PBAC's latest decision on Mycophenolic acid: Recommended with restriction (2012). Considered for treatment of biopsy-proven WHO Class III, IV or V lupus nephritis in adults.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2012
Submissions
1
2012 → 2012
Eligible population
adult patients with biopsy-proven WHO Class III, IV or V lupus nephritis
Therapy area
Rheumatology
Line of therapy
Later-line
Evidence base
RCT | Registry
Primary endpoint
OS | PFS | DFS | ORR | QoL | Surrogate
Key trials
Appel 2009 [ALMS-induction]; El-Shafey 2010; Ginzler 2005; Li 2009; Mulic-Bacic 2008; Ong 2005; Contreras 2004; Houssiau 2010; Dooley 2011 [ALMS-maintenance]
Comparator
IV cyclophosphamide (induction phase) and azathioprine (maintenance phase)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis performed; no ICER calculated. PBAC recommended on cost-minimisation basis.