PBAC's latest decision on Avacopan: Not recommended (2024). Considered for Treatment of severe active granulomatosis with polyangiitis (GPA) and severe active microscopic polyangiitis (MPA) in combination with rituximab or cyclophosphamide/azathioprine.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2023
Submissions
2
2023 → 2024
Eligible population
Adult patients with newly diagnosed or relapsed ANCA-associated vasculitis with severe active GPA or severe active MPA defined as at least one major or three non-major items or at least two renal items of haematuria and proteinuria on the BVAS, receiving concomitant therapy with rituximab (induction/maintenance) or cyclophosphamide (induction)/azathioprine (maintenance).
Therapy area
Immunology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Induced and sustained disease remission
Key trials
ADVOCATE
Comparator
glucocorticoids
Economic model
CUA
ICER note
The exact ICER value is redacted in the PSD (shown as $ to $ per QALY); numerical values are marked as commercially sensitive.
Why PBAC said no
Reasons cited in the latest PSD: Inadequate evidence of comparative benefit for remission at 26 weeks, insufficient evidence for maintenance therapy use from 26-52 weeks, uncertainties regarding additive benefit to rituximab in maintenance phase, limited longer-term safety and efficacy data, clinical claim of superiority not adequately supported for maintenance therapy
Submission history
Jul 2023: Recommended with restriction · Authority Required