NVAF is a heart rhythm disorder affecting the top two chambers of the heart (atria). This causes the heart to beat irregularly and, occasionally, too fast so it cannot efficiently pump blood around the body. This can allow clots to form where the blood moves too slowly. These clots can then be carried to blood vessels in the brain causing potentially deadly blockages that result in stroke. However, the risk of stroke can be substantially reduced by drugs such as warfarin that prevent the blood from clotting (anticoagulants).
The condition affects around 800,000 people in the UK but it's thought around 250,000 others may be undiagnosed. Symptoms can include heart palpitations, dizziness, shortness of breath and fatigue.
Additional risk factors for stroke and blood clots in people with NVAF include congestive heart failure, high blood pressure, age 75 years or older, diabetes mellitus, and prior stroke or transient ischaemic attack (mini-stroke).
People with NVAF who have additional risk factors for stroke or blood clots are generally treated with warfarin and, increasingly, with the newer oral anticoagulants dabigatran, rivaroxaban and apixaban.
Edoxaban is an oral anticoagulant that directly inhibits factor X (factor Xa), which is a key component in the formation of blood clots.
Commenting on the draft guidance, Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "Many people with NVAF find taking warfarin difficult because, among other things, it requires regular monitoring and dose adjustments and can interact with many foods and other drugs. Because edoxaban, like the other newer agents, doesn't require frequent blood tests to monitor treatment it represents a significant potential benefit for many people with NVAF. There was also evidence that edoxaban had nearly half the rate of haemorrhagic stroke events compared to warfarin.
"The Committee concluded that, taking all the evidence into account, edoxaban is clinically and cost effective compared with warfarin and can be recommended as an alternative to warfarin for preventing stroke and systemic embolism for people with NVAF who have 1 or more additional risk factors for stroke."
The draft guidance states that the decision about whether to start treatment with edoxaban should be made after an informed discussion between the clinician and the person about the risks and benefits of edoxaban compared with warfarin, apixaban, dabigatran etexilate and rivaroxaban. For people who are taking warfarin, the potential risks and benefits of switching to edoxaban should be considered in light of their ability to maintain their blood clotting to acceptable levels.
The draft guidance is now with consultees, who have the opportunity to appeal against it. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.
Notes to Editors
About the draft guidance
- The draft guidance will be available at /Guidance/InDevelopment/GID-TAG475 from Friday 7 August 2015.
- Edoxaban costs £58.80 for a 28-tablet pack (60 mg or 30 mg) and the daily cost of treatment is £2.10 (excluding VAT). Costs may vary in different settings because of negotiated procurement discounts.
- The Committee noted that the inclusion of all the ERG's preferred values in the model resulted in a deterministic ICER of £16,000 per QALY gained and a probabilistic ICER of £22,100 per QALY gained relative to warfarin.
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