Mycophenolate sodium

PBAC's latest decision on Mycophenolate sodium: Recommended with restriction (2011). Considered for treatment, initiated by a nephrologist, of a patient with biopsy-proven WHO Class III, IV or V lupus nephritis.

Eligible population

adult patients with biopsy-proven WHO Class III, IV or V lupus nephritis

Therapy area

Rheumatology

Line of therapy

First-line

Evidence base

RCT | Single-arm

Primary endpoint

OS | PFS | DFS | ORR | QoL | Surrogate

Key trials

Flanc (2004), Mak (2008), Traitanon (2008), Vazquez (2006), Appel (2009), El-Shafey (2010), Ginzler (2005), Ong (2005), Chan (2005), Contreras (2004), Houssiau (2010), Wofsy (2010)

Comparator

intravenous cyclophosphamide (IVCP) for induction phase; azathioprine (AZA) for maintenance phase

Economic model

Cost-minimisation

ICER note

Cost-effectiveness analysis presented as cost per additional responder (less than $15,000) rather than as ICER per QALY or LY. No ICER in standard AUD per QALY/LY format was stated.