Pharmeca.cz

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.

The text of the opinion was translated using ChatGPT 4o.

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

Pharmeca a.s. provides services in the areas defined by this legislative framework:

Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts, as amended.  

Implementing Regulation:

• Decree No. 376/2011 Coll., which implements certain provisions of the Public Health Insurance Act, as amended,
• Decree No  384/2007 Coll., on the list of reference groups, as amended,
• Decree No  385/2007 Coll., on the list of active substances for adjunct or add-on therapy;
• Decree No. 63/2007 Coll., on the reimbursement of medicinal products and foods for special medical purposes, as amended.
• Decree No. 618/2006 Coll., which issues framework agreements, as amended,
• Decree No. 134/1998 Coll., which issues a list of medical services with point values, as amended,
• Decree No. 527/2021 Coll., on determination of the amount of reimbursement of expenses for professional acts and the method of determination of the amount of compensation of expenses for professional consultations carried out by the State Institute for Drug Control under the Public Health Insurance Act, as amended,
• Decree on the determination of point values, the amount of payments for paid services and regulatory restrictions - always issued for the current year,
• Government Regulation No. 307/2012 Coll., on local and temporal availability of health services, as amended.

Act No. 551/1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended.

Act No. 280/1992 Coll., on departmental, branch, corporate and other insurance companies, as amended.

Act No. 592/1992 Coll., on public health insurance premiums, as amended.

Implementing Regulation:

• Decree No. 351/2022 Coll., on the transmission of data on the consumption of medicinal products by insured persons of the public health insurance when changing the health insurance company, as amended

Act No. 526/1990  Coll., on Prices, as amended.

Price Regulations – Medicinal Products:

• Price Regulation of the Ministry of Health No. 4/2024/OLZP, on the determination of a special distribution surcharge for medicinal products released from the reserve stock system,
• Price Decision of the Ministry of Health No. 3/2024/OLZP, dated November 29, 2023, setting out lists of ATC groups with the relevant route of administration, for which the ex-factory price of the medicinal product is not subject to price regulation or maximum price regulation,
• Price Regulation of the Ministry of Health No. 2/2024/OLZP, dated November 29, 2023, on the price regulation of medicinal products and foods for special medical purposes,
• Price Regulation of the Ministry of Health No. 11/2023/OLZP, dated October 25, 2023, on the determination of the distribution and dispensing surcharge for medicinal products reimbursed under Section 32c of Act No. 48/1997 Coll.,
• Price Regulation No. 3/2022/OLZP, on the price regulation of individually prepared medicinal products containing cannabis for medical use.

Price Regulations – Medical Devices:

• Price Regulation of the Ministry of Health No. 1/2024/OLZP, dated October 25, 2023, on the price regulation of medical devices and in vitro diagnostic medical devices,
• Price Regulation of the Ministry of Health No. 2/2022/OLZP, dated January 7, 2022, amending Price Regulation No. 1/2019/CAU, dated May 22, 2019, on the price regulation of medical devices,
• Price Decision 2/13-FAR, establishing a list of medical devices with deregulated manufacturer prices.

Act No. 378/2007 Coll., on Pharmaceuticals, as amended.

Implementing Regulation:

·         Decree No. 457/2023 Coll., establishing a list of human medicinal products exempt from the obligation of the marketing authorization holder to ensure their supply after the announced date of supply interruption or discontinuation, as amended.

• Decree No. 84/2008 Coll., on good pharmaceutical practice, detailed conditions of handling pharmaceuticals in pharmacies, healthcare facilities and other operators and facilities supplying medicinal products, as amended,
• Decree No. 85/2008 Coll., which lays down a list of active substances and excipients which may be used in the preparation of medicinal products, as amended,
• Decree No 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended,
• Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
• Decree No. 229/2008 Coll., on the manufacture and distribution of pharmaceuticals, as amended,
• Decree No. 236/2015 Coll., on the determination of conditions for prescription, preparation, distribution, dispense and use of individually prepared medicinal products containing cannabis for medical use, as amended,
• Decree No. 329/2019 Coll., on prescribing medicinal products in the provision of health services, as amended,
• Decree No. 463/2021 Coll., on the detailed conditions for conducting a clinical trial of medicinal products for human use, as amended.

