The State
Institute for Drug Control (the Institute) initiated ex officio proceedings
to change the maximum price of an orphan medicinal product pursuant to
Section 39da(10) of Act No. 48/1997 Coll., on Public Health Insurance.
According to the provision in force on the date the proceedings were initiated: “No later
than 3 years from the date on which the decision establishing the amount and
conditions of reimbursement of an orphan medicinal product becomes enforceable,
the Institute shall initiate ex officio administrative proceedings to change
the maximum price pursuant to Section 39i. Sections 39l and 39p shall apply
mutatis mutandis.”
The marketing
authorisation holder (MAH) argued that the proceedings should not have been
initiated “automatically”, but only “where necessary”. According
to the MAH, the Institute should have assessed whether the proceedings served a
meaningful purpose and would result in actual savings; otherwise, the
proceedings should have been discontinued. The Institute
stated that the law imposes an unconditional obligation to initiate
proceedings to change the maximum price within 3 years of the date on which the
orphan reimbursement decision becomes enforceable. According to the
Institute, the condition “where necessary” does not apply to the
initiation of proceedings to change the maximum price of an orphan medicinal
product itself. In this case, the three-year requirement for initiating the
proceedings was therefore met.
The MAH further
argued that the statutory requirement of annual savings of CZK 30 million,
applicable to the review proceedings referred to in Section 39da(10), had not
been demonstrated. In the MAH’s view, the Institute should have demonstrated
the expected savings to the public health insurance system; without doing so,
the proceedings were unlawful or not subject to proper review. The Institute
maintained that demonstrating such savings is not a statutory requirement
for this type of proceeding. The requirement that the relevant provisions
apply mutatis mutandis does not mean that the conditions governing the
initiation of a reimbursement review are transferred to these individual
proceedings concerning a change in the maximum price of an orphan medicinal
product. The purpose of these proceedings is not to generate reimbursement
savings, but to change the maximum price.
The MAH also
argued that the maximum price of the medicinal product concerned had already
been changed previously and that there was therefore no justification for
further ex officio proceedings. The Institute
stated that the earlier proceedings cannot be regarded as fulfilling the
obligation under Section 39da(10), as the law requires these specific
proceedings to be initiated no later than 3 years after the orphan
reimbursement decision becomes enforceable, irrespective of whether another
change in the maximum price has taken place in the meantime.
The Institute
rejected all the objections and issued a decision in the matter, against which
the MAH filed an appeal.
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updated overview of decisions issued by SÚKL and the Ministry of Health in the field
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Access to reimbursement for
orphan medicinal products is subject to specific legislative procedures.
However, the procedural pathway chosen by the marketing authorisation holder
(MAH) fundamentally determines which criteria will be assessed when evaluating
clinical benefit and economic effectiveness. This is illustrated by a
comparison of two administrative proceedings concerning the same medicinal
product in the same indication. Despite this, the regulator reached different
conclusions regarding the choice of comparator, which in clinical practice is
primarily reimbursed through individual approval by a health insurance fund’s
reviewing physician under Section 16 of the Public Health Insurance Act.
Success in the “Orphan”
Pathway, Failure in the “Standard” Pathway In the earlier proceedings
specifically designed for orphan medicinal products (Section 39da), a
comparator reimbursed under Section 16 was considered relevant. However, when the same MAH
subsequently sought permanent reimbursement for the same medicinal product
through the standard reimbursement procedure, different rules applied.
According to the State Institute for Drug Control (the Institute), a medicinal
product reimbursed under Section 16 cannot be used as a legally relevant
comparator in this type of proceeding. This approach was subsequently upheld by
the Ministry of Health.
The main reason given was that
a medicinal product reimbursed under Section 16 is not considered “reimbursed”
in the context of usual therapeutic practice, as such reimbursement is limited
to exceptional, individual cases. By contrast, in the “orphan”
proceedings, the medicinal product reimbursed under Section 16 was accepted as
an appropriate comparator for demonstrating cost-effectiveness and thus became
a necessary element in establishing eligibility for reimbursement.
