Xarelto Receives Final Draft Approval for Blood Clots from NICE

In final draft guidance, the NICE (National Institute for Health and Clinical Excellence) announced that they are recommending the use of Bayer’s xarelto (rivaroxaban) to treat deep vein thrombosis (DVT) and avoid recurrent DVT and pulmonary embolism (PE) in adults diagnosed with acute deep vein thrombosis.

The new draft endorsement shadows the delivery of additional data from Bayer Healthcare which NICE requested in their earlier draft guidance.

In the preceding draft guidance the agency asked Bayer to deliver additional proof regarding the drug’s clinical and cost effectiveness.

Professor Carole Longson, director of NICE’s health technology evaluation centre, commented that NICE “are pleased to say that, following the submission of additional information and analysis from the manufacturer during consultation, the committee is able to recommend rivaroxaban as a cost-effective option for treating DVT and preventing recurrent DVT and PE in adults.”

The current treatment for deep vein thrombosis includes a dual drug approach of low molecular weight heparin (LMWH) administered by subcutaneous injection, followed by a vitamin K antagonist, such as warfarin.

“For many people, using warfarin is difficult because of the need for regular monitoring with blood tests, dosing adjustments and the need to be careful about their diet because of warfarin’s interact with certain foods,” noted Longson.

Remarking on the agency’s draft approval, Dr Gerry Dolan, consultant haematologist at Nottingham University Hospital, commented that the simplification of venous blood clot treatment is a vital clinical goal, and that rivaroxaban “has the potential to offer that simplicity.”

“The current dual standard of care in DVT is effective when controlled, but presents numerous challenges and drawbacks including injection site problems and the complication of a dual regimen,” he added, noting that the new draft guidance “is recognition that an effective, well-tolerated and fixed-dose regimen which can be initiated rapidly is welcome news for physicians and their patients.”

In 2010-11, there were more than 35,000 symptomatic DVTs treated in hospitals across England, and an additional 35,000 pulmonary embolisms.  This condition is potentially life-threatening and is also a key cause of morbidity, with more than 60% of patients with proximal symptomatic DVT developing Post Thrombotic Syndrome, noted Bayer, pointing out that the overall (direct and indirect) yearly cost to the NHS of managing DVT and PE is estimated at around £640 million.

It is projected that there will be more than 46,000 cases of acute DVT in England and Wales this year, increasing to almost 50,000 by 2016, owing in part to the ageing population.

Xarelto is an orally administered medication that aids to prevent blood clotting.  The length of treatment is founded on a valuation of the benefit of anticoagulation in comparison with the risk of bleeding, and normally varies from 3 to 12 months.  Certain people who have on-going risk factors for recurrence of VTE require on-going treatment, possibly for multiple years or lifelong.

The draft recommendation is now with the consultees, who have the chance to appeal against it.


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