following a full submission:
andexanet alfa (Ondexxya®) is accepted for use within NHSScotland on an interim basis subject to ongoing evaluation and future reassessment.
Indication under review: For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
In an open-label single-arm study andexanet alfa reduced anti-FXa activity and improved haemostatic efficacy in adults with major bleeds.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
Medicine details
- Medicine name:
- andexanet alfa (Ondexxya)
- SMC ID:
- SMC2273
- Indication:
For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
- Pharmaceutical company
- Portola Pharmaceuticals UK Ltd
- BNF chapter
- Nutrition and blood
- Submission type
- Full
- Status
- Interim acceptance
- Date advice published
- 07 September 2020