The Methodology sets out the procedures for including new
ZUM in the VZP Medical Devices Reimbursement Catalogue, making changes to
devices already included in the Catalogue, and increasing their price and
reimbursement.
A new version 3.0 takes effect on 1 September 2026,
introducing a major change in the assessment of innovative ZUM.
The previous distinction between moderate and substantial
innovation has been replaced by three pathways: medical device innovation
bonus, expert assessment of innovation, and economic and clinical assessment
(HTA).
📈 Medical Device
Innovation Bonus
A simplified pathway for ZUM where the clinical benefit can
be demonstrated by meeting predefined clinical criteria. If at least one of
these criteria is met, a 15% bonus may be granted compared with the
reference comparator or group of reference comparators. The criteria include,
for example, improvement in a clinically relevant outcome, shorter
hospitalisation or recovery time, or a reduced risk of reoperation or reimplantation.
🔎 Expert Assessment of
Innovation
This pathway is intended for ZUM providing a relevant
clinical, safety or organisational benefit where a full economic and clinical
assessment is not required. The assessment focuses in particular on clinical
effectiveness, safety, quality of evidence, organisational benefits,
implementation requirements, and the expected budget impact. A budget impact
analysis (BIA) must be included in the submission.
📊 Economic and
Clinical Assessment (HTA)
The most comprehensive pathway applies to innovative ZUM
with a significant impact on the public health insurance system or where it is
necessary to assess whether the additional costs are proportionate to the
claimed clinical benefit. The assessment covers clinical benefits, safety,
cost-effectiveness and budget impact. This pathway is also subject to the VZP
ČR Methodology for the Economic and Clinical Assessment of Medical Devices.
The Methodology also addresses, among other matters, maximum
assessment timelines for selected procedures, the possibility of increasing
prices and reimbursement in accordance with the applicable Price Regulation,
and the possibility of suspending the assessment process in order to obtain
expert opinions.
Do you need assistance with preparing the documentation
for the establishment of the price and reimbursement of your medical
device by VZP? Do not hesitate to contact us.
Pharmeca a.s. has extensive experience, including in the
field of economic and clinical assessment (HTA). This expertise enables us to
support you in preparing a complete documentation package for the assessment of
your medical device.
Our knowledge, your opportunity.
The English translation was prepared using the latest available ChatGPT model.
VZP has published a new methodology governing the inclusion, changes, and increases in the price and reimbursement of separately charged materials (ZUM) within its Reimbursement Catalogue.
The first assessment reports
have been issued in proceedings concerning immunological medicinal products
conducted under the new rules introduced by the amendment to the Public Health
Insurance Act.
As part of these proceedings,
the importance of vaccination was assessed from several key perspectives:
Societal and social benefits –
the assessment considered not only the impact of vaccination on reducing the
number of infections, but also, for example, the deterioration in children’s
school performance associated with illness and protection against permanent
functional impairment, which in adult patients may affect independence, family
life and overall quality of life.
Economic benefits – the
assessment focused on direct costs, including savings resulting from a reduced
need for treatment and a lower burden on healthcare facilities, as well as
indirect costs, such as loss of household income, productivity losses and reduced
government expenditure on sickness benefits, disability pensions and similar
social benefits.
In these specific cases, prevention through vaccination was
found to be a more economically favourable strategy than the subsequent
treatment of complicated cases of disease.
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 English translation was prepared using the latest available ChatGPT model.
The Ministry of Health (MoH) rejected an application to reopen the proceedings.
The applicant argued that, following the conclusion of the original reimbursement review, previously unknown facts had emerged—namely data on the supply and consumption of medicinal products and their market shares. According to the applicant, these data called into question, or even ruled out, the correctness of the established usual daily therapeutic dose (UDTD).
According to the MoH, data on the supply and consumption of medicinal products are known to the State Institute for Drug Control (the Institute) through its official activities and are published by the Institute on a monthly basis. The applicant could therefore have had access to these data already during the original proceedings. Moreover, specific documents containing data on the consumption of the medicinal products concerned in 2022 had formed part of the case file throughout the original reimbursement review. The statutory requirement of “previously unknown facts” was therefore not met.
