Bristol-Myers Squibb and Pfizer have announced that the National Institute for Health and Care Excellence (NICE) has published final guidance recommending the use of Eliquis (apixaban) as an option for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adults. As part of the 90-day implementation plan, the National Health Service (NHS) now has three months for apixaban to be made available to patients in England and Wales whose doctors believe it is a clinically appropriate treatment for them.
The guidance means that doctors now have access to an additional NICE-appraised treatment option for venous thromboembolism (VTE), an umbrella term that covers DVT and PE and causes an estimated 60,000 deaths in the UK each year, many of which are preventable.
The guidance follows European Commission approval for this indication in July 2014 and is based on results from two pivotal phase III studies, AMPLIFY and AMPLIFY-EXT, which evaluated the efficacy and safety of apixaban in patients with VTE.
The six-month AMPLIFY trial showed non-inferiority of apixaban (10mg twice daily orally for seven days followed by 5mg twice daily orally) versus standard anticoagulant therapy (low molecular weight heparin in combination with a vitamin K antagonist) for the treatment of DVT and PE with a lower rate of major bleeding.
In the 12-month AMPLIFY-EXT study, apixaban (2.5mg twice daily orally) demonstrated superior efficacy versus placebo for the prevention of recurrent DVT/PE with a similar major bleeding profile to placebo in patients who had completed six to twelve months of anticoagulant treatment for DVT and/or PE and for whom there was clinical equipoise regarding the continuation or cessation of anticoagulation therapy.
“Ongoing treatment for the prevention of recurrent DVT and PE is a balance between reducing the risk of recurrence with the risk of bleeding associated with anti-coagulation treatment” said Rick Lones, medical director, UK, BMS. “Apixaban offers a further treatment choice for these patients, with a licensed dose that is lower for the prevention of recurrent DVT and PE than for initial treatment of DVT and PE”.
“Additionally, apixaban may help to simplify treatment for VTE, because unlike the current standard of care for VTE treatment, it does not require initial injections or frequent blood tests to monitor International Normalised Ratio levels, with no known dietary restrictions and few drug-drug interactions vs vitamin K antagonists.”