Fully
reimbursed medicinal products play a key role in ensuring access to healthcare
for patients in the Czech Republic. Their regulation is derived from Act No.
48/1997 Coll., on Public Health Insurance, which sets the conditions for their
inclusion in the List of Prices and Reimbursements (SCAU). The goal is to
ensure patients have access to treatment while optimizing public health
insurance expenditures.
Full
Reimbursement in Inpatient and Outpatient Care
Act No. 48/1997 Coll. stipulates that, during
the provision of inpatient care, the following are fully reimbursed:
·
medicinal
products and foods for special medical purposes,
·
individually
prepared medicinal products,
·
radiopharmaceuticals,
·
transfusion
products,
·
medical
devices,
·
medicinal
products for advanced therapy,
·
tissues
and cells.
These items
are reimbursed in the least economically demanding version, and the insured
person does not contribute to their payment.
In outpatient care, Annex No. 2 of the
Act plays a crucial role in ensuring that at least one medicinal product in
each therapeutic group is fully reimbursed by public health insurance. This
guarantees patient access to treatment without co-payments, especially for
chronic and severe diseases.
Full
Reimbursement and Real Availability of Medicinal Products
However,
full reimbursement of a medicinal product does not automatically mean its
actual availability on the market. Data shows that only a portion of fully
reimbursed medicines are genuinely available to patients, influenced by factors
such as manufacturers’ supply decisions, demand fluctuations, and regulatory
measures.
The list of medicinal products and foods for
special medical purposes reimbursed by health insurance (SCAU250401) includes a
total of 8,873 items, of which 987 are fully reimbursed. Out of this
number, 748 products are available. The full reimbursement guarantee
under Annex No. 2 of the Act applies to 467 of them, while 281
products are not included in Annex No. 2.
Fully
reimbursed products make up 11.12% of all items in the reimbursed medicines
list.
Available
fully reimbursed products represent 75.79% of the total number of fully
reimbursed products.
Of
the fully reimbursed items, 47.32% fall under Annex No. 2 of the Act.
Outside
Annex No. 2, 28.47% of fully reimbursed products exist.
Available
fully reimbursed products constitute only 8.43% of the total number of items in
the list.
Of
the available fully reimbursed ones, 62.42% are from Annex No. 2.
Outside
Annex No. 2, 37.58% of the available fully reimbursed products remain.
Fully reimbursed medicinal products play a key role in ensuring access to healthcare for patients in the Czech Republic. Their regulation is based on the Public Health Insurance Act, which aims to...
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.
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.
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.
Cost-Effectiveness Assessment of
Pharmaceuticals: Key Questions
Cost-effectiveness assessment is a crucial
element of the administrative process for determining drug reimbursement, not
only in the Czech Republic. A well-prepared cost-effectiveness analysis,
including budget impact assessment, not only supports the applicant's arguments
but also minimizes requests for additional documentation from the State
Institute for Drug Control (SÚKL/Institute) via cooperation requests, which
have become standard practice.
This article presents a selection of key
questions that applicants seeking drug reimbursement (where cost-effectiveness
assessment is required) should be able to answer within their submitted
evaluation.
Cost-effectiveness assessment is a crucial element of the administrative process for determining drug reimbursement, not only in the Czech Republic. A well-prepared cost-effectiveness analysis,...
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.
The pharmaceutical market in the Czech Republic
is undergoing a gradual shift in decision-making practices, which may
significantly impact pricing and reimbursement regulations as well as the
entire pharmaceutical sector. Section 39c(2)(b) of the Public Health Insurance
Act has been in use for a long time; however, its true potential to influence
reimbursement dynamics is only now becoming apparent. The uncertainty arises
from the gradual convergence of differences between innovative biological
molecules entering the market and those already reimbursed. The concept of
comparably effective therapy thus becomes a risk factor for new medicinal
products.
How Does the New Approach Work? In a recent reimbursement revision
decision regarding JAK inhibitors (Ref. No. SUKLS274309/2022), SUKL determined
the reimbursement for certain indications based on the daily costs of
comparably effective therapy. This means that medicinal products were not
necessarily placed in the same reference group as the compared therapies, yet
their reimbursement was set according to cheaper alternatives from another
reference group, which included, for instance, generic drugs. In the case of
filgotinib, the reference product, a head-to-head clinical study (Combe, B. et
al.) comparing its efficacy with the TNF-alpha inhibitor adalimumab confirmed
direct clinical equivalence between these therapies.
This approach has several critical
consequences:
Reduction
in the reimbursement of innovative medicines – if the reimbursement of a medicinal
product is set according to another reference group that includes
generics, it automatically decreases regardless of the original
therapeutic value.
Domino
effect on other groups – once reimbursement is lowered in one group, this decrease can
reflect in reimbursement revisions across other reference groups, leading
to a gradual overall reduction in reimbursements.
Unpredictability
for pharmaceutical manufacturers – companies bringing new medicinal
products to market lack certainty about how their reimbursement will be
determined, as it may be derived from different reference groups without
formal inclusion in them.
Long-Term Impacts This new approach has not only short-term
effects on the reimbursement of specific medicines but also long-term
consequences for the entire pharmaceutical sector:
Reduced
attractiveness of the Czech market – if innovative medicines are
systematically undervalued, pharmaceutical companies may be discouraged
from introducing new medicines to the Czech market.
Impact
on patients –
lower reimbursements may lead to reduced availability of innovative
therapies and fewer treatment options for both patients and physicians.
Disruption
of reimbursement policy transparency – linking reimbursements across different
reference groups may complicate predictability and planning in the field
of pharmaco-economics.
Open Question: Where is the Boundary Between
Efficiency and Innovation Regulation? How might the domino effect manifest in
non-referential indications in the future? This case represents a breakthrough
in setting more than one additional increased reimbursement, meaning the
barrier of "only one increased reimbursement" is eliminated. On the
other hand, this new trend may lead to an intricate network of interconnected
reference groups with generic-based reimbursements, discouraging marketing
authorization holders from including their products in such groups.
The pharmaceutical market in the Czech Republic is undergoing a gradual shift in decision-making practices, which may significantly impact pricing and reimbursement regulations as well as the...
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.
