Boehringer Ingelheim’s oral anticoagulant Pradaxa (dabigatran) has received preliminary backing from NICE to treat two potentially fatal types of blood clots.
In draft guidance the Institute recommended Pradaxa as an option for treating and preventing recurrent blood clots in the legs – deep vein thrombosis (DVT) and lungs – pulmonary embolism (PE) – in adults.
The decision puts Pradaxa on course to catch up with Bayer’s rival oral anticoagulant Xarelto (rivaroxaban), which was recommended by NICE for use in these indications back in 2012.
People with suspected DVT or PE are generally treated immediately with anticoagulants – most commonly injections of low molecular weight heparin (LMWH). When diagnosis is confirmed, this is overlapped with an oral anticoagulant such as warfarin.
Patients will usually be treated for three or more months, but those deemed at high risk of another blood clot may be given life-long treatment with anticoagulants.
Professor Carole Longson, NICE’s Health Technology Evaluation Centre director, said: “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 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.”
Neither Boehringer’s submissions, nor NICE’s Evidence Review Group (ERG), found any significant difference in efficacy between Pradaxa and Xarelto – and NICE’s Appraisal Committee noted the two drugs’ costs were very similar.
NICE’s draft Pradaxa guidance is now out for consultation, with final guidance expected to be published in December.
This could give Pradaxa around six months before NICE rules on the use of another oral anticoagulant in DVT and PE, with it guidance on Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban) due to be finalised by June 2015.