Preparation of the dossier for state HTA in terms of the analysis of the economic feasibility of a medical technology – specialists of the HTA Department of the Center held a workshop for applicants and stakeholders.
This is the second part of the course – the first took place recently and was devoted to preparing the dossier regarding the clinical efficacy and safety of the medical technology.
The training was organized as part of the Center's external training, under the auspices and organization of the Agency for Methodological and Scientific-Practical Work of the Center. A course of lectures and practical sessions was delivered by specialists of the Center's HTA Department.
The seminar was opened, and the program and speakers were presented, by the Agency’s leading specialist Valeriia Yefremova.
Director of the HTA Department, Candidate of Pharmaceutical Sciences Oresta Piniazhko drew attention to the role of HTA in improving patients' access to clinically effective and cost-effective treatment. She introduced the basic HTA model and its components – comparative analysis of clinical effectiveness and safety, pharmacoeconomic evaluation, and budget impact analysis. She presented the key aspects of preparing applications and dossiers in accordance with the updated current version of the guideline on state HTA and the requirements of the Procedure for Conducting State Health Technology Assessment, approved by resolution of the Cabinet of Ministers of Ukraine of 23.12.2020 No. 1300, as amended.
Valeriia Serediuk, Acting Head of the Unit for Economic Feasibility Assessment of Medical Technologies of the HTA Directorate, and Deputy Head Marharyta Khmelovska focused on practical cases of pharmacoeconomic analysis – choice of method, definition of perspective and time horizon, types of costs, conducting sensitivity analysis, discounting, presentation of results, and recommendations on budget impact analysis.
To consolidate the knowledge gained, a master class was held on the methodology of building a Markov model – mathematical modeling that makes it possible to integrate clinical study data with economic indicators, the results of which are one of the criteria in the decision-making process in the field of pharmaceutical provision for patients.
Seminar participants noted the high practicality and appropriateness of such training for effective planning and high-quality preparation of dossiers and for the implementation of those medical technologies that will truly help improve patients' access to clinically effective, cost-effective medicinal products in Ukraine. Upon completion, the group received certificates.
