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...
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...
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...
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...
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 Advisory Board for the Reimbursement of Medicinal
Products Intended for the Treatment of Rare Diseases at the Ministry of Health
of the Czech Republic has published a summary report evaluating its application
practice from May 2022 to March 2025.
In addition to listing the legal requirements related to
orphan drugs and a comprehensive overview of all proceedings within the
reviewed period, one chapter focuses on the key lessons learned from the
advisory board's experience.
The Advisory Board for the Reimbursement of Medicinal Products Intended for the Treatment of Rare Diseases at the Ministry of Health of the Czech Republic has published a summary report evaluating...
