At the beginning of December, the State Institute for Drug Control
(SÚKL) held a seminar entitled Current Topics in Price and Reimbursement
Regulation. The following article presents key practical information
delivered at the seminar and includes SÚKL’s interpretation of selected topics
previously addressed in the Dawn of the Amendment to the Public Health
Insurance Act series.
This article is therefore a transcription of texts based on presentations published on the SÚKL website, where their
full versions are available.
Vaccine Reimbursement as of 2026
The amendment in the area of medicinal products intended for
immunisation will ensure full reimbursement of more effective and more modern
vaccines.
By submitting an application for the determination of
reimbursement pursuant to Section 39db et seq., it is possible to request:
reimbursement of new
indications of an already reimbursed vaccine, resulting in the
determination of an additional reimbursement entry in the List of Reimbursed
Medicinal Products (SCAU);
reimbursement in
an indication already reimbursed under the previous legislation, resulting in
the revocation of the existing reimbursement and the determination of a new
one. In the event of a partial overlap between the newly proposed
reimbursement conditions and an existing reimbursed indication, the Institute
will revoke the existing reimbursement only in the overlapping part and
determine a new reimbursement for that part.
reimbursement of
a vaccine not previously reimbursed,by submitting an application for the
determination of themaximum price and the amount and conditions of
reimbursement (MC and VaPÚ).
Joint Proceedings Concerning Combinations of Medicinal Products
Types of administrative proceedings under the amendment:
VILP + VILP
combination – procedure pursuant to Section 39d
et seq. of the Public Health Insurance Act (ZoVZP);
LPVO + VILP
combination – procedure pursuant to Section 39da
et seq. ZoVZP;
LPVO + LPVO
combination – procedure pursuant to Section 39da
et seq. ZoVZP.
Administrative proceedings are initiated only upon submission of
thesecond application, which must be filed within 30 days of the first
application. The web-based application forms have been amended to require
explicit indication that the case concerns a joint proceeding with another
medicinal product.
Withdrawal of one of the applications leads to termination of the
proceedings; all applicants have dispositive rights over the subject matter of
the application.
Assessment of Highly innovative medicinal product (VILP) status
In VILP + VILP
applications, VILP status is not assessed separately for each medicinal
product used in combination; the combination as a whole must meet the
VILP criteria.
In LPVO + VILP
applications, VILP criteria are not assessed in any orphan indication. The
VILP already has temporary reimbursement established in another indication.
Assessment of Orphan (LPVO) Status
In LPVO + LPVO
applications, both products have active orphan status; at least one of them
has orphan status in the given indication.
In LPVO +
non-reimbursed medicinal product without orphan status, the non-orphan
product must have the relevant orphan indication included in its SPC.
Similar Medicinal Products (PP)
Initiation of an abbreviated review (ZR) following entry of the
first PP
Under the amendment, the abbreviated review is initiated only
after verification of commercial availability (pursuant to Sections 13a and 13b
of Decree No. 376/2011 Coll.) of a reimbursed similar product in relation to
the originally reimbursed product.
The market share of all similar products within the relevant ATC
group is assessed for a given calendar month, excluding the originally
reimbursed product:
PP in a reference
group containing prescription-only medicines:
at least a 5% share of the average monthly volume (DIS-13);
PP in a reference
group containing only separately reimbursed medicinal products (ZÚLP): at least a 2% share of the average monthly volume (REG-13).
Comprehensive and Abbreviated Reviews
Comprehensive review (HR)
Section 39l(3): a reduction of the base reimbursement by more than
80% compared to the base reimbursement established in the first completed
comprehensive review.
For reference
groups containing prescription medicines, SÚKL will remove indication
restrictions (except for off-label indications) and reassess prescribing
restrictions.
For reference
groups containing ZÚLP, SÚKL will reassess indication restrictions, with
possible removal following BIA assessment.
The justification for applying this provision is assessed either
directly within the ongoing comprehensive review or after issuance of a
decision in an abbreviated review in which reimbursement decreased by more than
80%.
A comprehensive review cannot be initiated if, within the last 12
months, a decision has been issued in another comprehensive review within the
same group of essentially therapeutically interchangeable medicinal products.
In an individual administrative proceeding (ISŘ) concerning a
change in the amount and conditions of reimbursement (VaPÚ), it is not possible
to establish more restrictive reimbursement conditions than those set in the
most recent comprehensive review.
