Final draft guidance from NICE recommends Xarelto (rivaroxaban) to treat pulmonary embolism (PE) and deep vein thrombosis (DVT) and prevent their recurrence.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

New draft NICE guidance recommends giving tamoxifen or Evista (raloxifene) to women with a family history of breast cancer as a preventative drug.

The provisional guidance update makes new suggestions for genetic testing, screening and preventative treatment in women at high risk of breast cancer.

If confirmed by NICE, the recommendations would mean the first use of a drug by the NHS to prevent breast cancer.

Breast cancer is diagnosed in 50,000 women in the UK each year. Women with a sister and a mother or aunt who have developed breast cancer before the age of 50 are considered at high risk of developing the disease for genetic reasons.

Breast cancer is also likely to occur earlier, and to be harder to treat, in this patient class, who are fewer than 1% of women aged under 30.

Genetic testing can identify either of two mutant genes that are linked to increased risk of breast cancer, as well as ovarian cancer.

NICE emphasises the need to reduce the incidence of breast cancer in high-risk women. It estimates that for every 1000 women treated with tamoxifen or Evista for a five-year period, there would be 20 fewer cases of breast cancer.

However, the drugs have side-effects including increased risk of blood clots, so their preventative use would need to be carefully considered.

Tamoxifen was developed by AstraZeneca but has long been off patent. Lilly’s Evista came off patent more recently. Neither drug has UK marketing authorisation for prevention of breast cancer.

Chris Askew, Chief Executive of the charity Breakthrough Breast Cancer, said the draft guidance was “a historic step for the prevention of breast cancer”.

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.

AstraZeneca’s Brilique (ticagrelor) has been recommended in final guidance, in combination with aspirin for up to a year, as an option to treat adults with acute coronary syndromes (ACS).

NICE has also recommended the treatment as a treatment option for people admitted to hospital with unstable angina.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says that evidence shows Brilique is “effective at reducing myocardial infarction (MI) and deaths from cardiovascular causes”.

Every year in England, around 200,000 people are diagnosed with ACS, of whom approximately 75% have unstable angina or Non-ST-segment-elevation myocardial infarction (NSTEMI).

The medication works by reducing or preventing blood clots, so that the flow to the heart muscle can be maintained to prevent further damage. It is licensed for the treatment of people with ACS who are managed medically or who are to undergo percutaneous coronary intervention (PCI) – a procedure to widen narrowed arteries in the heart.

The guidance recommends the use of anti-platelets treatment, in combination with aspirin, as a treatment option in people with STEMI who are to undergo PCI and in people with NSTEMI.

“Today’s guidance, in recommending the use of ticagrelor where clinically appropriate, is an affirmation of that effectiveness and good news for patients with ACS, wherever they live in England and Wales, because it increases the number of treatment options available to them,” said Professor Carole Longson, NICE Health Technology Evaluation Centre Director.

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.

NICE has confirmed its previous draft guidance and recommended AstraZeneca’s Brilique (ticagrelor) as an option to treat adults with acute coronary syndromes (ACS).

Evidence presented demonstrated that Brilique plus aspirin significantly reduces myocardial infarction and death from cardiovascular causes compared with clopidogrel plus aspirin.

Dr Carole Longson, NICE Health Technology Evaluation Centre Director, says the final guidance “recognises the potential” the treatment offers to the NHS in dealing with long-term management of ACS.

Brilique is licensed for the treatment of people with ACS who are managed medically, or who undergo a percutaneous coronary intervention (PCI) to widen narrowed arteries in the heart.

The final draft guidance recommends its use, along with aspirin, as a treatment option in people with STEMI who are set to receive a PCI and in people with Non-ST-segment-elevation myocardial infarction (NSTEMI).

Each year in England around 200,000 people are diagnosed with ACS, of whom around three quarters have unstable angina or NSTEMI.

ACS covers a number of conditions from unstable angina to heart attacks. They are caused by blood clots forming, following the rupture of a plague of fatty deposits in the coronary artery.

AZ’s oral reversibly bound antagonist works by reducing or preventing the formation of blood clots. It is also recommended as a treatment option for people with unstable angina.

Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) has become the first treatment in more than 50 years to be approved in Europe for the prevention of atrial fibrillation-related (AF) strokes.

The breakthrough oral anticoagulant has had its label extended in the EU for the prevention of stroke and systemic embolism (SSE) based on results from the RE-LY study.

Professor Andreas Barner, Chairman of the Board of Managing Directors at Boehringer, says Pradaxa’s approval is an “important milestone” after two decades of R&D.

Pradaxa was initially granted EU approval in 2008 for the prevention of blood clots in adults who have undergone elective total hip or knee replacement surgery.

People with AF are five-times more likely to suffer a stroke, resulting in up to three million individuals suffering strokes each year through the world.

More than 18,000 AF patients conducted in the RE-LY study. The 150mg dose – recommended for the majority of patients – was shown to reduce the risk of SSE by 35%, while also significantly reducing the risk of life-threatening and intracranial bleeding, compared to well-controlled warfarin.

The 110mg – specifically available for elderly patients aged 80 years or above – was shown to be non-inferior to warfarin in reducing the risk of SSE with a significantly lower rate of bleeding.

Professor Gregory Lip, Consultant Cardiologist & Professor of Cardiovascular Medicine, University of Birmingham Centre for Cardiovascular Sciences, says Pradaxa’s approval in Europe is a “major advance” to treat the condition.

“For the past 50 years physicians worldwide have been waiting for an alternative to vitamin K antagonist therapies, such as long time standard of care, warfarin,” he said.

Pradaxa has already been approved for the prevention of stroke in AF in the US, Canada, Japan, Australia and several other countries.