NICE has recommended the use of Eliquis (apixaban) as a treatment option for the NHS for the prevention of stroke and systemic embolism in some people with non-valvular atrial fibrillation (AF) in final guidance.

The recommendation came after NICE’s Appraisal Committee concluded Eliquis was more clinical effective than warfarin in reducing stroke and systemic embolism.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said that patients would benefit using the convenient treatment “because it doesn’t require such regular monitoring and dose adjustments.”

Eliquis, which only received its license for this indication in November 2012, is an orally administered anticoagulant that helps prevent the blood from clotting.

AF is the most common irregular heart beat. People with the condition are at a higher risk of developing blood clots and subsequent stroke. Existing therapies, such as warfarin, substantially reduces the risk of 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,” said Professor Longson.

“From the evidence submitted, the Committee concluded that Eliquis was more clinically effective than warfarin for the primary efficacy outcome of reducing stroke and systemic embolism. The Committee also noted that treatment with Eliquis 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.”

The Scottish Medicines Consortium (SMC) has accepted Eliquis (apixaban) for prevention of strokes in patients with atrial fibrillation (AF).

The drug, produced by Pfizer and Bristol-Myers Squibb (BMS), has also been provisionally recommended by NICE.

Its use in Scotland with AF patients over 40 is predicted to prevent nearly 1,000 strokes and over 300 deaths per year.

Following its EMA approval in November 2012, the SMC has accepted Eliquis for prevention of strokes in patients with non-valvular AF who have one or more risk factors (e.g. hypertension, diabetes).

Based on recent clinical trials, the SMC said Eliquis was superior to warfarin in preventing strokes and was associated with fewer major bleeds.

It also requires no monitoring and dosage adjustment, thus reducing the cost of treatment and avoiding the risks associated with poor monitoring.

AF affects over 60,000 people in Scotland over the age of 40. It causes a fivefold increase in stroke risk, resulting in 7% of all strokes. Strokes due to AF are more severe, and more likely to recur, than strokes with other causes.

Difficulties in setting the dosage of warfarin, the standard anticoagulant, mean that fewer than half of Scottish AF patients at high risk of stroke are receiving it.

Dr Derek Connelly, Consultant Cardiologist at the Royal Infirmary, Glasgow, said: “The SMC acceptance of apixaban is an important step forward for patients with atrial fibrillation in Scotland. The availability of a new treatment option that does not require [clotting time] monitoring may help decrease the impact atrial fibrillation has on the quality of life of patients, their families and carers.”

According to Amadou Diarra, BMS General Manager, UK and Ireland, the risk of stroke in patients with non-valvular AF is “a serious public health concern” that Eliquis can help to address.

NICE has provisionally recommended Eliquis in the same indication, with final guidance expected shortly.

The alliance between BMS and Pfizer to develop drugs against cardiovascular disease began in 2007.

The Atrial Fibrillation Association has welcomed NICE’s recommendation in final draft guidance of Eliquis (apixaban) for the prevention of stroke and systemic embolism in certain people with non-valvular atrial fibrillation.

NICE’s independent Appraisal Committee concluded the convenient drug was more clinically effective than warfarin and resulted in fewer bleeding events.

Trudie Lobban MBE, founder and CEO of the charity Atrial Fibrillation Association, said NICE’s decision is “excellent news for patients” with AF in England and Wales.

Eliquis’ recommendation follows the recent recommendations by the Institute of Xarelto (rivaroxaban) and Pradaxa (dabigatran etexilate) for the same indication.

“Having the choice of effective new treatments which do not require INR monitoring can help reduce the impact that atrial fibrillation has on patients, their families and carers,” said Trudie Lobban.

Final draft guidance states that Eliquis can be considered a treatment option on the NHS in accordance with its licensed indications if informed discussions about the risks and benefits of the drug compared with warfarin, Xarelto and Pradaxa are conducted.

Eliquis, which only received its license for the indication in November 2012, is co-marketed by Bristol-Myers Squibb and Pfizer.

