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The State Institute for Drug Control (SÚKL) has initiated its first ex officio proceeding to re-evaluate whether a Highly Innovative Medicinal Product (VILP) continues to meet the required criteria following the entry of a new comparator into the reimbursement system.

Under the Public Health Insurance Act, if, during the validity of a decision granting temporary reimbursement for a VILP, SÚKL subsequently grants reimbursement under Section 39g to another medicinal product with comparable clinical use, the Institute must promptly initiate ex officio administrative proceedings. The purpose of these proceedings is to assess whether the VILP still fulfils the criteria for a highly innovative medicinal product. This obligation does not apply if the temporary reimbursement would expire in less than 12 months.

Such a situation has now occurred. The reason for initiating the proceeding was a decision effective from 1 November 2024, which granted permanent reimbursement to a new relevant comparator for a similar indication—namely, maintenance monotherapy in adult patients with BRCA1/2-mutated (FIGO stage III or IV) advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response following first-line platinum-based chemotherapy.

SÚKL has now issued a final assessment report regarding the reimbursement of a medicinal product for patients with advanced ovarian cancer, recommending that the second temporary reimbursement of the product remain in force.
In its assessment, the Institute compared the efficacy and safety of niraparib versus olaparib in patients with and without BRCA mutations. It concluded that comparable efficacy was demonstrated only in patients with BRCA mutations, and not in BRCA wild-type (BRCAwt) or unknown-status patients. Due to a lack of clinical evidence, no efficacy comparison was possible for the BRCAwt/unknown subgroup. For this subpopulation, the Institute found that the criteria for high innovativeness continue to be met, and that the appropriate comparator remains best supportive care (i.e., watch and wait approach).

SÚKL emphasized that within the scope of this administrative proceeding, it cannot modify the existing reimbursement conditions by limiting coverage to only part of the patient population. The decision to revoke or maintain reimbursement must therefore be based on whether the VILP criteria are met overall.

Given that the VILP criteria remain fulfilled for a subpopulation of patients (BRCAwt/unknown), and that the product demonstrated at least a 30% improvement in the primary endpoint of progression-free survival (PFS) versus the relevant comparator in the overall population, SÚKL has decided to maintain the temporary reimbursement.

Timeline:

• 03/2024 – Medicinal product containing niraparib: second temporary reimbursement granted in SCAU
• 11/2024 – Medicinal product containing olaparib: permanent reimbursement granted in SCAU
• 11/2024 – Ex officio proceeding initiated to reassess fulfilment of high innovativeness criteria

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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

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 text was translated using ChatGPT 4o. 

The State Institute for Drug Control (SÚKL) has rejected a request by the marketing authorization holder (MAH) of an orphan medicinal product (OMP) to suspend the proceedings on the setting of the maximum price and reimbursement.

The Ministry of Health issued a binding opinion for the OMP stating that the SÚKL is not allowed to grant reimbursement for the given OMP. The MAH disagreed with the negative binding opinion and submitted a request for its review. At the same time, the MAH asked the SÚKL to suspend the reimbursement proceedings for the OMP until the review of the opinion is completed.

The SÚKL argues that it is bound by the binding opinion of the Ministry and is obliged to issue a decision. According to SÚKL, the submission of a review request is not a valid reason for suspension because the outcome of the review is not determinative for this proceeding. The SÚKL holds a binding opinion from the Ministry, which is key for the decision, and must act in accordance with it, also considering the legitimate expectations of other parties to the proceeding. Therefore, the SÚKL will not suspend the reimbursement proceedings.

Since the new legislation concerning pricing and reimbursement of orphan drugs came into effect in 2023, the Ministry of Health has issued a total of 31 binding opinions. In 10 of these cases, the Ministry did not agree with the granting of reimbursement, in 2 cases it proposed changes to the reimbursement conditions compared to SÚKL’s proposal, and in 1 case it suggested a change in the reimbursement amount compared to SÚKL’s proposal.

