NHS cost regulators have backed funding for Alexion's Ondexxya (andexanet alfa) to reverse anticoagulation of the direct factor Xa (FXa) inhibitors apixaban or rivaroxaban in adults who experience a life-threatening or uncontrolled bleed in the gastrointestinal (GI) tract.
Until now, there has been no licensed therapy to reverse FXa-associated major bleeds when treated with apixaban or rivaroxaban, which are increasingly used for the prevention and treatment of thrombotic events, such as deep vein thrombosis and pulmonary embolism, or if a patient is at high risk of a stroke due to an irregular heart rate (atrial fibrillation).
FXa inhibitors stop the blood from clotting normally to help prevent unwanted clots from forming, but in doing so can also raise the risk of major and potentially life-threatening bleeds.
Studies have shown that Ondexxya can reverse the anticoagulant effect of apixaban or rivaroxaban within two minutes of administration.
However, in a final appraisal document (FAD), NICE highlighted limitations in the clinical evidence and concluded that the drug is likely to be a cost effective use of resources for gastrointestinal bleeding, but not for intracranial haemorrhage (ICH) or bleeds in other part of the body.
Alexion said it is collecting additional data for the use of Ondexxya in ICH bleeds and is committed to continuing to work closely with NICE, NHS England and all other stakeholders “to find a sustainable path forward to secure future funded access” to the drug for those patients in England who experience an ICH bleed and “could benefit from this first-in-class therapy”.