The MoH further stated that potentially higher consumption of certain strengths of the medicinal products is not decisive for determining the UDTD. Other factors are key to determining the UDTD, including WHO recommendations, the SmPC, scientific literature and clinical guidelines, all of which had been duly assessed in the original proceedings. The applicant’s submission could therefore not have resulted in a different conclusion on the matter.
The MoH therefore rejected the application to reopen the proceedings and did not permit the proceedings to be reopened.
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 English translation was prepared using the latest available ChatGPT model.
In an abbreviated
reimbursement review triggered by the market entry of the first similar
medicinal product (generic), the State Institute for Drug Control (the
Institute) reduced the base reimbursement for a group of medicinal products
stimulating platelet production following the launch of the first generic
product. One of the
parties to the proceedings, the marketing authorisation holder of a
medicinal product included in the same group but containing a different active
substance than the newly introduced first similar medicinal product, challenged
the therapeutic interchangeability of the individual active substances. The
party submitted new scientific evidence and raised objections regarding safety.
However, the Institute rejected these arguments, referring to previous
administrative proceedings and the legislation governing abbreviated
reimbursement reviews.
In its response,
the Institute stated that the purpose of an abbreviated review is not to
reassess the therapeutic interchangeability of medicinal products. That issue
is addressed within full reimbursement reviews. In the present proceedings, the
Institute relied on conclusions that had already become final in previous full
reimbursement reviews and individual administrative proceedings.
According to the
Institute, the purpose of an abbreviated review under the Act is to ensure a swift
procedure, avoiding extensive scientific debate with the parties in order to
achieve timely savings for the public health insurance system.
Its role is
limited to recalculating reimbursement levels on the basis of the current
external price reference.
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 English translation was prepared using the latest available ChatGPT model.
The Public Health Insurance Act
establishes a reimbursement cap applicable where the State Institute for Drug
Control (the Institute) decides on temporary reimbursementfor a new
therapeutic indication of a highly innovative medicinal product (VILP)
that already has permanent reimbursement established for another indication. The newly established temporary
reimbursement may not exceed the existing reimbursement granted for that
medicinal product. An exception applies where the product has been assigned to
a reference group containing other therapeutically interchangeable medicinal
products.
According to Section 39d(9) of
the Public Health Insurance Act: “Where proceedings are conducted
to establish temporary reimbursement for a medicinal product that is already
reimbursed from public health insurance in another therapeutic indication
pursuant to a decision of the Institute under Section 39h, the Institute shall
establish temporary reimbursement at an amount not exceeding the reimbursement
determined by that decision under Section 39h. This shall not apply where,
pursuant to a decision under Section 39h, the medicinal product has been
assigned to a reference group or another group of essentially therapeutically
interchangeable medicinal products that already includes other medicinal
products. Where temporary reimbursement has also been established for another
highly innovative medicinal product and the available evidence demonstrates
that it has comparable clinical use and comparable or similar efficacy and
safety, the Institute shall establish temporary reimbursement for the assessed
medicinal product at an amount not exceeding the temporary reimbursement granted
to the highly innovative medicinal product with comparable clinical use and
comparable or similar efficacy and safety, taking into account differences in
dosage and pack size.”
The Institute verifies compliance
with this statutory reimbursement cap in each proceeding concerning
temporary reimbursement. In one such proceeding, where the reimbursement
proposed by the applicant was equal to the permanent reimbursement already
established for another indication, the Institute granted reimbursement in line
with the applicant’s proposal.
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 English translation was prepared using the latest available ChatGPT model.
The State
Institute for Drug Control (the Institute) received a joint request from medical
societies to establish increased reimbursement for medicinal products
containing a selected active substance for the treatment of paraphilic
disorders, an indication that falls outside the approved marketing
authorisation (i.e. an off-label indication). In their statement, the medical
societies explained that the request was supported by clinical experience,
scientific evidence, and safety considerations.
