NICE recommends Xarelto for stroke prevention
pharmafile | May 23, 2012 | News story | Sales and Marketing | Bayer, DVT, NICE, Pradaxa, Xarelto, anticoagulant
NICE is recommending Bayer’s anticoagulant pill Xarelto to help reduce the risk of stroke in certain patients.
The watchdog’s final guidance recommends Xarelto (rivaroxaban), a Factor Xa inhibitor, as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation.
Its licence is specifically for patients with non-valvular atrial fibrillation who have one or more risk factors such as congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, prior stroke or transient ischaemic attack.
This is the second recommendation for an oral anticoagulant this year after NICE recommended Boehringher’s Pradaxa (dabigatran) for the same licence in March.
Both drugs are looking to replace warfarin, an oral anticoagulant that has been on the market for over 50 years.
Boehringer recently lowered its drug’s price by 13% – down from £2.52 to £2.20 per day – in order compete with Xarelto, which is priced at £2.10 per day.
But NICE’s guidance states that the decision about whether to start treatment with Bayer’s drug should be made after a discussion between the doctor and their patient about the risks and benefits of Xarelto compared with warfarin.
It also recommends that for people who are taking warfarin, the potential risks and benefits of switching to Bayer’s drug should be considered in light of their level of international normalised ratio (INR)i control.
Pradaxa’s recommendation came with the same precautions, after a number of safety concerns about the drug were brought to the attention of the EMA.
Professor Carole Longson, NICE health technology evaluation centre director, said: “We know that some people taking warfarin can find it difficult to maintain their blood clotting at a proper level. Xarelto, like Pradaxa, which NICE recently approved as an option for this indication, can benefit people with AF.
“We are therefore pleased to recommend Xarelto as another cost effective option for the prevention of stroke and systemic embolism in people with atrial fibrillation.”
Atrial fibrillation occurs when the electrical impulses controlling the heart rhythm become disorganised, so that the heart beats irregularly and, occasionally, too fast and so cannot efficiently pump blood around the body.
People with AF are at higher risk of developing blood clots and subsequent stroke (with an approximately five-fold greater risk than that of people without AF) because the erratic heart rhythm of AF causes turbulent blood flow within the heart chambers.
However, the risk of stroke can be substantially reduced by appropriate use of antithrombotic therapy, such as warfarin, Pradaxa and Xarelto.
NICE is also appraising Xarelto for the treatment of deep vein thrombosis (DVT) and preventing recurrent DVT and pulmonary embolism, following an acute DVT in adults and for the prevention of VTE in people hospitalised for acute medical conditions.
The watchdog has already recommended the drug for the prevention of venous thromboembolism in adults having elective total hip replacement surgery, or elective total knee replacement surgery.
Ben Adams
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