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NICE backs Boehringer's Pradaxa for atrial fibrillation

Oral anticoagulant deemed cost effective options for atrial fibrillation patients in England and Wales

Boehringer Ingelheim's oral anticoagulant Pradaxa will be available much more freely in England and Wales for patients with atrial fibrillation, following a positive review by the National Institute for Health and Clinical Excellence (NICE).

Pradaxa (dabigatran etexilate) has been deemed a cost-effective option for preventing stroke and systemic embolism in adult patients with non-valvular AF and one or more risk factors, according to NICE. The product was also backed for use in venous thromboembolism (VTE) by the agency in 2008.

"This landmark decision means dabigatran must now be made available for use by the National Health Service and that patients have the right to receive it if clinicians deem it clinically appropriate," said Boehringer Ingelheim in a statement.

The final verdict is in line with NICE's earlier draft guidance in the AF setting, which recommended that the decision about whether to start treatment with Pradaxa should be made after "an informed discussion about the risks and benefits of dabigatran compared with warfarin", currently the most widely used anticoagulant in this setting.

Pradaxa is estimated to cost £2.52 per day, or £919.80 per year (around €1,100), while warfarin costs the UK NHS £14.60 per year (roughly €17.50), although the latter does not take into account additional costs related to the need for regular monitoring with blood tests.

NICE's backing is a major boost for Pradaxa, given that the US Food and Drug Administration (FDA) is still carrying out a safety review of the drug's safety in patients with non-valvular AF after reports of fatal bleeds among patients taking the drug. 

The European Medicines Agency (EMA) finished its own safety review of Pradaxa last year and concluded that the current labelling for the drug was adequate to allow its safe use.

The green light from NICE comes shortly after the Institute asked for more data on Bayer's anticoagulant Xarelto (rivaroxaban), which has been competing toe-to-toe with Pradaxa in the marketplace. NICE also asked for more data during its review of Pradaxa.

Boehringer Ingelheim estimates that 1.2 million people are diagnosed with AF in the UK, of which 77 per cent are eligible for treatment with an anticoagulant. The company says that if all eligible patients were treated with Pradaxa instead of warfarin up to 5,000 strokes would be prevented, saving the NHS £59m in the first year.

• NICE's verdict on Pradaxa was held after a local NHS appeal against the Institute's final appraisal determination on the grounds NICE had failed to act fairly and had exceeded its powers.

NHS Salford also argued NICE had dramatically underestimated the take-up of Pradaxa and that approval would require a complete redesign of anticoagulant services at the primary care trust level.

The appeal, which was held on February 7, dismissed NHS Salford's objections.

15th March 2012

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