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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

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 text was translated using ChatGPT 4o. 

In the context of administrative proceedings on the determination of reimbursement and reimbursement conditions for medicinal products, it is, under certain circumstances, possible to take into account the so-called subjective parameter. This factor allows for the reflection of specific features of a medicinal product that cannot be fully captured through standard objective criteria.
However, subjective parameters are not always relevant to the proceedings, as demonstrated by the following examples from practice. In some cases, they may even be perceived as a limitation of the submitted documentation.

Subjective Parameter in Reimbursement Indication Restriction

The Ministry of Health upheld SÚKL’s approach of including the MSWS-12 questionnaire—a subjective parameter—in the reimbursement indication restriction for a particular medicinal product.
The Ministry justified the correctness of this procedure by referencing the wording of the Summary of Product Characteristics (SmPC), which allows the prescribing physician, already at the initiation of treatment, to evaluate efficacy using the MSWS-12 questionnaire instead of the objective T25FW test.
For this reason, the Ministry dismissed the appellant’s objection, which questioned the demonstration of efficacy through a subjective questionnaire. The Ministry stated that efficacy proven by such a tool is sufficiently supported by the conditions established during the marketing authorization process.
Moreover, the Ministry emphasized that the inclusion of subjective parameters in cost-effectiveness analyses is not considered a flaw or deficiency of such analyses in general.

Subjective Parameter in Clinical Evaluation

In certain cases, the use of a subjectively assessed primary efficacy endpoint in the evaluation of therapeutic appropriateness for reimbursement purposes has been accepted by SÚKL:

The primary efficacy endpoint assessed in clinical trials was based on purely subjective patient assessment. Considering that the MG-ADL score is more sensitive to changes in condition than the QMG score, and given the observed correlation between changes in MG-ADL and QMG scores, this benefit parameter is deemed acceptable. The treatment’s efficacy compared to placebo can be considered statistically significant, even though the difference in the primary endpoint was not clinically significant.

In contrast, in other proceedings, the subjective nature of the primary study endpoint has been labeled an unacceptable limitation for the purpose of reimbursement determination:

SÚKL proposes not to grant reimbursement for the medicinal product in the indication of symptomatic treatment of myotonia. In view of the study’s limitations and other concerns (e.g., potential overestimation of efficacy, the dose used, and the subjective nature of the primary endpoint)...
The study’s primary endpoint had a subjective character (VAS scale based on patient evaluation). The secondary endpoint (chair test) was objectively measurable. Even so, variability exists between different types of NDM, with some types affecting upper limbs and facial muscles more, and others affecting the legs. EMA also stated that direct measurement of muscle strength would have been more appropriate.

These examples illustrate that the subjective nature of a study’s primary endpoint may in some cases be a limitation for reimbursement purposes. However, if the parameter is embedded in the indication restriction in accordance with the product’s SmPC, it should be accepted by SÚKL for the purpose of reimbursement determination.

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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

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 text was translated using ChatGPT 4o.  

Full text of the opinion published on the website of the Ministry of Health of the Czech Republic:

Opinion of the Ministry of Health of the Czech Republic on the Selection of a Medicinal Product Intended for the Treatment of a Rare Disease with Reimbursement Granted under Section 39da as a Comparator in Cost-Effectiveness Assessment in Proceedings for the Determination or Modification of Reimbursement in the So-Called Permanent Reimbursement Regime Conducted under Section 39g or Section 39i of Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Certain Related Acts, as Amended

Cost-effectiveness assessment, as part of evaluating the appropriateness of a therapeutic intervention, is a necessary element of administrative proceedings for the determination or modification of the amount and conditions of reimbursement of a medicinal product conducted under Section 39g or 39i of Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Certain Related Acts, as amended (hereinafter referred to as "Act No. 48/1997 Coll." or the "Public Health Insurance Act"), in cases enumerated in Section 15(9) of this Act. Fulfilment of the condition of an appropriate therapeutic intervention is one of the basic conditions for granting reimbursement for a medicinal product for a given indication (regardless of whether this indication is defined by a specific formulation of the reimbursement restriction or by the summary of product characteristics), as Section 15(6)(d) of Act No. 48/1997 Coll. stipulates that "The Institute shall not grant reimbursement for medicinal products and foods for special medical purposes that do not meet the conditions of an appropriate therapeutic intervention."

