Oresta Piniazhko, PhD, President of ISPOR Ukraine Chapter, Director of HTA Department, State Expert Centre of Ministry of Health of Ukraine, ISPOR Ukraine Chapter, orestapb@gmail.com
Marharyta Khmelovska, Expert of the Division of economic evaluation of health technologies of HTA Department, State Expert Centre of Ministry of Health of Ukraine, ISPOR Ukraine Chapter, hmelyovska@dec.gov.ua
Valeriia Serediuk, Acting head of the Division of economic evaluation of health technologies of HTA Department, State Expert Centre of Ministry of Health of Ukraine, leraseredjuk@gmail.com
Olha Zaliska, Professor, Founder of ISPOR Ukraine Chapter, Head of the Department of Management and Pharmacoeconomics of Danylo Halytsky Lviv National Medical University, olzaliska@ukr.net
Oleksandra Oleshchuk, Professor, Head of Pharmacology with Clinical Pharmacology Department of I. Horbachevsky Ternopil National Medical University, oleshchuk@tdmu.edu.ua
On March 17, 2023, the first joint event on health technology assessment (HTA) between Ukraine and the UK was held between the HTA Department of the State Expert Centre of the Ministry of Health of Ukraine (SEC of MoH of Ukraine) and the National Institute for Health and Care Excellence (NICE), informing a future project between the two countries on evolving HTA process and practices in Ukraine. Participants at the roundtable discussed the methods, processes and experiences of HTA in England and Ukraine, and looked at stakeholders' challenges and potential solutions. The first part of the joint roundtable focused on exchanging knowledge on HTA between UK and Ukraine experts, while the second part sought views from participating stakeholders on their experience with HTA in Ukraine.
Among the participants from the Ukrainian side were Viktor Liashko, Minister of Healthcare, Mykhailo Babenko, Director of the SEC of MoH, Oresta Piniazhko, Director of HTA Department of the SEC of MoH, experts of the HTA Department, decision makers, industry, patients’ and academia representatives.
From the UK side, the participants included Pilar Pinilla-Dominguez, Associate Director of NICE International, Federica Ciamponi, Senior Scientific Adviser at NICE and Amanda Adler, Professor of Oxford University and former Chair of a NICE Technology Appraisal Committee.
The event was opened with welcome remarks from Viktor Liashko, Minister of Healthcare of Ukraine and Mykhailo Babenko, Director of the SEC of MoH Ukraine and Nigel Huddleston, Minister of State at the UK Department for Business and Trade, and it was supported by the British Embassy and UK Department for Business and Trade in Ukraine.
The first part of the roundtable focused on the principles of HTA in both countries, where both Ukraine and the UK shared experiences and exchanged knowledge. Pilar Pinilla-Dominguez, Federica Ciamponi, and Oresta Piniazhko delivered presentations with information concerning the HTA systems, main methods, and processes, experience in developing and concluding managed entry agreements (MEAs), and mechanisms for cooperation with stakeholders.
Oresta Piniazhko focused on the provision of pharmaceuticals in Ukraine over the last year. She presented the main stages of institutionalization of HTA in Ukraine, and how Ukraine has applied HTA since 2019. She further discussed the results of implementing HTA following the HTA roadmap based on the first Decree №1300 “On the approval of the procedure for the state HTA” approved by the Cabinet of Ministers of Ukraine on December 23, 2020 [1] patient-oriented results of medicines evaluations by indications, an international direction of cooperation as well as the direction of interaction with stakeholders. It is worth noting that as of March 2023, the SEC of MoH of Ukraine has received and processed over 100 company submissions and MoH requests to conduct a state HTA, 78 conclusions with recommendations have been prepared and provided to the MoH, 65% of them – during the wartime. Despite the challenges and hard times caused by Russia’s full-scale invasion of Ukraine, the first 10 MEAs informed by HTA recommendations were concluded at the end of 2022, resulting in savings of 10 million dollars and 100 million Ukrainian hryvnias in 2022 based on publicly available information on MoH website [2]. In addition, the HTA regulatory framework continues to develop, close cooperation with international partners continues, an educational training program was developed and more than 20 training sessions for industry representatives were held. The HTA Department of SEC of MOH of Ukraine constantly communicates with foreign partners: International Society for Pharmacoeconomics and Outcomes Research (ISPOR), SAFEMed, International Network of Agencies for Health Technology Assessment (INAHTA), Health Technology Assessment international (HTAi), European Network for Health Technology Assessment (EUnetHTA) regarding organizational, methodological and educational issues in this activity.
