Scottish Medicines Consortium accepts rivaroxaban for NHS use in two new indications in Scotland


The anticoagulant rivaroxaban (Bayer HealthCare, Xarelto) has been accepted by the Scottish Medicines Consortium (SMC) for use in eligible patients within NHS Scotland in two new therapeutic indications, based on licences granted by the European Commission:

  • The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation who have one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
  • The treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism, following an acute DVT in adults.

The advice follows an assessment by the SMC of the clinical trial and cost-benefit data supporting rivaroxaban, and makes it the first once-daily tablet for the prevention of stroke in non-valvular atrial fibrillation patients to be recommended for use in NHS Scotland since the introduction of coumarin-based anticoagulants such as warfarin more than six decades ago.

The SMC accepts that for eligible patients with atrial fibrillation, the medicine should be made available to those who are not receiving an adequate level of anticoagulation while taking warfarin, or are allergic to it, or are unable to tolerate it. Warfarin is currently the most widely-prescribed drug in the UK for the prevention of stroke in patients with atrial fibrillation. It is an effective stroke prevention therapy, but is subject to limitations in some patients including unpredictable anticoagulant effects which can cause difficulties in maintaining an appropriate therapeutic range, as well as a requirement for frequent routine coagulation monitoring. Additionally, for some patients warfarin can interact with numerous drugs and a wide array of food and drink.

Rivaroxaban is also the first non-vitamin K antagonist (VKA) oral anticoagulant to be recommended by any UK review body for the treatment of DVT.

“Oral treatments which can replace current therapies for the prevention and treatment of potentially dangerous blood clots represent a highly significant advance in anti-thrombotic therapy. Previously, for many individuals, there had been no equally efficacious alternative oral agent to the vitamin K antagonists, usually warfarin” said Michael Greaves, professor of Haematology and head of the College of Life Sciences and Medicine at the University of Aberdeen, Scotland. “Selected NHS patients in Scotland now have a long-awaited alternative approach to thrombosis prevention, which could be particularly important for those on long-term oral antithrombotic therapy who may be able to achieve a stable level of anticoagulation whilst avoiding the need for frequent blood tests and dose adjustments.”

The recommended dose for patients with AF is 20 mg once daily, which is also the recommended maximum dose. For patients with moderate renal impairment, the recommended dose is 15 mg once daily. Xarelto is not recommended for use in patients with severe renal impairment (creatinine clearance

According to The Stroke Association and Atrial Fibrillation Association, an estimated 750,000 people in the UK are affected by atrial fibrillationand approximately 70,000 of these live in Scotland. Atrial fibrillation increases the risk of stroke fivefold.

According to Lifeblood, The Thrombosis Charity, an estimated one in 1,000 patients are admitted to hospital in the UK every year with a venous thromboembolism (VTE).The current standard of care for the treatment of DVT is the dual-drug approach of low molecular weight heparin (LMWH), which acts quickly to provide an anti-clotting effect, followed by warfarin, which can take several days to begin working. LMWH requires administration by weight-related subcutaneous injection, which, although effective, can cause bruising and discomfort especially in older patients. Patients may also require support by a district nurse or carer to assist them with injections. Oral rivaroxaban provides a unique single drug solution, without the need for injections and has been shown to be effective and well-tolerated versus the dual-drug approach of heparin and warfarin. Like other anticoagulants (such as warfarin and heparin), rivaroxaban may cause bleeding.

Rivaroxaban was approved for use in the United Kingdom by the European Commission (EC) in both indications in December 2011 following a close review of the drug’s clinical trial data by the European Medicines Agency (EMA).

The UK’s National Institute for Health and Clincal Excellence (NICE) is currently assessing Rivaroxaban in both indications, and is expected to deliver final guidance on its use for stroke prevention in atrial fibrillation in May 2012 and the treatment and secondary prevention of DVT in July 2012.