In proceedings
concerningorphan medicinal products, State Institue for Drug Controla (SÚKL) is authorised to assess the
pharmacoeconomic analyses submitted by the partiesbut does not have the
competence to generate such analyses itself.
Although, in
proceedings under Section 39da initiated at the request of a health insurance
fund, the marketing authorisation holder is not formally subject to an
enforceable obligation to submit pharmacoeconomic analyses of a defined
quality, the assessment of clinical benefit, cost-effectiveness and budget
impact remains a key prerequisite for determining the appropriateness of
reimbursement from public health insurance. The absence of a cost-effectiveness
analysis is therefore considered a material deficiency.
While the results
of the cost-effectiveness analysis (ICER) are not formally applied as a
decision-making threshold, budget impact and value for money considerations
remain implicitly present in the assessment of the public interest.
A declared
intention to conclude budget cap agreements does not constitute a binding basis
for a reimbursement decision unless such arrangements have been incorporated
into SÚKL’s assessment report prior to the issuance of the opinion of the
Ministry of Health.
Individual
reimbursement granted under Section 16 for exceptional cases does not establish
an automatic entitlement to system-wide reimbursement under Section 39da, where
the existence of a public interest constitutes the primary statutory
condition.
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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.
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.
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 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...
The Ministry of Health of the
Czech Republic (MoH), acting as the appellate authority, examined whether the
submission of two consecutive applications for a change in the reimbursement of
the same medicinal product—applications concerning different therapeutic
indications or reimbursement conditions—constitutes two separate proceedings or
whether they relate to the same matter.
The MoH clearly concluded that
the subject of the proceedings is identical and comprehensive, thereby
upholding the resolution of the State Institute for Drug Control (the
Institute) to discontinue the second proceeding due to litispendence.
At the same time, within the
proceedings, the MoH emphasized that the subject of the procedure is not an
isolated change to a single condition, but always a comprehensive assessment
and determination of a new, complete set of reimbursement levels and conditions
for the given product. The reimbursement level and reimbursement conditions
form an inseparable and mutually interconnected pair.
In its reasoning, the MoH
relied on case law of the Supreme Administrative Court (SAC), particularly on
its view that even an extension of indication (and even a completely new
indication) does not in itself constitute a change to the subject of the proceedings.
According to the MoH, allowing
two parallel proceedings would risk the issuance of two contradictory
reimbursement decisions, which would introduce absolute uncertainty into the
system.
For completeness, we add that under the amendment to the Act
on Public Health Insurance, from 1 January 2026 it will be possible to conduct
two parallel proceedings concerning an extension of reimbursement for the same
product, provided that the application for the later proceeding is submitted
after a decision has been issued in the earlier proceeding, and that both
proceedings are conducted for different indications.
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
A continuously
updated overview of decisions issued by SÚKL and the Ministry of Health in the
field of pricing and reimbursement is available on the Pharmeca a.s. website.
In-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...
Section 39i(2) of
the Act on Public Health Insurance stipulates the obligation of the State
Institute for Drug Control (hereinafter “the Institute”) to immediately
initiate ex officio proceedings to amend the determined amount and conditions
of reimbursement of a medicinal product in cases where the current
reimbursement or reimbursement conditions do not correspond to the basic
reimbursement of the reference group or to the reimbursement conditions
established in a revision procedure.
Within the ongoing
proceedings initiated by the Institute pursuant to the cited provision, the
Institute addressed issues related to the amount of the usual daily therapeutic
dose (ODTD) and its binding nature.
According to the
Institute, the purpose of this type of proceeding is not to establish a new
ODTD, but to harmonize the reimbursement levels with the latest enforceable
decision issued in the revision procedure.
The incorporation
of the ODTD from the revision decision into individual administrative
proceedings is in accordance with the law, the decree, and established
administrative practice, even if the ODTD is not explicitly stated in the
operative part of the decision. It constitutes an inherent component of the
operative part concerning the amount of the basic reimbursement, as confirmed
by relevant decisions of the Ministry of Health of the Czech Republic.
The Institute
further emphasized that the ODTD forms the technical basis for calculating the
basic reimbursement, and its value is legally binding for all subsequent
administrative proceedings concerning changes to the amount and conditions of
reimbursement until the next in-depth reimbursement revision.
The Institute
therefore considered objections regarding the absence of the ODTD in the
operative part of the revision decision or the request for a new determination
of the ODTD within the ongoing proceedings to be unfounded.
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
A continuously
updated overview of decisions issued by SÚKL and the Ministry of Health in the
field of pricing and reimbursement is available on the Pharmeca a.s. website.