Act No 167/1998 Coll, on addictive substances and amending certain other acts, as amended

Implementing Regulation:

• Decree No. 53/2014 Coll., on forms under the Addictive Substances Act, as amended,
• Decree No. 123/2006 Coll., on evidence and documentation of addictive substances and preparations, as amended,
• Decree No. 243/2009 Coll., on establishing a list of persons indicating their workplaces for their work is not required permit to treatment of addictive substances and preparations containing them, as amended,
• Government Regulation No. 463/2013 Coll., on lists of addictive substances, as amended,
• Decree No. 235/2022 Coll., on the cultivation and processing of cannabis plants for medicinal use, as amended,
• Decree No 53/2022 Coll., on the determination of the amount of compensation of expenses for professional acts performed by the State Institute for Drug Control pursuant to the Act on Addictive Substances, as amended.

Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices, as amended. 

Implementing Regulation:

• Decree No 377/2022 Coll., on the implementation of certain provisions of the Act on medical devices and in vitro diagnostic medical devices, as amended, 

·         Decree No. 378/2022 Coll., on the template of the inspector's identification card of the State Institute for Drug Control under the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended.

• Decree No 379/2022 Coll., on the determination of the amount of compensation of expenses for professional acts performed by the State Institute for Drug Control pursuant to the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended. 

Act No 376/2022 Coll. amending certain acts in connection with the adoption of the Act on medical devices and in vitro diagnostic medical devices, as amended.

Act No. 268/2014 Coll., on medical devices and amending Act No. 634/2004 Coll., on administrative fees, as amended.

Act No. 89/2021 Coll., on medical devices and amending Act No. 378/2007 Coll., on pharmaceuticals and on amendments to certain related acts (Act on pharmaceuticals), as amended.

Implementing Regulation:

·         Notification of the Ministry of Health No. 54/2022 Coll., on the commissioning of the central repository of electronic vouchers.

Act No. 22/1997 Coll., on Technical Requirements for Products and amendments to some related acts, as amended.  

Act No. 90/2016 Coll., on the assessment of the conformity of specified products when they are placed on the market, as amended.

Act No. 372/2011 Coll., on health services and conditions for their provision (the Health Services Act), as amended.  

Decree No. 373/2016 Coll., on the transfer of data to the National Health Information System, as amended.

Act No. 40/1995 Coll., on the regulation of advertising and on amending and supplementing Act No. 468/1991 Coll., on the operation of radio and television broadcasting, as amended. 

Act No 242/2022 Coll., on the services of video sharing platforms and amending certain related acts (Act on the services of video sharing platforms), as amended.

Act No. 387/2024 Coll., on General Product Safety and Amendments to Certain Related Acts, as amended.

Act No. 500/2004 Coll., Administrative Code, as amended.

Current price decisions, opinions and methodological instructions or regulations of the Ministry of Health of the Czech Republic.

Instructions and methodologies of SÚKL.

A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant sanofi-aventis, s.r.o., against the decision of the State Institute for Drug Control from 23. 3. 2021, under the no. SUKLS172396/2020:

• the remainder of the appeal is dismissed and the decision under appeal is upheld.

More information: MZCR.cz.

A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 9. 4. 2021, under the no. SUKLS182256/2020:

• the remainder of the appeal is dismissed and the decision under appeal is upheld.

More information: MZCR.cz.

A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 12. 4. 2021, under the no. SUKLS182359/2020:

• the remainder of the appeal is dismissed and the decision under appeal is upheld.

More information: MZCR.cz.

A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Union of Health Insurance Companies, against the decision of the State Institute for Drug Control from 10. 8. 2022, under the no. SUKLS85858/2022:

• the decision under appeal is reversed and the issue is referred back to the State Institute for Drug Control for reappraisal.
  

More information: MZCR.cz.

A decision of the Ministry of Health of the Czech Republic regarding the appeal of the appelant Otsuka Pharmaceutical Netherlands B. V., against the decision of the State Institute for Drug Control from 15. 3. 2021, under the no. SUKLS246602/2020:

• the remainder of the appeal is dismissed and the decision under appeal is upheld.

More information: MZCR.cz.