UK's NICE Draft Guidance Recommends Daiichi Sankyo's Lixiana to Treat and Prevent DVT and PE

July 13, 2015—The United Kingdom’s National Institute for Health and Care Excellence (NICE) announced the publication of a draft guidance recommending the antithrombotic drug edoxaban tosylate (Lixiana, Daiichi Sankyo Company, Ltd.) as an option for treating and preventing the recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE). Edoxaban tosylate, an oral anticoagulant that directly inhibits factor X (factor Xa), was recently granted marketing authorization by the European Commission and was approved by the United States Food and Drug Administration in January. 

The draft guidance is now with consultees, who have the opportunity to appeal against it. The final publication date is anticipated to be in October 2015. When NICE issues a final guidance, it will replace local recommendations across the country. 

In a note to the announcement, NICE stated that edoxaban tosylate costs £210 for a 100-tablet pack (excluding tax) and the daily cost of treatment is £2.10; however, 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 other new oral anticoagulants and the testimony of the experts, the committee concluded that the most plausible incremental cost-effectiveness ration (ICER) was likely to be in line with the other oral anticoagulants already recommended in previous NICE guidance.

In the announcement, Prof. Carole Longson, PhD, NICE Health Technology Evaluation Center Director, commented, “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.”

She continued, “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 minimizes 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,” concluded Prof. Longson.

In June, Daiichi Sankyo announced that the European Commission granted authorization for edoxaban to be marketed as Lixiana. It is approved for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, previous stroke, or transient ischemic attack, as well as for the treatment of DVT and PE and prevention of recurrent DVT and PE in adults.

In January, the company announced that the United States Food and Drug Administration approved edoxaban, marketed as Savaysa in the United States, for the reduction of the risk of stroke and SE in patients with NVAF. The FDA also approved Savaysa for the treatment of DVT and PE after 5 to 10 days of initial therapy with a parenteral anticoagulant.