Following the receipt of further evidence from Bayer HealthCare of the clinical and cost effectiveness of its drug rivaroxaban (Xarelto), NICE has published final draft guidance recommending rivaroxaban as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation.
Atrial fibrillation (AF) occurs when the electrical impulses controlling the heart rhythm become disorganised, so that the heart beats irregularly and, occasionally, too fast and so cannot efficiently pump blood around the body.
People with AF are at higher risk of developing blood clots and subsequent stroke (with an approximately five-fold greater risk than that of people without AF) because the erratic heart rhythm of AF causes turbulent blood flow within the heart chambers. However, the risk of stroke can be substantially reduced by appropriate use of antithrombotic therapy, such as warfarin.
Rivaroxaban is an orally administered drug that helps to prevent blood from clotting. It does this by stopping a substance called Factor Xa from working. Factor Xa is necessary in the formation of thrombin and fibrin, the key components in blood clot formation.
Rivaroxaban has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation who have one or more risk factors such as congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, prior stroke or transient ischaemic attack.
The draft guidance states that the decision about whether to start treatment with rivaroxaban should be made after an informed discussion between the clinician and the person about the risks and benefits of rivaroxaban compared with warfarin. It also recommends that for people who are taking warfarin, the potential risks and benefits of switching to rivaroxaban should be considered in light of their level of international normalised ratio (INR)i control.
Commenting on NICE’s draft recommendation, Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “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 atrial fibrillation and comorbidities are more likely to have poorly controlled clotting and may be at an increased risk of stroke or bleeding. Rivaroxaban, like dabigatran etexilate, which NICE recently approved as an option for this indication, can benefit people with AF in these circumstances because it doesn’t require such regular monitoring and dose adjustments.
Professor Longson continued: “We are pleased to say that the additional information and analysis received from the manufacturer following our initial draft guidance has enabled us to recommend rivaroxaban as a cost-effective option for the prevention of stroke and systemic embolism in people with atrial fibrillation.”
The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.