The Atrial Fibrillation Association has welcomed NICE’s recommendation in final draft guidance of Eliquis (apixaban) for the prevention of stroke and systemic embolism in certain people with non-valvular atrial fibrillation.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Final draft guidance states that Eliquis can be considered a treatment option on the NHS in accordance with its licensed indications if informed discussions about the risks and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.”

The European Medicines Agency (EMA) has requested a label update to provide clearer guidance on the safe use of the anticoagulant Pradaxa (dabigatran).

The review has confirmed the drug’s positive benefit-risk balance as a stroke prevention treatment for certain patients, but stated the need for clearer notes on the medicine’s risks and what to do in case of bleeding.

The Boehringer Ingelheim drug is recommended for patients with non-valvular atrial fibrillation or following hip or knee replacement.

Because all blood-thinning drugs can cause bleeding, the EMA has maintained close post-market surveillance of this product.

The EMA’s scientific advisory committee, the CHMP, found that the incidence of fatal bleedings with Pradaxa in post-marketing data was significantly lower than in the clinical trials that led to the drug’s authorisation in 2008.

In November 2011, a safety review concluded that the drug should be used with caution, and at lower doses, with patients who were elderly or had moderate renal impairment.

Pradaxa “remains an important alternative to other blood-thinning agents,” the EMA said.

However, the guidance for doctors and patients should be strengthened to include details of the risks, when the drug must not be used, and how to manage patients if bleeding occurs.

In particular, patients taking Pradaxa should seek urgent medical attention of they fall or suffer any injury.

The European Commission is expected to confirm this opinion.

NICE has recommended Xarelto (rivaroxaban) in final guidance as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF).

The recommendation means patients will get access to the first single tablet, once-daily, oral stroke prevention medicine since the introduction of warfarin in the 1950s

Luis-Felipe Graterol, Medical Director, Bayer HealthCare UK, said the company is “delighted” with NICE’s decision and will now work with local NHS fundraisers to “help evolve services” with Xarelto.

Up to 700,000 people in England and Wales have AF. People with the condition are at a higher risk of developing blood clots and subsequent stroke.

Xarelto is an orally administered drug that helped prevent blood from clotting and has a UK marketing authorisation for the prevention of stroke and system embolism in those with non-valvular AF who have associated risks.

The guidance adds that the decision to swap treatment from warfarin to Xarelto should be discussed between the clinician and patient to highlight any reported risks and benefits.

“We know that some people taking warfarin can find it difficult to maintain their blood clotting at a proper level,” said Professor Carole Longson, NICE Health Technology Evaluation Centre Director. 

“Rivaroxaban, like dabigatran etexilate, which NICE recently approved as an option for this indication, can benefit people with AF. We are therefore pleased to recommend rivaroxaban as another cost-effective option for the prevention of stroke and systemic embolism in people with atrial fibrillation.”

NICE recommended Boehringer Ingelheim’s Pradaxa as a treatment option in final guidance for the same indication back in March.

Boehringer Ingelheim’s anticoagulant Pradaxa (dabigatran etexilate) has been shown by a phase III clinical trial to be safer than warfarin, the standard stroke prevention drug.

The global 18,000-patient RE-LY trial showed significantly lower rates of fatal and traumatic intracranial haemorrhage (ICH) in patients treated with Pradaxa rather than with well-controlled warfarin.

The new findings suggest that Pradaxa may offer an alternative to warfarin in patients with atrial fibrillation (AF), easing the burden of dosage adjustment.

AF is experienced by one in four adults over the age of 40, and is a major risk factor for strokes. Anticoagulation therapy is widely used as a preventative measure – but ICF is a widespread side-effect, causing disability and death.

Warfarin (first introduced in 1948 as a rodent poison) is the standard treatment for prevention of strokes. However, very careful dosage adjustment is needed to minimise the risk of ICF.

The RE-LY trial evaluated 154 intracranial haemorrhages that occurred in 153 patients during the trial period, comparing the effects of Pradaxa and well-controlled warfarin:

• Pradaxa 110mg and 150mg doses were associated with significantly fewer fatal ICH events (11 and 13 respectively vs. 32) than warfarin.