Abbreviated review (ZR)
Abbreviated
reimbursement reviews are differentiated for groups containing ZÚLP (savings of
CZK 20 million) and groups not containing ZÚLP (savings of CZK 30 million).
Removal of the
statutory three-year time limit for conducting an abbreviated maximum price
review.
Abbreviated
reviews (cost-saving, including savings based on DNC/DoÚ) cannot be initiated
if another abbreviated review decision for the same medicinal product group was
issued within the last 12 months.
Abbreviated
maximum price reviews are conducted for reference groups or groups of
essentially therapeutically interchangeable products (the rule based on active
substance and route of administration has been removed).
Changes Affecting VILP and LPVO
VILP criteria
a) The primary clinically relevant endpoint in the clinical trial
demonstrated at least a 30% improvement in a quality-of-life–relevant parameter
in direct comparison, or at least a 35% improvement in indirect comparison
versus reimbursed therapy; in the case of progression-free survival, median PFS
must be extended by at least three months; or
b) Median overall survival is prolonged by at least 30% versus
reimbursed therapy, and by at least three months; where median OS is not
reached, a reduction in the OS hazard ratio of at least 35% versus reimbursed
therapy is demonstrated; or
c) A medicinal product with conditional marketing authorisation
pursuant to Regulation (EC) No 726/2004, where no alternative with permanent or
temporary reimbursement exists, or where the alternative is supportive or
symptomatic treatment only, andthe MAH has committed to reimbursing
health insurance funds for costs incurred should the conditional authorisation
expire, lapse or be withdrawn.
For medicinal products with conditional marketing authorisation
applying for VILP status under point (c), criteria under points (a) and (b) are
not assessed. The sole condition is the absence of causal treatment within the
reimbursement system and the conclusion of an agreement.
Assessment of Benefits and Costs of Hospital Medicinal Products
Section 17(6): ...upon request of a health insurance fund or MAH, the
Institute assesses the benefits and costs associated with the use of such
medicinal products. MAHs, health insurance funds and relevant professional
societies provide cooperation.
This is not a
formalised process (i.e. not administrative proceedings or an OOP).
A non-public file
is established; access pursuant to Section 38 of the Administrative Procedure
Code.
SÚKL does not act
as a regulator issuing a substantive decision.
SÚKL does not
decide on the amount and conditions of reimbursement of hospital medicinal
products listed in SCUP.
SÚKL processes
submitted documentation from health insurance companies, marketing authorisation holders, and professional societies in an impartial manner.
Assessment
compares costs and benefits of the hospital medicinal product versus
alternative treatment options.
Submission of Pharmacoeconomic Models
Models – general requirements
Preferred format:
Excel or TreeAge.
Fully functional,
allowing parameter adjustments with automatic recalculation of results.
Non-functional
models, incorrect formulas or source codes trigger a request for correction.
Technical
documentation must be submitted (does not replace structured submission).
Maximum
recalculation time: 10 seconds; justified cases 30–60 seconds.
Required for all
types of administrative proceedings (determination/change, VILP §39d, LPVO
§39da, immunisation products §39db ZoVZP).
Determination of the Maximum Manufacturer Price of Medicinal Products
The procedure for determining the maximum price (MC) for medicinal products that are significant for the provision of healthcare and which the Ministry of Health, with regard to the public interest in maintaining their availability, designates in a special price measure (Section 39a(3)) is as follows:
a) the average of prices in up to seven reference basket countries, provided that the medicinal product is present in at least two reference basket countries;
b) the average of identified prices within the EU, where point (a) cannot be applied;
c) a therapeutically comparable medicinal product (TPLP) in the Czech Republic, where points (a) and (b) cannot be applied
(i.e. the lowest price of a medicinal product containing the same active substance, pharmaceutical form and strength; where more than one TPLP exists, the lowest price of the medicinal product with the same or the closest pack size is used);
d) the average price of TPLP in the reference basket, where points (a) to (c) cannot be applied
(from each reference basket country, the lowest price of a medicinal product containing the same active substance, pharmaceutical form and strength is used; where more than one such product exists, the lowest price of the medicinal product with the same or the closest pack size is applied).
