the end of 2025 will continue to be reimbursed under the same conditions and
at the same reimbursement level. This applies until the State Institute for Drug Control (SÚKL) publishes their
new reimbursement within the new system.
The
manufacturer/importer (notifier) of FSMP reimbursed in 2025 must submit a
notification to SÚKL by the end of September 2026, otherwise, the respective
FSMP will cease to be reimbursed.
All
administrative proceedings concerning FSMP that have not been concluded under
the previous legislation will be discontinued as of 1 January 2026.
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As part of the Dawn of the Amendment to the Public Health Insurance Act article series, we have gradually introduced the updates related to medicinal products. In the following article, we focus on...
A health insurance fund may agree with an inpatient care provider on the method
of reporting and reimbursement of medicinal products used in the provision of
inpatient care, for which the fund has negotiated the reimbursement amount and
conditions with the marketing authorization holder or manufacturer.
For the purpose of negotiating the reimbursement amount and conditions between
payers and the marketing authorization holder for medicines used exclusively in
inpatient care, the State Institute for Drug Control (the Institute) will, at
the request of payers or the holder, conduct an assessment of benefits and
costs (analogous to HTA). All entities concerned (including marketing
authorization holders) are obliged to cooperate with the Institute.
Drug lump sums, which are no longer applied in practice, are abolished.
Deductible
co-payments
The conditions for recognizing co-payments for children under 4 years
of age are expanded by defining selected dosage forms and by specifying the
calculation method of the co-payment in these cases.
Reimbursement
of expenses
Changes also apply to the reimbursement of expenses for acts performed
by the Institute, which will no longer apply to applicants requesting an
increase in the maximum price in the public interest or to applicants for
unregistered medicinal products whose use has been authorized under the
Medicines Act.
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 on the topic of inpatient care...
The amendment
introduces the concept of an “original reimbursed product” and clarifies the
definition of the “first similar product,” for which a marketing commitment
will no longer be submitted; instead, its actual market availability will
trigger an abbreviated revision due to its entry into the reimbursement system.
The Institute will newly assess the appropriateness of therapeutic intervention
for similar products originating from the same marketing authorization holder,
with the aim of preventing circumvention of contractual arrangements.
The conditions for the automatic recognition of an appropriate therapeutic
intervention are defined.
The assessment of market availability of a similar product will now be governed
by criteria focused on the total quantity of all supplied similar products and
by calculating the average monthly volume.
Combination
product
The amendment introduces a significant change in the calculation of
reimbursement for combination products, taking into account situations where
all included active substances are reimbursed individually on the one hand, and
situations where one of the substances is not reimbursed on the other.
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 on the topic of similar and...
In-depth
reimbursement revision
Under the new rules, in an in-depth revision in which a significant decrease in
the basic reimbursement compared to the first in-depth revision is
demonstrated, the State Institute for Drug Control (Institute) will carry out a review or, where applicable,
cancellation of the indication restriction, and in certain cases also a
reassessment of the prescribing restriction, depending on the nature of the
medicinal product (Rx, ZULP).
A minimum interval between individual in-depth reimbursement revisions within
the same reference group is introduced in order to minimise excessive
administrative burden on the Institute.
Abbreviated
price and reimbursement revision
The amendment introduces changes to the thresholds relevant for initiating an
abbreviated reimbursement revision, depending on the type of medicinal
products.
Revisions of maximum prices will newly be conducted for products included in
the same reference group.
A deadline for commenting on the assessment report is introduced, excluding the
possibility of submitting an obstruction appeal against the resolution setting
this deadline.
The conditions for initiating a reimbursement revision due to product unavailability
are updated.
As with in-depth revisions, a minimum interval between individual revisions is
set, during which no new revision may be initiated. However, this time
limitation does not apply to revisions initiated, for example, due to the entry
of the first similar medicinal product or the need to ensure the availability
of a fully reimbursed product.
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 on the topic of in-depth and...
The
amendment introduces a special reimbursement procedure for certain selected
vaccines, particularly those that are non-mandatory.
Participants
in the proceedings will newly include not only marketing authorization holders
and health insurance companies, but also the Czech Medical Association of J. E.
Purkyně.
For the
purpose of determining the amount and conditions of reimbursement, the State Institute for Drug Control(Institute) will assess vaccines with regard to medical, social, economic, and
ethical aspects, as well as their impact on public health.
The
Institute’s assessment report will newly include a statement from the National
Institute of Public Health, which is issued after the initiation of the
procedure and may differ from the Institute’s own position. As in the
case of orphan medicines, the assessment report will be reviewed by the
advisory body of the Ministry of Health in a non-public session, during
which a conciliation procedure will take place.
The Institute will then issue a decision in accordance with
the binding opinion of the Ministry of Health, which may, among other things,
differ from the original proposal of the assessment report — for example, in
the amount or conditions of reimbursement.
The
amendment abandons the “economically least demanding variant” (ENNV) regime for
vaccines, which previously favored older vaccines at the expense of modern
ones. Vaccines that are already reimbursed will retain their current
reimbursement after the amendment, with the possibility of individual changes
in selected cases.
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: products Intended for...
The amendment
changes the rules for assessing Highly Innovative Medicinal Products by
defining several criteria under which medicines may be included in this group.
It changes the
conditions for any application of the statutory limitation of the reimbursement
amount.
Changes also occur
in the cost-limitation agreements between marketing authorisation holders and
payers, which will now be mandatory, with a possible sanction in the form of
loss of temporary reimbursement.
Lastly, the
patient’s right to complete ongoing treatment at the expense of the marketing
authorisation holder has been updated.
A completely new
element is a joint reimbursement proceeding for combinations with a VILP,
intended to address situations where only one product in the combination has an
established reimbursement.
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: highly Innovative Medicinal...
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...
