Andexanet alfa for reversing anticoagulation
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1.1 Andexanet alfa is not recommended, within its marketing authorisation, for reversing anticoagulation with apixaban or rivaroxaban in adults with uncontrolled or life-threatening bleeding.
Why the committee made these recommendations
Apixaban and rivaroxaban are anticoagulants used for preventing and treating thromboembolism in conditions such as deep vein thrombosis and pulmonary embolism. They can increase the risk of major bleeding that cannot be controlled and may be life-threatening. Andexanet alfa aims to stop (reverse) their effects.
The clinical evidence is very limited. There is no direct evidence that andexanet alfa is better than an existing treatment, prothrombin complex concentrate, at helping people survive a major bleed. Also, there is not enough evidence to know whether andexanet alfa reduces long-term disability in people who have had an intracranial haemorrhage (bleeding inside the skull), paralysis in people who had an intraspinal bleed and monocular blindness in people who had an intraocular bleed.
The lack of evidence makes the cost-effectiveness estimates for andexanet alfa very uncertain. Therefore, it cannot be recommended.