The National Institute for Health and Care Excellence has provisionally recommended edoxaban tosylate (Lixiana) for treating and preventing the recurrence of potentially fatal blood clots.
NICE has issued a Final Appraisal Determination recommending the drug as an option for the treatment and prevention of recurrent deep vein thrombosis and pulmonary embolism in adults.
It follows assessment of the drug, manufactured by Daiichi Sankyo, by a NICE technology appraisal committee.
Edoxaban tosylate is an oral anticoagulant that directly inhibits factor X (factor Xa), which is a key component in the formation of blood clots.
“Patients value newer oral anticoagulants, such as edoxaban tosylate, which cause less disruption to their day to day lives than warfarin”
It is part of a class of blood-thinning drugs known as Non-VKA Oral Anti-Coagulants that are used as an alternative to warfarin.
After a five-day lead in with heparin treatment, edoxaban can be taken once a day and was shown in trials to have comparable efficacy to warfarin, but with a more favourable safety profile.
It is administered orally, with a recommended dosage of 60mg once daily or 30mg once daily in specific patient groups – for example people with renal impairment or low body weight.
NICE’s final draft version of the guidance is now with consultees, who have the opportunity to appeal against it until 27 July.
Once the institute issues its final guidance, which is expected in October, it will replace local recommendations across England and Wales.
Edoxaban tosylate costs £210 for a 100-tablet pack (excluding VAT) and the daily cost of treatment is £2.10.
Commenting on the draft guidance, Professor Carole Longson, director of NICE’s Health Technology Evaluation Centre, said: “The newer oral anticoagulants, like edoxaban tosylate, are an alternative to warfarin as the mainstay of treatment to prevent recurrent blood clots.”
However, she noted that use of the newer drugs varied widely across the country, due to “many and varied” reasons, of which local clinical leadership and policies were “likely to play an important role”.
“The [appraisal] committee concluded that patients value newer oral anticoagulants, such as edoxaban tosylate, which cause less disruption to their day to day lives than warfarin,” she said.
She added: “We are pleased, therefore, to be able to recommend edoxaban tosylate as a further cost-effective option for treating DVT and PE and preventing further episodes in adults.”