New drugsNICE has recommended Lixiana (edoxaban) to help patients suffering from blood clots in the legs and lungs.

The approval follows on from recent European marketing authorisation, granted in June, for two indications:

  • Treatment of DVT and PE, and prevention of recurrent DVT and PE in adults
  • Prevention of stroke and systemic embolism (SE) in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ݠ75 years, diabetes mellitus, prior stroke or transient ischaemic attack.

Earlier this month, NICE also published a Final Appraisal Determination for its Single Technology Appraisal of Lixiana for the prevention of stroke and SE in people with NVAF.

The final NICE recommendation states: “Edoxaban is recommended, within its marketing authorisation, as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary embolism in adults. The Committee concluded that edoxaban could be recommended as a cost-effective use of National Health Service (NHS) resources.”

Once daily edoxaban is initiated after a five-day lead in with heparin treatment, in line with current clinical practice. In the pivotal Hokusai-VTE study, edoxaban was shown to have proven efficacy and a significantly better bleeding profile than well-managed warfarin.

Dr Alexander Cohen, Consultant Vascular Physician from Guys and St Thomas Hospitals, Kings College London, who has researched edoxaban for VTE, welcomed an additional resource to tackle the condition. He said: “No two patients are identical and what suits one may not suit another. Venous thromboembolism has a high rate of recurrence, which can be fatal. We need more tools to protect patients from a second incident and edoxaban will be of great use to doctors to help tailor treatments to specific patients.”

Dr Simon Clough, UK Managing Director for Daiichi Sankyo, which manufactures the drug, said: “We are very pleased to be able to offer patients and doctors in England and Wales a new and convenient-to-use alternative in the treatment armoury against VTE. It is gratifying that NICE has found our therapy to be clinically effective and cost effective shortly after receiving our European authorisation.”

According to NICE, there are about 83,500 new cases of VTE each year in England. This equates to approximately one case per 500 people (200 cases per 100,000). In addition to new annual cases, there is another group of about 42,000 patients needing long-term anticoagulation treatment.