Bypassing Agents Prophylaxis In Patients With Haemophilia And Inhibitors Undergoing Surgery: A Decision Analysis In Spain

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Surgery poses a risk condition for haemophilia patients. Prophylactic strategy is required to avoid increasing of bleeds. This study aimed to estimate the cost of activated prothrombin complex concentrate (aPCC) and recombinant activated factor VIIa (rFVIIa) prophylaxis therapy in haemophilia patients with inhibitors undergoing surgery. A decision analytic model was developed to estimate the cost for the Spanish National Health system of providing hemostatic coverage with bypassing agents for haemophilia patients with inhibitor undergoing surgery. Age split (children and adults) and correspondent average weights related to haemophiliac population derived from literature. Annual number of surgeries (0.33/patient) was obtained from local data. Dental extraction and major surgeries were assumed only to happen in adult population (≥14 years) whilst minor surgery occurrence was split into children 22.80% (<14 years) and adults 77.20%. Drug costs (€,2017) considered official ex-factory prices with 7.5% of mandatory deduction (0.74€/IU [aPCC], 0.54€/IU [rFVIIa]) and the recommended dosing stated on Summaries of Products Characteristics and duration regimens according to each surgery group (1 day for dental extraction, 4 and 15 days for minor and major surgery, respectively), validated by a haematologists expert panel. The estimated average costs per patient were €10,100.73 (aPCC) and €14,265.89 (rFVIIa) for dental extraction; €24,043.88 (aPCC) and €62,301.08 (rFVIIa) for minor; and €126,595.81 (aPCC) and €347,731.09 (rFVIIa) for major surgery. Assuming an estimation of 23 annual surgeries for 69 haemophiliac inhibitors patients in Spain, and proportion of surgery types (19% for dental extraction, 50% for minor surgery and 31% for major surgery) the total annual cost of prophylaxis would be €1,209,682.35 using aPCC while €3,221,929.28 for rFVIIa. Results suggest that aPCC reduces cost (-62.5%) versus rFVIIa. Assuming potential equivalence on effects, aPCC resulting a cost-saving option, would be the preferred strategy as prophylactic treatment preventing bleeds in haemophiliac inhibitor patients undergoing surgeries.