Final draft guidance from NICE recommends Xarelto (rivaroxaban) to treat pulmonary embolism (PE) and deep vein thrombosis (DVT) and prevent their recurrence.

The Bayer drug offers an alternative to warfarin, the standard treatment for dangerous internal blood clotting.

Xarelto presents fewer dose management challenges than warfarin, and has fewer interactions with other drugs and with foods.

DVT, an abnormal blood clot formation in the leg or pelvis, can lead to PE and other dangerous circulatory malfunctions that cause disability or death. Risk factors for DVT include prolonged travel and/or immobility.

Suspected PE is treated with an anticoagulant, usually initial injections of heparin followed by longer-term oral doses of warfarin. However, warfarin presents complex dose adjustment challenges and can interact dangerously with other medications and with foods.

NICE determined that Xarelto was cost-effective both as a treatment for PE and DVT over three, six or 12 months and as a lifelong treatment to prevent the recurrence of PE or DVT.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “The regular monitoring and dose adjustment needed with warfarin, which needs regular visits to hospital or GP appointments, can be costly and inconvenient. Also, because warfarin has many drug interactions, it may be unsuitable for people with comorbidities. In addition, the Committee heard that warfarin has various food interactions which often require people to adjust and monitor their diet.

“Rivaroxaban therefore represents a significant potential benefit for people with PE and DVT because it avoids the need for initiation with heparin and the subsequent transition to warfarin.”

Final NICE guidance is expected in May 2013.

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.

Widely prescribed drugs including insulin, warfarin and aspirin are less effective in patients who take herbal medicines and dietary supplements.

A systematic review of relevant studies showed that popular OTC products such as St John’s wort and magnesium and calcium supplements interact with many prescribed drugs.

The researchers have recommended that GPs find out and record any OTC medicine use by patients for whom they are prescribing.

The review covered 85 studies of interactions between prescribed medicines and herbal medicines or dietary supplements, finding 882 distinct interactions.

The prescribed drugs with the greatest number of reported interactions were warfarin, insulin, aspirin, digoxin and ticlopidine.

The herbal medicines and supplements with the most interactions were St John’s wort, magnesium, calcium, iron and ginkgo – found to interact with 147, 102, 75, 71 and 51 prescribed drugs respectively.

In 42% of cases, the drug interaction was caused by the OTC product altering the pharmacokinetics of the prescribed drug.

Where the interaction meant an outright contraindication (25% of cases), the most frequent involved treatments for gastrointestinal disorders (16.4%), followed by neurological disorders (14.5%).

Professor Edzard Ernst of the University of Exeter said: “We have to become vigilant and finally agree to monitor this sector adequately. Each individual doctor can contribute to this process by routinely including questions about alternative medicine use.”

Selling medicines in today’s marketplace should be built on partnership principles. ABPI CEO Stephen Whitehead talks exclusively to Pharmaceutical Field about the importance of NHS/industry partnerships.

Back in 2009, Chris Brinsmead – then President of the ABPI – told Pharmaceutical Field that the future role of the pharma field force would be to facilitate partnerships between the NHS and industry. Three years later and the partnership agenda is slowly inching forward. Progress has been made, but adoption of a more collaborative approach across the country has been variable. As ever, there are early adopters, and those that wait. Last month, Pf led with an ABPI announcement that predicted the NHS and industry would ‘become partners within 3-5 years’. Why not now, came the familiar cry? Why not, indeed. The ABPI seems determined to address this.

This month, Pf spoke exclusively to Stephen Whitehead as he approached the first anniversary of his tenure as CEO at the ABPI. It is clear that, in challenging times for the UK industry as it battles to ensure that patients gain access to life-changing medical innovations, partnership sits at the heart of the ABPI agenda.

“There is a currently a big commitment to move the joint working agenda forward,” says Stephen. “Strategically, over the past 15 years there has been the emergence of many different influences on prescribing – NICE, local commissioning and local formularies are obvious examples. The industry now has to work with a wide variety of stakeholders to demonstrate the value of its medicines. And traditional sales representatives have to work with many different and more complex audiences than they used to when they were purely detailing. Increasingly, I think joint working is the vehicle best suited to satisfy these varying demands.”

Innovation Health and Wealth
The environment for a more collaborative approach is certainly improving. The Innovation Health and Wealth review last December reiterated the need for greater partnership working to help accelerate the adoption and diffusion of innovation in the UK. Crucially, it said that the NHS needed to be ‘open for business’ on partnership. As such, advocates from both parties are working hard to raise the profile (and the benefits) of the approach. But resistance and misunderstandings around joint working remain.