Amadou Diarra, Vice-President, BMS UK and Ireland, said the “fast-tracked recommendation” by NICE highlights the value of the drug as a cost-effective treatment. “We look forward to working with the NHS and other partners to ensure that, where clinically appropriate, patients are provided with rapid access to apixaban, which has been shown to prevent strokes, reduce bleeds and be potentially life-saving compared to the current standard of care, warfarin.”

A new drug for stroke prevention that offers a safer and more effective alternative to warfarin has been launched in the UK.

Eliquis (apixaban) from BMS and Pfizer is available for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors such as diabetes or advanced age.

Whereas patients treated with warfarin risk serious side-effects and need frequent dosage adjustment, Eliquis is taken (in tablet form) in one of two approved doses.

AF affects 1.2 million people and causes 12,500 strokes every year in the UK.

Clinical trials have shown that Eliquis is more effective than warfarin in preventing strokes and causes less bleeding, as well as presenting less challenge in terms of monitoring.

The ARISTOTLE trial evaluated apixaban versus warfarin in 18,201 patients with non-valvular AF who were suitable for warfarin. Professor John McMurray of the Institute of Cardiovascular & Medical Sciences, University of Glasgow, said that in the study “apixaban has demonstrated superiority in the reduction of stroke and systemic embolism over warfarin together with a significant reduction in major bleeding.”

In addition, he noted, “apixaban was better tolerated than warfarin, with fewer people stopping treatment.”

Trudie Lobban, CEO of the Atrial Fibrillation Association, added: “Patients being treated with warfarin have to undergo regular blood tests. Having the choice of effective new treatments which do not require monitoring provides the option to tailor therapy to the individual patient.

“This could also help to reduce the burden on the NHS to monitor INR and the associated impact on patients, their families and carers.”

BMS developed Eliquis, and since 2007 has worked in partnership with Pfizer to promote and sell the drug.

A new drug for stroke prevention that offers a safer and more effective alternative to warfarin has been launched in the UK.

Eliquis (apixaban) from Bristol-Myers Squibb (BMS) and Pfizer is available for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors such as diabetes or advanced age.

Whereas patients treated with warfarin risk serious side-effects and need frequent dosage adjustment, Eliquis is taken (in tablet form) in one of two approved doses.

AF affects 1.2 million people and causes 12,500 strokes every year in the UK.

Clinical trials have shown that Eliquis is more effective than warfarin in preventing strokes and causes less bleeding, as well as presenting less challenge in terms of monitoring.

The ARISTOTLE trial evaluated apixaban versus warfarin in 18,201 patients with non-valvular AF who were suitable for warfarin. Professor John McMurray of the Institute of Cardiovascular & Medical Sciences, University of Glasgow, said that in the study “apixaban has demonstrated superiority in the reduction of stroke and systemic embolism over warfarin together with a significant reduction in major bleeding.”

In addition, he noted, “apixaban was better tolerated than warfarin, with fewer people stopping treatment.”

Trudie Lobban, CEO of the Atrial Fibrillation Association, added: “Patients being treated with warfarin have to undergo regular blood tests. Having the choice of effective new treatments which do not require monitoring provides the option to tailor therapy to the individual patient.

“This could also help to reduce the burden on the NHS to monitor INR and the associated impact on patients, their families and carers.”

BMS developed Eliquis, and since 2007 has worked in partnership with Pfizer to promote and sell the drug.

The FDA has delayed making a decision on whether to approve the use of Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

Further data supplied by Pfizer and Bristol-Myers Squibb on patient trials after the original application will take an additional three months to review, the Agency has said.

Pfizer and BMS said in a joint statement they will continue to work closely with FDA during the review period.

Eliquis is not yet approved in any country for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

It faces competition from Boehringer’s Pradaxa (dabigatran) and J&J’s Xarelto (rivaroxaban) for the indication.

Industry analysts predict all three have the potential to become ‘blockbuster’ brands as doctors and patients search for an alternative to warfarin.

Eliquis was approved in May 2011 by the European Union as a treatment option for the prevention of blood clots in patients who have undergone hip or knee replacement surgery.

BernsteinResearch analyst Dr Timothy Anderson forecasts total sales of Eliquis to reach $395 million this year, rising to $2.5 billion in 2015 and $3.7 billion by 2020.

