In final draft guidance, the National Institute for Health and Clinical Excellence (NICE) says it recommends the use of Bayer Healthcare's Xarelto (rivaroxaban) as an option for treating deep vein thrombosis (DVT) and preventing recurrent DVT and pulmonary embolism (PE) in adults diagnosed with acute DVT.
The new draft recommendation follows the receipt of further information from Bayer which NICE had requested in its previous draft guidance, says the Institute.
NICE's independent appraisal committee had initially been unable to recommend Xarelto based on the data presented by Bayer Healthcare, because it did not adequately demonstrate the drug's clinical and cost effectiveness in the context of UK clinical practice, commented Professor Carole Longson, director of NICE’s health technology evaluation centre.
However, she added: "we 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 standard of care for the treatment of DVT 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," said Prof Longson.
Commenting on the Institute’s new draft guidance, Dr Gerry Dolan, consultant haematologist at Nottingham University Hospital, said that the simplification of venous blood clot treatment is an important 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drawbacks including injection site problems and the complication of a dual regimen," he went on, adding that the new draft guidance from NICE "is recognition that an effective, well-tolerated and fixed-dose regimen which can be initiated rapidly is welcome news for physicians and their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 over 35,000 symptomatic DVTs treated in hospital in England, and a further 35,000 PEs. This potentially life-threatening condition is also a major cause of morbidity, with over 60% of patients with proximal symptomatic DVT developing Post Thrombotic Syndrome, , says Bayer Healthcare, pointing out that the total (direct and indirect) annual cost to the NHS of managing DVT and PE is put at £640 million.
It is estimated that there will be over 46,000 cases of acute DVT in England and Wales this year, rising to nearly 50,000 by 2016, due in large part to the ageing population, says NICE.
The draft guidance is now with consultees.
- 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. However, actual costs may vary in different settings because of negotiated procurement discounts.