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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1 Andexanet alfa is recommended as an option for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding, only if:

  • the bleed is in the gastrointestinal tract and

  • the company provides andexanet alfa according to the commercial arrangement (see section 2).

1.2 Andexanet alfa is recommended only in research for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding in the skull (intracranial haemorrhage).

Why the committee made these recommendations

Apixaban and rivaroxaban are anticoagulants used for preventing and treating thromboembolism (blood clots). They can increase the risk of major bleeding, which may be life-threatening. If someone has a major bleed the anticoagulation effects need to be reversed. Andexanet alfa aims to reverse the effects of apixaban and rivaroxaban, in case of uncontrolled or life-threatening bleeding.

There is no clinical trial evidence directly comparing andexanet alfa with an existing treatment, prothrombin complex concentrate, so an indirect comparison of 2 trials was done. This suggests that andexanet alfa improves survival in people with gastrointestinal bleeding or intracranial haemorrhage (ICH), but lowers survival for people with bleeds in other parts of the body. However, there are differences between the 2 trials in the indirect comparison, so the results are uncertain. Also, there is not enough evidence about whether it reduces long-term disability in ICH.

Because of the limitations of the clinical evidence, the cost-effectiveness estimates for andexanet alfa are uncertain. They are likely to be within what NICE considers a cost-effective use of NHS resources for gastrointestinal bleeding, but not for ICH or bleeds in other parts of the body. Therefore, andexanet alfa for reversing anticoagulation is recommended only in gastrointestinal bleeding. It is recommended only in research in ICH.