According to the Ministry of Health
(MZ), even a single health insurance company can demonstrate that the presented
budget impact exceeds the current financial capacity of its fund, even if
this applies only to that specific insurer.
Rejecting
the statement of one insurance company solely because other insurers remain
silent or their statements are less convincing (or not sufficiently
substantiated) is, in the Ministry’s view, irrational. If the presented budget
impact poses an economic risk to even one health insurance company, this is
clearly a factor indicating the unacceptability of the proposed budget impact.
The
requirement by SÚKL for statements from all health insurance companies
regarding the acceptability of the budget impact has no legal basis, according
to the Ministry of Health.
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 text was translated using ChatGPT 4o.
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.
The State Institute for Drug Control questioned the cost-effectiveness of the medicinal product from the group of drugs used for the treatment of functional gastrointestinal disorders, as presented in the administrative proceedings. The reason was significant uncertainties in the submitted analysis.
Upon reviewing the
documentation, the Institute identified several problematic aspects. Pharmaceutical
costs had increased compared to the originally submitted data. Uncertainties
regarding dosage—the method of dose determination was unverifiable, and it was
impossible to clearly establish the considered dosage for individual patients. Serious
discrepancies in total cost presentation—different values appeared in various
sections of the documentation.
All these
inconsistencies prevented a proper assessment of cost-effectiveness.
Given these
findings, the Institute concluded that the submitted analysis did not meet the
minimum quality requirements, and therefore, the medicinal product could not be
considered a cost-effective intervention.
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 text was translated using ChatGPT 4o.
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.
SÚKL, in the reimbursement review, assessed the expansion of JAK
inhibitors reimbursement for rheumatoid arthritis ("RA") with
moderate disease activity as sufficiently supported by clinical data and
desirable for clinical practice in the Czech Republic.
Given that such an expansion of reimbursement conditions would result in
an increase in the number of treated patients, it is necessary to evaluate the
cost-effectiveness and the budget impact. Since SÚKL did not receive a
pharmacoeconomic evaluation from the participants in the required scope, the
expansion of reimbursement for rheumatoid arthritis with moderate disease
activity was carried out by setting the reimbursement for JAKi at the cost
level of another therapy that is (at least) equally effective and already
reimbursed for the target group of patients with RA and moderate disease
activity. The approach chosen by SÚKL in the ongoing reimbursement review,
therefore, by setting two reimbursement levels, ensures that JAKi remain
reimbursed for RA with high disease activity in the second and subsequent lines
of treatment with higher reimbursement, while JAKi are also newly reimbursed
for moderate disease activity, though at a lower reimbursement amount.
The participant argued that a medicinal product may only have one
additional increased reimbursement level set, alongside the basic reimbursement
(not multiple increased reimbursement levels, as SÚKL did). SÚKL refers to
Section 39b, paragraph 11 of the Health Insurance Act, which does not exclude
the possibility of applying it based on the evaluation of a medicinal
substance, product, or pharmaceutical form for several selected indications or
for multiple patient groups.
SÚKL also states that during the ongoing reimbursement review, no
statements were received from payers regarding any difficulties in reporting
healthcare when establishing multiple reimbursement levels.
Articles from decision-making practice are based on publicly available
texts from decisions by the Ministry of Health of the Czech Republic and
decisions by SÚKL.
On the website of Pharmeca a.s., you can continuously follow an overview of the pricing and reimbursement decisions issued by SÚKL and the Ministry of Health of the Czech Republic.
Articles on decision-making practice are based on publicly available texts of the Ministry of Health and SÚKL decisions.
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.
The European Medicines Agency (EMA) has
announced the launch of a new platform designed to routinely monitor shortages
of centrally authorized medicines. This platform is a direct result of Regulation
(EU) 2022/123, which aims to improve preparedness for and mitigation of
medicine shortages across EU member states.
Key Points:
Platform
Availability:
The European Shortages Monitoring Platform (ESMP) is now accessible
online.
Mandatory
Usage:
Starting from February 2, 2025, all Marketing Authorization Holders (MAHs)
with centrally authorized products will be required to use the ESMP.
Early
Familiarity:
EMA encourages MAHs to familiarize themselves with the platform before the
mandatory deadline.
Data
Submission:
Until February 2, 2025, MAHs and National Competent Authorities (NCAs) can
submit data on supply, demand, and availability of both centrally and
nationally authorized medicines to the EMA's Executive Steering Group on
Shortages and Safety of Medicinal Products (MSSG).
Medicine
Monitoring:
The platform will be used for routine monitoring of all centrally
authorized medicines and may also be used for monitoring nationally
authorized medicines under special circumstances.
The European Medicines Agency (EMA) has announced the launch of a new platform designed to routinely monitor shortages of centrally authorized medicines.
Starting january 1, 2025, Pharmeca a.s. will provide an overview of issued decisions by the State Institute for Drug Control (SÚKL) and the Ministry of Health of the Czech Republic (MZ ČR) related to pricing and reimbursement on its website.
