The State Institute for Drug Control (SÚKL) has rejected a request by
the marketing authorization holder (MAH) of an orphan medicinal product (OMP)
to suspend the proceedings on the setting of the maximum price and
reimbursement.
The Ministry of Health issued a binding opinion for the OMP stating that
the SÚKL is not allowed to grant reimbursement for the given OMP. The MAH
disagreed with the negative binding opinion and submitted a request for its
review. At the same time, the MAH asked the SÚKL to suspend the reimbursement
proceedings for the OMP until the review of the opinion is completed.
The SÚKL argues that it is bound by the binding opinion of the Ministry
and is obliged to issue a decision. According to SÚKL, the submission of a
review request is not a valid reason for suspension because the outcome of the
review is not determinative for this proceeding. The SÚKL holds a binding
opinion from the Ministry, which is key for the decision, and must act in
accordance with it, also considering the legitimate expectations of other
parties to the proceeding. Therefore, the SÚKL will not suspend the
reimbursement proceedings.
Since the new legislation concerning pricing and reimbursement of orphan
drugs came into effect in 2023, the Ministry of Health has issued a total of 31
binding opinions. In 10 of these cases, the Ministry did not agree with the
granting of reimbursement, in 2 cases it proposed changes to the reimbursement
conditions compared to SÚKL’s proposal, and in 1 case it suggested a change in
the reimbursement amount compared to SÚKL’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 State Institute for Drug Control (SÚKL) has rejected a request by the marketing authorization holder (MAH) of an orphan medicinal product (OMP) to suspend the proceedings on the setting of the...
In the context of administrative
proceedings on the determination of reimbursement and reimbursement conditions
for medicinal products, it is, under certain circumstances, possible to take
into account the so-called subjective parameter. This factor allows for the
reflection of specific features of a medicinal product that cannot be fully
captured through standard objective criteria. However, subjective
parameters are not always relevant to the proceedings, as demonstrated by the
following examples from practice. In some cases, they may even be perceived as a
limitation of the submitted documentation.
Subjective
Parameter in Reimbursement Indication Restriction
The Ministry of
Health upheld SÚKL’s approach of including the MSWS-12 questionnaire—a subjective
parameter—in the reimbursement indication restriction for a particular
medicinal product. The Ministry
justified the correctness of this procedure by referencing the wording of the Summary
of Product Characteristics (SmPC), which allows the prescribing physician,
already at the initiation of treatment, to evaluate efficacy using the MSWS-12
questionnaire instead of the objective T25FW test. For this reason,
the Ministry dismissed the appellant’s objection, which questioned the
demonstration of efficacy through a subjective questionnaire. The Ministry
stated that efficacy proven by such a tool is sufficiently supported by the
conditions established during the marketing authorization process. Moreover, the
Ministry emphasized that the inclusion of subjective parameters in cost-effectiveness
analyses is not considered a flaw or deficiency of such analyses in general.
Subjective
Parameter in Clinical Evaluation
In certain cases,
the use of a subjectively assessed primary efficacy endpoint in the evaluation
of therapeutic appropriateness for reimbursement purposes has been accepted by
SÚKL:
The primary
efficacy endpoint assessed in clinical trials was based on purely subjective
patient assessment. Considering that the MG-ADL score is more sensitive to
changes in condition than the QMG score, and given the observed correlation
between changes in MG-ADL and QMG scores, this benefit parameter is deemed
acceptable. The treatment’s efficacy compared to placebo can be considered
statistically significant, even though the difference in the primary endpoint
was not clinically significant.
In contrast, in
other proceedings, the subjective nature of the primary study endpoint has been
labeled an unacceptable limitation for the purpose of reimbursement
determination:
SÚKL proposes not
to grant reimbursement for the medicinal product in the indication of
symptomatic treatment of myotonia. In view of the study’s limitations and other
concerns (e.g., potential overestimation of efficacy, the dose used, and the
subjective nature of the primary endpoint)... The study’s primary
endpoint had a subjective character (VAS scale based on patient evaluation).
The secondary endpoint (chair test) was objectively measurable. Even so,
variability exists between different types of NDM, with some types affecting
upper limbs and facial muscles more, and others affecting the legs. EMA also
stated that direct measurement of muscle strength would have been more
appropriate.
These examples
illustrate that the subjective nature of a study’s primary endpoint may in some
cases be a limitation for reimbursement purposes. However, if the
parameter is embedded in the indication restriction in accordance with the
product’s SmPC, it should be accepted by SÚKL for the purpose of reimbursement
determination.
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.
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.
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.
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.
The process
of determining the reimbursement of medicinal products in the Czech Republic is
complex and involves several key stakeholders who collectively influence the
final decision. In our recent post on decision-making practices, we highlighted
the role of health insurance companies in the reimbursement process. Now, let’s
take a closer look at the entities involved and how the entire mechanism works.
The process of determining the reimbursement of medicinal products in the Czech Republic is complex and involves several key stakeholders who collectively influence the final decision. In our...
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.