According to the second sentence of Section 15(7) of Act No. 48/1997 Coll., "An appropriate therapeutic intervention shall mean healthcare services provided for the prevention or treatment of disease with the aim of achieving the most effective and safest treatment while maintaining cost-effectiveness." Thus, cost-effectiveness is one of the cumulative conditions of an appropriate therapeutic intervention within the meaning of Section 15(7).

However, the definition of an appropriate therapeutic intervention for a medicinal product intended for the treatment of a rare disease (hereinafter also referred to as "LPVO") with reimbursement granted under Section 39da differs from the definition applicable to a medicinal product in the so-called permanent reimbursement regime, i.e., with reimbursement from public health insurance granted in proceedings conducted under Section 39g or Section 39i of Act No. 48/1997 Coll. According to the third sentence of Section 15(7) of Act No. 48/1997 Coll., "In the case of medicinal products intended for the treatment of a rare disease under Section 39da, an appropriate therapeutic intervention shall mean healthcare services provided for the prevention or treatment of a rare disease with the aim of achieving the most effective and safest treatment, provided that the pharmacotherapeutic impact of this disease has a societal significance and the financial impact on the health insurance system (hereinafter the 'budget impact') is in accordance with the public interest pursuant to Section 17(2)."

This different approach to the requirement of appropriate therapeutic intervention in proceedings for the determination or modification of reimbursement for LPVOs under Section 39da as compared to medicinal products in the so-called permanent reimbursement regime is further expressed in Section 39da(3)(i) of Act No. 48/1997 Coll., which states that "In the proceedings for determining the amount and conditions of reimbursement of a medicinal product intended for the treatment of a rare disease, the following shall be assessed..., (i) cost-effectiveness analysis, however, without taking into account its result in the form of the incremental cost-effectiveness ratio..."

A medicinal product intended for the treatment of a rare disease for which reimbursement has been granted under Section 39da of the Public Health Insurance Act thus does not necessarily meet the condition of an appropriate therapeutic intervention as defined by the requirements of the law for medicinal products under the so-called permanent reimbursement regime. An LPVO reimbursed under Section 39da does not have to meet the condition of maintaining cost-effectiveness and therefore may not qualify as an appropriate therapeutic intervention within the meaning of the second sentence of Section 15(7) of the Act (although it does qualify under the third sentence of Section 15(7)). The anticipated inability of LPVOs to demonstrate their cost-effectiveness as required in proceedings under Section 39g is one of the reasons why LPVOs are granted a different procedure for determining reimbursement under Section 39da.

For the above reasons, when proving the appropriate therapeutic intervention of a medicinal product entering the so-called permanent reimbursement system under Section 39g, or in proceedings for modifying reimbursement under Section 39i of the Act, it is not possible to rely on the appropriate therapeutic intervention demonstrated by an LPVO that entered the reimbursement system under Section 39da. These are two different types of appropriate therapeutic intervention, requiring the demonstration of different circumstances and applicable in different types of proceedings. Therefore, it is not valid to equate them or assume that if an LPVO reimbursed under Section 39da meets the condition of appropriate therapeutic intervention pursuant to the third sentence of Section 15(7) of the Act, it also meets the condition pursuant to the second sentence of that same provision.

Using an LPVO reimbursed under Section 39da as a comparator in the base-case scenario of a cost-effectiveness analysis in proceedings for the determination or modification of reimbursement in the so-called permanent reimbursement regime would lead to methodological inconsistencies in the cost-effectiveness assessment submitted by the applicant and subsequently to inequalities in the Institute's assessment compared to other medicinal products in the permanent reimbursement regime.

