Cost regulators for the National Health Service in England and Wales have backed the use of Bayer's blood thinner Xarelto as an option to prevent and treat clots in the vein and lung.

In final guidance published this week the National Institute for Health and Clinical Excellence has endorsed the use of Xarelto (rivaroxaban) to either treat or prevent DVT and prevent pulmonary embolism in adults diagnosed with acute DVT.

The news will be particularly sweet for the firm given that the drug was initially rejected by the Institute's Appraisal Committee, because at the time the data were insufficient to demonstrate its clinical and cost effectiveness.

The current standard of care for the treatment of DVT includes a dual approach an injectable anticoagulant such as a low molecular weight heparin (LMWH) with overlapping treatment by a vitamin K antagonist such as warfarin.

Xarelto is an orally administered drug that helps prevent blood from clotting by inhibiting Factor Xa, which is necessary in the formation of thrombin and fibrin, key components in blood clot formation.

Many people find warfarin problematic because of they need regular monitoring with blood tests and dosing adjustments, as well as the drug's potential interaction with certain foods.

"Because rivaroxaban does not require frequent blood tests to monitor treatment it represents a potential benefit for many people who have had a DVT, particularly those who have risk factors for recurrence of VTE and who therefore need longer term treatment," said Professor Carole Longson, NICE Health Technology Evaluation Centre Director.

"We are pleased, therefore, to be able to recommend rivaroxaban as a cost-effective option for treating DVT and preventing recurrent VTE in adults,” she added.

46,000 cases of DVT

According to estimates, there will be over 46,000 cases of acute DVT in England and Wales during 2012, rising to nearly 50,000 by 2016 due in large part to the aging population, highlighting the need for effective treatments to help manage the condition.

Xarelto costs £2.10 per 15mg or 20mg tablet, and the cost of treatment is estimated to be £235.86, £427.61 and £811.13 for three, six and twelve months of treatment, respectively. 

With the committee’s preferred assumptions, the incremental cost for long-term treatment with the drug was under £19,400 per QALY (quality adjusted life year) gained, and so within the normal cost-effectiveness threshold.