PNS146 Development of Updated Recommendations for Budget IMPACT Scale for HTA in Ukraine

Abstract

To update the budget impact scale when assessing the inclusion of medicines on the National List of Essential Medicines (National List) and central procurement programs at the expense of state and local budgets in the analysis of economic feasibility of medicines during HTA in Ukraine. The analysis is conducted using published methodological recommendations for assessing the budget impact of medicines for inclusion on the National List or central procurement. The study used drugs sales data provided by the Pharmexplorer market and National Health Service of Ukraine as for 2019. The scale is developed by comparing a given extra budget with the average budget required to fund one INN in the procurement list. The results are also presented as per-member-per-year costs to procure one INN. Different values of budget impact scale are proposed for central and regional regulatory lists of medicines. When the cost of medicine by INN, which is evaluated during the HTA for inclusion on the National List, exceeds €1,44 million per year, the budget impact will be excessive. If the costs by INN are in the range of €0,69-€1,44 million, the impact will be large, if the costs are from €0,43 million to €0,69 million - moderate, and less than €0,43 million - insignificant. Provided that medicine is included in the central procurement, the budget impact scale has the following gradation: €1,80 million, €0,95-1,80 million, €0,52-€0,95 million, less than €0,52 million respectively. The comparative analysis of threshold values showed that a large level of budget impact is on 25% higher if the medicine is included in the central programs. This scale is recommended for use during HTA and as a supportive tool for the decision-making process of the inclusion of new medicines on the regulatory lists in Ukraine.