PBAC's latest decision on Anifrolumab: Recommended with restriction (2024). Considered for Treatment of patients with severe systemic lupus erythematosus (SLE) with high disease activity (SLEDAI-2K ≥10) despite standard of care (triple therapy comprising an antimalarial, immunosuppressant, and oral corticosteroid ≥7.5 mg/day).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
3
first 2022
Submissions
3
2022 → 2024
Eligible population
Adult patients (≥18 years) with severe systemic lupus erythematosus with persistent disease activity (SLEDAI-2K ≥10) despite standard of care triple therapy (hydroxychloroquine, immunosuppressant, and prednisolone ≥7.5 mg/day), excluding those with severe active lupus nephritis or severe active CNS lupus.
Therapy area
Rheumatology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
LLDAS response
Key trials
TULIP-1, TULIP-2, TULIP LTE
Comparator
Standard of care alone (placebo)
Economic model
CUA
ICER note
ICER value redacted in public document; economic model presented but specific ICER figure not publicly stated
Risk sharing
Risk-sharing arrangement in place — 2-tier Risk Sharing Agreement (RSA) proposed to address uncertainty in patient population size and response rates in clinical practice
Submission history
Jul 2022: Recommended with restriction · Authority Required
Mar 2023: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Authority Required