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NICE publishes draft guidance on belimumab for systemic lupus erythematosus

The National Institute for Health and Care Excellence (NICE) has today (27 April) published final draft guidance on the use of belimumab (Benlysta) for treating systemic lupus erythematosus. In the draft guidance, belimumab is not recommended within its licensed indication as add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus who have a high degree of disease activity (for example, positive anti-double-stranded DNA and low complement) despite the individual receiving standard therapy.

Systemic lupus erythematosus(SLE) is an incurable autoimmune condition which mainly affects women, with the condition being more common in women of African Caribbean origin than any other group. In SLE, the whole body is affected as the immune system attacks healthy tissue and organs, and can lead to serious organ damage - for example to the kidneys and heart. SLE is complex, poorly-understood and can be difficult to diagnose as symptoms can be similar to other more common conditions. Standard therapy for SLE is likely to consist of non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and/or immunosuppressants such as rituximab in some cases.

Sir Andrew Dillon, NICE Chief Executive said: "NICE's independent appraisal committee has looked very carefully at the evidence provided on the use of belimumab for treating systemic lupus erythematosus (SLE), including the views of people with the condition, those who represent them, and clinical specialists. The Committee concluded that compared with standard care, there was some evidence of the clinical effectiveness of belimumab. However, the evidence considered did not persuade the Committee that belimumab provided enough health benefit for patients in view of how much the NHS would need to pay for it compared to standard care, as the cost of the drug in relation to how well it works is very high. As some people with severe disease currently receive rituximab, it was also considered relevant to compare belimumab with rituximab although it isn't licensed for this use. However, there were no reliable data to show the relative efficacy of belimumab compared with rituximab, and no sound case presented to the Committee on the cost effectiveness of belimumab compared with rituximab.

"Whilst recognising the severity of the disease, the Committee concluded that based on this evidence, belimumab could not be considered a good use of NHS resources compared with current clinical practice."

NICE has not yet issued final guidance to the NHS. The draft guidance is now with consultees, who have the opportunity to appeal against it. People currently receiving belimumab in the clinical circumstances for which the drug is not recommended in the draft guidance should be able to continue treatment until they and their clinician consider it appropriate to stop. Until final guidance is issued NHS bodies should make decisions locally on the funding of specific treatments.

Ends

Notes to Editors

About the appraisal ‘Belimumab for the treatment of active autoantibody-positive systemic lupus erythematosus'

1. More information on this appraisal can be found here: http://guidance.nice.org.uk/TA/Wave25/12 . Please contact the press office for an embargoed copy of the final appraisal determination.

2. The full draft recommendations are:

a) Belimumab is not recommended within its licensed indication as add-on therapy in adults with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity (for example, positive anti-double-stranded DNA and low complement) despite standard therapy.

b) People currently receiving belimumab that is not recommended according to (a) should be able to continue treatment until they and their clinician consider it appropriate to stop.

3. The manufacturer of belimumab (Benlysta) is GlaxoSmithKline.

4. Belimumab is priced at £121.50 for a 120mg vial and £405 for a 400mg vial. Costs may vary in different settings because of negotiated procurement discounts. The recommended dose regimen is 10 mg/kg belimumab on days 0, 14 and 28, and at 4 week intervals thereafter. The SPC states that discontinuation of treatment with belimumab should be considered if there is no improvement in disease control after 6 months of treatment. Assuming vial wastage, the drug cost per administration for a patient weighing 65-76 kg is £769.50. The cost over the first 4 weeks is therefore £2308.50, then £769.50 every four weeks. The manufacturer of belimumab has agreed a patient access scheme with the Department of Health, in which a discount on the list price of belimumab is offered. The details of the patient access scheme are commercial in confidence at the request of the manufacturer.

5. For belimumab compared with standard care, the likely incremental cost-effectiveness ratio (ICER, the cost of the drug in relation to how well it works) without the patient access scheme was £61,200 per quality adjusted life year (QALY) gained. The patient access scheme that the manufacturer had agreed with the Department of Health reduced the ICER for belimumab compared to standard care. However, the ICER with the patient access scheme applied remained above the threshold range usually considered as an acceptable use of NHS resources. The details of the ICER calculated using the patient access scheme are commercial in confidence at the request of the manufacturer. ICERs in the region of £20,000 to £30,000 fall within the normally accepted threshold range.

6. There are currently around 15,000 people in England and Wales with SLE, with around 90% of cases occurring in women. Between 10-15% of systemic lupus erythematosus patients have high disease activity despite standard therapy.

7. The Scottish Medicines Consortium issued guidance on 9 April 2012 which said that belimumab is not recommended for use within NHS Scotland.

8. End-of-life considerations were not discussed.

About NICE

9. The National Institute for Health and Care 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

10. 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.

11. 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

12. 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.

This page was last updated: 26 April 2012

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.