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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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.
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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 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.
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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.
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.
If an applicant has previously submitted
and succeeded in a different type of administrative proceeding to determine the
amount and conditions of reimbursement for a medicinal product in a certain
indication, they cannot subsequently apply for reimbursement under Section 39da
of the Act on Public Health Insurance (Rules for the Reimbursement of Medicinal
Products for Rare Diseases) for the same medicinal product and the same
indication—even if the product holds orphan medicinal product (LPVO) status.
According to the Ministry of Health, this
condition follows from Section 39da(1): “If it is in the public interest under Section 17(2) and no application has
been submitted for the same indication for temporary reimbursement under
Section 39d or for determination of the amount and conditions of reimbursement
in proceedings under Section 39g, the Institute shall decide on the amount and
conditions of reimbursement for a medicinal product intended for the treatment
of a rare disease…”
The Ministry stated that this provision
must be applied not only to parallel administrative proceedings concerning the
same indication but also to proceedings that have already taken place and have
been lawfully concluded for the same indication of the given medicinal product.
An amendment to the Act on Public Health
Insurance, scheduled to enter into force on 1 January 2026, explicitly
establishes the rule that reimbursement for an LPVO cannot be requested if the
product already has temporary reimbursement set for the same indication.
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.
VZP is requesting that all applicants submit EMDN codes (European Medical Device Nomenclature) for all medical devices (ZÚM) listed in the VZP Reimbursement Catalogue – Medical Devices (ÚK VZP – ZP) by 30 June 2025.
This requirement follows a request from the Ministry of Health in connection with forthcoming legislation. The inclusion of EMDN codes, in accordance with Article 26 of the MDR / Article 23 of the IVDR, is essential for setting clear, transparent, and predictable rules, both within the legislative process and for the inclusion, modification, or price/reimbursement adjustment of medical devices in the ÚK VZP – ZP.
According to the current wording of the MDR / IVDR, manufacturers must assign an EMDN code to their device, which will be used for registration in the EUDAMED database and linked to the device’s Unique Device Identifier (UDI-DI).
Using the EMDN hierarchical structure, manufacturers must always assign the code at the lowest applicable level available (i.e., the most specific level of the categorisation tree).
If one ZÚM item includes multiple devices (catalogue numbers) with different EMDN codes, list each EMDN code in the corresponding “EMDN” column.
If a single device (catalogue number) has multiple intended purposes and therefore multiple potential EMDN codes, select and submit only one EMDN code.
A single submission may contain up to 5,000 ZÚM items.
The template and submission instructions are available on the VZP website.
The text of the opinion was translated using ChatGPT 4o.
The Ministry of Health (MoH) has issued a binding
opinion agreeing to the reimbursement of a medicinal product for rare diseases
(LPVO) after the advisory board unanimously recommended approval.
Although the LPVO under assessment will be
reimbursed, it will still be necessary to submit an application for an
exceptional individual reimbursement under Section 16 of the Act on Public
Health Insurance. This is because the LPVO is used in the given indication in
combination with another medicinal product that is not covered by public health
insurance. For this second product, an application for exceptional
reimbursement will therefore need to be submitted, as stated by the Ministry in
its opinion.
The Ministry agrees to the reimbursement terms
particularly with regard to the age of the patients for whom the treatment is
indicated, the seriousness of the disease, and after careful review of the
evidence on the efficacy and safety of the LPVO in question.
Since the entry into force of the new legislation on
pricing and reimbursement of rare disease medicines in 2023, the Ministry of
Health has issued a total of 35 binding opinions. Of these, in 11 cases
reimbursement was not approved, in 2 cases the Ministry proposed a change in
the reimbursement conditions compared to the SUKL’s proposal, and in 1 case it
proposed a change in the reimbursement amount.
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.
Position of the Ministry of Health of the Czech Republic on Administrative Proceedings for Reimbursement Applications for Indications of Diseases Meeting the Definition of a Rare Disease, Involving Medicinal Products Not Designated as Orphan Medicines under Regulation (EC) No 141/2000
Act No. 48/1997 Coll., on Public Health Insurance and on Amendments and Supplements to Certain Related Acts, as amended (hereinafter referred to as the "Act"), does not regulate a special procedure for the entry into the reimbursement system for a medicinal product intended for the treatment of a rare disease that has not been granted so-called orphan designation under the relevant Regulation. Such a medicinal product cannot be classified as an orphan medicinal product (LPVO) under the Act, as the second sentence of Section 39da(1) stipulates: “An orphan medicinal product shall mean a medicinal product designated as such under directly applicable EU legislation on orphan medicinal products.” This means that a medicinal product not designated as an orphan under Regulation (EC) No 141/2000 cannot apply for reimbursement under Section 39da, even if it is authorized for a rare disease.
It is worth noting that submitting a reimbursement application under Section 39da is a right, not an obligation, of the marketing authorization holder. Entry into the reimbursement system is also possible via the procedures set out in Sections 39g or 39d of the Act.
Thus, medicinal products that cannot be considered LPVOs under the Act can only enter the reimbursement system via procedures under Sections 39g, 39i, or 39d. In proceedings under Sections 39g or 39i, resulting in permanent reimbursement of a non-orphan medicinal product for a rare disease indication, it is necessary, among other things, to meet the condition of a purposeful therapeutic intervention under the second sentence of Section 15(7) of the Act. However, during cost-effectiveness assessment in such procedures, it is not appropriate to use LPVOs reimbursed under Section 39da as comparators in the base-case scenario, as clarified in the Ministry's statement from 7 April 2025.
