Final draft guidance from NICE recommends Xarelto (rivaroxaban) to treat pulmonary embolism (PE) and deep vein thrombosis (DVT) and prevent their recurrence.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 devised six key statements for the management of people with a suspected or confirmed venous thromboembolic (VTE) disease in a draft quality standard.

Statements include: people with suspected VTE have diagnostic investigations within 24 hours of initial clinical suspicion and those with unprovoked VTE are offered cancer tests.

Dr Gillian Leng, Deputy Chief Executive and Director of Health and Social Care at NICE, said the draft quality standard “will contribute to improving the diagnosis and treatment” of people with VTE.

VTE diseases range from asymptomatic deep vein thrombosis (DVT) to fatal pulmonary embolism (PE). Latest figures estimate that around 1,000 per week are diagnosed with blood clots in their legs or lungs.

Additional statements advise that people with suspected DVT – where diagnostic investigations take longer than four hours – are offered interim therapeutic dose anticoagulation therapy. If an individual is suspected to have PE, they should be offered the same therapy when investigations take longer than an hour.

NICE is now inviting comments from stakeholders on the suggested statements. A final decision on the quality standard is expected in April next year.

NICE has recommended Bayer Healthcare’s convenient Xarelto (rivaroxaban) in final guidance as a treatment option for adults with acute deep vein thrombosis (DVT).

The positive recommendation sees Xarelto become the first non-VKA oral anticoagulant to be recommended for use on the NHS after it impressed in phase III clinical trials.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said the treatment is “a potential benefit for many people who have DVT”.

It is estimated there will be more than 46,000 cases of acute DVT in England and Wales this year, with that figure rising to 50,000 within the next four years.

Xarelto is orally administered, enabling patients to avoid the process of regular monitoring through blood tests, dosage adjustments and concerns over diets due to the existing treatment’s interaction with certain food groups.

Dr Gerry Dolan, Consultant Haematologist, Department of Haematology, Nottingham University Hospital, said the guidance provides patients with “an important new therapy choice”.

He added: “Xarelto is proven as an effective agent for DVT treatment which removes some of the challenging constraints of current standard therapy, and can help re-shape and improve anticoagulation services by reducing our reliance on regular coagulation monitoring.”

NICE has changed its original decision on the use of Xarelto (rivaroxaban) as an option for deep vein thrombosis (DVT) and preventing recurrent DVT and pulmonary embolism (PE).

The Institute now recommends Xarelto’s use in final draft guidance after Bayer supplied requested data on the long-term clinical and cost effectiveness of the treatment.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said the “additional information and analysis” convinced NICE’s Appraisal Committee.

Earlier this year in March, NICE issued draft guidance that failed to recommend Xarelto after concerns were raised about its use in the context of UK clinical practice.

However, Bayer supplied the requested information on patients who were assigned treatment durations of 3, 6 and 12 months and data on the drug’s cost effectiveness compared to existing options.

As a result, the Committee concluded that Xarelto is more clinically and cost effective than enoxaparin followed by a vitamin K antagonist for preventing recurrent VTE in people in whom treatment for up to 12 months is indicated.

There are believed to be more than 46,000 cases of acute DVT in England and Wales with that figure expected to rise to nearly 50,000 by 2016 due to the ageing population.

Xarelto was recently shortlisted for the globally acclaimed Prix Galien medal.

New innovations from ten of the world’s leading drug companies will compete for the most prestigious distinction in pharmaceutical research later this year – a globally revered Prix Galien medal.

Twelve medicines have made the shortlist for the final of UK Prix Galien, which will return to the House of Commons this coming September.

The shortlist reflects the strength and diversity of pharmaceutical innovation, with treatments for a broad range of disease areas set to be assessed by Prix Galien’s esteemed judging panel – led by NICE Chairman Professor Sir Michael Rawlins. Medicines developed to treat schizophrenia, hepatitis C, MS, DVT, constipation, coronary disease and a variety of cancers will battle it out for the Innovative Drug Award. A treatment for the rare bone cancer in adolescents, osteosarcoma, will be considered for the Orphan Drug Award. All shortlisted products were launched or granted a new indication in the UK between 1 January 2010 and March 31 2012.