Based on the above, it is clear that an assessed intervention in proceedings for the determination or modification of reimbursement in the so-called permanent reimbursement regime cannot be considered to meet the condition of appropriate therapeutic intervention if a medicinal product reimbursed under Section 39da is used as a comparator in the base-case scenario of the cost-effectiveness analysis.

The Ministry is therefore convinced that the use of a medicinal product intended for the treatment of a rare disease reimbursed under Section 39da as a comparator in the base-case scenario of the cost-effectiveness assessment in proceedings for the determination or modification of reimbursement in the so-called permanent reimbursement regime cannot in any way prove that the assessed intervention meets the condition of appropriate therapeutic intervention within the meaning of the second sentence of Section 15(7) of Act No. 48/1997 Coll. Failure to demonstrate appropriate therapeutic intervention under the second sentence of Section 15(7) of Act No. 48/1997 Coll. in reimbursement proceedings under the so-called permanent reimbursement regime constitutes a legal reason for denying reimbursement pursuant to Section 15(6)(d) of the same Act.

This is an unofficial translation generated with the assistance of ChatGPT-4o. It is provided for informational purposes only and does not constitute an official or legally binding translation.

As part of a streamlined reimbursement review for cost-saving purposes (§ 39p(1)), the State Institute for Drug Control unified reimbursement conditions by removing the “A” symbol (indicating use in ambulatory care) for products that can be self-administered by patients after prior training.

The Institute argued that if all products in a given group serve the same purpose and can be administered by patients, there is no reason for them to be subject to different reimbursement conditions. Previously, some products required immediate administration by a physician (marked with the “A” symbol), while others—therapeutically interchangeable—were not subject to such restriction.

The appeal body agreed with this reasoning and described the previous arrangement as inefficient.

The Institute had already reached the same conclusion in 2022, stating that if the accompanying texts (SPC/PIL) allow for patient self-administration after proper training instead of administration in ambulatory care, the “A” prescription restriction (ZULP for ambulatory care) may be removed without requiring a pharmacoeconomic assessment, as no expansion in the number of treated patients occurs.

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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

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 text was translated using ChatGPT 4o.  

The Ministry of Health annulled the decision of the State Institute for Drug Control (SÚKL) on the grounds that the Institute had failed to respect the Ministry’s previous binding legal opinion, as set out in its earlier decision — which we reported in our regular 2021 newsletter.

In 2021, the Association of Health Insurance Companies (Svaz ZP) appealed against the extension of reimbursement conditions for products containing inosine pranobex as part of a comprehensive reimbursement review. The Institute had approved the extension without assessing the cost-effectiveness and budget impact of the proposed change.

The Ministry stated that the removal of reimbursement conditions, such as prescription and indication restrictions, constitutes an expansion of reimbursement that leads to an increase in the number of treated patients. Following the change, all medical specialists could prescribe these products for reimbursement from public health insurance within the approved therapeutic indications listed in the SPC. However, the Ministry emphasized that the prevalence of the relevant conditions in the general Czech population was likely much higher than the number of patients covered under the prior reimbursement restrictions. The contested decision would thus logically lead to increased use and higher reimbursement costs.

By extending reimbursement without a proper assessment of cost-effectiveness and budget impact, the Institute acted unlawfully.

In the further course of the administrative proceedings, the Institute was not allowed to change the reimbursement conditions in a way that would increase the number of treated patients without the submission and assessment of the relevant pharmacoeconomic analyses from the parties to the proceedings. However, after the participants failed to provide the requested analyses, the Institute performed its own calculations and again extended the reimbursement conditions. This decision was again challenged — all payers filed an appeal.

Following further review, the Ministry of Health reiterated that the Institute may not create its own pharmacoeconomic analyses for the purpose of changing reimbursement conditions in the absence of such analyses submitted by the parties. The Institute is only authorized to perform corrective recalculations or similar adjustments within the scope of analyses provided by the parties.

