A Comprehensive Overview of New HTA Guideline for Medicines in Ukraine
Author(s)
Piniazhko O1, Khmelyovska M1, Masheiko A1, Serediuk V1, Topachevskyi O2, Oleshchuk O3, Romanenko I1, Malyshevska I1
1State Expert Center of the Ministry of Health of Ukraine, Kyiv, Ukraine, 2Expert Committee on Selection and Use of Essential Medicines, Kyiv, Ukraine, 3Expert Committee on the Selection and Use of Essential Medicines; I. Horbachevsky Ternopil National Medical University, Ternopil, Ukraine
OBJECTIVES: The study aims to provide a comprehensive review of the first approved HTA Guideline for medicines in Ukraine. The first achieved goal was to implement the Decree of Cabinet of Ministers of Ukraine №1300 “On the approval of the state health technology assessment procedure” dated on 23 December, 2020 and to develop and approve HTA Guideline. METHODS: Comprehensive review of the HTA Guideline “The state health technology assessment for medicines” approved by the Order of MoH №593 on 29 March, 2021 was conducted. RESULTS: HTA Guideline is the first methodological recommendations for state HTA for medicines in Ukraine, developed by leading experts of HTA Department of State Expert Center of MoH and Expert committee of MoH. Supplementing the provisions of the Decree №1300, the Guideline provides stakeholders with updated methodological recommendations for planning and conducting HTA, including presentation of trial results in the applications and dossiers for the inclusion of medicines on regulatory lists (National list, nomenclature), development of conclusions and recommendations by Ukrainian authorized institution on HTA (temporarily HTA Department) based on the results of dossier submissions, and the use of HTA recommendations for decision-making and in real clinical practice. The provisions of the Guideline reflect harmonized international recommendations and approaches to HTA (EUnetHTA, NICE, ICER, AOTMiT), that are based on the latest research in this field of knowledge, in particular, the stages of HTA, comparative efficacy and safety analysis, pharmacoeconomic analysis, and budget impact analysis including recommendations for cost-effectiveness thresholds and budget impact test in Ukraine. Authors conducted several rounds of public discussion and consultations with stakeholders before MoH approval. CONCLUSIONS: Compliance with the provisions of this Guideline by stakeholders will facilitate planning and conducting HTA in a systematic way and will optimize the assessment of dossier submissions, as well as improve patients' access to publicly funded medicines in Ukraine.
Conference/Value in Health Info
2021-11, ISPOR Europe 2021, Copenhagen, Denmark
Value in Health, Volume 24, Issue 12, S2 (December 2021)
Code
POSA278
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Reimbursement & Access Policy, Systems & Structure, Value Frameworks & Dossier Format
Disease
No Specific Disease