In proceedings concerning the determination or modification of the
amount and conditions of permanent reimbursement of medicinal products, where
pharmacoeconomic evidence is submitted, comparative clinical efficacy and
safety must be demonstrated against all relevant comparators. According to
the methodology of the State Institute for Drug Control (SÚKL), relevant
comparators may include therapies that are commonly or routinely used and
reimbursed from public health insurance. These are not limited to medicinal
products.
The requirement for relevant comparators was modified in 2022 for
proceedings on the reimbursement of orphan medicinal products (Section 39da),
when the advisory body of the Ministry of Health introduced the following
requirement for this specific type of proceedings: “…that any future application for reimbursement of an orphan
medicinal product for which comparators reimbursed from public health insurance
exist (whether with reimbursement determined by the Institute in administrative
proceedings or under Section 16 of Act No. 48/1997 Coll.) must include a
cost-effectiveness analysis against such comparators.” As a result, in reimbursement proceedings for orphan medicinal
products conducted under Section 39da, therapies reimbursed not routinely but
under exceptional reimbursement pursuant to Section 16 are commonly
included among comparators—even in cases where their use is off-label
within the given indication.
This approach has also been identified in proceedings concerning
the determination of permanent reimbursement for a non-orphan medicinal
product, where SÚKL likewise accepted as a comparator a product reimbursed
under Section 16. However, in another case involving the use of a comparator
reimbursed under Section 16, SÚKL argued in its assessment report, for example,
as follows: “…treatment provided under Section 16 of the Public Health
Insurance Act is, by its nature, exceptional and cannot be considered the least costly standard option for the purposes of general reimbursement
setting…’”
It remains to be seen whether, in the future, the approach to the
use of Section 16 comparators will become harmonised across different
groups of medicinal products, and whether the position of Section 16–reimbursed
treatments will gain greater importance even in standard reimbursement
proceedings.
Section 16 of Act No. 48/1997 Coll., on Public Health Insurance The competent health insurance fund shall reimburse, pursuant to
Section 19(1)(a), in exceptional cases healthcare services otherwise not
covered by health insurance, provided that the provision of such healthcare
services constitutes the only option in view of the insured person’s health
condition.
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In the case of rare diseases, it is not uncommon in practice that reimbursement is granted under Section 16. However, a medicinal product reimbursed in this way may also play a significant role in...
The Ministry of Health (MoH)
assessed whether the medicinal product under review met the criteria for being
designated as a highly innovative medicinal product (VILP). In the proceedings
on the determination of the amount and conditions of price and reimbursement,
the Institute for Drug Control (SÚKL) had refused to grant initial temporary reimbursement, as it
concluded that the product did not meet the VILP criteria.
The main reasons cited were:
Insufficient therapeutic benefit
Issues related to the selection and positioning of
comparators
Failure to meet VILP criteria across all proposed indications
Insufficient evidence on survival outcomes
Methodological concerns in comparative analyses
According to the SÚKL,
unless the VILP criteria are met against all relevant comparators under
assessment, the product cannot be granted temporary reimbursement, even under
modified conditions.
The MoH upheld the SÚKL’s
decision and additionally highlighted the inappropriateness of relying on
abstracts, which are condensed summaries and do not provide sufficient detail
on the underlying data. On this basis, the administrative authority cannot
responsibly assess the presented evidence. Furthermore, the MoH recommends not submitting key scientific
data under confidentialityrestrictions if a detailed evaluation
is expected, as any public assessment of such protected data can only remain of
a general nature.
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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.
Under the previous wording of
the Public Health Insurance Act, abbreviated proceedings for similar medicinal
products allowed the selection of even the most expensive product in the group
as the reference product, which led to inequalities within the reference group
and disadvantaged other medicinal products. As of 1 January 2026, it now
applies that the applicant may not request a reimbursement level higher than
that established for the first similar medicinal product or higher than that
derived from the base reimbursement of the reference group.
Pursuant to Section 39b(5),
the Institute determines the amount and conditions of reimbursement of the
assessed similar medicinal product based on the amount and conditions of
reimbursement of the medicinal product to which it is similar. Where more than
one such reference product exists, or where an application for reimbursement
has already been submitted by another marketing authorisation holder, the
applicant may not request a reimbursement level higher than that established
for the first similar medicinal product pursuant to Section 39b(6), or higher
than that derived from the base reimbursement of the reference group pursuant
to Section 39b(8).
In the first months of this
year, this rule was applied in two proceedings. In both cases, the applicant
selected a reference medicinal product whose reimbursement level did not
correspond to the base reimbursement of the reference group (RS) within the meaning
of Sections 39b(5) and (8) of the Act. In other words, the selected reference
product had a base reimbursement (and thus also a core reimbursement) higher
than the base reimbursement of the reference group. As a result, one proceeding was terminated following the
withdrawal of the application, while in the other case, after the modification
of the submission, reimbursement was successfully determined.
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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.
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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.
There is no
legal basis in the Public Health Insurance Act for excluding a medicinal
product from price
referencing on the grounds that its price is a tender price, nor does any other
legal provision allow such a procedure.
In
administrative proceedings concerning the determination of price and
reimbursement initiated from 1 January 2026, it is possible, beyond the
previously existing options, to exclude the manufacturer price in an EU Member
State where that state has introduced a market-wide measure affecting the
manufacturer price of the medicinal product. In such cases, however, SÚKL must
receive official information from the relevant foreign authorityor from the
Ministry of Health.
