Andexanet alfa for reversing anticoagulation from apixaban or rivaroxaban – second appraisal consultation

In DRAFT guidance, NICE recommends andexanet alfa as an option for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding, only if the bleed is in the GI tract and it is provided according to the commercial arrangement.

SPS commentary:

In the first appraisal consultation document, issued in March 2020, NICE did not recommend andexanet alfa within its marketing authorisation. In June 2020 the committee discussed a number of issues, some of which had not been included in the first appraisal consultation document.

There is no clinical trial evidence directly comparing andexanet alfa with prothrombin complex concentrate, so an indirect comparison of 2 trials was conducted. This suggests that andexanet alfa improves survival in people with gastrointestinal bleeding or intracerebral haemorrhage (ICH), but lowers survival for people with bleeds in other parts of the body. However due to differences between these 2 trials, the results are uncertain.

The cost-effectiveness estimates are uncertain due to the limitations in the evidence. NICE has concluded that they are likely to be within what NICE considers a cost-effective use of NHS resources for gastrointestinal bleeding, and it recommends andexanet alfa in GI bleeds as defined in the ANNEXA-4 trial and used as part of a major GI bleed protocol. For ICH, the committee concluded the extent of benefits in terms of mortality and long-term disability from andexanet alfa are unclear and it was not confident that the cost-effectiveness results for ICH were robust. The draft guidance therefore states that andexanet alfa is recommended only in research for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled ICH.

The potential benefits of andexanet alfa in the ‘other major bleeds’ cohort were not supported by evidence and the cost-effectiveness estimates were very uncertain.

Source:

National Institute for Health and Care Excellence