OBJECTIVES: Recombinant activated factor VIIa room temperature stable (rFVIIa RTS) enables immediate access to treatment, which may lead to more rapid bleeding control and require less product compared to original rFVIIa, leading to cost savings despite the greater cost of rFVIIa RTS. The total annual cost of managing mild/moderate bleeds in one average haemophilia patient with high titre, high responding inhibitors by original rFVIIa and rFVIIa RTS was examined. METHODS: Only main medications costs were compared from the public payer perspective. Resource utilisation and clinical outcomes were based on a review of international literature. Excel based budget impact model (BIM) was developed to assess the financial consequences of treating bleeding episodes with rFVIIa compared to current treatment practices. Cohort of individuals in BIM can be followed sequentially from bleed initiation, taking into consideration first-line efficacy, switching to other products, re-bleeds and bleed cessation. RESULTS: Patients with rFVIIa RTS were treated on an outpatient or home basis. First-line and second-line efficacy was assumed to be 92% for original rFVIIa and rFVIIa RTS. An early treatment with rFVIIa was associated with a lower incidence of re-bleeds compared to delayed treatment 5.2% vs. 13.7% and therefore with less product usage 2.1 vs. 2.3 doses per treatment line. Total annual costs per patient from initiation to cessation in the current treatment environment was CSD 12.58 million (€0.12 million). One-way sensitivity analyses showed that at price of rFVIIa RTS from 0% to 16% premium introduction of this new form can deliver savings for the Serbian health care budget due to immediate patients’ access to the treatment. If not literature but current real life treatment patterns are considered savings can reach 56%. CONCLUSIONS: rFVIIa room temperature stable (RTS) in comparison to the original rFVIIa represents cost-saving first-line treatment option for the Serbian health care system.