Regulatory Focus™ > News Articles > NICE Opens Second Consultation on GSK's Belimumab for Lupus

NICE Opens Second Consultation on GSK's Belimumab for Lupus

Posted 24 July 2013 | By Louise Zornoza

The UK's National Institute for Health and Care Excellence (NICE) has released new draft guidance recommending against the National Health Service's (NHS) use of GlaxoSmithKline's Benlysta (belimumab) within its licensed indication as an add-on therapy in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 mainly affecting women, and particularly women of African or Caribbean origin. SLE is complex, poorly-understood, hard to diagnose and can result in serious organ damage. Standard therapy consists mainly 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This is the second draft guidance consultation in the belimumab appraisal, as an appeal on final draft guidance was upheld in 2012.

Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: "NICE's independent appraisal committee has again looked very carefully at the evidence provided on the use of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 We understand that it will be disappointing that this draft guidance doesn't recommend belimumab; this draft decision is because the evidence considered did not persuade the Committee that belimumab was good value for money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," Dillon continued. "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."

NICE Draft Guidance on Belimumab

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