Following the receipt of further evidence from Bayer HealthCare of Xarelto (rivaroxaban)'s clinical and cost-effectiveness, the National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance recommending it an option for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF).

Xarelto, an orally-administered drug that helps to prevent blood from clotting, has a UK marketing authorisation (MA) for the prevention of stroke and systemic embolism in patients with non-valvular AF who have one or more risk factors such as congestive heart failure, hypertension, age 75 or older, diabetes mellitus, prior stroke or transient ischaemic attack (ITA).

The draft guidance states that the decision about whether to start treatment with Xarelto should be made after an informed discussion between the clinician and the person about its risks and benefits compared with warfarin.

"We know that people taking warfarin can find it difficult to maintain their blood clotting at a proper level and are often not within the target therapeutic range. For example, older people with AF and comorbidities are more likely to have poorly-controlled clotting and may be at an increased risk of stroke or bleeding," said Professor Carole Longson, director of NICE's health technology evaluating centre.

Xarelto, like Boehringer Ingelheim's oral anticoagulant Pradaxa (dabigatran etexilate) - which NICE approved as an option in this indication in March - can benefit people with AF in these circumstances because it does not require such regular monitoring and dose adjustments, she added.

The final draft guidance was welcomed by John Camm, professor of clinical cardiology at St George's University of London, who said: "the availability of a once-daily warfarin alternative which demonstrates equivalent efficacy and safety profile for patients living with AF while removing monitoring requirements marks a further advance in antithrombotic care. This news could be particularly important for patients who require long-term or lifelong anticoagulation for non-valvular AF who may be seeking a simplified regimen."

The draft approval, following NICE's final recommendation for Pradaxa, is "a fantastic leap forward in anticoagulation therapy," added the Atrial Fibrillation Association (AFA), which forecast that the once-daily oral tablet is "set to shake up the healthcare industry."

Bayer HealthCare notes that NICE is expects to publish its final guidance for this use of Xarelto as early as this month, with further guidance on its use in acute deep vein thrombosis (DVT) and the prevention of recurrent DVT and pulmonary embolism (PE) as early as June.

- Meantime, NICE has also issued draft guidance recommending Amgen's Xgeva (denosumab) for certain groups of cancer patients whose disease has spread to their bones.

Based on current prices and with the discount available under the patient access scheme (PAS) agreed for Xgeva between Amgen and the Department of Health, NICE's independent appraisal committee considered the drug to be a cost-effective option in people who would be treated with Novartis' Zometa (zoledronic acid) - or other bisphosphonates in the case of metastatic breast cancer.

However, the panel added that, in comparison with best supportive care, and even with the PAS in place, Xgeva was associated with high incremental cost-effectiveness ratios (ICERs), the lowest of which remained above £70,000 per quality-adjusted life year (QALY) gained, so it could not be considered cost-effective when compared with best supportive care.

Amgen estimates that there are over 150,000 patients in the UK with solid tumours and bone metastases, of which breast and prostate cancer account for more than 80%.

This draft guidance is now out for public consultation until April 24.