For these reasons, the Ministry annulled the Institute’s decision once again.

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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

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 text was translated using ChatGPT 4o.  

In its decision, the Ministry of Health confirms the possibility of ensuring patients’ right to free (i.e., fully reimbursed) medicinal products from the groups listed in Annex No. 2 to Act No. 48/1997 Coll., even through products that are not available on the Czech market at the time of the SÚKL decision, as long as it is certain that such products will be available in sufficient quantities at the time the administrative decision becomes enforceable.

This typically applies to contractual arrangements between marketing authorization holders and health insurance companies, which include a binding commitment to ensure availability of the respective medicinal products.

On the other hand, the right to free medicinal products cannot be ensured through products that are not present on the Czech market or are available only in negligible quantities.

Furthermore, according to the Ministry of Health of the Czech Republic, SÚKL is not obliged to verify whether a product has been reported as temporarily unavailable on the domestic market, since such a temporary unavailability concerns only a transitional period, unlike permanent discontinuation of supply.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

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 text was translated using ChatGPT 4o.  

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? Feel free to contact us.

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According to the Ministry of Health (MZ), even a single health insurance company can demonstrate that the presented budget impact exceeds the current financial capacity of its fund, even if this applies only to that specific insurer.

Rejecting the statement of one insurance company solely because other insurers remain silent or their statements are less convincing (or not sufficiently substantiated) is, in the Ministry’s view, irrational. If the presented budget impact poses an economic risk to even one health insurance company, this is clearly a factor indicating the unacceptability of the proposed budget impact.

The requirement by SÚKL for statements from all health insurance companies regarding the acceptability of the budget impact has no legal basis, according to the Ministry of Health.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

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 text was translated using ChatGPT 4o.  

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? Feel free to contact us.

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The State Institute for Drug Control questioned the cost-effectiveness of the medicinal product from the group of drugs used for the treatment of functional gastrointestinal disorders, as presented in the administrative proceedings. The reason was significant uncertainties in the submitted analysis.

Upon reviewing the documentation, the Institute identified several problematic aspects. Pharmaceutical costs had increased compared to the originally submitted data. Uncertainties regarding dosage—the method of dose determination was unverifiable, and it was impossible to clearly establish the considered dosage for individual patients. Serious discrepancies in total cost presentation—different values appeared in various sections of the documentation.

All these inconsistencies prevented a proper assessment of cost-effectiveness.

Given these findings, the Institute concluded that the submitted analysis did not meet the minimum quality requirements, and therefore, the medicinal product could not be considered a cost-effective intervention.

Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

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 text was translated using ChatGPT 4o.  

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Our market position and experience allow us to support you whenever you need expert guidance.

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SÚKL, in the reimbursement review, assessed the expansion of JAK inhibitors reimbursement for rheumatoid arthritis ("RA") with moderate disease activity as sufficiently supported by clinical data and desirable for clinical practice in the Czech Republic.

Given that such an expansion of reimbursement conditions would result in an increase in the number of treated patients, it is necessary to evaluate the cost-effectiveness and the budget impact. Since SÚKL did not receive a pharmacoeconomic evaluation from the participants in the required scope, the expansion of reimbursement for rheumatoid arthritis with moderate disease activity was carried out by setting the reimbursement for JAKi at the cost level of another therapy that is (at least) equally effective and already reimbursed for the target group of patients with RA and moderate disease activity. The approach chosen by SÚKL in the ongoing reimbursement review, therefore, by setting two reimbursement levels, ensures that JAKi remain reimbursed for RA with high disease activity in the second and subsequent lines of treatment with higher reimbursement, while JAKi are also newly reimbursed for moderate disease activity, though at a lower reimbursement amount.

