OBJECTIVES: To evaluate the Budget impact of rFIXFc for prophylactic treatment of moderate to severe patients with hemophilia B without inhibitors, for the third-party payer in Colombia.

METHODS: We evaluated the potential budget impact of the inclusion of rFIXFc in the formulary of a third payer in Colombia for the prophylactic treatment adults and pediatric patients with moderate to severe hemophilia B without inhibitors. We estimated a total eligible population of 557 patients using a prevalence of 1.60 cases per 100.000, of which 72% are moderate to severe and 97% of which do not have inhibitors. Only direct medical costs related to prophylaxis and on-demand treatment of bleeding episodes and follow-up were included. We used local standardized sources for drug (SISMED 2017Q4 to 2018Q3) and physician visits (Social Secure Institute Tariff Manual +30%) costs. The model compared a current scenario based on local sources and compared it with a market share acquisition for rFIXFc of 20%, 30% and 40% for 2019, 2020 and 2021, respectively. The results were presented in 2018 Colombian pesos. We used a dose of 80 IU/kg per week for conventional FIX products considering local prescribing practice. The dose for rFIXFc was calculated based on a dose-adjustment factor obtained from literature.

RESULTS: The inclusion of rFIXFc could result in budget saving of COP$6.338.862.018 over 3 years with COP$1.383.385.174 (-0.69%, per patient per year [PPPY] COP$2.457.584), COP$2.107.855.237 (-1.04%, PPPY COP$3.705.088) and COP$2.847.621.607 (-1.40%, PPPY COP$4.952.593) for 2019, 2020, 2021, respectively.

CONCLUSIONS: The inclusion of rFIXFc in the formulary of a third-party payer in Colombia for the prophylactic treatment of patients with hemophilia B could lead to budget savings. Future studies are needed to assess potential additional benefits clinical and economic benefits for rFIXFc in Colombia (e.g., bleed protection, joint health, dosing and consumption, adherence, and quality of life).