On April 16, the Center held a workshop for interested representatives of the pharmaceutical market on conducting state health technology assessment of medicinal products.
The purpose of the training is to highlight methodological approaches to the preparation by manufacturers of a high-quality dossier in accordance with regulatory requirements, to promote the implementation of the HTA methodology in practice, and to consolidate efforts to meet the needs of patients and the health care sector for those medicinal products that will be the most clinically effective in combating diseases and cost-effective for the state.
The course covered the theoretical and practical aspects of preparing a medicinal product dossier, in particular its general and clinical sections: description of the proposal, choice of comparator, the PICO scheme, analysis of comparative efficacy and safety, application of a search strategy and selection of publications, selection of relevant clinical endpoints, and interpretation of the results obtained.
The speakers were specialists of the Center with many years of experience in health technology assessment – 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 training was organized by the Agency for Methodological and Scientific-Practical Work of the Center.
Participants became familiar with the main requirements for the content of the dossier, including in light of the latest updates to HTA legislation, discussed problematic issues arising in the preparation of materials, and received valuable guidance and recommendations from the regulator. At the end, the group received certificates.
Please note that the next HTA seminar will be devoted to preparing the dossier with regard to the analysis of the economic feasibility of a medical technology and will include a master class on pharmacoeconomic analysis using the Markov model. The seminar will take place on May 01, 2024.
Registration is open, so we invite everyone interested https://www.dec.gov.ua/materials/omt-instrument-oczinky-czinnosti-medychnyh-tehnologij-v-chastyni-analizu-ekonomichnoyi-doczilnosti-medychnyh-tehnologij/