In a draft guidance published, National Institute for Health and Care Excellence (NICE), an executive non-departmental public body of the Department of Health in the United Kingdom, has recommended Daiichi Sankyo's anti-blood clotting drug edoxaban tosylate (Lixiana) as an option for treating and preventing the recurrence of potentially fatal blood clots.

Deep vein thrombosis (DVT) occurs when a blood clot (thrombus) forms in the deep veins, most commonly in the leg or pelvis. Blood flow through the affected vein can be limited by the clot, and can cause swelling and pain.

If the blood clot dislodges and travels to the lungs, this can lead to a potentially fatal pulmonary embolism (PE) when the clot blocks the blood supply to the lungs. Even if blood clots are not fatal, they can still result in long-term illness, including venous ulceration and chronic pain, swelling and skin changes in the affected limb which can have a significant impact on quality of life.

Risk factors for DVT and PE include a history of DVT, recent surgery, immobility, active cancer or cancer treatment, age over 60 years, obesity, hormone replacement therapy or oestrogen containing contraceptive therapy and the presence of other conditions such as heart disease.

People with suspected DVT or PE are generally treated immediately with drugs that help to prevent the blood from clotting (anticoagulants), most commonly with injections of low molecular weight heparin (LMWH). When the diagnosis has been confirmed, this is overlapped with an oral anticoagulant such as warfarin. The length of treatment is based on a person’s risk of having another DVT or PE, as well as their risk of bleeding. The usual length of treatment in UK practice is 3 months or more. However, people who are at high risk of having another blood clot may be given life-long treatment with anticoagulants to prevent further episodes.

Edoxaban tosylate 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Commenting on the draft guidance, professor Carole Longson, NICE Health Technology Evaluation Centre director, said “The newer oral anticoagulants like edoxaban tosylate are an alternative to warfarin as the mainstay of treatment to prevent recurrent blood clots, however their use shows wide variation across the country. The reasons for this are many and varied but local clinical leadership and policies are likely to play an important role.

“For many people, using warfarin can be difficult because of the need for frequent checks to make sure their blood is clotting properly, and having to adjust the dose of the drug if it’s not. The Committee heard that the most important issue for patients is to have an effective treatment which minimises disruption to their day-to-day lives.

“The Committee concluded that patients value newer oral anticoagulants such as edoxaban tosylate, which cause less disruption to their day to day lives than warfarin. 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.”

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.

Edoxaban tosylate costs £210 for a 100-tablet pack (excluding VAT) and the daily cost of treatment is £2.10. Costs may vary in different settings because of negotiated procurement discounts.

Taking into account the lack of any clear evidence that edoxaban tosylate was significantly different from the other new oral anticoagulants, and the testimony of the experts, the Committee concluded that the most plausible ICER was likely to be in line with the other oral anticoagulants already recommended in previous NICE guidance.