As expected, Boehringer Ingelheim’s bloodthinner Pradaxa (dabigatran) is now routinely available on the National Health Service for treating and preventing potentially fatal blood clots in the lungs and legs.

The National Institute for Health and Care Excellence has published final guidance endorsing Pradaxa for treating and preventing the recurrence of deep vein thrombosis and pulmonary embolism, recommending its use twice daily after treatment with a parenteral anticoagulant for at least five days.

People with suspected DVT or PE are generally treated immediately with bloodthinners, most commonly with injections of low molecular weight heparin, and when the diagnosis is confirmed this is then overlapped with an oral anticoagulant such as warfarin. But using warfarin can present difficulties for patients; the drug is associated with a high bleeding risk and so patients must to be monitored on a frequent basis to ensure that the blood is clotting properly.

The most plausible incremental cost effectiveness ratio for dabigatran compared with warfarin for acute treatment was uncertain, but both the company’s and the Expert Review Group’s figure remained in the range which could be considered a cost effective use of NHS resources - both were under £20,000 per QALY gained, NICE said.

For combined treatment and secondary prevention, the Committee thought the ICER for Pradaxa versus warfarin was likely fall somewhere between the company’s estimate of £9,973 per QALY gained and the ERG’s figure of £35,786 per QALY gained, enabling the Institute to recommend its use in either setting.

Potential benefit

“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.” 

Welcoming the move, Charles de Wet, Medical Director for Boehringer Ingeheim UK and Ireland, said broadening the use of Pradaxa will “provide a welcome additional option for the management of DVT/PE”.

Pradaxa is already accepted for use in England and Wales for the primary prevention of venous thromboembolism (VTE) after elective total hip or knee replacement surgery and for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation.

Positive advice from the Scottish Medicines Consortium (SMC) for Pradaxa in this setting was published in October.