Deep vein thrombosis (or ‘DVT’) occurs when a blood clot (thrombus) forms in the deep veins of the leg or pelvis. Blood flow through the affected vein can be limited by the clot, and it can cause swelling and pain in the leg.

If the blood clot dislodges and travels to the lungs, this can lead to a potentially fatal pulmonary embolism (or ‘PE’) when the clot blocks the blood supply to the lungs. Even if blood clots are not fatal, they can still result in long-term illness, including venous ulceration and chronic pain, swelling and skin changes in the affected limb which can have a significant impact on quality of life.

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 therapy or oestrogen 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 (LMWH). 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 3 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.

Commenting on the draft guidance, Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “For many people, using warfarin can be difficult because of the need for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. 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The draft guidance is now with consultees, who have the opportunity to appeal against it.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 NICE issues its final guidance on a technology, it replaces local recommendations across the country.

Ends

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

About the draft guidance

1. The draft guidance will be available at http://www.nice.org.uk/Guidance/InDevelopment/GID-TAG361 from Friday 31 October 2014. Embargoed copies of the draft      guidance are available from the NICE press office on request.

1. Dabigatran costs £65.90 for a 60‑capsule pack of the 150 mg or 110 mg doses (excluding VAT; BNF 67) and costs £2.20 per day of treatment. Costs may vary in different settings because of negotiated procurement discounts.
2. The most plausible 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.
3. Neither the company nor the ERG had found any significant difference in efficacy between dabigatran etexilate and rivaroxaban for acute treatment of venous thromboembolism in their indirect comparisons, and the costs were also very similar between these two treatments.
4. For combined treatment and secondary prevention of VTE, the Committee considered that although the company’s base case ICER for dabigatran etexilate compared with warfarin was likely to be too low (£9973 per QALY gained), the ERG’s exploratory base case for dabigatran etexilate compared with warfarin may have overestimated the ICER (£35,786 per QALY gained). The Committee was prepared to accept that the ICER probably lay somewhere between the 2 estimates.
5. The Committee also noted that dabigatran etexilate and rivaroxaban had not been shown to have different efficacy, and their costs were very similar.