• Pradaxa was associated with significantly fewer traumatic ICH events (11 vs. 24) than warfarin.

• The rate of ICH with Pradaxa was similar to the rate in patients receiving antiplatelet therapy.

Dr Stuart Connolly, Director of the Division of Cardiology at McMaster University, Hamilton, Ontario, said: “In our hospital, we see patients frequently presenting with intracranial haemorrhage as a result of warfarin and unfortunately, this complication is associated with a high mortality rate.

“These data show us that not only is Pradaxa associated with lower rates of intracranial haemorrhage overall, but that fatal and traumatic intracranial bleeding is also reduced, highlighting the favourable safety profile of Pradaxa.”

Bayer HealthCare’s Xarelto (rivaroxaban) has been recommended in final draft guidance as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF).

NICE revised its original decision not to recommend the convenient pill after Bayer supplied requested additional evidence on the clinical and cost effectiveness of the medication.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said she was “pleased” additional information had been supplied enabling NICE to recommend the treatment.

It is estimated there are currently up to 700,000 people with AF in England and Wales. People with the condition are at a higher risk of developing blood clots and subsequent stroke.

However, the risk of stroke can be reduced by the appropriate use of antithrombotic therapy. Xarelto is the first in a class of drugs known as Factor Xa inhibitors, which act at a critical point in the blood-clotting process to prevent clots forming.

It has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients with non-valvular AF who have one or more risk factors and has been demonstrated in a clinical study to be non-inferior to warfarin, the current standard of care.

Professor John Camm, Professor of Clinical Cardiology at St George’s University of London, welcomed its recommendation. He said: “This news could be particularly important for patients who require long-term or lifelong anticoagulation (for non-valvular AF) who may be seeking a simplified regimen.”

Final guidance is now expected as early as next month.

NICE recently published final guidance recommending the use of Pradaxa (dabigatran) – which recently had its UK price reduced by Boehringer Ingelheim – for the same indication.

Boehringer Ingelheim has reduced the UK price of its oral anticoagulant Pradaxa (dabigatran etexilate) by 13%, two weeks after receiving NICE recommendation.

While NICE had judged Pradaxa to be cost-effective for stroke prevention in patients with atrial fibrillation (AF) at £2.52 per day, the new price of £2.20 will increase its appeal to prescribers.

The timing of the price change reflects growing industry awareness that NICE approval is only a step on the way to meeting the value criteria of the NHS.

The final NICE guidance recommended that Pradaxa be considered for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors, a potential 900,000 people.

The price drop will help to drive access to the first new oral anticoagulant for stroke prevention in patients with AF in 60 years.

According to a recent BMJ report, drug therapy for stroke prevention in patients with AF is sub-optimal in many cases. Up to 30% receive no treatment, a significant proportion of those treated with warfarin are not well controlled, and treatment with aspirin is not adequate.

There is therefore a large unmet need for effective stroke prevention treatment in these patients, whose risk of stroke may be significantly reduced by Pradaxa.

Duncan Cantor, Boehringer’s Director of Communications, said: “We are committed to working with the NHS to offer the very best value we can. Although NICE deem Pradaxa to be cost effective at £2.52 per day, we believe it is important to make our medicines as affordable as possible in this tough financial climate.

“By lowering the price by 13% to £2.20, the NHS now has every opportunity to make sure this medicine is available to all eligible patients.”

NICE has recommended the use of Pradaxa (dabigatran) as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF) in final guidance.

The treatment is the first new oral-anticoagulant in nearly 60 years to be recommended after NICE concluded it was more effective than warfarin.

Boehringer Ingelheim called the appraisal a “landmark decision”.

The recommendation comes after a failed appeal on the draft guidance by NHS Salford who argued that NICE had failed to act fairly and had exceeded its powers.

It claimed NICE had underestimated the likely use of Pradaxa and that its recommendation would require a design overhaul of anticoagulant services at a PCT level.

