NICE wants more information on Xarelto
pharmafile | March 13, 2012 | News story | Sales and Marketing | Bayer, DVT, NICE, Xarelto
NICE is asking Bayer for more information about its blood thinner Xarelto in new guidance.
The watchdog is currently minded not to recommend Xarelto (rivaroxaban) for the treatment of deep vein thrombosis (DVT) and preventing recurrent DVT and pulmonary embolism (PE), following an acute DVT.
NICE said Bayer will need to provide further evidence relating to Xarelto’s clinical and cost effectiveness, specially relating to its long-term efficacy.
Meindert Boysen, programme director technology appraisals at NICE, said: “The independent appraisal committee noted the evidence from patient experts, which stated that many patients find taking warfarin to be a source of stress.
“However, the committee was unable to make a decision on the data presented by the manufacturer because it felt that the data failed to demonstrate the drug’s clinical and cost effectiveness in the context of UK clinical practice.
“In particular, the committee was concerned that an analysis for patients who required treatment beyond 12 months was not presented, and noted the comments of clinical specialists to the effect that some people with DVT need to continue on anticoagulant therapy permanently.
“The committee has therefore requested further information from Bayer about the clinical and cost effectiveness of rivaroxaban used as a long-term treatment, and has also asked for comment on the differences between the subgroups receiving different intended treatment-durations.”
Treatments for this condition include low-molecular weight heparin, which in the UK is usually Sanofi’s Lovenox (enoxaparin).
This is then overlapped with drugs such as warfarin, until the oral blood thinner is effective and a proper dose is achieved.
Xarelto costs £2.10 per tablet, with the total cost of treatment is estimated to be just over £800 for a year’s worth of treatment.
Last month the Scottish Medicines Consortium recommended the drug for funding in the Scottish NHS, but also said that its cost effectiveness over one year was uncertain.
NICE said in 2009 that the drug could be funded by the NHS for the prevention of venous thromboembolism after total hip or total knee replacement in adults.
It also undergoing a NICE appraisal for the prevention of stroke in patients with a heart flutter (atrial fibrillation).
Ben Adams
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