As part of a
streamlined reimbursement review for cost-saving purposes (§ 39p(1)), the State Institute for Drug Control unified reimbursement conditions by removing the “A” symbol (indicating use in ambulatory
care) for products that can be self-administered by patients after prior
training.
The
Institute argued that if all products in a given group serve the same purpose
and can be administered by patients, there is no reason for them to be subject
to different reimbursement conditions. Previously, some products required immediate
administration by a physician (marked with the “A” symbol), while others—therapeutically
interchangeable—were not subject to such restriction.
The appeal
body agreed with this reasoning and described the previous arrangement as inefficient.
The
Institute had already reached the same conclusion in 2022, stating that if the
accompanying texts (SPC/PIL) allow for patient self-administration after proper
training instead of administration in ambulatory care, the “A” prescription
restriction (ZULP for ambulatory care) may be removed without requiring a
pharmacoeconomic assessment, as no expansion in the number of treated patients
occurs.
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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 Ministry of
Health annulled the decision of the State Institute for Drug Control (SÚKL) on
the grounds that the Institute had failed to respect the Ministry’s previous
binding legal opinion, as set out in its earlier decision — which we reported
in our regular 2021 newsletter.
In 2021, the
Association of Health Insurance Companies (Svaz ZP) appealed against the
extension of reimbursement conditions for products containing inosine pranobex
as part of a comprehensive reimbursement review. The Institute had approved the
extension without assessing the cost-effectiveness and budget impact of the
proposed change.
The Ministry stated
that the removal of reimbursement conditions, such as prescription and
indication restrictions, constitutes an expansion of reimbursement that leads
to an increase in the number of treated patients. Following the change, all
medical specialists could prescribe these products for reimbursement from
public health insurance within the approved therapeutic indications listed in
the SPC. However, the Ministry emphasized that the prevalence of the relevant
conditions in the general Czech population was likely much higher than the
number of patients covered under the prior reimbursement restrictions. The
contested decision would thus logically lead to increased use and higher
reimbursement costs.
By extending
reimbursement without a proper assessment of cost-effectiveness and budget
impact, the Institute acted unlawfully.
In the further
course of the administrative proceedings, the Institute was not allowed to
change the reimbursement conditions in a way that would increase the number of
treated patients without the submission and assessment of the relevant
pharmacoeconomic analyses from the parties to the proceedings. However, after
the participants failed to provide the requested analyses, the Institute
performed its own calculations and again extended the reimbursement conditions.
This decision was again challenged — all payers filed an appeal.
Following further
review, the Ministry of Health reiterated that the Institute may not create its
own pharmacoeconomic analyses for the purpose of changing reimbursement
conditions in the absence of such analyses submitted by the parties. The
Institute is only authorized to perform corrective recalculations or similar
adjustments within the scope of analyses provided by the parties.
For these reasons,
the Ministry annulled the Institute’s decision once again.
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 its decision,
the Ministry of Health confirms the possibility of ensuring patients’
right to free (i.e., fully reimbursed) medicinal products from the groups
listed in Annex No. 2 to Act No. 48/1997 Coll., even through products
that are not available on the Czech market at the time of the SÚKL decision,
as long as it is certain that such products will be available in
sufficient quantitiesat the time the administrative decision becomes
enforceable.
This typically
applies to contractual arrangements between marketing authorization
holders and health insurance companies, which include a binding
commitment to ensure availability of the respective medicinal
products.
On the other hand, the
right to free medicinal products cannot be ensured through products that
are not present on the Czech market or are available only in
negligible quantities.
Furthermore,
according to the Ministry of Health of the Czech Republic, SÚKL is
not obliged to verify whether a product has been reported as temporarily
unavailable on the domestic market, since such a temporary
unavailability concerns only a transitional period, unlike permanent
discontinuation of supply.
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.
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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.
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.
On February 21, 2025, the Ministry of Health of the Czech Republic published the following opinion on the procedure for assessing the financial impact on the health insurance system when determining or changing the amount and conditions of reimbursement for a medicinal product or food for special medical purposes:
"The Department of Medicinal Products and Medical Devices of
the Ministry of Health of the Czech Republic (hereinafter referred to as
"the Ministry"), in view of the wording of the applicable Act No.
338/2024 Coll., amending Act No. 48/1997 Coll., on Public Health Insurance and
on Amendments and Supplements to Certain Related Acts, as amended, Act No.
592/1992 Coll., on Insurance Contributions for Public Health Insurance, as
amended, and Act No. 378/2007 Coll., on Medicinal Products and on Amendments to
Certain Related Acts (the Medicinal Products Act), as amended, which, with
effect from January 1, 2025, changes the principles in the area of monitoring
limits of deductible co-payments for partially reimbursed medicinal products
and foods for special medical purposes (the protective limit) and the
subsequent reimbursement of deductible co-payments exceeding the protective
limit under Act No. 48/1997 Coll., on Public Health Insurance and on Amendments
and Supplements to Certain Related Acts, as amended (hereinafter referred to as
"the Public Health Insurance Act"), hereby issues its opinion on the
procedure for assessing the financial impact on the health insurance system
when determining or changing the amount and conditions of reimbursement for medicinal
products or foods for special medical purposes.
