OBJECTIVES: : Haemophilia A is a rare genetic disorder caused by a deficiency in the clotting protein, Factor VIII. BAY 94-9027 and turoctocog alfa pegol (N8-GP) are both extended half-life PEGylated recombinant factor VIII (rFVIII) products used to prevent bleeds in persons with haemophilia A. This study compared bleeding rates and rFVIII consumption between BAY 94-9027 and N8-GP for haemophilia prophylaxis using matching-adjusted indirect treatment comparisons (MAIC). METHODS: The feasibility of indirect comparison was assessed for different outcomes related to bleeds and rFVIII consumption using data from the pivotal trials of BAY 94-9027 (PROTECT VIII) and N8-GP (PATHFINDER 2). Patient data from PROTECT VIII were weighted to achieve similar age, weight, race, prior treatment (prophylaxis/on demand) and prior level of bleeding to patients in PATHFINDER 2. Secondary analyses included a simulated treatment comparison (STC) and subgroup analyses focusing on specific treatment regimens [(a) pooled 2x/week & every 5 day treatment regimens from PROTECT VIII vs. PATHFINDER 2 and (b) every 5 day and every 7 day treatment regimens from PROTECT VIII vs. PATHFINDER 2]. RESULTS: Comparisons were feasible for annualized bleeding rate (ABR), proportion of patients without any bleeds and rFVIII consumption. Matching-adjusted mean ABR and percentages of patients with zero bleeds were statistically similar between BAY 94-9027 and N8-GP. The adjusted mean rFVIII utilization was 30% lower for BAY 94-9027 than N8-GP (3388.4 vs 4845.0 IU/kg/year; difference: -1456.6; 95%CI: [-2223.5; -774.2] IU/kg/year). Results of the sensitivity analyses were generally similar to the main analysis with no statistical difference in mean ABRs and percentages of patients with zero bleeds, and a statistically significant reduction in rFVIII utilization. CONCLUSIONS: BAY 94-9027 was found to achieve similar efficacy as N8-GP, but with lower drug consumption.