The legislative framework

The NIHO Act

Act No. 358/2021 Coll. on the National Institute for Value and Technologies in Health Care and on amendments to certain acts is a law that entrusts the institute with specific tasks, time limits and basic framework for its functioning.

• Paragraph 3 (1) to (4) governs the main role of NIHO.
• Paragraph 3 (5) refers to other tasks that NIHO may perform.
• Paragraph 5 refers to demands placed on the Director of NIHO.
• Paragraphs 6 to 8   govern the selection process of the Director of NIHO.
• Paragraphs 9 to 10 regulate the composition and competence of the NIHO Supervisory Board.
• Paragraph 11 regulates the financial management of NIHO.

Other relevant legislation

• § 15a of Act 581/2004 Coll. on health insurance companies, supervision of health care and amendments to certain laws refers to NIHO financing.
• Act No. 363/2011 Coll. on the level and conditions of medicine reimbursement, medical devices and dietetic foods on the basis of public health insurance and on amendments to certain acts describes the entire process of categorization of medicines, dietetic foods, medical devices and specialized medical supplies.
• Decree No. 298/2022 Coll. on the calculation details of the relevant multiple of the gross domestic product for the determination of the threshold value of the assessed medicine defines auxiliary criteria to be taken into account when determining the maximum willingness to pay for 1 QALY – one year of life in perfect health brought to patients by the technology (the so-called cost effectiveness threshold).
• Decree 422/2011 Coll. on the details of the pharmacoeconomic analysis of a medicine defines information that the marketing authorization holder must provide in the pharmacoeconomic analysis included in the application for categorization of the medicine.
• Decree 280/2022 Coll. on the method of determining the standard dose of a medicine, determining, reducing and increasing the maximum amount of reimbursement of health insurance companies for the standard dose of the medicinal product and determining, changing and cancelling the reimbursement group provides useful information on the method of grouping medicines in the List of reimbursed medicines and on determining the maximum amount of reimbursement within the reimbursement group.
• Decree 284/2022 Coll. on establishing key performance indicators of National institute for Value and technologies in Health, methods of their calculation, their target values, their percentages of weight. Key performance indicators are tool to measure, whether NIHO is fullfilling its main role according to law.

Methodological manual of MoH SR

The methodological manual of the Ministry of Health of the Slovak Republic for Decree No. 422/2011 defines requirements for pharmacoeconomic analyses in submitted dossiers. It also includes a template for analysis as an attachment.

The aim of the methodological manual is to assist applicants in preparing submissions through clear guidelines, to increase transparency and to standardize the quality of submitted documentation. Higher quality of the dossiers can reduce the duration of reimbursement application process in Slovakia (by adhering to the guidelines, the need for additional communication and evidence may be reduced).

The manual was prepared in close collaboration between NIHO and the Ministry of Health of the Slovak Republic. The first version of the manual was issued in April 2024, and its use is mandatory for applications submitted from August 1, 2024.

Documents (in Slovak) can be downloaded here: 
https://health.gov.sk/?kategorizacia-liekov-1