In its decision, the Ministry emphasised that the acceptance
of a comparator reimbursed under Section 16 in the previous “orphan”
proceedings does not establish a right to use the same comparator in standard
reimbursement proceedings, where the results of the cost-effectiveness analysis
are a key factor in the reimbursement decision.
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 Czech Ministry
of Health (MoH) annulled a decision issued in an abbreviated reimbursement
review and referred the case back to the State Institute for Drug Control (the
Institute), as the Institute had failed to include in the administrative
proceedings all medicinal products that were therapeutically interchangeable at
the time the proceedings were initiated, as well as their marketing
authorisation holders. The Institute
justified its approach by stating that it had excluded medicinal products
containing an active substance that had not yet undergone a full reimbursement
review and therefore, in its view, could not be subject to an abbreviated
review.
However, the MoH
found this approach to be unlawful, pointing out that an abbreviated review is
conducted as joint proceedings covering all medicinal products included in the
relevant reference or pseudo-reference group. The medicinal product concerned
had been included in the relevant pseudo-reference group (albeit through
individual proceedings) and had been reimbursed from public health insurance
since 1 May 2023, i.e. for more than a year before the reviewed proceedings
were initiated. It therefore demonstrably met the statutory requirement of
inclusion in the group, and the Institute should have initiated the proceedings
in respect of that product as well.
The MoH further
referred to a provision of the Act that expressly permits an abbreviated review
to be initiated and conducted in respect of medicinal products for which
reimbursement proceedings are simultaneously ongoing – and which, logically,
have therefore not undergone any previous reimbursement review. If an
abbreviated review may include a medicinal product whose inclusion in the
relevant group is only anticipated, it must, all the more so, include a product
that has already been validly and finally included in that group.
The MoH also
criticised a degree of inconsistency in the Institute’s approach. On the one
hand, the Institute denied that administrative proceedings could be initiated
and conducted in respect of the medicinal product concerned, while on the other
hand treating that same product as a reference medicinal product. Although the
MoH did not generally rule out the possibility that such a situation could
arise in practice and, under certain circumstances, be consistent with the
applicable legislation, it concluded that this was not the case here.
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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 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.
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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 (SÚKL) has launched the Innovation Office for Medical Devices, a new service designed to support innovation in the Czech healthcare sector.
The Innovation Office for Medical Devices will provide expert consultations to entities developing innovative medical devices, in vitro diagnostic medical devices (IVDs), and medical software.
The new service has been established in cooperation with the Ministry of Health as part of broader initiatives aimed at fostering innovation in the healthcare sector and creating a predictable regulatory environment for the development of new medical technologies.
The objective of the Innovation Office is to help developers gain an early understanding of regulatory requirements and identify, at an early stage of their projects, any issues or risks that may affect further product development. Early consultation can contribute to more efficient development planning, an appropriate regulatory strategy, and a smoother route to market.
Expert consultations may cover topics such as the intended purpose of a medical device, its regulatory status, qualification and classification, clinical evaluation or performance evaluation, conformity assessment procedures, and the need to involve a notified body.
At the same time, SÚKL has published the Guidance of the Innovation Office for Medical Devices, which sets out the conditions for submitting applications, the scope of expert consultations, and the procedures for providing them. The guidance also includes a triage form, which serves as the basis for the preliminary assessment of applications and the preparation of expert consultations.
In its initial phase, the Innovation Office is being implemented as a pilot project. Its purpose is to validate the established processes in practice and to gather feedback from both applicants and SÚKL experts. Based on the experience gained during the pilot phase, both the methodology and the scope of consultations may be further refined to better meet the needs of innovators and regulatory practice.
This article is based on information published on the SÚKL website, where the full version is available.
The English translation was prepared using the latest available ChatGPT model.
