The four conditions specified within the guidance are:
• There is evidence for serological disease activity (defined as positive anti-double-stranded DNA and low complement) and a Safety of Estrogen in Lupus National Assessment – Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score of greater than or equal to 10 despite standard treatment.
• Treatment with belimumab is continued beyond 24 weeks only if the SELENA-SLEDAI score has improved by 4 points or more.
• The company provides belimumab with the discount agreed in the patient access scheme.
• Under the conditions for data collection, monitoring, patient eligibility and consent, ongoing treatment, cost to the NHS, and review by NICE as laid out in the guidance.