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Modelling the economic impact of recombinant activated Factor VII compared to activated prothrombin-complex concentrate in the home treatment of a mild to moderate bleed in adults with inhibitors to clotting Factors VIII and IX in the UK

Summary This study estimated the costs and consequences of using recombinant activated Factor VII (rFVIIa; NovoSeven®) at home, compared to activated prothrombin-complex concentrate (aPCC; FEIBA®*) at home, to manage a minor (i.e. mild to moderate) bleeding episode in adults with high titre, high responding inhibitors (>10 BU). The analysis was performed from the perspective of the UK's National Health Service (NHS). NovoSeven and FEIBA are registered trademarks of Novo Nordisk and Baxter Healthcare, respectively. Clinical outcomes and resource utilisation attributable to managing a minor bleed were obtained from published literature, supplemented with information about treatment patterns and associated resource utilisation derived from interviews with a panel of 22 consultant haematologists experienced in managing inhibitor patients. Using these data sources a decision tree modelling the management of a minor bleed, initially at home, was constructed. Unit resource costs at 1999/2000 prices were applied to the resource utilisation estimates in the model to estimate the expected NHS cost of managing a minor bleeding episode. Consensus on the probabilities and resource utilisation estimates in the model were reached at a meeting comprising seven panel members. The expected NHS cost of managing a minor bleeding episode initially treated with rFVIIa or aPCC at home was estimated to be £12,944 and £14,645, respectively. Additionally, the expected time to resolving a minor bleeding episode when initially treated with rFVIIa or aPCC at home was estimated to be 32 hours and 60 hours, respectively. Hence, rFVIIa improves clinical outcome compared to aPCC, but at no additional cost to the NHS, resulting in rFVIIa being the cost-effective treatment. This finding warrants further investigation in a prospective, comparative, randomised, controlled study.