Regulatory Focus™ > News Articles > NICE Green Lights New Drug for Atrial Fibrillation

NICE Green Lights New Drug for Atrial Fibrillation

Posted 28 February 2013 | By Louise Zornoza

The UK's cost containment agency, the National Institute for Health and Clinical Excellence (NICE), has issued final guidance recommending  the use of apixaban (Eliquis) by the National Health Service (NHS) for the prevention of stroke.

The product received EU-wide marketing approval on 21 November 2012, specifically for the prevention of stroke and systemic embolism in some people with non-valvular atrial fibrillation (AF) with one or more risk factors such as:

  • prior stroke or transient ischaemic attack
  • age 75 years or older
  • hypertension
  • diabetes mellitus
  • symptomatic heart failure.

The expedited clearance for the reimbursement of the innovative new drug is based on the significant therapeutic improvement that it provides to patients with AF.  The drug co-marketed by Pfizer and Bristol-Myers Squibb (BMS) not only is more effective than warfarin in preventing blood from clotting, but its use also results in fewer intracranial bleeding events, resulting in fewer deaths. 

Professor Carole Longson, Director at the Health Technology Evaluation Centre, commented that "many people with [AF] 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."

In addition, "Apixaban, like rivaroxaban anddabigatran etexilate, which NICE recently approved as options for this indication, has potential benefits for people with AF in these circumstances because it doesn't require such regular monitoring and dose adjustments," Longson said.

AF is the most common cardiac arrhythmia (irregular heart beat). It occurs when the electrical impulses controlling the heart rhythm become disorganized, so that the heart beats irregularly and, occasionally, too fast and so cannot efficiently pump blood around the body. People with AF are at higher risk of developing blood clots and subsequent stroke.

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