The National Institute for Health and Clinical Excellence (NICE) has published final draft guidance recommending Bristol-Myers Squibb/Pfizer's Eliquis (apixaban) as an option for the prevention of venous thromboembolism (VTE) in adults who have undergone planned total hip replacement or total knee replacement surgery.
Eliquis should be given shortly after surgery and for a few weeks after to help prevent VTE, says NICE, which points out that it has produced this final draft guidance just six months after Eliquis received its license for the prevention of VTE in patients who have undergone such surgery.
People having this type of surgery are at risk of VTE because of the nature of the trauma during surgery and because they need to remain inactive for a period of time after their operation, commented Professor Carole Longson, director of NICE's health technology evaluation centre.
She also noted that the Institute’s clinical guideline on reducing the risk of VTE recommends that people having elective hip replacement or elective knee replacement surgery should be offered low molecular weight heparin, Boehringer Ingelheim's Pradaxa (dabigatran etexilate), Bayer/Johnson & Johnson's Xarelto (rivaroxaban) or GlaxoSmithKline's Arixtra (fondaparinux) to prevent VTE.
Although Eliquis had only been directly compared with one of the options recommended by the clinical guideline - Sanofi's Lovenox (enoxaparin), a low molecular weight heparin - the Institute 's independent appraisal committee was satisfied that Eliquis "is a clinically and cost-effective option for preventing blood clots, alongside other effective treatments already recommended by NICE," it says.
The decision has been welcomed by Dr Rick Lones, UK executive medical director at Bristol-Myers Squibb, who said that it confirms the value of Eliquis "as a cost-effective oral anticoagulant for patients who have undergone elective total knee or total hip replacement surgery."
"It is an important step in helping to reduce the burden of thrombotic disorders by providing orthopaedic surgeons and their patients, in England and Wales, with another treatment option that offers oral administration, convenient for patients when they return home after surgery where their risk of clotting complications persists," he said.
During 2010, nearly 120,000 hip and knee replacements were carried out in England and Wales. As these procedures have a high risk of VTE, they require effective anticoagulation to protect patients from potentially fatal clots.
If there are no appeals against this draft recommendation, NICE is expected to publish its final guidance at the end of January.