“One of the problems is that there are variable definitions and understandings of what joint working is,” says Stephen. “In simple terms, joint working is a partnership approach focused on solving a patient-driven issue. The industry has disease expertise, it knows how to manage conditions and has developed medicines in those areas. Joint working is about bringing that expertise together with the providers and focusing on patient outcomes. And often we can find cost savings in delivering those outcomes as well.”

Importantly, says Stephen, joint working is not sponsorship. “This is not about industry paying for something. Historically we have funded a lot of things and sometimes there is a real benefit to us bringing money to the table. But this is about changing that perception. Partnership is where two parties, with different strengths and weaknesses, come together to focus on a shared goal. In this case, that has to be patient care.

“The fundamental issue is about recognising the value of innovation and its implications for a pathway of care. By working together to find out how these medicines can be used appropriately, we can save money in the system, we can prevent unnecessary and costly hospitalisation and we can improve patient care.”

Medicines in the middle
In recent years, discussion has focused on whether UK pharma companies should reconsider their product-centric approach to customer engagement, and concentrate instead on developing services with the NHS. The caveat being that a specific medicine would form the core part of any service. But joint working is not an exact science. There is no one-size-fits-all solution – it’s simply about working together to establish the most appropriate approach in a given disease area. “It’s about products and services,” says Stephen. “Some of our members do offer services. But the way I look at joint working is that there is always a medicine in the middle of it – because that’s what we discover, develop and sell. In today’s environment, the only way that the value of that medicine can be truly realised is through joint working that reengineers the pathway of care.”

At present, most joint working initiatives are being built around new innovations – and are being used to redesign services and improve the care pathway. A good example of this is in the field of anticoagulants, where a number of new brands are coming to market. “The new class of drugs have gone through NICE have been recommended and should therefore be utilised,” says Stephen. “Old warfarin clinics should now be closing as patients move onto the new drugs. But to achieve that, and to free up the funds to be able to use the new innovations, we need to take other measures. And you can only do that, in my view, through joint working.

“It is my passionate belief that in most cases, innovative medicines will save money in the system – in the short, medium and long term. We simply need to work together to deliver it.”

Implications for pharma sales
The implications for pharmaceutical sales professionals are significant. While joint working is not always appropriate – aspects such as disease area or where a particular product is along its lifecycle are key factors in whether the approach is applicable – adopting a partnership approach most certainly is. “Joint working is a natural evolution of partnership principles,” says Stephen. “Industry engagement has changed from being a simple seller/buyer transaction, into seeking to work in partnership with customers to ensure the NHS properly maximises the value of medicines. The UK has a low price and a slow uptake of medicine – and as a consequence, the UK system is not as efficient as it could be. It would be more efficient if it adopted innovation more quickly. And if it did, we would certainly have better patient outcomes.

“Joint working is best used when you want to coax the system into innovation. It is not always the most appropriate approach. But whatever you have in your medicine chest, partnership is always applicable. In today’s marketplace, how you approach selling that medicine should always be built upon partnership principles.”

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.

One UK patient in six is affected by incorrect GP drug prescriptions each year, according to a General Medical Council review.

The most common type of error was incomplete information, followed by dosage errors and the timing of doses.

The GMC recommended that GP consultations be extended from 10 to 15 minutes, and called for improvements in checking and better use of IT.

The study examined 6,046 prescription items for 1,777 patients. It found that 1 in 20 were incorrectly prescribed or monitored, amounting to at least one error per year for 18% of patients.

Risk factors for prescription errors included age (over 65 or under 15) and multiple prescription items, as well as the following therapy areas: cardiovascular, infection, cancer, immunosuppression, musculoskeletal, eye, skin and ENT.

Only 4% of prescription items were associated with a ‘severe’ error, and it was noted that pharmacy staff would have corrected many of the minor errors.

The ‘severe’ errors included patients being given drugs they were allergic to, and poor monitoring of potentially dangerous drugs such as warfarin.

The report concluded that “prescribing errors in general practices are common, although severe errors are unusual.”

Katherine Murphy of the Patients’ Association commented: “It is deeply worrying that such dangerous mistakes are being made. Patient safety is paramount yet still these avoidable errors are slipping through the net.”