Mycophenolate SodiumMyfortic
Induction and maintenance treatment of adult patients with biopsy-proven WHO Class III, IV or V lupus nephritis.
Decisions on record
- Meeting Jul 2012 Recommended Lupus nephritis
- Meeting Nov 2011 Deferred Lupus nephritis
- Meeting Mar 2003 Recommended To prevent rejection in kidney transplant no PSD
Access path
- TGA registered · Myfortic
TGA label narrower than the PBS population
- Nov 2011Deferred
vs intravenous cyclophosphamide (IVCP) for induction phase…
- Jul 2012Recommended · restricted
Comparator changed: intravenous cyclophosphamide (IVCP) for induction phase; azathioprine…
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated. The re-submission presented an updated economic evaluation using a cost-consequence approach rather than estimating an ICER.
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
Decision context
PopulationAdult patients with biopsy-proven WHO Class III, IV or V lupus nephritis, managed by or in consultation with a nephrologist.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2012 | Recommended · restricted | intravenous cyclophosphamide (induction phase) and azathioprine (maintenance phase) | — | Meta-analysis |
| Nov 2011 | Deferred | intravenous cyclophosphamide (IVCP) for induction phase; azathioprine (AZA) for maintenance phase | — | RCT | Single-arm · OS | PFS | DFS | ORR | QoL | Surrogate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to biopsy-proven disease and requires initiation by nephrologist; TGA label does not specify these requirements.