For marketing authorization holders, knowledge of SÚKL and MZ ČR decisions in the area of pricing and reimbursement is essential. The outcomes of individual proceedings shape decision-making practices that influence future decisions.
To address this need, Pharmeca a.s. now offers an interactive overview of decisions issued in the past five weeks.
Pharmeca a.s. provides services in the areas defined by this
legislative framework:
Act No. 48/1997 Coll.,on
Public Health Insurance and on Amendments to Some Related Acts, as
amended.
Implementing Regulation:
Decree
No. 376/2011 Coll.,
which implements certain provisions of the Public Health Insurance Act, as
amended,
Decree
No 384/2007 Coll., on
the list of reference groups, as amended,
Decree
No 385/2007 Coll., on
the list of active substances for adjunct or add-on therapy;
Decree
No. 63/2007 Coll.,
on the reimbursement of medicinal products and foods for special medical
purposes, as amended.
Decree
No. 618/2006 Coll.,
which issues framework agreements, as amended,
Decree
No. 134/1998 Coll.,
which issues a list of medical services with point values, as amended,
Decree
No. 527/2021 Coll.,
on determination of the amount of reimbursement of expenses for
professional acts and the method of determination of the amount of
compensation of expenses for professional consultations carried out by the
State Institute for Drug Control under the Public Health Insurance Act, as
amended,
Decree
on the determination of point values, the amount of payments for paid
services and regulatory restrictions - always issued for the current year,
Government
Regulation No. 307/2012
Coll., on local and temporal availability of health services, as amended.
Act No. 551/1991 Coll., on the
General Health Insurance Company of the Czech Republic, as amended.
Act No. 280/1992 Coll., on
departmental, branch, corporate and other insurance companies, as amended.
Act No. 592/1992 Coll., on
public health insurance premiums, as amended.
Implementing Regulation:
Decree
No. 351/2022 Coll.,
on the transmission of data on the consumption of medicinal products by
insured persons of the public health insurance when changing the health
insurance company, as amended
Price
Regulation of the Ministry of Health No. 4/2024/OLZP, on the
determination of a special distribution surcharge for medicinal products
released from the reserve stock system,
Price
Decision of the Ministry of Health No. 3/2024/OLZP, dated November 29,
2023, setting out lists of ATC groups with the relevant route of
administration, for which the ex-factory price of the medicinal product is
not subject to price regulation or maximum price regulation,
Price
Regulation of the Ministry of Health No. 2/2024/OLZP, dated November
29, 2023, on the price regulation of medicinal products and foods for
special medical purposes,
Price
Regulation of the Ministry of Health No. 11/2023/OLZP, dated October
25, 2023, on the determination of the distribution and dispensing
surcharge for medicinal products reimbursed under Section 32c of Act No.
48/1997 Coll.,
Price
Regulation No. 3/2022/OLZP, on the price regulation of individually
prepared medicinal products containing cannabis for medical use.
Price Regulations – Medical Devices:
Price
Regulation of the Ministry of Health No. 1/2024/OLZP, dated October
25, 2023, on the price regulation of medical devices and in vitro
diagnostic medical devices,
Price
Regulation of the Ministry of Health No. 2/2022/OLZP, dated January 7,
2022, amending Price Regulation No. 1/2019/CAU, dated May 22, 2019, on the
price regulation of medical devices,
Price
Decision 2/13-FAR, establishing a list of medical devices with
deregulated manufacturer prices.
Act No. 378/2007 Coll., on
Pharmaceuticals, as amended.
Implementing Regulation:
·
Decree No. 457/2023 Coll.,
establishing a list of human medicinal products exempt from the obligation of
the marketing authorization holder to ensure their supply after the announced
date of supply interruption or discontinuation, as amended.
Decree
No. 84/2008 Coll., on
good pharmaceutical practice, detailed conditions of handling
pharmaceuticals in pharmacies, healthcare facilities and other operators
and facilities supplying medicinal products, as amended,
Decree
No. 85/2008 Coll., which
lays down a list of active substances and excipients which may be used in
the preparation of medicinal products, as amended,
Decree
No 226/2008 Coll., on
good clinical practice and detailed conditions of clinical trials on
medicinal products, as amended,
Decree
No. 228/2008 Coll.,
on the marketing authorisation of medicinal products, as amended,
Decree
No. 229/2008 Coll.,
on the manufacture and distribution of pharmaceuticals, as amended,
Decree
No. 236/2015 Coll.,
on the determination of conditions for prescription, preparation,
distribution, dispense and use of individually prepared medicinal products
containing cannabis for medical use, as amended,
Decree
No. 329/2019 Coll.,
on prescribing medicinal products in the provision of health services, as
amended,
Decree
No. 463/2021 Coll.,
on the detailed conditions for conducting a clinical trial of medicinal
products for human use, as amended.
