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...
In connection with the new Act No. 288/2025 Coll., on the categorization of medical devices prescribed on voucher and reimbursed from public health insurance, and on the amendment of Act No. 48/1997 Coll., on public health insurance and on the amendment and supplementation of certain related acts, as amended, the State Institute for Drug Control (SÚKL) has published a set of questions and answers.
The following text highlights selected points that focus not only on the new obligations for the entities concerned.
Is it possible to submit a notification of an annual increase in the manufacturer’s price already in November, effective from 1 January 2026?
Yes. Under the currently valid price regulation, an annual increase in the manufacturer’s price may be submitted from 1 November 2025. These notifications are processed into lists published in December, effective from 1 January 2026.
Will the change of reimbursement group be carried out automatically based on the current classification of the medical device, or must the authorization holder (manufacturer/authorized representative) actively submit a new notification in the ISZP system?
The Institute cannot automatically reclassify products into a newly established reimbursement group. It is necessary to submit a notification of the change of the reimbursement group (UHS) pursuant to Section 39s(7) of the Act on Public Health Insurance, as amended and effective from 1 January 2026.
When and how will it be possible to notify a change in the reimbursement group according to the new Act on the Categorization of Medical Devices?
The change of the reimbursement group must be submitted between 1 January 2026 and 31 January 2026 via the ISZP system.
Which date is decisive for assessing the reimbursement amount and the correct classification of a medical device – the date of the voucher being issued by the physician or the date of actual dispensing of the medical device by the pharmacy/distributor?
If a medical device is prescribed under the Act on Public Health Insurance (ZoVZP) and redeemed before the new Act on the Categorization of Medical Devices (ZoKaZP) takes effect, it is reimbursed under the original conditions of ZoVZP (see Section 3(1) of ZoKaZP).
If the device is prescribed under ZoVZP but redeemed after ZoKaZP takes effect, it is reimbursed under the new conditions of ZoKaZP (see Section 3(2) of ZoKaZP).
In the case of a voucher issued by 30 April 2026 for an elastoviscous solution in reimbursement group UHS 11 — i.e. for a medical device reimbursed under the transitional provisions of Section 3(4) of ZoKaZP — and if the voucher is redeemed (the patient collects it) in the following month (May 2026), such a medical device is reimbursed under the conditions of UHS 07.07.01.01 ZoKaZP.
Can an existing power of attorney still be recognized if it does not include the newly established reimbursement group 07.07.01.01, provided it is clear from its content that it applies to the categorization and reimbursement of medical devices in general?
If the power of attorney covers all medical devices of a manufacturer, it may continue to be used as an approved valid authorization. However, if the power of attorney lists specific reimbursement groups or specific medical devices and does not include the new reimbursement group or the related devices, it cannot be used for medical devices in the new reimbursement group.
Is it possible to submit an application now using the existing power of attorney, and later provide an updated version including the new group (for example, as an amendment to the power of attorney) after it is issued?
SÚKL does not and has not accepted any amendments, supplements, or declarations to existing powers of attorney. In assessing powers of attorney, the Institute must act consistently for both medicinal products and medical devices.
Do you recommend any alternative formal way to ensure timely submission of the application during the period when the new reimbursement group is not yet included in the issued authorization or in public lists?
If the new reimbursement group is not included in the approved power of attorney, it is necessary to submit a new application with a new power of attorney containing the respective group or devices, or a power of attorney covering all the manufacturer’s medical devices.
Please note that if several powers of attorney are submitted for all medical devices of the same manufacturer, a problem may arise where previous powers of attorney for other representatives of the same manufacturer will be terminated due to multiple authorizations. Therefore, if you represent only certain medical devices of a manufacturer, please carefully consider the scope of your power of attorney.
In case of any uncertainties or other questions regarding powers of attorney, please use the email address plne_moci@sukl.gov.cz, or consult your company’s legal representative.
The complete article is available on the SÚKL website.
Do you need to request an annual increase in the manufacturer’s price or advice on how to submit a notification through ISZP? Contact us.
The State Institute for Drug Control (SÚKL), in connection with new legislation also covering medical devices, has published a set of questions and answers highlighting, among other things, the new...
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...
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.
