Mycophenolic Acid
Recommended · restricted RheumatologyAuthority RequiredLater-line line
treatment of biopsy-proven WHO Class III, IV or V lupus nephritis in adults
1
Submissions
1 resub
2012–12
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Jul 2012Recommended · restricted
vs IV cyclophosphamide (induction phase) and azathioprine…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated. PBAC recommended on cost-minimisation basis.
The PBAC recommended mycophenolate sodium on a cost minimisation basis to IV cyclophosphamide in the induction phase and on a cost minimisation basis to azathioprine in the maintenance phase. PBAC · 2012
Cost-effectiveness accepted
Decision context
Populationadult patients with biopsy-proven WHO Class III, IV or V lupus nephritis
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2012 | Recommended · restricted | IV cyclophosphamide (induction phase) and azathioprine (maintenance phase) | — | RCT | Registry · OS | PFS | DFS | ORR | QoL | Surrogate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to biopsy-proven diagnosis and later-line treatment; TGA label does not specify these requirements.