Pradaxa recommended after new data


NICE has recommended Boehringer Ingleheim’s Pradaxa (dabigatran) for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF) in final draft guidance.

The positive recommendation follows the disclosure of further information from Boehringer that had been requested on a number of areas, including its cost effectiveness and use in clinical practice.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says the medication “represents a significant potential benefit for many people with AF”.

Questions were initially raised by NICE’s Independent Appraisal Committee over the cost to the NHS and a “more plausible set of assumptions” on Pradaxa’s use were required from Boehringer.

But NICE says it is “pleased” the additional information and analysis it received has enabled the Committee to recommend the treatment as a cost-effective use of NHS resources.

“The Independent Appraisal Committee accepted evidence that showed dabigatran 150mg twice daily is more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, and that dabigatran 110mg twice daily is as effective as warfarin. However, there were a number of uncertainties relating to the drug’s cost-effectiveness in the original evidence submission from the manufacturer which required clarification,” said Professor Longson.

Dr Charles de Wet, Medical Director at Boehringer Ingelheim, welcomed the revised decision by NICE. “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 has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients aged 75 years with AF who have had a previous stroke, heart attack or systemic embolism.

It is also authorised for people with AF over 65 who have diabetes, coronary heart disease or hypertension.

Final guidance is now expected to be published next month.