In the
determination of the maximum manufacturer price, a foreign price is also
excluded in cases where the lowest price deviates by more than 20% from the
average of the second and third lowest prices, or where more than three prices
are identified and the price associated with an exchange rate deviating by more
than 10% from the average exchange rate over the previous six calendar quarters
is excluded.
When determining the base reimbursement, a
foreign price may also be excluded if it is at least 20% lower than the average
of the second and third lowest prices. However, this rule does not apply to highly innovative and orphan medicinal products.
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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.
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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 State Institute for Drug Control decided on the determination of the maximum price and reimbursement for a medicinal product containing the active substance tamoxifen citrate.
The proceedings were initiated upon the company’s application pursuant to Section 32d of the Public Health Insurance Act. The purpose of this specific procedure is to ensure the availability of irreplaceable medicinal products in situations where a supply disruption in the Czech Republic is imminent or has already occurred.
The primary reason for the decision was to ensure continued treatment availability for oncology patients, as supply of the previously registered medicinal products containing the above active substance had been interrupted for manufacturing reasons. As no other registered alternative for oral administration was available within the relevant group, the Ministry of Health approved a specific treatment programme for an unregistered medicinal product. The Institute subsequently determined its maximum price and reimbursement level, adopting the reimbursement conditions of the originally reimbursed product that had become unavailable.
The decision on the determination of price and reimbursement was issued 24 days after submission of the application.
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Pharmeca a.s.? Feel free to contact us.
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that can be tailored to your needs at any time.
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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 Institute
initiated an ex officio abbreviated reimbursement review on the grounds
of the entry of the first similar medicinal product into the
reimbursement system, without undue delay after verifying that the product
concerned had been placed on the Czech market.
However, one of
the affected marketing authorisation holders appealed against the initiation of
the proceedings, arguing that the entering product was not the first similar
medicinal product and referring to earlier proceedings in which the newly
entering product had not been assessed as similar.
The Ministry of
Health (MoH) rejected this objection, stating that although in the referenced
proceedings the assessed product and the reference (originator) product
contained the same active substance, they differed in dosage, standardisation
units and pharmaceutical forms. At the same time, the products were assessed
against additional criteria—such as therapeutic indications or pharmacological
properties—and, on that basis as well, were not considered similar.
In the present
case, however, the MoH considers the medicinal product concerned to be a generic
within the meaning of the Act on Medicinal Products. The products involved in
the proceedings contain the same active substance and a comparable
pharmaceutical form as the reference product, and the appellant repeatedly
failed to demonstrate otherwise.
In the case under
review, the conditions for initiating a review on the grounds of the entry of
the first similar medicinal product were therefore met.
The MoH further notes that although, under the legislation applicable at the time, SÚKL could have initiated the proceedings earlier, the appellate authority considers the approach whereby SÚKL waited for the first actual supply of the medicinal product concerned to be appropriate and well justified. This prevented a reduction in reimbursement for similar products based on a first similar medicinal product that was not yet commercially available.
Pursuant to the amendment to the Public Health Insurance Act, in abbreviated reviews initiated after 1 January 2026, there is now an obligation to verify market availability at a minimum level of 5%, or 2% for ZÚLP.
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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.
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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 Ministry of Health (MoH) assessed whether the conditions
for increasing reimbursement on the grounds of ensuring at least one fully
reimbursed medicinal product within a group of substitutable products had been
met in the context of a comprehensive review (Section 39c(5) of the Public
Health Insurance Act).
According to the MoH, it was not possibleto designate the
product referenced in the proceedings as a relevant fully reimbursed medicinal
product for two main reasons:
the referenced product had
reported an interruption of its placing on the domestic market effective as of
25 December 2023, i.e. prior to the date on which the contested decision
(issued on 27 November 2023) became enforceable. In the case of a product with
a notified interruption, a temporary supply disruption may reasonably be
assumed, and consequently the practical impossibility of its full
reimbursement;
the referenced product is also
reimbursed for the treatment of bladder cancer. The products for which the
reimbursement increase was assessed are reimbursed exclusively for patients
with renal cancer and soft tissue sarcoma. Although bladder cancer and renal
cancer both fall under carcinomas of the urogenital tract, the MoH does not
consider them to constitute diseases of the same type within the meaning of the
legal opinion of the Constitutional Court.
Full reimbursement for the group of patients with the
indication of bladder cancer could therefore not be ensured through the
assessed product but was secured through other medicinal products.
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 proceedings
concerningorphan medicinal products, State Institue for Drug Controla (SÚKL) is authorised to assess the
pharmacoeconomic analyses submitted by the partiesbut does not have the
competence to generate such analyses itself.
Although, in
proceedings under Section 39da initiated at the request of a health insurance
fund, the marketing authorisation holder is not formally subject to an
enforceable obligation to submit pharmacoeconomic analyses of a defined
quality, the assessment of clinical benefit, cost-effectiveness and budget
impact remains a key prerequisite for determining the appropriateness of
reimbursement from public health insurance. The absence of a cost-effectiveness
analysis is therefore considered a material deficiency.
While the results
of the cost-effectiveness analysis (ICER) are not formally applied as a
decision-making threshold, budget impact and value for money considerations
remain implicitly present in the assessment of the public interest.
A declared
intention to conclude budget cap agreements does not constitute a binding basis
for a reimbursement decision unless such arrangements have been incorporated
into SÚKL’s assessment report prior to the issuance of the opinion of the
Ministry of Health.
Individual
reimbursement granted under Section 16 for exceptional cases does not establish
an automatic entitlement to system-wide reimbursement under Section 39da, where
the existence of a public interest constitutes the primary statutory
condition.
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.
