Mykhailo Lobas, Deputy Director for Clinical Affairs, shared the achievements and plans of the State Expert Center of the Ministry of Health of Ukraine in the process of changes on the path to developing state health technology assessment in Ukraine during the 5th anniversary forum on health technology assessment “The role of health technology assessment in the holistic ecosystem of access to clinically effective and cost-effective medical technologies”. The event took place in Kyiv on September 25-26, 2024.
Mykhailo Lobas recalled the main stages in the development of state HTA, namely: since 2019, when a new structural unit, the Department of Health Technology Assessment, was created at the State Expert Center of the Ministry of Health of Ukraine and a team of multidisciplinary experts was formed, which now numbers 26 highly qualified specialists. During this time, the specialists of the HTA Department have processed 137 applications and dossiers and issued 108 HTA conclusions with recommendations for the Ministry of Health of Ukraine.
“Aware of the uncertainty and complexity of the conditions in which our country lives today, and of the short timeframes allotted for implementing the changes to Resolution of the Cabinet of Ministers of Ukraine No. 1300 of December 22, 2023, the Center's specialists understand that an independent HTA organization must begin its work based on a model, structure and processes that must correspond to the best international practices and Ukraine's European integration vector. To this end, the Center is systematically studying the experience of developed countries,” emphasized Mykhailo Lobas.
In order to learn from others’ experience, the Center’s team cooperates with leading HTA agencies. From the most recent visit: at the invitation of Ailsa Brown, Lead Health Economist of the Scottish Medicines Consortium, which is part of the national health organization of Scotland (Healthcare Improvement Scotland), and the chair of the SMC expert committee, Professor Scott Muir, a working visit took place, which contributed to a detailed familiarization with the organizational model of HTA of the consortium, HTA procedures and methods, the practice of using the horizon scanning tool, and experience in conducting HTA for medical devices.
Another emphasis was placed on becoming familiar with the various organizational models of HTA organizations. Also, Center employees had the honor of being invited to participate in a meeting of the SMC expert committee on HTA. “We had an exclusive opportunity to observe a highly professional scientific discussion and decision-making processes on recommendations for the rational selection of medicinal products,” he noted.
Mykhailo Lobas expressed great gratitude to the USAID/SAFEMed project for many years of support for the development of the HTA area in Ukraine. Within the project “Safe, Affordable, and Effective Medicines for Ukrainians,” USAID/SAFEMed organized a global training program for HTA experts, conducted training events for trainers, organized a training on the use of the horizon scanning tool, and launched a training event on HTA for medical devices with the involvement of international experts.
Specialists of the HTA Department continue to improve their professional knowledge and practical skills by participating in training programs: with the Norwegian Institute of Public Health (NIPH) on forecasting the need for a medical technology for budget impact analysis.
Thanks to an initiative of the Department for Business and Trade of the UK Government, a comprehensive Expert Capacity Development Program was developed together with the National Institute for Health and Care Excellence (NICE), which provided for the exchange of experience and training on organizational, procedural, and methodological issues. The results of this training were: approval of a new edition of the guideline on state HTA, which was peer-reviewed by NICE colleagues, and the development and approval of a new HTA procedure – methodological consultations on comparator selection. “In September of this year, a joint meeting took place that summed up this cooperation, and a joint action plan was developed; the possibility of holding a set of training activities on HTA for medical devices was also discussed, the result of which should be a peer-reviewed draft of the corresponding guideline,” the speaker said.
“The process of developing HTA requires broad awareness and understanding of the basic principles of evidence-based medicine among all stakeholders, and the training of highly qualified specialists. In order to create comprehensive training and development programs, the Center signed memoranda of interaction and cooperation with a number of higher medical and pharmaceutical educational institutions,” he said.
To achieve this goal, the Center continues systematic work on organizing and conducting educational programs on a regular basis. In particular, the Center cooperates with Krzysztof Landa, a physician, graduate of the Faculty of Medicine of Jagiellonian University, founder of the WATCH HEALTH FOUNDATION, and former Deputy Minister of Health of Poland, who is a lecturer of the comprehensive training program on evidence-based medicine (EBM), which is the basic training program at McMaster and Oxford Universities. In Ukraine, such a course is aimed at training certified instructors who will subsequently teach a course on evidence-based medicine and HTA for specialists at all levels.
This program is currently ongoing successfully at Cherkasy Medical Academy and in the near future will be introduced at the P. L. Shupyk National Healthcare University of Ukraine, and subsequently at other higher education institutions with which the Center cooperates.
“The State Expert Center of the Ministry of Health of Ukraine is always open to dialogue and the exchange of expert opinions and experience, and is ready to implement the changes needed to improve patients’ access to clinically effective and cost-effective medical technologies,” emphasized Mykhailo Lobas.
The event took place with the support of the international technical assistance project of the United States Agency for International Development (USAID) “Safe, Affordable, and Effective Medicines for Ukrainians” (SAFEMed). The aim of the project is to provide targeted technical and legal assistance to increase the transparency and financial efficiency of Ukraine's pharmaceutical sector, institutionalize the rational selection of medicinal products, systematize public medical procurement, support sustainable financing, etc.
