Application of the HTA tool for effective decision-making in the healthcare system – a certified seminar-training for applicants took place at the Center.
Key learning objectives are to deepen awareness of the role and functions of HTA in the healthcare system and its scope of application in Ukraine and worldwide; to cover methodological approaches to the HTA procedure; to provide recommendations for preparing a dossier in accordance with the requirements of regulatory practice; to introduce in detail the methods of pharmacoeconomic analysis and budget impact analysis; and to provide a step-by-step modeling algorithm for analyzing the cost-effectiveness of medicinal products.
Center specialists with many years of experience shared their experience and knowledge – Oresta Piniazhko, Director of the Department of HTA and Rational Pharmacotherapy, Candidate of Pharmaceutical Sciences; Yuliia Malyshevska, Deputy Director of the Department; heads of the departments for assessment of clinical effectiveness and cost-effectiveness of medical technologies – Iryna Romanenko and Valeriia Serediuk; and Marharyta Khmelovska, expert of the Department for Assessment of Cost-Effectiveness of Medical Technologies. 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.
During the theoretical part of the seminar, Oresta Piniazhko reminded participants of the importance of HTA for improving patient access to clinically effective and cost-effective treatment, informed them about the latest updates to the HTA Guideline and their impact on the preparation of applications and dossiers, and introduced the basic HTA model and its components – clinical data, safety, pharmacoeconomic evaluation, budget impact.
Deputy Director of the HTA Department Yuliia Malyshevska covered the theoretical and practical aspects of preparing a medicinal product dossier: requirements for completing the general and clinical sections, selection of a comparator, formulation of a clinical question using the PICO framework, and interpretation of the results obtained.
Iryna Romanenko elaborated on the search strategy, the selection of relevant clinical endpoints and their interpretation, and indirect comparisons.
Marharyta Khmelovska, an expert of the Department for Economic Feasibility Assessment of Medical Technologies, presented to the group the basic principles and methods of pharmacoeconomic analysis: choice of method, determination of the perspective and time horizon of the analysis, types of costs, sensitivity analysis, discounting, and presentation of results.
During the practical part of the seminar, together with HTA experts, the participants took part in a modeling master class – they practiced building a Markov model for analyzing the economic feasibility of medicinal products.
Concluding the seminar, Oresta Piniazhko expressed the hope that the knowledge gained would help applicants in the effective planning and high-quality preparation of dossier materials, and that cooperation with the Center in the area of HTA would help implement those medical technologies that will truly contribute to improving patients' access to clinically effective, safe and cost-effective medicinal products in Ukraine.