The participant argued that a medicinal product may only have one additional increased reimbursement level set, alongside the basic reimbursement (not multiple increased reimbursement levels, as SÚKL did). SÚKL refers to Section 39b, paragraph 11 of the Health Insurance Act, which does not exclude the possibility of applying it based on the evaluation of a medicinal substance, product, or pharmaceutical form for several selected indications or for multiple patient groups.

SÚKL also states that during the ongoing reimbursement review, no statements were received from payers regarding any difficulties in reporting healthcare when establishing multiple reimbursement levels.

Articles from decision-making practice are based on publicly available texts from decisions by the Ministry of Health of the Czech Republic and decisions by SÚKL.

On the website of Pharmeca a.s., you can continuously follow an overview of the pricing and reimbursement decisions issued by SÚKL and the Ministry of Health of the Czech Republic. 

Articles on decision-making practice are based on publicly available texts of the Ministry of Health and SÚKL decisions.  

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.

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On February 21, 2025, the Ministry of Health of the Czech Republic published the following opinion on the procedure for assessing the financial impact on the health insurance system when determining or changing the amount and conditions of reimbursement for a medicinal product or food for special medical purposes:

"The Department of Medicinal Products and Medical Devices of the Ministry of Health of the Czech Republic (hereinafter referred to as "the Ministry"), in view of the wording of the applicable Act No. 338/2024 Coll., amending Act No. 48/1997 Coll., on Public Health Insurance and on Amendments and Supplements to Certain Related Acts, as amended, Act No. 592/1992 Coll., on Insurance Contributions for Public Health Insurance, as amended, and Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts (the Medicinal Products Act), as amended, which, with effect from January 1, 2025, changes the principles in the area of monitoring limits of deductible co-payments for partially reimbursed medicinal products and foods for special medical purposes (the protective limit) and the subsequent reimbursement of deductible co-payments exceeding the protective limit under 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 Public Health Insurance Act"), hereby issues its opinion on the procedure for assessing the financial impact on the health insurance system when determining or changing the amount and conditions of reimbursement for medicinal products or foods for special medical purposes.

The method of assessing the financial impact on the health insurance system (hereinafter referred to as "budget impact") is expressed in the third and fourth sentences of Section 15(8) of the Public Health Insurance Act, which state that "The budget impact is determined as the difference between the costs of treating a given disease associated with the use of a medicinal product or food for special medical purposes that would be reimbursed from health insurance funds, and the costs of treatment using another medicinal product, food for special medical purposes, or treatment method that is already reimbursed from health insurance funds. The budget impact must be in accordance with the public interest pursuant to Section 17(2)."

If, under Section 15(9) of the Public Health Insurance Act, the anticipated budget impact associated with determining reimbursement for a medicinal product or food for special medical purposes shows an increase in expenditures from the health insurance system, the budget impact assessment must be conducted through a budget impact analysis submitted by the applicant, which the State Institute for Drug Control assesses during the proceedings [see Section 39b(2)(c) of the Public Health Insurance Act].

The requirements of the third and fourth sentences of Section 15(8) of the Public Health Insurance Act for the applicant-submitted budget impact analysis and the procedure of the State Institute for Drug Control in its assessment are elaborated in the methodology SP-CAU-27 (hereinafter referred to as "the methodology") as of the date of this opinion. For the purpose of quantifying the budget impact, the methodology allows only the perspective of health insurance expenditures (for completeness, it should be noted that this applies outside of proceedings conducted under Section 39da of the Public Health Insurance Act).

The Ministry is aware from its own official activities that the State Institute for Drug Control currently considers only direct costs (both pharmaceutical and non-pharmaceutical) demonstrably incurred from health insurance in connection with the therapy of the given disease as relevant costs in the budget impact assessment, whereby the State Institute for Drug Control considers only the costs at the level of reimbursement from health insurance, or costs corresponding to the maximum consumer price if this price is lower than the reimbursement amount, as direct pharmaceutical costs for both the evaluated intervention and the comparator.

