Boehringer gets NICE nod for Pradaxa

pharmafile | December 16, 2014 | News story | Sales and Marketing |  Boehringer, NHS, NICE, Pradaxa, VTE, dagibatran, ingelheim, warfarin 

NICE has confirmed a recommendation for Boehringer Ingelheim’s controversial anti-blood clotting drug Pradaxa, as a treatment for blood clots in the legs and lungs.

In its final guidance NICE recommends Pradaxa (dabigatran) in 110mg and 150mg doses, as options to treat and prevent recurrent and potentially fatal blood clots in the legs (deep vein thrombosis or DVT) and the lungs (pulmonary embolism or PE) in adults.

The blood thinner 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. It is also recommended for the primary prevention of venous thromboembolism (VTE) after elective total hip or knee replacement surgery.

The guidance broadens the market for which the anticoagulant is available. Charles de Wet, medical director for Boehringer UK and Ireland, says the guidance is ‘great news for patients’, adding: “This news broadens the ways in which Pradaxa can be used, allowing patients to have more choices.”

Professor Carole Longson, NICE health technology evaluation centre director says: “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.

“The appraisal committee felt that Pradaxa 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 Pradaxa as a cost-effective option for treating DVT and PE and preventing further episodes in adults.”

Pradaxa is one of three oral anticoagulants, including Bayer’s Xarelto (rivaroxaban) and Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban), that are marketed in Europe as more convenient alternatives to the 50-year-old generic blood-thinner warfarin.

These anticoagulants have had a controversial past with regulators, and Pradaxa faces ongoing scrutiny of its safety. In the US Boehringer has settled 4,000 lawsuits alleging that Pradaxa caused severe or fatal bleeding – a well-known side effect of anticoagulant medicines.

A BMJ investigation also raised concerns that Boehringer had hidden trial data showing that the drug does in fact require patient monitoring. And the EMA has made the company issue a safety warning of the potential for kidney problems related to use of the drug.

Lilian Anekwe