Anifrolumab Subsidized under s100 PBS for SLE Patients
Key Questions
What approval has anifrolumab received under the PBS for SLE patients?
Anifrolumab has received s100 PBS subsidy approval for SLE patients, marking the second major biologic access expansion. This is supported by efficacy data stratified by type I IFN gene signature and advocacy from ASCIA for future subcutaneous formulations.
What does recent real-world and long-term data show about anifrolumab in SLE?
Real-world ASTER study data and a small cohort confirm improvements in SLEDAI scores mainly in skin, joint, and hematologic domains, plus steroid-sparing benefits. Four-year data demonstrate sustained hematologic and serologic improvements, aligning with treat-to-target strategies.
What are the findings of the new cost-effectiveness model for anifrolumab in Australia?
The model using LLDAS treat-to-target states shows an ICER of approximately $120k/QALY for anifrolumab. Co-authored by Morand and Nikpour, it provides concrete data to support PBS advocacy and potentially reshape SLE reimbursement evaluations.
PBS s100 subsidy approval for anifrolumab in SLE patients—second major biologic access expansion. Efficacy stratified by type I IFN gene signature; ASCIA advocacy notes Saphnelo subcutaneous/autoinjector formulation (2026). Real-world ASTER study shows SLEDAI improvement mainly in skin/joint/hematologic domains. New four-year data confirm sustained hematologic/serologic improvement and a 74% reduction in cardiovascular damage vs real-world SoC. New cost-effectiveness model using LLDAS treat-to-target states, applied to anifrolumab in Australia (Morand, Nikpour co-authors), shows ICER ~$120k/QALY – a concrete data point for PBS advocacy. A new case report (2026) adds evidence for anifrolumab in autoimmune hemolytic anemia, supporting broader utility beyond standard SLE domains. Recent real-world data (ex-dd0d7598) shows early haematologic response, further reinforcing utility in hematologic manifestations. New pharmacovigilance data (ex-90fe3f3d) confirms herpes zoster as the only robust safety signal vs belimumab, reinforcing need for monitoring protocols.