NICE says 'yes' to new anticoagulant Lixiana

Daiichi Sankyo's new anticoagulant Lixiana should be available on the NHS in England and Wales for the treatment and prevention of recurrent blood clots in the legs and lungs, according to NICE.

The UK's cost-effectiveness agency issued final guidance this week backing the use of Lixiana (edoxaban) for deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults, two months after it was approved for marketing in the EU.

The latest endorsement by NICE follows draft guidance earlier this month backing the use of the drug to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF).

Lixiana is a once-daily selective Factor Xa inhibitor and is the fourth entrant in a relatively new category of novel oral anticoagulants (NOACs) that offer advantages over older drugs such as warfarin, including a reduced need for coagulation status monitoring.

The other NOACs available on the market are two other Factor Xa inhibitors – Johnson & Johnson/Bayer's Xarelto (rivaroxaban) and Bristol-Myers Squibb/Pfizer's Eliquis (apixaban) – as well as Boehringer Ingelheim's direct thrombin inhibitor Pradaxa (dabigatran). Lixiana was launched in the UK in July.

The drug commands a daily price of £2.10 – roughly in line with the other NOACs – although it may be subject to procurement discounts in some parts of England and Wales.

According to NICE, there are approximately 83,500 new cases of DVT and PE, known collectively as venous thromboembolism (VTE), each year in England, with another group of approximately 42,000 patients needing long-term anticoagulation treatment.

VTE is associated with considerable clinical burden related to recurrence and complications including post-thrombotic syndrome and pulmonary hypertension, and is often fatal.

There is a high rate of recurrence after a first VTE event, which is reduced with anticoagulant treatment. Without that, around half of patients will suffer another VTE within three months, according to Daiichi Sankyo.

"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," said Alexander Cohen of Guys and St Thomas Hospitals, Kings College London, who was involved in clinical trials of the drug in VTE.