But its objections were dismissed on all points by an independent Appeal Panel chaired by NICE’s chair Professor Sir Michael Rawlins.

The guidance recommends Pradaxa as a treatment option in accordance with its licensed indications, and that treatment should start after an informed discussion about its risks and benefits compared with warfarin.

Pradaxa has a UK marketing authorisation for the prevention of stroke and systemic embolism in adults with nonvalvular AF who have previously suffered a stroke, transient ischaemic attack or systemic embolism and other heart related problems. It is also authorised for those aged 65 years old or over with AF who have diabetes, coronary heart disease or hypertension.

It’s estimated that there are around 700,000 people with AF in England and Wales. Boehringer believes that the use of Pradaxa twice daily has the potential to prevent around 530 more strokes per 100,000 compared to warfarin. And, if all eligible patients received Pradaxa twice daily, it could prevent up to 5,000 strokes and save the NHS up to £59 million in the first year of use.

Charles De Wet, Medical Director at Boehringer Ingelheim, said “We are committed to sharing value and our priority and commitment now is to work closely with the Trusts to ensure dabigatran is accessible to all eligible patients on the NHS and appropriately prescribed by clinicians”.

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.

Health authorities will be forced to prescribe patients with treatments recommended by NICE instead of cheaper alternative generics, Health Secretary Andrew Lansley has said.

The move is an attempt to end current ‘postcode prescribing’ and to prevent a number of PCTs ‘blacklisting’ expensive treatments such as Lipitor and Crestor.

Mr Lansley promised MPs that he would introduce an “effective compliance regime” to prevent cheaper alternatives being prescribed to patients who need them the most.

PCTs have been ‘blacklisting’ expensive branded treatments preventing doctors from prescribing them in an attempt to save money. Health authorities have favoured cheaper generic alternatives, despite research demonstrating these to be less effective and producing more side effects.

A study involving patients that switched from Lipitor to a generic simvastatin found that dangerous ‘bad’ levels of cholesterol increased by five to six per cent.

An additional survey last year revealed that at least 14 different treatments which had been recommended by NICE had been ‘blacklisted’. These include Plavix and Pradaxa.

Speaking in the House of Commons, Mr Lansley said patients would be able to receive recommended treatments regardless of where they lived. “We will make certain that where NICE gives a positive appraisal for medicine that it is automatically included,” said the Health Secretary.

“We will establish an effective compliance regime on NICE appraisals and establish a new NICE implementation collaborative to make it happen.”

More effective diagnosis and treatment of atrial fibrillation (AF) is needed to prevent an ‘epidemic’ of strokes, according to a new report from the Atrial Fibrillation Association (AFA) and AntiCoagulation Europe.

The health charities noted that AF affects 1 in 4 people in the UK and causes 45% of embolic strokes, but only 18% of AF patients in the UK receive drug therapy that could help to prevent stroke.

Better use of anticoagulants such as Pradaxa could help to prevent many of the 12,000 strokes caused by AF in the UK every year, the AF Report said.

The report warned that the incidence of AF is expected to more than double in the next 40 years – leading to a major increase in the frequency of embolic strokes (caused by blood clots), the most damaging type of stroke.

To prevent a stroke ‘epidemic’, the report said, a number of measures are necessary, including:

• a targeted programme of routine pulse checks by GPs

• equal access to AF treatments and services, regardless of location

• improved GP awareness of the need for patient education and appropriate referral, supported by a public education programme

• support for research into the causes, prevention and treatment of AF.

The AFA has launched a public-access website at www.afstrokerisk.org, enabling people diagnosed with AF to assess their risk of stroke by answering simple questions.

“The detection of AF and subsequent prevention of stroke with appropriate anticoagulant treatment must be a key priority in health services,” said Eve Knight, CEO of AntiCoagulation Europe. “If existing guidelines were followed, then many more at-risk AF patients would receive the life-saving anticoagulation that they need.

“With the addition of routine pulse checks we could revolutionise detection and management of AF.”