In the second part of the meeting, during a panel discussion with stakeholders, moderated by Oresta Piniazhko and Pilar Pinilla-Dominguez, the participants discussed the main challenges and ways to improve HTA in Ukraine. More than 40 participants joined the discussion – among them: Amanda Adler, Professor of Oxford University, and former Chair of a NICE Technology Appraisal Committee, Rabia Suku, Senior Technical Advisor for Pharmaceutical Policy and Governance in the Safe, Affordable, and Effective Medicines project (USAID SAFEMed) in Ukraine, Oleksandra Oleshchuk, Professor and Head of Pharmacology with Clinical Pharmacology Department of I. Horbachevsky Ternopil National Medical University, Oleksandr Topachevskyi, Managing director of Digital Health Outcomes LLC, Yevhenii Honchar, Head of the Department of Policy Formation of the Medical Guarantee Program and Medical Support of the MoH of Ukraine, Borys Danevych, Co-chair of the Healthcare Committee of American Chamber of Commerce in Ukraine, Dmytro Lurie, Manager of the Committee on Health Protection of the European Business Association, Tetyana Kulesha, Head of the public union “Orphan Diseases of Ukraine”, Kostyantyn Kosyachenko, Professor and adviser to the director of the SEC of MoH of Ukraine.
Among the main challenges and opportunities, the participants emphasized the following:
• Ukraine is a country with a unique experience – HTA was implemented in Ukraine in the shortest possible time, despite the country's income being lower middle level
• One of the biggest challenges in Ukraine is the financial capabilities of the state as a payer to ensure patients’ access to new innovative health technologies. Taking into account that the health care sector as well as the whole country is operating in wartime, the monitoring of economic feasibility is even more important in conditions of even greater scarcity of financial resources
• In line with NICE’s experience, MEA should be the exception rather than the norm, and they emphasized that there are other price negotiation mechanisms in England to facilitate commercial discussions beyond MEA. Consideration of the introduction of other negotiation tools for the rational use of financial resources and harmonization of the use of various pricing tools that are used in Ukraine is urgent
• Importance of transparency and publicity, management of conflict of interests, independence of assessment
• Introduction of the single positive list for alignment of procurement processes for medicines is needed as the effective tool in practical use
• Part of the success of NICE relies on principles and practices such as transparency, management of conflicts of interest, consultations, or independence of the appraisal evaluation system
• The use of HTA in Ukraine has evolved and will continue to develop; this Ukraine needs to further institutionalize and develop its expert potential, as well as spread awareness of HTA, strengthen the cooperation between people who undertake and use HTA, and between regulators, clinicians, scientists, and patients
The team from Ukraine are very grateful for and appreciate their British counterparts for initiating the opportunity to discuss the UK experience, provide valuable recommendations, as well as to Ukrainian experts and partners for their active cooperation, comments, and suggestions.
References
[1] https://zakon.rada.gov.ua/laws/show/1300-2020-%D0%BF#Text; HTA Guidelines for medicines (https://zakon.rada.gov.ua/rada/show/v0593282-21#Text)
[2] https://moz.gov.ua/article/news/vpershe-v-ukraini-pacientam-budut-bezoplatno-dostupni-liki-proti-spinalnoi-mjazovoi-atrofii