Pradaxa Receives Final Draft OK From NICE

Final draft guidance released from the UK’s National Institute for Health and Clinical Excellence (NICE) recommends the use of Boehringer Ingelheim’s Pradaxa (dabigatran) for the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.

In addition, the draft guidance recommends that the decision on whether to start treatment with Pradaxa should be made after an “informed discussion” about the drug’s risks and benefits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 their positive endorsement follows the receipt of additional information about the product from the manufacturer, which they had requested in their previous draft guidance.

Atrial fibrillation occurs when the electrical impulses controlling the heart rhythm become disorganised, resulting in the heart beating irregularly and, occasionally, too fast, meaning that it cannot efficiently pump blood around the body. People with atrial fibrillation 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 atrial fibrillation find it difficult to comply with warfarin because 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 substantial potential benefit for many people with atrial fibrillation, she added.

Prof Longson also added 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, Professor Longson stated that “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 atrial fibrillation.”

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 atrial fibrillation who are at risk of stroke,” he commented.

Pradaxa is an orally-administered anticoagulant that inhibits the formation of the thrombin enzyme. It has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients aged 75 years and over with nonvalvular atrial fibrillation 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 Class 2 or above.

The drug also has a UK marketing authorisation for people with atrial fibrillation 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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