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New data gets Pradaxa final draft OK from NICE

UK News | November 01, 2011


Lynne Taylor

New data gets Pradaxa final draft OK from NICE

Newly-published final draft guidance from the National Institute for Health and Clinical Excellence (NICE) recommends the use of Boehringer Ingelheim's Pradaxa (dabigatran) for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF).

The draft guidance also recommends that the decision about whether to start treatment with Pradaxa should be made after an "informed discussion" about the drug's risks and benefits compared with warfarin, and in light of a person's current level of international normalised ratio (INR) control if they are already taking warfarin.

NICE says that its positive recommendation follows the receipt of further information about the product from the manufacturer, which it had requested in its previous draft guidance.

AF occurs when the electrical impulses controlling the heart rhythm become disorganised, so that the heart beats irregularly and, occasionally, too fast, and therefore cannot efficiently pump blood around the body, the Institute notes. People with AF are at higher risk of developing blood cuts and subsequent stroke, although the risk of stroke can be substantially reduced by appropriate use of antithrombotic therapy, such as warfarin, which is the most commonly-used antithrombotic.

However, many people with AF find it difficult to comply with warfarin because, among other things, it requires regular INR monitoring and dose adjustments which can cause disruption and inconvenience, notes Professor Carole Longson, director of NICE's health technology evaluation centre.

Because Pradaxa does not require frequent blood tests to monitor treatment, it represents a significant potential benefit for many people with AF, she said.

Prof Longson also noted that NICE's independent appraisal committee had accepted evidence showing that Pradaxa 150mg twice daily is more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, and that Pradaxa 110mg twice daily is as effective as warfarin.

But there had been a number of uncertainties relating to Pradaxa's cost-effectiveness in the original evidence submission supplied by the manufacturer, and these required clarification.

However, she said today: “we are pleased to say that the additional information and analysis received from the manufacturer has enabled the committee to recommend dabigatran as a cost-effective use of NHS resources for the prevention of strike and systemic embolism in people with AF."

Charles de Wet, medical director at Boehringer Ingelheim, welcomed the final draft guidance. "Pradaxa is the first new oral anticoagulant in 50 years and we are committed to working closely with the NHS to ensure appropriate prescribing in suitable patients with AF who are at risk of stroke," he said.

Pradaxa is an orally-administered anticoagulant that inhibits the formation of the thrombin enzyme. It has a UK marketing authorisation (MA) for the prevention of stroke and systemic embolism in patients aged 75 years and over with nonvalvular AF who have had a previous stroke, transient ischaemic attack or systemic embolism, and/or left ventricular ejection fraction below 40%, and/or symptomatic heart failure of New York Heart Association (NYHA) Class 2 or above.

The drug also has a UK MA for people with AF aged 65 years or over who have diabetes, coronary heart disease or hypertension.

- Final NICE guidance on this use of Pradaxa is expected to be published in December.

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