NICE consults on belimumab for systemic lupus erythematosus
The National Institute for Health and Care Excellence (NICE) has today (30 September) opened its public consultation on the use of belimumab (Benlysta) for treating systemic lupus erythematosus. In the draft guidance, NICE is provisionally unable to recommend belimumab for treating adult patients with active autoantibody-positive systemic lupus erythematosus, where patients have a high degree of disease activity despite the individual receiving standard therapy, in line with the drug's marketing authorisation.
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.
The draft recommendations are available for consultation; NICE has not yet issued final guidance to the NHS. Until final guidance is issued NHS bodies should make decisions locally on the funding of specific treatments.
Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: "Systemic lupus erythematosus (SLE) is a debilitating condition which severely affects an individual's quality of life. NICE's independent appraisal committee has looked very carefully at the evidence provided on the use of belimumab for treating SLE, including the views of people with the condition, those who represent them, and clinical specialists. The evidence considered did not persuade the Committee that belimumab was good value for money compared to standard care, as the cost per year of improved health is very high. It was also considered relevant to compare belimumab with rituximab, because some people with severe disease currently receive 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.
"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. We welcome comments on this draft recommendation as part of the consultation."
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 .
2. The consultation closes on 21 October 2011.
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 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 per year of improved health) is at the higher end of a range between £64,410 and £71,000 per life year gained for the target population. The patient access scheme that had been agreed with the Department of Health reduced the ICER. 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.
7. 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
8. 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.
9. 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
10. 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: 30 September 2011