In final guidance NICE has recommended that Pfizer and Bristol-Myers Squibb’s Eliquis, Bristol-Myers Squibb be funded by the NHS for certain patients to help prevent stroke.
Specifically the NHS drug pricing watchdog says that Eliquis (apixaban) is recommended in accordance with its licensed indications, as an option for the prevention of stroke and systemic embolism in some people with non-valvular atrial fibrillation.
But the guidance also recommends that the decision about whether to start treatment with Eliquis should be made after an informed discussion about the risks and benefits of the drug when compared with the established treatment warfarin, and its competitors Pradaxa, by Boehringer and Bayer/Janssen’s Xarelto.
Both of these drugs were available in the UK before Eliquis and have NICE’s backing, but Eliquis is believed to be more efficacious than warfarin, and could still do well despite coming to the market third. Analysts’ estimates put peak annual sales of the drug anywhere between $2 billion and $4 billion.
It should also be used in light of a person’s current level of international normalised ratio control, if they are already taking warfarin.
Commenting on NICE’s final recommendations, Professor 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 [Xarelto] and dabigatran etexilate [Pradaxa], 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.
Professor Longson continued: “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.”
Eliquis, which received its European license for this indication in November 2012, is an orally administered anticoagulant that helps to prevent blood from clotting. It does this by stopping a substance called Factor Xa from working. Factor Xa is necessary in the formation of thrombin and fibrin, the key components in blood clot formation.