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
- Paragraph 15a of Act 581/2004 Coll. on health insurance companies, health care supervision and on amendments to certain acts 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.