The state and prospects of development of HTA for medical devices in Ukraine were discussed during the 5th Anniversary Forum on Health Technology Assessment. The event took place on 25-26 September in Kyiv, organized by the international technical assistance project USAID/SAFEMed, the MoH of Ukraine, and the State Expert Center.
Health technology assessment for medical devices (MDs) is currently at the stage of preparation for implementation in Ukraine. The HTA tool for MDs will contribute to rationalizing the expenditures of the state as a payer for those MDs that are used for prevention, treatment, diagnostic purposes and screening programs in the health care system (for example, therapeutic and diagnostic equipment, devices for laboratory use, digital technologies, and others).
As the Director of the HTA Department of the Center Oresta Piniazhko recalled, in fulfillment of the requirement of the Resolution of the Cabinet of Ministers of Ukraine of December 23, 2020, No. 1300, the Center's specialists developed a draft state HTA guideline for medical devices, which is currently under consideration by the Ministry of Health of Ukraine. The document incorporates examples of the best HTA guidelines for medical devices adopted in the EU, the United Kingdom and the United States, as well as the knowledge gained during trainings and consultations with international specialists and experts.
According to the Deputy Head of the Division for Economic Evaluation of Medical Technologies of the HTA Department of the Center, Marharyta Khmelovska, the guideline on state HTA for medical devices (MD) is a continuation and supplement to the guideline on state HTA for medicinal products, since its provisions are applicable to the process, stages and basic methodological approaches of conducting HTA for MD. The basic HTA methodology, for example, in the selection of evidence and the assessment of its reliability, is acceptable for the evaluation of MD, but requires more attention in definition, description and assessment. Currently, the draft guideline is proposed for those MD registered in Ukraine – class IIb (medium-to-high-risk devices) and class III (high-risk devices), which can potentially contribute to cost savings and the rationalization of expenditure from the perspective of the healthcare system – the state payer, as well as for MD used for diagnostic purposes and screening programs.
During the panel discussion devoted to the effectiveness of implementing HTA for medical devices in Ukraine, with the participation of specialists from the MoH, the NHSU, the Center, representatives of the Healthcare Committee of the European Business Association, industry, and the patient community, the discussion covered the prioritization of those categories of medical devices in the healthcare system that need to be assessed through the HTA tool, the timelines for implementing the guideline, and further regulatory refinements.
Among the main challenges voiced by the panel discussion participants:
- a list of medical devices purchased with budget funds is necessary, for its subsequent population with medical devices based on HTA results
- conducting an analysis of those medical devices that the state already procures
- prioritization of diseases and conditions in the health care system for which an assessment of MV is necessary
- raising stakeholder awareness of conducting HTA.
The organizers of the event pointed out that Health Technology Assessment International (HTAi) is currently conducting HTA training for MV, initiated by the project of the Health Office of the U.S. Agency for International Development (USAID) “Safe and Affordable Medicines for Ukrainians” (SAFEMed).