The 2012 ceremony comes at a time when the value of medical innovation finds itself under great scrutiny in the UK. The Innovation Health and Wealth Review, published at the end of 2011, outlined the growing need to accelerate the adoption and diffusion of innovation in the NHS – setting out a blueprint designed to ensure innovations that can improve health outcomes actually reach their target patients.

“The challenge for the UK pharmaceutical industry is to demonstrate that its medicines truly add value, and can help the NHS meet its quality and productivity goals. The ethos of Prix Galien is very much aligned with the aspirations of both QIPP and Innovation Health and Wealth. It provides the perfect platform for the UK industry to promote its position as world leaders in pharmaceutical research and development,” says Karen Westaway, Joint Chief Executive at WG Consulting, which has owned the UK Prix Galien franchise for eight years and managed the process since 1996.

UK Prix Galien takes place every two years and is judged by a highly respected panel of influential, eminent and experienced NHS professionals. Alongside Professor Sir Michael Rawlins, the judging team includes experts such as Professor Dame Carol Black, Professor Parveen Kumar, Professor Gordon Duff and the current National Cancer Director, Professor Sir Michael Richards.

“The judges are all high-achieving, influential stakeholders who have shaped, and are still shaping, healthcare,” says Karen Westaway. “Their continued commitment to Prix Galien is itself an endorsement of the process.”

UK Prix Galien 2012

The 2012 ceremony will take place on Wednesday 26 September at the House of Commons, London. The Rt. Hon. Kevin Barron, MP, a former shadow health minister and chair of several all-party parliamentary groups including those relating to the pharmaceutical industry and health, takes over from Lord Walton of Detchant as the Parliamentary Sponsor. Current Secretary of State for Health, Andrew Lansley, is a long-standing supporter of UK Prix Galien and was the Parliamentary Sponsor for many years. The Health Secretary presented the most recent UK Prix Galien awards in 2010, describing them as a ‘fascinating occasion’ that allows people to acknowledge ‘the volume of innovation and new medicines that have been coming through.’

The 2010 Prix Galien medal for innovation was won by Xarelto (rivaroxaban), Bayer Healthcare’s revolutionary treatment for the prevention of venous thromboemolism (VTE). Shire Pharmaceuticals’ Firazyr (icatibant), a treatment for hereditary angioedema, won the Orphan Drug Award.

Prix Galien around the world

Prix Galien is internationally renowned, with a further ten national franchises conducting ceremonies around the globe, as well as an International Prix Galien every two years. The award has been described as ‘the highest distinction which may honour a pharmaceutical product’, and ‘a prestigious testimony and acknowledgement of the vitality of our pharmaceutical research.’ In 2008, US President Barack Obama said: “The Prix Galien is a welcome initiative to stimulate creative research and promote excellence.”

For more information about UK Prix Galien, please visit www.prixgalien.co.uk

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.

The European Commission has granted approval for two new indications in the UK for Bayer HealthCare’s Xarelto (rivaroxaban).

The oral anticoagulant has been approved for the prevention of stroke and non-CNS systemic embolism in adults with non-valvular atrial fibrillation (AF) and one or more risk factors for stroke and for the treatment of deep vein thrombosis (DVT).

AF, the most common sustained cardiac rhythm disorder, affects around 750,000 people in the UK. In England each year, more than 25,000 people die from DVT contracted in hospital.

Xarelto is already indicated in the UK to help prevent VTE in patients undergoing elective total hip or knee replacement surgery. It’s believed to have been used in more than 100,000 patients in the UK and has treated more than a million patients worldwide for this indication.

The latest indication for the prevention of stroke and non-CNS systemic embolism was based on the results from ROCKET AF trial which demonstrated consistent findings.

NICE Guidelines recommend oral anticoagulants for the majority of AF patients to prevent stroke. However, current treatment options, such as warfarin, have limitations that challenge both healthcare professionals and patients. It is subject to potential limitations including unpredictable anticoagulant effects and can interact with numerous drugs and a wide array of food and drink in certain patients.

Xarelto is the first in a class of non-VKA anticoagulants called Factor Xa inhibitors. It offers a convenient oral dosing and a lower risk of interactions with other drugs compared with VKA antagonists, such as warfarin.

“Treatments which act at a key point in the blood-clotting process are now emerging as an important therapy option in both short and long-term clinical settings, and have the potential to help re-shape clinical practice,” said Professor Keith Fox, Professor of Cardiology at the University of Edinburgh.