Final guidance from the National Institute for Health and Clinical Excellence (NICE) recommends Boehringer Ingelheim's Pradaxa (dabigatran) for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF).
The guidance - whose publication follows the dismissal on all points of an appeal against the draft version - also recommends that the decision about whether to start treatment with Pradaxa should be made after an informed discussion about its risks and benefits compared with warfarin, and in light of the person's current level of international normalised ratio (INR) control if they are already taking warfarin.
"Atrial fibrillation can be a distressing condition and people with it have an increased risk of suffering a stroke," said Professor Carole Longson, director of NICE's health technology evaluation centre. "Many people with the condition find it difficult to comply with the most commonly-used antithrombotic, warfarin, because among other things, it requires regular INR monitoring and dose adjustments, which can cause disruption and inconvenience. Because dabigatran does not require frequent blood tests to monitor treatment, it represents a useful alternative option for people with atrial fibrillation," she added.
Prof Longson also reported that NICE's independent appraisal committee had accepted evidence from clinical trials that showed Pradaxa 150mg twice daily to be more clinically effective than warfarin in reducing the risk of stroke for systemic embolism, and that at 110mg twice daily is it as effective as warfarin.
Boehringer Ingelheim points out than an estimated 1.2 million in the UK are diagnosed with AF, of whom 77% are eligible for treatment with an anticoagulant. The use of Pradaxa 150mg twice daily has the potential to prevent 530 more strokes per 100,000 patients every year compared to warfarin, the current standard of care and, if all eligible patients were to receive Pradaxa 150mg twice daily instead of warfarin, this could mean preventing up to 5,000 strokes, saving the NHS as much as £59 million in the first year, the firm adds.
Many patients and doctors will welcome NICE's recommendation, commented Martin Cowie, professor of cardiology at the Royal Brompton Hospital. "The NHS needs to act to optimise the diagnosis and treatment of atrial fibrillation, a very common reason for strokes in the UK," he said adding: "we have waiting for more than 50 years for an alternative to warfarin, and I am delighted that at last we have another option to offer to patients who might benefit.”
The guidance marks a positive step forward for AF patients whose risk of stroke is not being appropriately managed, added Peter Rowe, recently retired Primary Care Trust (PCT) chief executive and national Quality, Innovation, Productivity and Prevention (QIPP) lead for medicines use and procurement at the Department of Health.
"I would urge NHS colleagues to work in partnership with Boehringer-Ingelheim to ensure patients get appropriate and early access to the medicine and that both patient and system benefits are realised," he said.
Charles De Wet, medical director at Boehringer-Ingelheim, said the firm's "commitment now is to work closely with the Trusts to ensure dabigatran is accessible to all eligible patients on the NHS and appropriately prescribed by clinicians."
