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 In the new draft guidance, belimumab is not recommended, within its licensed indication, as an add-on therapy in adults with active, autoantibody-positive systemic lupus erythematosus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This is the second draft guidance consultation in the belimumab appraisal, as an appeal on final draft guidance was upheld in 2012.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Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: "Systemic lupus erythematosus (SLE) is a debilitating condition which severely affects an individual's quality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 We understand that it will be disappointing that this draft guidance doesn't recommend belimumab; this draft decision is because the evidence considered did not persuade the Committee that belimumab was good value for money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.