In proceedings
concerning the determination of the price and reimbursement of a medicinal
product intended for immunisation, the State Institute for Drug Control (the
Institute) clarified its approach to handling information submitted as trade
secrets to substantiate foreign price references.
The Institute
stated that:
to demonstrate the actual manufacturer's price
in a reference country, supporting documents relating to the relevant period
are generally submitted, primarily invoices or other similarly reliable
evidence. Where such evidence is accepted and its content has been submitted as
a trade secret, the Institute takes the substantiated price into account
when determining the price and reimbursement, to the extent necessary to
justify its approach and conclusions, and removes the price used from trade
secret protection.
Where the marketing authorisation holder intends
to demonstrate only a different margin, for example by submitting a
declaration from a third party (such as a distributor) specifying an amount to
be deducted from the identified price, the entire declaration may be
designated as a trade secret.
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The English translation was prepared using the latest available ChatGPT model.
In
administrative proceedings concerning changes to the amount and conditions of
reimbursement, the State Institute for Drug Control (the Institute) assessed an
extension and modification of the reimbursement conditions for an oncology
medicinal product.
Before the
third assessment report was issued, the applicant submitted risk-sharing
agreements to the Institute. Although these agreements reduced the overall
budget impact on the public health insurance system, they did not reduce the
actual treatment costs sufficiently to meet the cost-effectiveness
criteria. The resulting incremental cost-effectiveness ratio (ICER) exceeded
the acceptable threshold of CZK 1.2 million per quality-adjusted life year
(QALY). Consequently, in its third assessment report, the Institute concluded
that the cost-effectiveness requirement had not been met and proposed not to
grant reimbursement in subsequent lines of treatment.
In response to
this conclusion, however, new cost-limitation agreements (pricing
agreements ensuring cost-effectiveness) were negotiated and concluded with
health insurance funds. Following the submission of these agreements, the
financial requirements were addressed, resulting in a positive fourth
assessment report recommending that reimbursement be granted.
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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 (the Institute) discontinued reimbursement for
specific variants of a medicinal product from the allergen group following an
application by the manufacturer. As part of the
proceedings, the Institute assessed market availability and the public
interest. The analysis confirmed that discontinuing reimbursement would not
put patients at risk, as fully adequate therapeutic alternatives for
the treatment of allergies are available within the relevant therapeutic group.
In assessing
treatment availability and the public interest in connection with the
discontinuation of reimbursement, the Institute considered the following:
1. Statutory
assessment criteria The Institute may
decide to discontinue the amount and conditions of reimbursement if a medicinal
product has not been supplied to the Czech market for more than 12 months and,
at the same time, the discontinuation of reimbursement is not contrary to
the public interest in ensuring access to effective and safe healthcare. Where
the application is submitted by the marketing authorisation holder, the
condition requiring the product to have been absent from the market for 12
months does not have to be met; however, the assessment of the public interest
remains essential.
2. Assessment
of market availability The Institute
examined actual supplies of the medicinal products to the market over the
preceding 12 months. For two of the three product codes, supplies to the
market had been recorded during this period.
3. Therapeutic
alternatives and ensuring access to care The key argument
supporting the conclusion that access to reimbursed healthcare would not be
jeopardised was the availability of alternatives within the same reference
group. The Institute confirmed that other reimbursed medicinal products were
available to patients. In view of this therapeutic
substitutability, the Institute concluded that discontinuing reimbursement
would not affect patients’ access to effective and safe healthcare.
4. Public
interest Based on the
availability of therapeutic alternatives described above, the Institute
concluded that the discontinuation of reimbursement was not contrary to the
public interest.
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pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
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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 (the Institute) received an application from the
General Health Insurance Company of the Czech Republic (VZP) for a change in
the amount and conditions of reimbursement from public health insurance for
selected orphan medicinal products, based on the following statutory provision: “In the
event of a significant change in the price references of an orphan
medicinal product, the Institute shall, upon application by a health insurance
fund, initiate proceedings pursuant to Section 39i to change the amount and
conditions of reimbursement of the orphan medicinal product.” This provision
has been effective since 1 January 2026 following the amendment to the Act.
VZP’s
application specified price references indicating a change in the price
references and, consequently, a change in the reimbursement amount. The Institute
subsequently issued a decision in the proceedings changing the reimbursement of
the medicinal product concerned. During the
proceedings, price references were identified that could potentially support
the conclusion that a significant change in price references had occurred.