Act No 167/1998 Coll,
on addictive substances and
amending certain other acts, as amended
Implementing Regulation:
Decree
No. 53/2014 Coll.,
on forms under the Addictive Substances Act, as amended,
Decree
No. 123/2006 Coll., on evidence
and documentation of
addictive substances and preparations, as amended,
Decree
No. 243/2009 Coll., on
establishing a list of persons indicating their workplaces for their work
is not required permit to treatment of addictive substances and
preparations containing them, as amended,
Government
Regulation No. 463/2013 Coll.,
on lists of addictive substances, as amended,
Decree
No. 235/2022 Coll.,
on the cultivation and processing of cannabis plants for medicinal use, as
amended,
Decree
No 53/2022 Coll.,
on the determination of the amount of compensation of expenses for
professional acts performed by the State Institute for Drug Control
pursuant to the Act on Addictive Substances, as amended.
Act No. 375/2022 Coll., on
medical devices and in vitro diagnostic medical devices, as
amended.
Implementing Regulation:
Decree
No 377/2022 Coll.,
on the implementation of certain provisions of the Act on medical devices
and in vitro diagnostic medical devices, as amended,
·
Decree No. 378/2022 Coll., on the
template of the inspector's identification card of the State Institute for Drug
Control under the Act on Medical Devices and In Vitro Diagnostic Medical
Devices, as amended.
Decree
No 379/2022 Coll.,
on the determination of the amount of compensationof
expenses for professional acts performed by the State Institute for Drug
Control pursuant to the Act on Medical Devices and In Vitro Diagnostic
Medical Devices, as amended.
Act No 376/2022 Coll.
amending certain acts in connection with the adoption of the Act on medical
devices and in vitro diagnostic medical devices, as amended.
Act No.268/2014 Coll.,on
medical devices and amending Act No. 634/2004 Coll., on administrative
fees, as amended.
Act No. 89/2021 Coll., on
medical devices and amending Act No. 378/2007 Coll., on pharmaceuticals and on
amendments to certain related acts (Act on pharmaceuticals), as amended.
Implementing Regulation:
·
Notification of the Ministry of Health No.
54/2022 Coll., on the commissioning of the central repository of electronic
vouchers.
Act No. 22/1997 Coll., on
Technical Requirements for Products and amendments to some related
acts, as amended.
Act No. 90/2016 Coll., on the
assessment of the conformity of specified products when they are placed on the
market, as amended.
Act No. 372/2011 Coll., on
health services and conditions for their provision (the Health
Services Act), as amended.
Decree No. 373/2016 Coll., on the
transfer of data to the National Health Information System, as amended.
Act No. 40/1995 Coll., on the
regulation of advertising and on amending and supplementing Act No. 468/1991
Coll., on the operation of radio and television broadcasting, as
amended.
Act No 242/2022 Coll., on the
services of video sharing platforms and amending certain related acts (Act
on the services of video sharing platforms), as amended.
Act No. 387/2024
Coll., on General Product Safety and Amendments to Certain Related Acts, as
amended.
Act No. 500/2004 Coll.,
Administrative Code, as amended.
The European Medicines Agency (EMA) has
announced the launch of a new platform designed to routinely monitor shortages
of centrally authorized medicines. This platform is a direct result of Regulation
(EU) 2022/123, which aims to improve preparedness for and mitigation of
medicine shortages across EU member states.
Key Points:
Platform
Availability:
The European Shortages Monitoring Platform (ESMP) is now accessible
online.
Mandatory
Usage:
Starting from February 2, 2025, all Marketing Authorization Holders (MAHs)
with centrally authorized products will be required to use the ESMP.
Early
Familiarity:
EMA encourages MAHs to familiarize themselves with the platform before the
mandatory deadline.
Data
Submission:
Until February 2, 2025, MAHs and National Competent Authorities (NCAs) can
submit data on supply, demand, and availability of both centrally and
nationally authorized medicines to the EMA's Executive Steering Group on
Shortages and Safety of Medicinal Products (MSSG).
Medicine
Monitoring:
The platform will be used for routine monitoring of all centrally
authorized medicines and may also be used for monitoring nationally
authorized medicines under special circumstances.
The European Medicines Agency (EMA) has announced the launch of a new platform designed to routinely monitor shortages of centrally authorized medicines.
The European Health Data Space should lead to the empowerment of citizens and support for research and innovation.
EU residents will have more control over their health data,
being able to access it electronically and share it across borders. This
is particularly beneficial for cross-border healthcare, allowing
individuals to access medical records and receive care seamlessly
throughout the EU.
The EHDS promotes the secondary
use of health data for research, innovation, and policy-making.
Researchers and innovators will be able to access health data more easily
and securely, which could drive the development of new treatments, medical
devices, and AI applications.
The main objectives of the European Health Data Space (source: excerpt from the Communication from the Commission to the European Parliament and the Council: The European Health Data Space: Harnessing the power of health data for people, patients, and innovation):
The European Health Data Space (EHDS) has advanced significantly since the initial concept of a digital transformation in healthcare across all EU member states.