The method of assessing the financial impact on the health
insurance system (hereinafter referred to as "budget impact") is
expressed in the third and fourth sentences of Section 15(8) of the Public
Health Insurance Act, which state that "The budget impact is determined
as the difference between the costs of treating a given disease associated with
the use of a medicinal product or food for special medical purposes that would
be reimbursed from health insurance funds, and the costs of treatment using
another medicinal product, food for special medical purposes, or treatment
method that is already reimbursed from health insurance funds. The budget
impact must be in accordance with the public interest pursuant to Section
17(2)."
If, under Section 15(9) of the Public Health Insurance Act,
the anticipated budget impact associated with determining reimbursement for a
medicinal product or food for special medical purposes shows an increase in
expenditures from the health insurance system, the budget impact assessment
must be conducted through a budget impact analysis submitted by the applicant,
which the State Institute for Drug Control assesses during the proceedings [see
Section 39b(2)(c) of the Public Health Insurance Act].
The requirements of the third and fourth sentences of
Section 15(8) of the Public Health Insurance Act for the applicant-submitted
budget impact analysis and the procedure of the State Institute for Drug
Control in its assessment are elaborated in the methodology SP-CAU-27
(hereinafter referred to as "the methodology") as of the date of this
opinion. For the purpose of quantifying the budget impact, the methodology
allows only the perspective of health insurance expenditures (for completeness,
it should be noted that this applies outside of proceedings conducted under
Section 39da of the Public Health Insurance Act).
The Ministry is aware from its own official activities that
the State Institute for Drug Control currently considers only direct costs
(both pharmaceutical and non-pharmaceutical) demonstrably incurred from health
insurance in connection with the therapy of the given disease as relevant costs
in the budget impact assessment, whereby the State Institute for Drug Control
considers only the costs at the level of reimbursement from health insurance,
or costs corresponding to the maximum consumer price if this price is lower
than the reimbursement amount, as direct pharmaceutical costs for both the
evaluated intervention and the comparator.
However, as the Public Health Insurance Act stipulates
that the budget impact is determined as the difference in treatment costs for
the given disease (from the perspective of health insurance) associated with
the use of medicinal products, the Ministry considers it necessary to include
in the relevant direct costs for the evaluated intervention and the comparator
also the amounts of deductible co-payments reimbursed by health insurance funds
above the protective limit of the insured, which, in connection with the
amendment to the Public Health Insurance Act, will be a direct expenditure of
health insurance funds paid to pharmacy service providers related to the
treatment of the given disease.
For this reason, it is necessary that the applicant, within
the submitted application, consider the anticipated budget impact, taking into
account any deductible co-payments for the evaluated and comparator
intervention.
If, in the assessment of the anticipated budget impact under
Section 39b(2)(j) of the Public Health Insurance Act in proceedings on
determining or changing the amount and conditions of reimbursement for a
medicinal product, it becomes apparent that this anticipated reimbursement
impact on health insurance funds, taking into account the anticipated amount of
deductible co-payments (representing the cost of treating the given disease),
shows an increase in expenditures from the health insurance system, in such a
case, the applicant must submit a budget impact analysis that also considers
the amount of the anticipated deductible co-payment.
According to the Ministry, in order to fulfill the purpose
of the aforementioned legal provisions concerning the new protective limit
rules, it is necessary that, in the budget impact assessment by the applicant
and the budget impact evaluation by the State Institute for Drug Control, the
deductible co-payment amounts applied in practice are considered, rather than
the highest possible deductible co-payment amounts calculated according to the
second sentence of Section 16b(1) of the Public Health Insurance Act.
The Ministry further emphasizes that the deductible
co-payments for partially reimbursed medicinal products and foods for special
medical purposes, which count towards the insured person's protective limit,
are known to the State Institute for Drug Control from its own official
activities, as well as to health insurance funds, and marketing authorization
holders can also determine the actually applied amounts of deductible
co-payments from the publicly available data on the website of the State
Institute for Drug Control at https://prehledy.sukl.cz/prehled_leciv.html#/ or
calculate them from data on already reimbursed medicinal products (comparators)
published at regular intervals on https://opendata.sukl.cz/?q=katalog/lek-13
(note: link valid as of the date of this opinion).
For practical implementation, the Ministry believes that the
above-mentioned change in the procedure for budget impact assessment can be
realized as follows. The budget impact analysis will, in addition to the
currently expressed budget impact, also include a separately calculated budget
impact incorporating the costs of deductible co-payments for partially
reimbursed medicinal products and foods for special medical purposes that would
arise for health insurance funds when exceeding the annual protective limit.
However, presenting a separately calculated budget impact with applied
deductible co-payments will not be entirely necessary (or would be redundant)
in cases where no deductible co-payment arises in the determination or change
of the reimbursement amount and conditions for the evaluated intervention.
In conclusion, the Ministry states that this opinion does
not interfere with the current practice of assessing cost-effectiveness
analyses."
The original document is available on the website of the Ministry of Health of the Czech Republic.
This is an unofficial translation generated with the assistance of ChatGPT-4o. It is provided for informational purposes only and does not constitute an official or legally binding translation.
The Ministry of Health of the Czech Republic has published an opinion on the procedure for assessing the financial impact on the health insurance system when determining or changing the amount and...
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
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Mandatory
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Starting from February 2, 2025, all Marketing Authorization Holders (MAHs)
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Early
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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
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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.
