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New anticoagulant nears approval from NICE

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The National Institute for Health and Care Excellence has given its provisional backing to a drug for preventing potentially fatal blood clots in patients with a common heart problem.

In draft guidance, NICE has recommended edoxaban (Lixiana) as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF) who have one or more further risk factors.

The heart rhythm disorder affects around 800,000 people in the UK but a further 250,000 may be undiagnosed.

“The Committee concluded that, taking all the evidence into account, edoxaban is clinically and cost effective compared with warfarin”

Carole Longson

Additional risk factors for stroke and blood clots in patients with NVAF include congestive heart failure, high blood pressure, age 75 years or older, diabetes, and prior stroke or transient ischaemic attack.

At present, patients 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, manufactured by Daiichi Sankyo, is an oral anticoagulant that directly inhibits factor X (factor Xa), which is a key component in the formation of blood clots.

Professor Carole Longson, director of the NICE Health Technology Evaluation Centre, said: “Many people with NVAF find taking warfarin difficult.

“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,” she said.

She added: “There was also evidence that edoxaban had nearly half the rate of haemorrhagic stroke events compared to warfarin.”

Professor Longson said the available evidence suggested edoxaban was clinically and cost effective compared with warfarin, and could in future be recommended as an alternative.

For patients 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, noted NICE.

The oral anticoagulant is now at the final appraisal determination stage of the NICE technology approval process – the last step before approval. The draft guidance is out for consultation until 21 August.

Edoxaban costs £58.80 for a 28-tablet pack (60mg or 30mg) and the daily cost of treatment is £2.10 (excluding VAT).

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