The procedure of state health technology assessment (hereinafter – HTA) in Ukraine is defined by Resolution of the Cabinet of Ministers of Ukraine of 23 December 2020 No. 1300 "On Approval of the Procedure for Conducting State Health Technology Assessment" (hereinafter – the Procedure). The functions of conducting state HTA are assigned to the authorized body – the Center, namely the HTA Department.
Health technology assessment is a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its life cycle, with the aim of informing decision-making in order to promote an equitable, efficient and high-quality health system. The value of a health technology can be determined by examining the intended and unintended consequences of its use compared with existing alternatives. These dimensions include clinical effectiveness, safety, costs and economic implications, ethical, social, cultural and legal issues, organizational and environmental aspects, as well as wider implications for the patient, relatives, caregivers and the population. The overall value may vary depending on the chosen perspective of the assessment, the stakeholders and the decision-making context.
HTA is a reliable and promising tool for decision-makers in the healthcare system in Ukraine (MoH, NHSU, SE “Medical Procurement of Ukraine”). State HTA is conducted in accordance with the Procedure for Conducting State HTA and the state HTA guidelines, in the following cases:
- inclusion (exclusion) of medicinal products in (from) the National List of Essential Medicines, approved by Resolution of the Cabinet of Ministers of Ukraine of 25 March 2009 No. 333 “Certain Issues of State Regulation of Prices for Medicinal Products and Medical Devices” (hereinafter – the National List);
- inclusion (exclusion) of medicinal products in (from) nomenclatures (lists, registers) procured with state budget funds for the implementation of programs and centralized public health measures;
- application of managed access agreement procedures, extension of their validity (prolongation);
- procurement of medicinal products by the structural units for health care matters of regional and Kyiv city state administrations for the implementation of regional targeted programs in the cases specified in paragraph 1-2 of the resolution of the Cabinet of Ministers of Ukraine of March 25, 2009 No. 333 “Certain Issues of State Regulation of Prices for Medicinal Products and Medical Devices”.
Based on expert opinions and recommendations, the medical technology for the relevant treatment regimen is selected that will be the most clinically effective, safe and cost-effective and will cover the largest number of patients to meet unmet medical needs. This is how rational use of financial resources can be achieved: using only those medical technologies that have the highest value for the patient and the state. At the same time, value is determined transparently and objectively, taking into account the interests of all stakeholders.
