NICE U-turns on Decision Not To Approve Anticoagulation Reversal Agent

Dawn O'Shea

September 18, 2020

In new draft guidance, NICE approves andexanet alfa for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled gastrointestinal (GI) bleeding. The treatment is not approved for the management of bleeds elsewhere in the body and is only approved for intracranial haemorrhage (ICH) in the research setting.

The draft decision is a u-turn on NICE’s initial decision not to approve andexanet alfa back in April 2020. At that time NICE referred to limitations in the clinical evidence submitted by the company.

There was no clinical trial evidence directly comparing andexanet alfa with an existing treatment, prothrombin complex concentrate, so an indirect comparison of two trials was done. The findings of this indirect comparison suggested that andexanet alfa improves survival in people with GI bleeding or ICH but lowers survival for people with bleeds in other parts of the body.

Evidence was also lacking on whether andexanet alfa reduces long-term disability in ICH. Because of heterogeneity between the two trials, the results were deemed to be uncertain. As a result, cost-effectiveness estimates were also uncertain.

In the new draft guidance, NICE says the company subsequently provided additional information and while cost-effectiveness remains uncertain, it considers andexanet alfa would be a cost-effective use of NHS resources for GI bleeding, but not for ICH or bleeds in other parts of the body.

The guidance is currently open to comment. The deadline for receipt of comments is 5 pm, Friday, 2 October 2020.

This article originally appeared on Univadis, part of the Medscape Professional Network.

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