However, as the Public Health Insurance Act stipulates that the budget impact is determined as the difference in treatment costs for the given disease (from the perspective of health insurance) associated with the use of medicinal products, the Ministry considers it necessary to include in the relevant direct costs for the evaluated intervention and the comparator also the amounts of deductible co-payments reimbursed by health insurance funds above the protective limit of the insured, which, in connection with the amendment to the Public Health Insurance Act, will be a direct expenditure of health insurance funds paid to pharmacy service providers related to the treatment of the given disease.

For this reason, it is necessary that the applicant, within the submitted application, consider the anticipated budget impact, taking into account any deductible co-payments for the evaluated and comparator intervention.

If, in the assessment of the anticipated budget impact under Section 39b(2)(j) of the Public Health Insurance Act in proceedings on determining or changing the amount and conditions of reimbursement for a medicinal product, it becomes apparent that this anticipated reimbursement impact on health insurance funds, taking into account the anticipated amount of deductible co-payments (representing the cost of treating the given disease), shows an increase in expenditures from the health insurance system, in such a case, the applicant must submit a budget impact analysis that also considers the amount of the anticipated deductible co-payment.

According to the Ministry, in order to fulfill the purpose of the aforementioned legal provisions concerning the new protective limit rules, it is necessary that, in the budget impact assessment by the applicant and the budget impact evaluation by the State Institute for Drug Control, the deductible co-payment amounts applied in practice are considered, rather than the highest possible deductible co-payment amounts calculated according to the second sentence of Section 16b(1) of the Public Health Insurance Act.

The Ministry further emphasizes that the deductible co-payments for partially reimbursed medicinal products and foods for special medical purposes, which count towards the insured person's protective limit, are known to the State Institute for Drug Control from its own official activities, as well as to health insurance funds, and marketing authorization holders can also determine the actually applied amounts of deductible co-payments from the publicly available data on the website of the State Institute for Drug Control at https://prehledy.sukl.cz/prehled_leciv.html#/ or calculate them from data on already reimbursed medicinal products (comparators) published at regular intervals on https://opendata.sukl.cz/?q=katalog/lek-13 (note: link valid as of the date of this opinion).

For practical implementation, the Ministry believes that the above-mentioned change in the procedure for budget impact assessment can be realized as follows. The budget impact analysis will, in addition to the currently expressed budget impact, also include a separately calculated budget impact incorporating the costs of deductible co-payments for partially reimbursed medicinal products and foods for special medical purposes that would arise for health insurance funds when exceeding the annual protective limit. However, presenting a separately calculated budget impact with applied deductible co-payments will not be entirely necessary (or would be redundant) in cases where no deductible co-payment arises in the determination or change of the reimbursement amount and conditions for the evaluated intervention.

In conclusion, the Ministry states that this opinion does not interfere with the current practice of assessing cost-effectiveness analyses."   

The original document is available on the website of the Ministry of Health of the Czech Republic.

This is an unofficial translation generated with the assistance of ChatGPT-4o. It is provided for informational purposes only and does not constitute an official or legally binding translation.

The European Medicines Agency (EMA) has announced the launch of a new platform designed to routinely monitor shortages of centrally authorized medicines. This platform is a direct result of Regulation (EU) 2022/123, which aims to improve preparedness for and mitigation of medicine shortages across EU member states.

Key Points:

• Platform Availability: The European Shortages Monitoring Platform (ESMP) is now accessible online.
• Mandatory Usage: Starting from February 2, 2025, all Marketing Authorization Holders (MAHs) with centrally authorized products will be required to use the ESMP.
• Early Familiarity: EMA encourages MAHs to familiarize themselves with the platform before the mandatory deadline.
• Data Submission: Until February 2, 2025, MAHs and National Competent Authorities (NCAs) can submit data on supply, demand, and availability of both centrally and nationally authorized medicines to the EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).
• Medicine Monitoring: The platform will be used for routine monitoring of all centrally authorized medicines and may also be used for monitoring nationally authorized medicines under special circumstances.

Additional Resources:

• Frequently Asked Questions