Advice
Following a full submission:
rivaroxaban (Xarelto®) is accepted for restricted use within NHS Scotland.
Indication under review: the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
SMC restriction: Rivaroxaban is accepted for use in patients who have poor INR control despite evidence that they are complying with a coumarin anticoagulant and in patients who are allergic to or unable to tolerate coumarin anticoagulants.
Rivaroxaban was non-inferior to standard oral anticoagulation at preventing stroke or systemic embolism in one large, double-blind study in patients with atrial fibrillation and moderate to high risk of stroke. This was not associated with a significantly increased risk of major or non-major clinically relevant bleeding.
The submitting company made an economic case for rivaroxaban use in the restricted patient population described above.
Download detailed advice194KB (PDF)
Medicine details
- Medicine name:
- rivaroxaban (Xarelto) atrial
- SMC ID:
- 756/12
- Indication:
- For atrial fibrillation
- Pharmaceutical company
- Bayer plc/Bayer Schering Pharma
- BNF chapter
- Cardiovascular system
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 13 February 2012