NICE U-turn on Boehringer’s Pradaxa
pharmafile | November 1, 2011 | News story | Sales and Marketing | NICE, Pradaxa
NICE is now recommending Boehringer Ingelheim’s Pradaxa for stroke prevention after initially rejecting the drug on cost-effectiveness issues.
NICE has changed its mind in its final draft guidance, recommending Pradaxa (dabigatran) for use on the NHS in preventing stroke and systemic embolism in patients with atrial fibrillation.
The change of heart was brought about by new data and analyses, and the pharma company did not have to offer any price discount.
The watchdog asked BI for more information on the drug, specifically relating to its differing doses in previous draft guidance, but is now satisfied with the drug’s cost-effectiveness.
Commenting on NICE’s draft recommendation, Professor Carole Longson, NICE health technology evaluation centre director, said: “Atrial fibrillation [AF] can be a distressing condition and people with it have an increased risk of suffering a stroke.
“Many people with the condition find it difficult to comply with the most commonly used antithrombotic warfarin because, among other things, it requires regular monitoring and dose adjustments which can cause disruption and inconvenience.”
She said because Pradaxa does not require frequent blood tests to monitor treatment – as warfarin does – it represents a ‘significant potential benefit’ for many people with AF.
Professor Longson continued: “The independent appraisal committee accepted evidence that showed Pradaxa 150 mg twice daily is more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, and that the 110 mg 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 [Boehringer] which required clarification.
“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 stroke and systemic embolism in people with atrial fibrillation,” she concluded.
The cost to the NHS of a pack of 60 capsules of either dabigatran 110 mg or 150 mg will be £75.60.
The cost per day per patient based on the recommended dosage will be £2.52, meaning the average cost per year, per patient, will be £919.80.
Pradaxa is already approved for NHS use by NICE for its first indication, prevention of venous thromboembolism (VTE) in patients who have elective knee or hip surgery, which NICE passed in 2008.
Boehringer welcomes decision
Boehringer has welcomed NICE’s decision and said it has worked towards filling in the gaps that NICE needed from its previous guidance.
Dr Charles de Wet, medical director at Boehringer, said: “[We] welcome the final appraisal determination issued by NICE, which clearly outlines why the appraisal committee concluded that that Pradaxa is a cost effective use of NHS resources when used within its licensed indication.
“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.”
Final guidance is likely to be published in December.
Ben Adams
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