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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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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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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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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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 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.
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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.
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.
For medicinal products included in
a reference group that are not granted a reimbursement amount or conditions
beyond those of interchangeable products, a cost-effectiveness analysis is not
required. Newly, however, a budget impact analysis (BIA) must be submitted including
a calculation of deductible co-payments.
According to the State Institute
for Drug Control (SÚKL), the BIA should consider all medicinal products
included in the relevant reference group. On the other hand, for example in
proceedings on price and reimbursement in reference group No. 104/7 –
therapeutic allergen extracts – standardised, depot injectable, the calculation
of deductible co-payments must reflect actual practice: a product containing
dust-mite allergens will in practice be replaced exclusively by products
containing only these allergens. For this reason, including other
interchangeable products (from the same reference group) in the BIA should not
affect the result, because their costs would be the same in the world with and
without the assessed intervention and therefore cancel out.
The analysis works with costs of
deductible co-payments that would accrue to health insurance companies when the
annual out-of-pocket cap is exceeded. Excluding the CZK 1,000 insured
person’s cap from the analysis was accepted by SÚKL in the above-mentioned case
as a conservative setting. SÚKL found that including a CZK 5,000 cap per
insured person would lead to higher deductions in the world with the assessed
intervention (CZK 5,000 per patient) than in the world without it (less than
CZK 5,000 per patient), thus lowering the resulting budget impact. If the CZK 1,000 cap were applied,
the patient in the world without the assessed intervention would exceed this
cap in the first year only, not in subsequent years. Even when accounting for
this lower cap, the resulting budget impact would remain lower.
The analysis should include separate
results for the budget impact without deductible co-payments and with deductible
co-payments.
Previously published SÚKL
guidance also states that the analysis must reflect co-payments actually
applied in practice. To calculate real deductible
co-payments, SÚKL uses average pharmacy prices per pack, obtained from reports
under guideline LEK-13.
Costs of deductible co-payments
relate to prescription-dispensed products; therefore, products billed on
requisition forms are not included in the consumption analysis.
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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.
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 a
previously conducted in-depth reimbursement review, the medicine containing
budesonide in tablet form was assessed as generally therapeutically
interchangeable with rectal formulations in the reference indication of
treatment of acute ulcerative colitis affecting the rectum and sigmoid colon.
This conclusion was primarily based on the results of the CORE I and CORE II
studies in a subgroup of patients with proctosigmoiditis.
However,
following the entry of another budesonide-based medicine in suppository form
into the reimbursement system during an ongoing review procedure, the Institute
(SÚKL) decided to narrow the reference indication to the treatment of acute
ulcerative colitis affecting the rectum only.
In the
issued assessment report, the Institute responded to objections raised by one
of the parties, pointing out that patients with ulcerative colitis limited to
the rectum were not included in the registration studies for the tablet
formulation. Therefore, it is not possible to draw conclusions regarding the
efficacy and safety of the tablet form for this specific patient group based on
those studies, nor to conduct a direct comparison with rectal formulations of
budesonide.
Given the
different clinical uses, the Institute proposes dividing the assessed medicines
into two separate groups:
a) Budesonide
for the treatment of ulcerative colitis affecting the rectum (rectal
formulations) – reference indication: treatment of acute ulcerative colitis
affecting the rectum.
b) Budesonide
for the treatment of ulcerative colitis (oral formulations) – reference
indication: treatment of acute ulcerative colitis affecting the rectum and
sigmoid colon.
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 reimbursement and pricing
administrative proceedings, the State Institute for Drug Control (the
Institute) determines not only the reimbursement amount but also the
reimbursement conditions. These include reporting and prescribing restrictions
that define which medical specialties or certified centers are authorized to
prescribe specific medicines and report them to health insurance companies for
reimbursement.
In one such proceeding, the
Ministry of Health (MoH) expressed the legal opinion that replacing the symbol
“S” with a prescribing restriction “E/DER” (i.e., extending prescribing rights
from a limited number of specialized centers to all physicians with defined
specializations) generally presumes an increase in the budget impact.
Specifically, the MoH stated
in its decision: “The reimbursed medicinal
products in question will now be dispensed to insured persons at
pharmacies—potentially without any link to a specialized center—based on a
prescription, and the dispensing pharmacy will routinely invoice the relevant
health insurance company the amount corresponding to the set reimbursement.
This change has certain economic consequences—at a minimum, in terms of
co-payments and pharmacy markups. These are not the only economic implications:
medicinal products with the ‘S’ symbol are reimbursed by the health insurance
fund only to providers with whom they have a special agreement to ensure the
economical use of such products, whereas no such legal obligation applies to
products without the ‘S’ symbol.”
For these reasons, the MoH
concluded that a cost-effectiveness and budget impact analysis was necessary,
which the Institute failed to conduct during the procedure. Although the Czech
Dermatovenerology Society, when consulted by the Institute, confirmed the
Institute’s assumption that the number of patients would not increase, the MoH
noted that budget impact can still rise even without an increase in patient
numbers. It also highlighted that the medical society did not comment at all on
the actual budget impact. As a result, the MoH annulled
the Institute’s decision.
Definitions of the Symbols:
Symbol “S” – Used for medicinal products that, in the public
interest, should be concentrated in specialized centers (as per Section 15(10)
of the Act). Only these specialized centers may invoice such products to health
insurance companies, and only based on a special agreement between the provider
and the insurance company.
Symbol “E“ – Used when, due to the medicine’s efficacy and
safety profile, prescribing should remain limited to physicians with a specific
specialty qualification listed in the prescribing restriction.
Symbol “DER” – Refers to the
specialties of dermatovenerology, pediatric dermatovenerology, and corrective
dermatology.
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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.
In proceedings concerning Highly Innovative Medicinal
Products (VILP), the Institute concluded that no publications are currently
available that would sufficiently demonstrate comparable efficacy in terms of
the parameter of objective response rate (ORR). On this basis, it did not
reduce the reimbursement amount pursuant to Section 39d(9) of the Act on Public
Health Insurance to the level of other products with similar clinical use.
The Act, in the referenced paragraph, requires the
Institute—in cases where another Highly Innovative Medicinal Product with
similar clinical use and comparable or close efficacy has already been granted
temporary reimbursement—to set the temporary reimbursement amount of the
assessed product at most to the level of that other product, taking into
account differences in dosing and pack size.
The Institute is responsible for demonstrating the existence
of another VILP with similar clinical use and comparable or close efficacy,
which is temporarily reimbursed under public health insurance. In particular,
it must prove the condition of comparable or close efficacy. If it fails to
gather the necessary evidence, it is not authorized to reduce the reimbursement
on these grounds.
The Institute also examines the possibility of reducing
reimbursement for a Highly Innovative Medicinal Product in cases where the
product is reimbursed in a different therapeutic indication and is not included
in a group of interchangeable products together with 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.