Therefore, the more suitable route for non-orphan designated products for rare diseases is through temporary reimbursement under Section 39d, as the features of this procedure are better suited to the nature of such medicinal products than the process for permanent reimbursement.
The first specific feature of the Section 39d procedure is the requirement to demonstrate at least one criterion for granting Highly Innovative Medicinal Product (VILP) status under Section 39d(2), which ensures that the product brings a degree of innovation that significantly impacts the treatment of a serious disease and plays a role in recommended treatment guidelines either in the Czech Republic or abroad. The applicant should specify in the submission, based on the principle of disposition, under which paragraph of Section 39d(2) the product fulfills the VILP criteria.
Fulfilment of at least one criterion for granting VILP status to a non-orphan designated medicinal product for which the first or second temporary reimbursement is requested in therapeutic indications for a condition meeting the definition of a rare disease is then assessed in comparison to therapies with reimbursement established under Section 39g of the Act, i.e., in a manner analogous to the procedure before 1 January 2022, when the amendment introducing the legal framework for the third reimbursement pathway under Section 39da for LPVOs entered into force. Given that the procedure under Section 39da is intended solely for a clearly defined group of LPVOs and applies specific requirements and criteria, where an LPVO reimbursed under Section 39da already exists in the reimbursement system at the time of the application for temporary reimbursement of a non-orphan medicinal product for a rare disease indication, the VILP criteria for such a product should not be assessed in comparison to the LPVO. This preserves the principle of assessing VILP criteria against therapies reimbursed under Section 39g, as is also the case when a temporary reimbursement is requested and a VILP is already reimbursed for the same indication. Otherwise, it would lead to an unjustified cumulative increase in entry requirements for newly entering medicinal products.
The relevant comparator for assessing the VILP criteria under Section 39d(2) and comparative effectiveness should thus be a reimbursed therapeutic intervention with reimbursement under Section 39g or Section 39i, or, if unavailable, another treatment alternative such as best supportive care (BSC). Nonetheless, even a reimbursed LPVO under Section 39da constitutes a therapeutic option, and thus in the clinical evaluation submitted by the applicant, a comparison with the LPVO in the given indication should be made. The entering VILP must meet the requirement of comparable or superior efficacy versus the LPVO in the assessed therapeutic indication—since setting reimbursement for a product with lower efficacy than a reimbursed LPVO cannot be considered in the public interest. Such a product would likely not bring patient benefit over the existing LPVO treatment. Regarding the evaluation of the VILP criterion for the non-orphan designated product, it is appropriate to note that where direct evidence is insufficient, indirect evidence or methodologically appropriate indirect comparisons may be accepted.
The second specific feature of the Section 39d procedure is the approach to assessing the purposefulness of therapeutic intervention, as under the third sentence of Section 39d(3) of the Act, “For temporary reimbursement, it is not required to fulfil the cost-effectiveness condition as one of the conditions for purposeful therapeutic intervention under Section 15(7).” This addresses cases where highly innovative medicines are not cost-effective due, for example, to a lack of sufficient data for a methodologically acceptable cost-effectiveness analysis, yet are reasonably expected to become cost-effective over time and clearly provide innovation.
Although failure to meet the cost-effectiveness condition under Section 15(7), second sentence, is not grounds to reject temporary reimbursement for a product eligible for VILP status, pharmacoeconomic evaluations—cost-effectiveness and budget impact analyses—must still be submitted. As per Section 15(8), fourth sentence, “The budget impact must align with the public interest under Section 17(2),” meaning an unacceptable budget impact may justify denial of temporary reimbursement.
Since the relevant clinical comparator for VILP assessment of a non-orphan medicinal product in a rare disease indication is therapy reimbursed under Section 39g or Section 39i or other alternatives, these should be used in the base-case scenario of the pharmacoeconomic assessment.
However, the alternative cost-effectiveness analysis scenario should include a comparator consisting of the LPVO reimbursed under Section 39da, provided that the analysis is methodologically sound and reviewable. Conversely, the LPVO must be used as the base-case comparator in the budget impact analysis under Section 39d(6), to ensure that estimated budget impacts reflect actual clinical practice and do not overestimate costs by omitting the LPVO as a comparator.
A product not designated as an orphan under Regulation (EC) No 141/2000 but intended for a rare disease indication may enter the reimbursement system under Section 39d if it demonstrates at least one VILP criterion compared to therapies reimbursed under Sections 39g or 39i and shows comparable efficacy to an LPVO reimbursed under Section 39da. The pharmacoeconomic base-case analysis should be performed using comparators reimbursed under Sections 39g or 39i, and the LPVO reimbursed under Section 39da must be included as a comparator in the base-case budget impact analysis and the alternative cost-effectiveness analysis.
This text was fully taken from the website of the Ministry of Health of the Czech Republic.
Position of the Ministry of Health of the Czech Republic on Administrative Proceedings for Reimbursement Applications for Indications of Diseases Meeting the Definition of a Rare Disease, Involving...