However, in its decision, the Institute did not address whether it actually
considered the identified change in price references to be significant, nor did
it indicate the percentage change in price references that would be required
for a change to be considered significant. Although the
Institute granted VZP’s application in full, VZP appealed against the decision
after it had been issued in order to withdraw its application in its entirety.
Following the withdrawal of the application, the proceedings were discontinued.
The Institute addressed
the interpretation of the term “significant change in price references” in
another proceeding concerning a change in the reimbursement of an orphan
medicinal product on the same grounds. A party to the proceedings argued that,
according to the explanatory memorandum, a significant change in price
references should be in the range of tens of percent, which was not the case in
the proceedings concerned, and that the Institute had failed to address whether
or not a significant change in price references had occurred. The Institute
stated that the term “significant change in price references” is not defined
by law and that the law does not require the Institute to define this
term in abstract terms beyond the wording of the Act. Although the
Institute acknowledged the reference to the explanatory memorandum, it
emphasised that the explanatory memorandum is not a legally binding document
for decision-making purposes and cannot substitute for the law. According to
the Institute, the fact that the explanatory memorandum mentioned a potential
decrease in the range of tens of percent does not mean that only a price
reduction of such magnitude can constitute grounds for initiating proceedings. The Institute
also pointed out that proceedings in the event of a significant change in price
references are initiated upon application by a health insurance fund.
According to the Institute, it is the health insurance fund that, by submitting
its application, implies that the change in price references in the
particular case is sufficiently relevant to warrant consideration by the
Institute in administrative proceedings.
The Institute
entirely refrained from assessing whether the statutory condition of a
significant change in price references had been met, even though this condition
is essential for the initiation of the proceedings.
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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 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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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.
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.
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 Methodology sets out the procedures for including new
ZUM in the VZP Medical Devices Reimbursement Catalogue, making changes to
devices already included in the Catalogue, and increasing their price and
reimbursement.
A new version 3.0 takes effect on 1 September 2026,
introducing a major change in the assessment of innovative ZUM.
The previous distinction between moderate and substantial
innovation has been replaced by three pathways: medical device innovation
bonus, expert assessment of innovation, and economic and clinical assessment
(HTA).
📈 Medical Device
Innovation Bonus
A simplified pathway for ZUM where the clinical benefit can
be demonstrated by meeting predefined clinical criteria. If at least one of
these criteria is met, a 15% bonus may be granted compared with the
reference comparator or group of reference comparators. The criteria include,
for example, improvement in a clinically relevant outcome, shorter
hospitalisation or recovery time, or a reduced risk of reoperation or reimplantation.
🔎 Expert Assessment of
Innovation
This pathway is intended for ZUM providing a relevant
clinical, safety or organisational benefit where a full economic and clinical
assessment is not required. The assessment focuses in particular on clinical
effectiveness, safety, quality of evidence, organisational benefits,
implementation requirements, and the expected budget impact. A budget impact
analysis (BIA) must be included in the submission.
📊 Economic and
Clinical Assessment (HTA)
The most comprehensive pathway applies to innovative ZUM
with a significant impact on the public health insurance system or where it is
necessary to assess whether the additional costs are proportionate to the
claimed clinical benefit. The assessment covers clinical benefits, safety,
cost-effectiveness and budget impact. This pathway is also subject to the VZP
ČR Methodology for the Economic and Clinical Assessment of Medical Devices.
The Methodology also addresses, among other matters, maximum
assessment timelines for selected procedures, the possibility of increasing
prices and reimbursement in accordance with the applicable Price Regulation,
and the possibility of suspending the assessment process in order to obtain
expert opinions.
Do you need assistance with preparing the documentation
for the establishment of the price and reimbursement of your medical
device by VZP? Do not hesitate to contact us.
Pharmeca a.s. has extensive experience, including in the
field of economic and clinical assessment (HTA). This expertise enables us to
support you in preparing a complete documentation package for the assessment of
your medical device.
Our knowledge, your opportunity.
The English translation was prepared using the latest available ChatGPT model.
VZP has published a new methodology governing the inclusion, changes, and increases in the price and reimbursement of separately charged materials (ZUM) within its Reimbursement Catalogue.
