NICE recommends new indication for troubled Pradaxa
pharmafile | October 31, 2014 | News story | Sales and Marketing | Boehringer, NHS, NICE, Pradaxa, dabigatran, ingelheim, warfarin
NICE has recommended Boehringer Ingelheim’s controversial anti-blood clotting drug Pradaxa for treating and preventing potentially-fatal blood clots in the legs and lungs.
Pradaxa (dabigatran) works as a blood thinner and is currently approved by NICE for the prevention of strokes and systemic embolism in patients with irregular heart rhythm (atrial fibrillation) – although the watchdog initially turned the drug down on cost-effectiveness grounds.
Under the new indication, Pradaxa is licensed to treat deep vein thrombosis (DVT), which can lead to pulmonary embolism (PE) if the blood clot travels from the legs to the lungs. Such blood clots can result in venous ulceration and chronic pain, swelling and skin changes in the affected limb which can have a significant impact on quality of life.
Pradaxa is one of three treatments including Bayer’s Xarelto (rivaroxaban) and Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban), that are being touted as more convenient alternatives to the 50-year old generic blood thinner warfarin.
“For many people, using warfarin can be difficult because of the need for frequent tests to see if the blood is clotting properly, and having to adjust the dose of the drug if it is not,” says Professor Carole Longson, NICE Health Technology Evaluation Centre director.
“The Appraisal Committee felt that dabigatran represents a potential benefit for many people who have had a DVT or PE, particularly those who have risk factors for recurrence of a blood clot and who therefore need longer term treatment. We are pleased, therefore, to be able to recommend dabigatran as a cost-effective option for treating DVT and PE and preventing further episodes in adults.”
This positive news arrives in contrast to the drug’s recent rocky past, as earlier this year Boehringer settled 4,000 lawsuits in the US alleging that it caused severe or fatal bleeding – a well-known side effect of anticoagulant medicines – and the EMA has made the company issue a safety warning of the potential for kindey problems related to use of the drug.
A BMJ investigation also raised concerns that Boehringer had hidden trial data showing that the drug does in fact require patient monitoring. This appeared to be confirmed by leaked internal documents, which showed that the company considered the information to be important for patients but a liability issue, as it would take away Pradaxa’s main benefit over Warfarin.
The German firm has in the past also come under fire several times for its marketing practices for the drug – including promoting the drug for stroke prevention in the UK before it was licensed for this and making unsubstantiated claims about its superiority to Sanofi’s Lovenox (enoxaparin).
Regulators continue to say that the drug’s stroke-prevention benefits outweigh its risks, however, and the drug has been a strong growth driver for Boehringer – bringing in $1.5 billion for the company last year.
George Underwood
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