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...
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 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 Ministry of Health of the Czech
Republic agreed to grant reimbursement for an orphan medicinal product (LPVO)
in the indication treatment of advanced gastrointestinal stromal tumour (GIST).
The medicine is intended for a small patient population and, although the
expected duration of therapy is measured in months and its effect is not
curative, it enables a significant prolongation of progression-free survival
while maintaining a good quality of life.
The advisory board unanimously supported
inclusion of this product in reimbursement, as the evidence in the file
demonstrated its efficacy in fourth-line treatment of a rare malignancy for
which no therapeutic alternative exists and where there is a clear unmet
medical need.
The Ministry’s approval was justified,
inter alia, by the fact that patients’ conditions require rapid treatment
initiation, which individual exceptional reimbursement applications under
Section 16 do not accommodate with sufficient flexibility.
According to the reasoning, contractual
arrangements with health insurance companies also contributed to the positive
opinion, resulting in a more favourable projected budget impact—not only
compared with the findings of the assessment report, but also relative to current
Section 16 practice.
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.
VZP informs applicants about the option to keep non-traded medical devices without EMDN in the Reimbursement Catalogue.
As part of the ongoing refinement of the VZP Reimbursement Catalogue – Medical Devices (ÚK VZP – ZP) and following a request from the Ministry of Health in connection with forthcoming legislation, all medical devices that were included in the ÚK VZP – ZP (ZUM) by 31 December 2023 and that, according to VZP ČR and SZP ČR data, were not traded (no recorded sales) between 1 January 2024 and 30 June 2025, and for which no EMDN category was submitted by 31 August 2025, and for which VZP ČR does not receive the relevant proposal, will be removed from the ÚK VZP – ZP (ZUM) as of 1 March 2026.
VZP hereby informs applicants of the possibility to keep non-traded ZUMs without EMDNin the Reimbursement Catalogue.
Applicants may, by 31 December 2025, submit the proposal “2. CH NÁVRH NA PONECHÁNÍ NEOBCHODOVANÝCH ZUM V ÚK VZP – ZP – VZP ČR” (Proposal to Retain Non-Traded medical devices in the ÚK VZP – ZP – VZP ČR) if they wish to keep non-traded medical devices without EMDN in the catalogue.
If the proposal is not submitted or is rejected, the ZUMs concerned will be removed from the ÚK VZP – ZP.
For medicinal products included in
a reference group that are not granted a reimbursement amount or conditions
beyond those of interchangeable products, a cost-effectiveness analysis is not
required. Newly, however, a budget impact analysis (BIA) must be submitted including
a calculation of deductible co-payments.
According to the State Institute
for Drug Control (SÚKL), the BIA should consider all medicinal products
included in the relevant reference group. On the other hand, for example in
proceedings on price and reimbursement in reference group No. 104/7 –
therapeutic allergen extracts – standardised, depot injectable, the calculation
of deductible co-payments must reflect actual practice: a product containing
dust-mite allergens will in practice be replaced exclusively by products
containing only these allergens. For this reason, including other
interchangeable products (from the same reference group) in the BIA should not
affect the result, because their costs would be the same in the world with and
without the assessed intervention and therefore cancel out.
The analysis works with costs of
deductible co-payments that would accrue to health insurance companies when the
annual out-of-pocket cap is exceeded. Excluding the CZK 1,000 insured
person’s cap from the analysis was accepted by SÚKL in the above-mentioned case
as a conservative setting. SÚKL found that including a CZK 5,000 cap per
insured person would lead to higher deductions in the world with the assessed
intervention (CZK 5,000 per patient) than in the world without it (less than
CZK 5,000 per patient), thus lowering the resulting budget impact. If the CZK 1,000 cap were applied,
the patient in the world without the assessed intervention would exceed this
cap in the first year only, not in subsequent years. Even when accounting for
this lower cap, the resulting budget impact would remain lower.
The analysis should include separate
results for the budget impact without deductible co-payments and with deductible
co-payments.
Previously published SÚKL
guidance also states that the analysis must reflect co-payments actually
applied in practice. To calculate real deductible
co-payments, SÚKL uses average pharmacy prices per pack, obtained from reports
under guideline LEK-13.
Costs of deductible co-payments
relate to prescription-dispensed products; therefore, products billed on
requisition forms are not included in the consumption analysis.
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 a
previously conducted in-depth reimbursement review, the medicine containing
budesonide in tablet form was assessed as generally therapeutically
interchangeable with rectal formulations in the reference indication of
treatment of acute ulcerative colitis affecting the rectum and sigmoid colon.
This conclusion was primarily based on the results of the CORE I and CORE II
studies in a subgroup of patients with proctosigmoiditis.
However,
following the entry of another budesonide-based medicine in suppository form
into the reimbursement system during an ongoing review procedure, the Institute
(SÚKL) decided to narrow the reference indication to the treatment of acute
ulcerative colitis affecting the rectum only.
In the
issued assessment report, the Institute responded to objections raised by one
of the parties, pointing out that patients with ulcerative colitis limited to
the rectum were not included in the registration studies for the tablet
formulation. Therefore, it is not possible to draw conclusions regarding the
efficacy and safety of the tablet form for this specific patient group based on
those studies, nor to conduct a direct comparison with rectal formulations of
budesonide.
Given the
different clinical uses, the Institute proposes dividing the assessed medicines
into two separate groups:
a) Budesonide
for the treatment of ulcerative colitis affecting the rectum (rectal
formulations) – reference indication: treatment of acute ulcerative colitis
affecting the rectum.
b) Budesonide
for the treatment of ulcerative colitis (oral formulations) – reference
indication: treatment of acute ulcerative colitis affecting the rectum and
sigmoid colon.
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.
