The National Institute for Health and Care Excellence isn't recommending NHS use of Portola Pharmaceuticals' Ondexxya (andexanet alfa) for reversing the effects of anticoagulation with apixaban or rivaroxaban in adults with uncontrolled or life-threatening bleeding.
Apixaban and rivaroxaban are anticoagulants used for preventing and treating thromboembolism in conditions such as deep vein thrombosis and pulmonary embolism, but they can increase the risk of major bleeding that cannot be controlled and may be life-threatening.
Ondexxya aims to stop (reverse) their effects. However, in a consultation document, NICE said there is “no direct evidence” that the drug is better than existing treatment prothrombin complex concentrate at helping people survive a major bleed.
“Also, there is not enough evidence to know whether andexanet alfa reduces long-term disability in people who have had an intracranial haemorrhage (bleeding inside the skull), paralysis in people who had an intraspinal bleed and monocular blindness in people who had an intraocular bleed,” it said.
The Institute concluded that the lack of evidence makes the cost-effectiveness estimates for a Ondexxya very uncertain, and so it is unable to recommend NHS funding at this time.
The second committee meeting for Ondexxya will occur on June, with an expected publication of its final decision on August 19.