NICE issues draft guidance for consultation on andexanet alfa for reversing anticoagulation

In DRAFT guidance, NICE does not recommend andexanet alfa, within its marketing authorisation, for reversing anticoagulation with apixaban or rivaroxaban in adults with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.

SPS commentary:

The guideline development committee noted that there is no direct evidence that andexanet alfa is better than prothrombin complex concentrate, at helping people survive a major bleed. Also, there is not enough evidence to show whether andexanet alfa reduces long-term disability in people who have had an intracranial haemorrhage, 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 and therefore, it cannot be recommended.


National Institute for Health and Care Excellence