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rivaroxaban (Xarelto) atrial


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.

Drug Details

Drug Name: rivaroxaban (Xarelto) atrial
SMC Drug ID: 756/12
Manufacturer: Bayer plc/Bayer Schering Pharma
Indication: For atrial fibrillation
BNF Category:
Sub Category: 2.8 Anticoagulants and protamine
Submission Type: Full submission
Status: Restricted
Date Advice Published: 13 February 2012