BUDGET IMPACT ANALYSIS OF INHIBITOR HAEMOPHILIA A THERAPY WITH BYPASSING AGENTS

The aim of this study is to analyse the budget impact of hemophilia A therapy with either APCC or rFVIIa, in case of persistent inhibitors development. The point of view is that of the Bulgarian health care system for a one-year period. A budget impact analysis (BIA) was performed following the recommendations of Guideline for Budget impact analysis with some modifications. The analysis is based on combination of literature evidences for both products’ efficacy; regulatory requirements for products standard dosage regimens; public expenditures data, and official approved prices of APPC and rFVIIa. Results show that the yearly per patient cost of therapy with APCC accounts for 162 573 Euro, while treatment with rFVIIa accounts for 377 487 Euro almost double the cost. If all the patients with inhibitors in each age group exhibit the same number of bleeding events and consume the same maximal dose, the total yearly cost of therapy with APCC will account for 5 621 068,04 Euro and cost with rFVIIa will account for 12 950 344,55 Euro. Therefore, applying APCC instead of rFVIIa would decrease the budget impact by 7.3 million Euro. In conclusion the treatment of inhibitors hemophilia A with APPC is cost saving for the Bulgarian health care system in comparison with rFVIIa.