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New HTA Decisions in England
May 2021
Drug name
ONDEXXYA® (andexanet alfa)
Company
Alexion
Decision date
01/04/2021
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Blood conditions
Decision
Recommended with restrictions
Indication
Andexanet alfa is recommended as an option for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding.
Decision Detail
It is recommended only if: • the bleed is in the gastrointestinal tract, and; • the company provides andexanet alfa according to the commercial arrangement (there is a simple discount patient access scheme for andexanet alfa.) 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.
Summary
Clinical evidence came from ANNEXA-4, a single-arm trial. 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.