NICE recommends Pradaxa for DVT and PE

In draft guidance published today, the UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has recommended German family-owned pharma major Boehringer Ingelheim’s anti-blood clotting drug Pradaxa (dabigatran) as an option for treating and preventing recurrent and potentially fatal blood clots in the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism; PE) in adults.

Risk factors for DVT and PE include a history of DVT, recent surgery, immobility, active cancer or cancer treatment, age over 60 years, obesity, hormone replacement or estrogen containing contraceptive therapy and the presence of co-morbidities such as heart disease.

People with suspected DVT or PE are generally treated immediately with drugs that help to prevent the blood from clotting (anticoagulants), most commonly with injections of low molecular weight heparin. When the diagnosis has been confirmed, this is overlapped with an oral anticoagulant such as warfarin. The length of treatment is based on a person’s risk of having another DVT or PE, as well as their risk of bleeding. The usual length of treatment in UK practice is three months or more. However, people who are at high risk of having another blood clot may be given life-long treatment with anticoagulants to prevent further episodes.

Cost-effective option for treating DVT and PE

Carole Longson, director of the NICE Health Technology Evaluation Centre, commented: “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. 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.”

The draft guidance is now with consultees, who have the opportunity to appeal against it. Once the NICE issues its final guidance on a technology, it replaces local recommendations across the country.

Pradaxa pricing

Dabigatran costs £65.90 ($106) for a 60 capsule pack of the 150mg or 110mg doses (excluding VAT) and costs £2.20 per day of treatment. The most plausible incremental cost-effectiveness ratio (ICER) for dabigatran etexilate compared with warfarin for acute treatment was uncertain, but both the company’s and the ERG’s exploratory ICER remained in the range which could be considered a cost effective use of NHS resources that is, both were under £20,000 per QALY gained.