Determination of MC / Price Referencing
Pursuant to the amendment to Decree No. 376/2011 Coll., new rules apply concerning the relevant exchange rate and exceptions in situations where, during price referencing for the purpose of MC determination, the exchange rate deviation exceeds 10% compared to the average quarterly exchange rates over the preceding six calendar months:
where no more than three medicinal product pricesare identified, conversion is carried out using theaverage exchange rate for the preceding six calendar quarters prior to the relevant exchange rate (Section 3(2) of the Decree);
where more than three medicinal product prices are identified, any price whose relevant exchange rate deviates by more than 10% from the average quarterly exchange rates over the preceding six calendar quarters is excluded (Section 7(2) of the Decree).
Exclusion of a Foreign Price from External Reference Pricing
The deviation of the lowest identified price exceeds 20% compared to the average of the second and third lowest prices, the average of the second and third lowest prices or the DNCV is applied (Section 7(1) of the Decree);
More than three prices are identified, SÚKL excludes the price associated with an exchange rate that deviates by more than 10% from the average exchange rate over the preceding six calendar quarters (Section 7(2) of the Decree);
Market-wide regulatory measuresaffecting the market have been introduced in an EU Member State and SÚKL has received official information from the competent authority of that Member State or from the Ministry of Health (Section 7(3) of the Decree).
Determination of Reimbursement for Medicinal Products
Determination of the base reimbursement amount (Section 39c(2)(a) of the Public Health Insurance Act)
Manufacturer price / ODTD in the EU:
where it is demonstrated in administrative proceedings that the medicinal product is not present on the market in a given EU country, such price reference is excluded;
availability requirements:
medicinal products within substitutability on the Czech market ≥ 5%;
a similar product for six months from the date on which the decision determining its reimbursement amount and conditions becomes enforceable, at the latest until another reimbursed similar product becomes available pursuant to Section 39b(4), first sentence, excluding the originally reimbursed product;
a medicinal product with a concludedDNCV (maximum manufacturer price agreement) orDoÚ (reimbursement agreement) forsix months from the effective date of the written agreement.
Determination of Reimbursement / Price Referencing
Where the relevant exchange rate deviates by more than 10% compared to the average quarterly exchange rates of the foreign exchange market published by the Czech National Bank over the preceding six calendar quarters, conversion into Czech currency is carried out using the average exchange rate published by the Czech National Bank over the preceding six calendar quarters (Section 11(2) of the Decree).
Determination of Base Reimbursement / Price Referencing
In the event of the introduction of market-wide measures, the Institute excludes the identified foreign manufacturer price in the EU Member State analogously pursuant to Section 7(3) (Section 12(4) of the Decree).
Where the deviation of the lowest identified price is ≥ 20% compared to the average of the second and third lowest prices, the price extreme is excluded. This does not apply to VILP and LPVO (Section 16(2) of the Decree).
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.
The Dawn of the Amendment to the Public Health Insurance Act article series has gradually introduced the changes that will take effect from 1 January 2026. With the aim of increasing awareness of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
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.
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 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...
SÚKL provides the following information regarding its year-end operations in 2025.
The SÚKL registry office will be open on 23 December 2025 and 31 December 2025 from 8:00 a.m. to 12:00 p.m.
The SÚKL cash desk will be open on 23 December 2025 from 9:30 a.m. to 11:00 a.m. From 27 December to 31 December 2025, the SÚKL cash desk will be closed.
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...
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.
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 Act on Public Health
Insurance provides that the amount and conditions of temporary reimbursement
for Highly Innovative Medicinal Products (VILP) are set for a period of 3
years, with the possibility of re-setting the reimbursement for no more than an
additional 2 years.
In an ongoing administrative
proceeding on the first temporary reimbursement for a VILP in tablet form, the
State Institute for Drug Control (the Institute) proposes to limit the duration
of the first temporary reimbursement so that it expires at the same time as the
first temporary reimbursement of a therapeutically interchangeable medicine
with the same active substance in capsule form for the same indication.
Accordingly, in this case, the first temporary reimbursement for the tablets
will be granted for a period shorter than 3 years.
The Institute also states that the public health insurance
expenditure on reimbursement of the product in tablet form, supplied to insured
persons during the validity of the temporary reimbursement decision, must not
exceed the amount specified in the budget impact analysis that served as the
basis for the decision in the previous administrative proceeding on the first
temporary reimbursement of the therapeutically interchangeable capsule
formulation.
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 response to requests from applicants (manufacturers/suppliers of ZUM) whose devices are listed in the ÚK VZP – ZP, VZP has also published a list of VZP codes for which, as of 7 October 2025, it records terminal EMDN branches; see List of ZUM with a Terminal EMDN Branch.
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.
