Prices for low and high dose will therefore be £13,875 and £24,975 per Andexanet alfa is injected directly into the bloodstream of patients who are taking anticoagulants and bleeding. In our online survey, 66% of hospitals who had not yet added andexanet alfa to formulary cited cost as a reason. marketing authorisation or licence. In an open-label single-arm study andexanet alfa reduced anti-FXa activity and improved haemostatic efficacy in adults with major bleeds. Table 1: Dosing regimens The wholesale price of a single 100-mg vial of andexanet alfa is $3,300 and in the most optimistic dosing scenario a single reversal would cost $29,700. Cost reported at around $30,000 to 50,000 per reversal NICE technology appraisal expected March 2020. Andexanet alfa poses a notable financial challenge for hospitals. The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and, following review by the SMC executive, advises NHS Boards and Area Drug and Therapeutics Committees on its use in NHSScotland. The effects of the therapy with Ondexxya were studied in 352 patients for safety and 167 patients for efficacy . Cost will remain constant with availability of the Generation 2 product ($5500/200 mg vial; $27 500 for low dose; $49 500 for high dose). This advice takes into account a confidential discount offered by the pharmaceutical company that improves the cost-effectiveness of andexanet alfa. Andexanet alfa for reversing anticoagulation [ID1101] In development [GID-TA10440] Expected publication date: 14 April 2021 Project information This means that andexanet alfa is accepted for use subject to ongoing evaluation and reassessment once further evidence is available. Andexanet alfa is currently being studied to see how well it works and whether it is safe to use. Cost analysis summary Two dose regimens of andexanet alfa are approved: a low and a high dose regimen, requiring 5 or 9 vials respectively. The European Medicines Agency (EMA) has recommended granting a conditional approval for andexanet alfa (Ondexxya) as an antidote to direct factor Xa (FXa) inhibitors when reversal of anti-coagulation is needed because of life-threatening or uncontrolled bleeding.. Andexanet alfa is a recombinant modified FXa protein. Specific reversal agents are available for dabigatran (Praxbind , idarucizumab), and apixaban and rivaroxaban (Ondexxya , andexanet alfa). By comparison, at a cost of approximately $1.50 per unit, 4-factor prothrombin complex concentrate would cost approximately $7,500 to reverse a 100-kg patient. andexanet alfa 200 mg powder for solution for infusion (Ondexxya®) Portola Pharmaceuticals UK Ltd. 07 August 2020 . As a result, andexanet alfa neutralises the anticoagulant effect of these inhibitors. If andexanet alfa is licensed in the UK, it will offer a new treatment for people with serious bleeding while taking anticoagulants. Andexanet alfa is administered as an intravenous bolus at a target rate of approximately 30 mg/min over 15 minutes (low dose) or 30 minutes (high dose), followed by administration of a continuous infusion of 4 mg/min (low dose) or 8 mg/min (high dose) for 120 minutes (see table 1). From: Medicines and Healthcare products Regulatory Agency The listed NHS price for 4 vials of Ondexxya® 200 mg powder for solution for infusion is £11,100, exclusive of VAT. In DRAFT guidance, NICE does not recommend andexanet alfa, within its marketing authorisation, for reversing anticoagulation with apixaban or rivaroxaban in adults with uncontrolled or life-threatening bleeding, due to limited clinical evidence of benefit.
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