the company provides andexanet alfa according to the commercial arrangement.
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; ICH), in the form of an ongoing randomised trial mandated by the regulator.
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 existing treatments, including prothrombin complex concentrate. An indirect comparison suggests that andexanet alfa improves survival in people with gastrointestinal bleeding or ICH, but lowers survival for people with bleeds in other parts of the body. However, there are differences between the populations in the 2 studies, so the results of the indirect comparison are uncertain. There is no robust evidence that andexanet alfa 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 for routine use only in gastrointestinal bleeding. It is recommended only in research in ICH.