PBAC's latest decision on Belimumab: Recommended with restriction (2020). Considered for Add-on therapy for active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity despite standard therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2019
Submissions
2
2019 → 2020
Eligible population
Adult patients with active SLE with a high degree of disease activity despite standard therapy, confirmed by elevated anti-dsDNA titre or low complement levels, SLEDAI-2K score ≥10, currently receiving hydroxychloroquine, immunosuppressant medication, and prednisolone ≥7.5 mg/day
Therapy area
Rheumatology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
SRI (Systemic Lupus Erythematosus Responder Index)
Key trials
BLISS-SC, EMBRACE, BLISS-LN
Comparator
placebo
Economic model
CUA
ICER note
ICER redacted; document states economic model was presented but values are not disclosed in public summary
Risk sharing
Risk-sharing arrangement in place — Risk Sharing Arrangements (RSA) mentioned in context of potential leakage in severe lupus nephritis due to increased use for renal patients
Submission history
Nov 2019: Recommended with restriction · Authority Required
Jul 2020: Recommended with restriction · Authority Required