The
Institute concluded that the therapy represents the only available treatment
option. Consequently, it did not require the submission of a cost-effectiveness
analysis; a budget impact analysis based on the number of patients reported by
the medical societies was considered sufficient.
Based on the
submitted documentation, the Institute concluded that reimbursement in this
off-label indication is adequately supported by current scientific evidence and
that the therapy constitutes the only available treatment option. It therefore
proposed granting increased reimbursement for this indication as well.
According to
Section 39b(3) of the Public Health Insurance Act: “…The
Institute may establish reimbursement for an unregistered medicinal product
where its use is sufficiently justified by current scientific knowledge and it
represents the only available treatment option, or where its use is
cost-effective compared with available treatment, for the duration of an
approved specific treatment programme. The Institute may also establish
reimbursement for a registered medicinal product for indications not included
in the Summary of Product Characteristics, provided that the use of the
medicinal product is sufficiently justified by current scientific knowledge and
represents the only available treatment option, or where it is cost-effective
compared with existing treatment.”
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 English translation was prepared using the latest available ChatGPT model.
As of 1 January
2026, an amendment to the Public Health Insurance Act has entered into force,
introducing, among other changes, new rules for determining the prices of
strategically important medicines. The aim is to prevent supply shortages
in the Czech Republic through a more flexible approach to setting maximum
prices.
For medicinal
products deemed to be in the public interest, the State Institute for
Drug Control (the Institute) now determines the maximum price based on:
·
the average of prices in up to seven of the
lowest-priced countries within the EU reference basket;
·
if the medicinal product is not available in at
least two reference basket countries, prices are compared across the entire EU,
or alternatively against therapeutically comparable medicines in the Czech
Republic or within the reference basket.
To prevent Czech
prices from being driven down by isolated price anomalies, the Institute applies
a number of exclusion rules:
·
if the lowest price in the EU is more than
20% lower than the average of the second and third lowest prices, it is
excluded from the calculation;
·
prices from countries experiencing significant
currency depreciation are excluded where three or more reference prices are
available;
·
prices distorted by government crisis
interventions in other countries are disregarded, provided that the Institute
has received official information about such measures.
The Institute
has already issued a number of decisions establishing maximum prices for
strategically important medicines. However, a concerning trend can be
observed in its decision-making practice. Although this “special regime” is
intended to enhance market stability, many decisions lack sufficiently
detailed reasoning clearly demonstrating that the statutory conditions for
applying this approach have been met.
The new framework
provides the state with a powerful tool for safeguarding the availability of
medicines. Its effectiveness, however, will depend on the transparency and
reviewability of decisions, ensuring that marketing authorisation holders
clearly understand how and why the final price was determined.
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.
A prescription voucher for a reimbursed medical device may
only be issued by a treating physician or by a healthcare professional with
specialised or special professional qualifications (e.g. a nurse, laboratory
technician, therapist, etc.). As of 1 January 2026, the use of an
electronic format (eVoucher) has become mandatory for this purpose,
subject only to specific exceptions.
On the other hand, the dispensing of medical devices
prescribed on a voucher, with subsequent reimbursement claimed from public
health insurance, may only be carried out by authorised dispensers. These
include pharmacies, medical device dispensing outlets, optical stores, or
contracted dispensing providers.
Provision of Medical Devices in a Physician’s Office
As noted above, a person authorised to issue a prescription
voucher is not authorised to dispense the prescribed medical device to the
patient and subsequently claim reimbursement from public health insurance on
the basis of that voucher.
However, certain groups of orthopaedic and prosthetic
medical devices (such as orthoses, cervical collars or crutches) are reimbursed
when prescribed on a voucher, while their intended purpose also allows their
use in the treatment of acute conditions. In such cases, and from the
perspective of appropriateness and patient safety, it is permissible for the
required medical device to be provided directly to the patient during treatment
in the physician’s office.
Several changes have been introduced since the beginning of the year in the area of prescribing and dispensing medical devices, including those related to the mandatory use of electronic...
