The National Institute for Health and Care Excellence (NICE) has published the outcome of an appraisal consultation document backing NHS funds for restricted use of Portola's Ondexxya (andexanet alfa) as an option for reversing anticoagulation from apixaban or rivaroxaban in adults with life threatening or uncontrolled bleeding.
However, treatment with the drug within the NHS will only be funded if the bleed is in the gastrointestinal tract and the company provides the drug as per the terms of agreed commercial arrangement.
Ondexxya is recommended by NICE only in research for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding in the skull.
There is no clinical trial evidence directly comparing Ondexxya with an existing treatment, prothrombin complex concentrate, so an indirect comparison of two trials was done.
This suggests that the drug improves survival in people with gastrointestinal bleeding or intracranial haemorrhage (ICH), but lowers survival for people with bleeds in other parts of the body, although the results are uncertain, NICE said.
Limitations of the clinical evidence mean that cost-effectiveness estimates for Ondexxya are uncertain, the Institute noted, adding that they are likely to be within what it considers a cost-effective use of NHS resources for gastrointestinal bleeding, but not for intercranial haemorrhage or bleeds in other parts of the body.