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NICE requests more data on Pradaxa

The National Institute for Health and Clinical Excellence has requested further information on Boehringer Ingelheim’s Pradaxa (dabigatran)

The National Institute for Health and Clinical Excellence (NICE) has requested further information on Boehringer Ingelheim's Pradaxa (dabigatran), a new alternative to warfarin.

NICE has asked the German pharmaceutical company for more information about Pradaxa, an orally administered anticoagulant that inhibits the formation of the thrombin enzyme, in particular data related to its cost effectiveness compared with warfarin. The agency thought Boehringer had overestimated the costs of monitoring patients on warfarin, thus overstating the cost-effectiveness of its alternative.

Pradaxa is estimated to cost £2.52 per day, or £919.80 per year ($1,520). Warfarin costs the UK NHS £14.60 per year ($24). However, the cost of warfarin does not include everything; because of individual dosing differences, patients using warfarin have to be monitored. Boehringer has estimated that cost at £414.90, but NICE puts the average at £115.14.

Dr Gillian Leng, NICE deputy chief executive and chief operating officer for NHS Evidence, said: "The committee heard that warfarin, the most commonly used antithrombotic, is associated with a number of inconveniences for the patient that make compliance difficult. These include regular monitoring and dose adjustments that cause disruption and changes to routine. Since it does not require frequent blood tests to determine the effectiveness of treatment, dabigatran may have potential benefits for people with atrial fibrillation. The committee also accepted evidence that showed dabigatran 150mg twice daily was more clinically effective than warfarin in reducing the risk of stroke/systemic embolism, ischaemic stroke and vascular mortality and that this represented an important development for patients with atrial fibrillation.”

NHS bodies should make decisions locally on the funding of specific treatments, until NICE issues final guidance. Once NICE issues its guidance on a technology it replaces local recommendations across the country.

Final guidance is due to be published in December 2011.

18th August 2011

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