NICE needs more evidence on new treatment for people with common heart condition

NICE needs more evidence on new treatment for people with common heart condition

06 January 2012

In preliminary recommendations published today (9 January) NICE is asking Bayer HealthCare for more information on its product rivaroxaban (Xarelto), for the prevention of stroke and systemic embolism in people with atrial fibrillation.

Atrial fibrillation (AF) occurs when the electrical impulses controlling the heart rhythm become disorganised, so that the heart beats irregularly and, occasionally, too fast and so cannot efficiently pump blood around the body. People with AF are at higher risk of developing blood clots and subsequent stroke (with an approximately five-fold greater risk than that of people without AF) because the erratic heart rhythm of AF causes turbulent blood flow within the heart chambers. However, the risk of stroke can be substantially reduced by appropriate use of antithrombotic therapy (e.g. warfarin).

Rivaroxaban is an orally administered drug that helps to prevent blood from clotting. It does this by stopping a substance called Factor Xa from working. Factor Xa is necessary in the formation of thrombin and fibrin, the key components in blood clot formation. Rivaroxaban has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation who have one or more risk factors such as congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, prior stroke or transient ischaemic attack.

Commenting on NICE's draft recommendation, Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "The importance of effective antithrombotic therapy in people with atrial fibrillation who are at risk of developing potentially fatal blood clots cannot be overestimated. The most commonly used antithrombotic - warfarin - is associated with a number of problems, such as the need for frequent monitoring of the blood's clotting, which can have an adverse effect on quality of life and make compliance difficult for some people. Rivaroxaban, like dabigatran, which NICE is also assessing, represents a significant potential benefit for people with AF because it doesn't require regular monitoring and dose adjustments.

Professor Longson continued: "The Committee concluded, however, that the population included in the single trial presented by the manufacturer as evidence of rivaroxaban's cost-effectiveness was not reflective of all the people with atrial fibrillation in the UK who would be eligible for treatment with the drug. In particular the Committee was concernedthat the people in the warfarin arm of the trial on average did not achieve as good control of their blood clotting as might be expected in clinical practice in the UK. It was also concerned that the risk of stroke and systemic embolism for the population in the trial was higher than for the overall population eligible for treatment with rivaroxaban. The Committee felt that both these factors could mean that the relative effectiveness of rivaroxaban compared with warfarin had been overestimated for the UK population. The Committee is therefore minded not to recommend the drug on the basis of the available evidence pending the receipt of additional information from the manufacturer that will address these issues."

NICE has not yet issued final guidance to the NHS. Those wishing to comment on NICE's draft recommendations have until 30 January to do so. Feedback received during consultation may result in changes to the preliminary recommendations and will be considered by the Appraisal Committee at their next meeting.

Notes to Editors
About the draft guidance

1. The draft guidance is available (from 9 January) on the NICE website at .

2. The provisional cost to the NHS of rivaroxaban is £2.10 per day and £766.50 annually. Costs may vary in different settings because of negotiated procurement discounts.
About NICE

3. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

4. NICE produces guidance in three areas of health:

public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

5. NICE produces standards for patient care:

quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

6. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.