On 23 January, the UK’s National Institute for Health and Clinical Excellence (NICE) issued a final draft guidance recommending apixaban (Eliquis, Bristol-Myers Squibb and Pfizer), in accordance with its licensed indications, for the prevention of stroke and systemic embolism in some people with non-valvular atrial fibrillation.
The draft guidance also recommends that the decision about whether to start treatment with apixiban should be made after an informed discussion about the risks and benefits of apixaban compared with warfarin, dabigatran etexilate and rivaroxaban, and in light of a person’s current level of international normalised ratio(INR) control if they are already taking warfarin.
Apixaban has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients with with non-valvular atrial fibrillation and one or more risk factors such as prior stroke or transient ischaemic attack, age 75 years or older, hypertension, diabetes mellitus, or symptomatic heart failure (New York Heart Association [NYHA] class 2 or higher).
Carole Longson, NICE Health Technology Evaluation Centre Director, said: “Atrial fibrillation can be a distressing condition and people with it have an increased risk of suffering a stroke. Many people with the condition find it difficult to comply with the most commonly used antithrombotic, warfarin, because, among other things, its use requires regular monitoring of the blood’s clotting properties and dose adjustments which can cause disruption and inconvenience. It also has multiple interactions with food, alcohol and drugs that can cause further inconvenience. The Appraisal Committee heard from patient experts that warfarin can have a greater impact on a person’s quality of life than atrial fibrillation itself. Apixaban, like rivaroxaban and dabigatran etexilate, which NICE recently approved as options for this indication, has potential benefits for people with AF in these circumstances because it does not require such regular monitoring and dose adjustments.
“From the evidence submitted, the Committee concluded that apixaban was more clinically effective than warfarin for the primary efficacy outcome of reducing stroke and systemic embolism. The Committee also noted that treatment with apixaban resulted in fewer bleeding events than warfarin, including a reduced rate of intracranial bleeding. The Committee recognised that intracranial bleeding has a high mortality rate and a large impact on a person’s quality of life, and is the most feared bleeding outcome for people taking any type of anticoagulant.”
NICE has not yet issued final guidance to the NHS. The Institute announded that registered consultees now have the opportunity to appeal the draft guidance. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments.
The final guidance is likely to be published in February 2013.
To access the final draft guidance click here.