NICE, the health and social care guidance body, has today (24 July) opened a second public consultation on the use of belimumab (Benlysta) for treating systemic lupus erythematosus. In the new draft guidance, belimumab is not recommended, within its licensed indication, as an add-on therapy in adults with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity despite 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.

This is the second draft guidance consultation in the belimumab appraisal, as an appeal on final draft guidance was upheld in 2012. Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: “Systemic lupus erythematosus (SLE) is a debilitating condition which severely affects an individual's quality of life. NICE's independent appraisal committee has again 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. We understand that it will be disappointing that this draft guidance doesn't recommend belimumab; this draft decision is because the evidence considered did not persuade the Committee that belimumab was good value for money compared with standard care.

“It was also considered relevant to compare belimumab with rituximab, because some people with severe disease currently receive rituximab (through individual funding requests), although it isn't licensed for this use. However, there were no reliable data to show the relative efficacy of belimumab compared with rituximab. Without this, the Committee could not reach a conclusion as to the cost effectiveness of belimumab compared with rituximab.

“Whilst recognising the severity of the disease, the Committee concluded that based on the evidence presented, belimumab could not be considered a good use of NHS resources. We welcome comments on this draft recommendation as part of the consultation.”

Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.

Ends

Notes to Editors

About the draft guidance

1. The draft guidance, ‘Belimumab for the treatment of active autoantibody-positive systemic lupus erythematosus' will be available from 24 July 2013

2. The consultation closes on 13 August 2013.

3. The full draft recommendations are:

(a) Belimumab is not recommended, within its marketing authorisation, 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.

4. The Committee concluded that, compared with standard care, there was some evidence of the clinical effectiveness of belimumab. However, the most plausible incremental cost effectiveness ratio (ICER) without the patient access scheme of those the Committee was presented with was £59,900 per quality-adjusted life year (QALY) gained provided in the Evidence Review Group (ERG) exploratory analysis. The Committee noted that a patient access scheme which reduced the ICER for belimumab compared with standard care had been agreed with the Department of Health. The Committee considered that the estimated ICERs with the revised patient access scheme may have been underestimated because of the uncertainties in the evidence. The Committee considered that the ICERs with the revised patient access scheme did not bring the estimate to within a range in which belimumab could be considered a cost-effective use of NHS resources compared with standard care.

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

6. The list price of belimumab is £121.50 for a 120 mg vial and £405 for a 400 mg vial (excluding VAT; British National Formulary edition 63). The recommended dose regimen is 10 mg/kg belimumab on days 0, 14 and 28, and at 4-week intervals thereafter. The summary of product characteristics 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. 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 size of the discount is commercial-in-confidence.

7. There are currently around 15,000 people in England and Wales with SLE, with around 90% of cases occurring in women. SLE predominantly affects women of child-bearing age from ethnic minority groups.

8. The Scottish Medicines Consortium decision is that belimumab (Benlysta®) is not recommended for use within NHS Scotland. (April 2012).

9. This is the second draft guidance consultation in this appraisal; the first consultation was in September 2011 on draft guidance which also did not recommend belimumab. Following an appeal in July 2012 on the final draft guidance (FAD), two points were upheld and the appraisal was returned to the Appraisal Committee for it to consider and address the issues on which the appeal has been upheld. This second draft guidance results from those further committee considerations. Information on the appeal is available at /proxy/?sourceUrl=http%3a%2f%2fguidance.nice.org.uk%2fTA%2fWave25%2f12%2fAppeal .

About NICE

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