Eliquis (apixaban) has been recommended in final NICE guidance as a treatment option for the prevention of venous thromboembolism (VTE) in adults who have undergone planned total hip replacement or total knee replacement surgery.

The treatment, which was launched in the UK in September 2011, was fast-tracked by NICE after the convenient drug was proven to help prevent blood clots.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says that Eliquis “has been shown to be a clinically and cost effective option”.

Hip and knee replacement surgery has a high risk of VTE developing and patients require effective treatment to prevent potentially fatal clots forming. Without the use of suitable medication, the incidence of deep vein thrombosis ranges from 41% to 85% after elective knee surgery and to 42% to 57% after elective hip surgery.

“VTE is often difficult to spot because patients may not always have symptoms to give a warning,” said Professor Longson. “Even if a blood clot does not come loose, it can still cause long-term damage to the veins – for example, ‘post-thrombotic syndrome’ may develop up to two years following DVT, causing chronic swelling and ulceration of the legs. We are therefore pleased to be able to recommend its use (Eliquis) in the NHS in England and Wales alongside other effective treatments already approved by NICE.”

Eliquis was also approved for the same indication by The Scottish Medicines Consortium (SMC) in December 2011.

Eliquis (apixaban), an oral drug from Pfizer and Bristol-Myers Squibb for the prevention of venous thromboembolism (VTE) in acutely ill patients, has failed to meet the required endpoint in a Phase 3 clinical study.

In the ADOPT trial, Eliquis did not meet the primary efficacy outcome of superiority to enoxaparin in preventing VTE and VTE-related death.

Eliquis performed 13% better than enoxaparin in preventing VTE events, which was not statistically significant, over 30 days.

Major bleeding, a key safety outcome, occurred more often with Eliquis than with enoxaparin but had a low frequency (0.47% and 0.19% respectively) in both groups.

VTE encompasses two dangerous events: pulmonary embolism and deep vein thrombosis (which can lead to pulmonary embolism).

Eliquis, an anticoagulant, is a direct factor Xa inhibitor and is currently approved in the EU for the prevention of VTE in adult patients who have undergone hip or knee replacement surgery.

ADOPT (Apixaban Dosing to Optimise Protection from Thrombosis) was a Phase 3, international, multi-centre, randomised, double-blind, controlled study comparing apixaban with enoxaparin in acutely ill patients.

Over 30 days, VTE events occurred in 2.71% of patients in the Eliquis group and 3.06% of patients in the enoxaparin group. Overall, the outcomes for both patient groups were similar.

Dr. Samuel Z. Goldhaber, senior cardiologist at Brigham and Women’s Hospital, commented: “ADOPT provides important insights for clinical trialists designing studies of extended duration VTE prophylaxis among medically ill hospitalised patients.

“Solving the problem of VTE post-hospitalisation remains a critical unmet need in preventing medically ill patients from developing deep vein thrombosis and pulmonary embolism.”

Eliquis has been co-developed by Pfizer and Bristol-Myers Squibb since 2007, following its discovery by BMS.

A convenient oral treatment patients can take at home to prevent venous thromboembolic events (VTE) following elective total hip or knee replacement surgery is now available in the UK.

Eliquis (apixaban) has been launched through a collaboration between Bristol-Myers Squibb and Pfizer and could help prevent up to 25,000 deaths each year resulting from blood clots.

Dr Ander Cohen, Honorary Consultant Vascular Physician at King's College Hospital, London, says the treatment “represents a new option” for surgeons in the UK.

VTE can lead to two serious conditions: deep vein thrombosis and pulmonary embolism which can lead to death if not treated.

The license of Eliquis is based on the ADVANCE-2 and ADVANCE-3 clinical trials in patients who underwent elective total hip or knee replacements. More than 8,000 patients were assessed during the trials which assessed the efficacy in preventing blood clots and death, and bleeding risk of Eliquis when compared to enoxaparin.

“Clinical data showed that apixaban was more effective than the anticoagulant enoxaparin and importantly, it also showed no increase in bleeding rates compared to enoxaparin,” said Dr Cohen.

Dr Rick Lones, UK Executive Medical Director, BMS, said the two companies “hope to reduce the burden of blood clots” in patients undergoing major surgery after the drug’s release in the UK.