POSA158 Actualization of the Budget Impact Scale for HTA Guideline in Ukraine

To provide an updated estimate of affordability threshold for medicines used in a budget impact scale in HTA Guideline in Ukraine. We performed descriptive statistics analysis to an estimated €470 million cost incurred in public procurement of 416 INNs across 4 programs: nomenclature of centralized procurement programs, regional procurement on the National List of Essential Medicines, reimbursement program “Affordable medicines”. The per INN cost was ranked from highest to lowest (ABC analysis) and the category C (55% of INNs, accounting for 5% of costs) was excluded from the analysis. Quartile ranges were calculated and formed a basis for a qualitative characteristic for a 4-grade budget impact scale. Data sources included: commercial sales database and public data from MoH and NHS websites. The scale includes four levels of budget impact. It was found that the per INN budget impact of medicines, included in the regulatory lists, for the state budget is “high” at a cost of more than €2,48 million, “average” in the range €1,15 - €2,48 million, “moderate” - in the range €0,68 - €1,15 million and “low” if the cost doesn’t exceed €0,68 million per INN. In addition, the following descriptive statistics results were reported: mean per INN budget impact – €2,36 million, median – €1,15 million, interquartile range – €0,68 - €2,48 million, as well as the recommended threshold value for assessing the degree of affordability (money required to cover 100% of patients), calculated as the mean multiplied by 2 (€4,71 million). The use of budget impact scale is a new instrument recommended in Ukraine’s HTA Guideline approved by the Order of MoH №593 dated 29.03.2021. It is meant to evaluate affordability, assess risks for all patients requiring innovative medicine and flag potential financing risks for payers.