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Published on 30 April 2012

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NICE turns down Benlysta on grounds of cost


The National Institute for Health and Clinical Excellence (NICE) has today published final draft guidance on the use of belimumab (Benlysta) for treating systemic lupus erythematosus.

In the draft guidance, belimumab is not recommended within its licensed indication as add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus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.


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