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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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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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.
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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.
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.
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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 Ministry of Health of the
Czech Republic (MoH), acting as the appellate authority, examined whether the
submission of two consecutive applications for a change in the reimbursement of
the same medicinal product—applications concerning different therapeutic
indications or reimbursement conditions—constitutes two separate proceedings or
whether they relate to the same matter.
The MoH clearly concluded that
the subject of the proceedings is identical and comprehensive, thereby
upholding the resolution of the State Institute for Drug Control (the
Institute) to discontinue the second proceeding due to litispendence.
At the same time, within the
proceedings, the MoH emphasized that the subject of the procedure is not an
isolated change to a single condition, but always a comprehensive assessment
and determination of a new, complete set of reimbursement levels and conditions
for the given product. The reimbursement level and reimbursement conditions
form an inseparable and mutually interconnected pair.
In its reasoning, the MoH
relied on case law of the Supreme Administrative Court (SAC), particularly on
its view that even an extension of indication (and even a completely new
indication) does not in itself constitute a change to the subject of the proceedings.
According to the MoH, allowing
two parallel proceedings would risk the issuance of two contradictory
reimbursement decisions, which would introduce absolute uncertainty into the
system.
For completeness, we add that under the amendment to the Act
on Public Health Insurance, from 1 January 2026 it will be possible to conduct
two parallel proceedings concerning an extension of reimbursement for the same
product, provided that the application for the later proceeding is submitted
after a decision has been issued in the earlier proceeding, and that both
proceedings are conducted for different indications.
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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.
Section 39i(2) of
the Act on Public Health Insurance stipulates the obligation of the State
Institute for Drug Control (hereinafter “the Institute”) to immediately
initiate ex officio proceedings to amend the determined amount and conditions
of reimbursement of a medicinal product in cases where the current
reimbursement or reimbursement conditions do not correspond to the basic
reimbursement of the reference group or to the reimbursement conditions
established in a revision procedure.
Within the ongoing
proceedings initiated by the Institute pursuant to the cited provision, the
Institute addressed issues related to the amount of the usual daily therapeutic
dose (ODTD) and its binding nature.
According to the
Institute, the purpose of this type of proceeding is not to establish a new
ODTD, but to harmonize the reimbursement levels with the latest enforceable
decision issued in the revision procedure.
The incorporation
of the ODTD from the revision decision into individual administrative
proceedings is in accordance with the law, the decree, and established
administrative practice, even if the ODTD is not explicitly stated in the
operative part of the decision. It constitutes an inherent component of the
operative part concerning the amount of the basic reimbursement, as confirmed
by relevant decisions of the Ministry of Health of the Czech Republic.
The Institute
further emphasized that the ODTD forms the technical basis for calculating the
basic reimbursement, and its value is legally binding for all subsequent
administrative proceedings concerning changes to the amount and conditions of
reimbursement until the next in-depth reimbursement revision.
The Institute
therefore considered objections regarding the absence of the ODTD in the
operative part of the revision decision or the request for a new determination
of the ODTD within the ongoing proceedings to be unfounded.
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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 Act on Public Health
Insurance provides that the amount and conditions of temporary reimbursement
for Highly Innovative Medicinal Products (VILP) are set for a period of 3
years, with the possibility of re-setting the reimbursement for no more than an
additional 2 years.
In an ongoing administrative
proceeding on the first temporary reimbursement for a VILP in tablet form, the
State Institute for Drug Control (the Institute) proposes to limit the duration
of the first temporary reimbursement so that it expires at the same time as the
first temporary reimbursement of a therapeutically interchangeable medicine
with the same active substance in capsule form for the same indication.
Accordingly, in this case, the first temporary reimbursement for the tablets
will be granted for a period shorter than 3 years.
The Institute also states that the public health insurance
expenditure on reimbursement of the product in tablet form, supplied to insured
persons during the validity of the temporary reimbursement decision, must not
exceed the amount specified in the budget impact analysis that served as the
basis for the decision in the previous administrative proceeding on the first
temporary reimbursement of the therapeutically interchangeable capsule
formulation.
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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 Ministry of Health of the Czech
Republic agreed to grant reimbursement for an orphan medicinal product (LPVO)
in the indication treatment of advanced gastrointestinal stromal tumour (GIST).
The medicine is intended for a small patient population and, although the
expected duration of therapy is measured in months and its effect is not
curative, it enables a significant prolongation of progression-free survival
while maintaining a good quality of life.
The advisory board unanimously supported
inclusion of this product in reimbursement, as the evidence in the file
demonstrated its efficacy in fourth-line treatment of a rare malignancy for
which no therapeutic alternative exists and where there is a clear unmet
medical need.
The Ministry’s approval was justified,
inter alia, by the fact that patients’ conditions require rapid treatment
initiation, which individual exceptional reimbursement applications under
Section 16 do not accommodate with sufficient flexibility.
According to the reasoning, contractual
arrangements with health insurance companies also contributed to the positive
opinion, resulting in a more favourable projected budget impact—not only
compared with the findings of the assessment report, but also relative to current
Section 16 practice.
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.
