HTA in practice: how to prepare a dossier of high methodological quality in terms of the comparative analysis of the clinical efficacy and safety of medical technologies – a seminar-training for stakeholders was held at the Center.
The purpose of the training is to deepen awareness of the health technology assessment process in Ukraine, to highlight methodological approaches to preparing dossiers for state HTA in accordance with regulatory requirements, and to promote the most effective implementation of HTA methodology in practice.
Specialists of the Center with many years of experience shared their experience and knowledge – Head of the HTA Department, Candidate of Pharmaceutical Sciences Oresta Piniazhko, Deputy Director of the Department Yuliia Malyshevska, and Head of the Division for Assessment of Clinical Effectiveness and Safety of Medical Technologies of the HTA Department Iryna Romanenko. The event was chaired by the Head of the Agency for Methodological and Scientific-Practical Work of the Center, Doctor of Pharmaceutical Sciences, Professor Oleksandr Hudzenko.
Opening the seminar, Oresta Piniazhko drew attention to the importance of HTA for improving patients' access to clinically effective and cost-effective treatment, introduced the basic HTA model and its components (clinical data, safety, pharmacoeconomic evaluation, budget impact), informed about the latest updates to the Guideline on State HTA and their impact on the preparation of applications and dossiers, and presented the Roadmap for implementing the HTA tool in Ukraine and the prospects for the development of this area.
Yuliia Malyshevska and Iryna Romanenko covered the theoretical and practical aspects of preparing a medicinal product dossier in terms of the general and clinical sections, taking into account the recommendations of the Guideline: description of the proposal regarding the medicinal product, choice of comparator, PICO scheme, analysis of comparative effectiveness and safety, application of the search strategy and selection of publications, selection of relevant clinical endpoints, and interpretation of the results obtained. They discussed with the audience the problematic issues that arise in the process of preparing dossier materials, and provided expert answers and recommendations from the standpoint of HTA expert evaluation.
The knowledge gained, in the opinion of the Center's experts, will help applicants to plan effectively and prepare high-quality materials submitted for state HTA, to establish communication with the Center, and to implement those medical technologies that will truly contribute to improving patients' access to clinically effective, safe and cost-effective medicinal products in Ukraine.
In conclusion, the speakers, together with the Head of the Agency Oleksandr Hudzenko, announced the upcoming professional development seminar on HTA, to be held as early as April 03. The training will cover evidence on the clinical efficacy of medicinal products and its critical appraisal when conducting health technology assessment. The seminar will be held online and will give an opportunity to earn an additional 10 points toward attestation.
Details and registration at the link https://bpr.dec.gov.ua/events/326/
