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The UK’s National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending the oral anticoagulant edoxaban tosylate (Lixiana) as an option for treating and preventing the recurrence of venous thromboembolism (VTE).
A committee advising NICE concluded that edoxaban is clinically effective, and the drug will be a cost-effective use of National Health Service resources.
“The newer oral anticoagulants like edoxaban tosylate are an alternative to warfarin as the mainstay of treatment to prevent recurrent blood clots,” said Carole Longson, NICE Health Technology Evaluation Centre Director.
“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 [VTE] and preventing further episodes in adults.”
Clinical effectiveness
Edoxaban was recently approved in the European Union to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE). This approval was based on results of the Hokusai-VTE trial. The committee advising NICE analyzed data from this trial when considering the clinical effectiveness of edoxaban.
For Hokusai-VTE, researchers evaluated edoxaban in 4921 patients with DVT and 3319 with PE. Patients received initial treatment with low-molecular-weight heparin and were then randomized to receive edoxaban or warfarin daily for 3 to 12 months.
Overall, edoxaban proved as effective as warfarin. Recurrent, symptomatic VTE occurred in 3.2% and 3.5% of patients, respectively (P<0.001 for non-inferiority).
In addition, the incidence of clinically relevant bleeding was significantly lower in the edoxaban arm than the warfarin arm—8.5% and 10.3%, respectively (P=0.004 for superiority).
Cost-effectiveness
The recommended dose of edoxaban is 60 mg once daily, or 30 mg once daily in specific patient groups—those with renal impairment, low body weight (60 kg or less), or concomitant use of potent permeability glycoprotein inhibitors—following treatment with a parenteral anticoagulant for at least 5 days.
Edoxaban costs £2.10 per 15 mg, 30 mg, or 60 mg tablet (excluding value-added tax). Costs may vary in different settings because of negotiated procurement discounts.
Taking into account the lack of any clear evidence that edoxaban is significantly different from the other new oral anticoagulants, as well as the testimony of experts, the committee advising NICE concluded that the most plausible incremental cost-effectiveness ratio for edoxaban was likely to be in line with the other oral anticoagulants already recommended by NICE.
The draft guidance for edoxaban 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.
