PBAC's latest decision on Imatinib mesylate: Recommended with restriction (2008). Considered for Extension of listing to treat four rare diseases: dermatofibrosarcoma protuberans (DFSP), hypereosinophilic syndrome/chronic eosinophilic leukaemia (HES/CEL), myelodysplastic/myeloproliferative diseases (MDS/MPD), and aggressive systemic mastocytosis (ASM).
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$75k/QALY
$15k/QALY–$75k/QALY · across 2 submissions
Submissions
3
first 2007
Submissions
3
2007 → 2008
Eligible population
Adult patients with unresectable, recurrent and/or metastatic DFSP; HES/CEL confirmed by FIP1L1-PDGFRA fusion gene detection; MDS/MPD with PDGFR gene re-arrangements where conventional therapies have failed; ASM with FIP1L1-PDGFRA fusion gene and absence of D816V c-kit mutation where conventional therapies have failed.
Therapy area
Haematology
Line of therapy
Later-line
Evidence base
Single-arm
Primary endpoint
ORR
Key trials
Study B2225
Comparator
standard medical management; radiotherapy (for DFSP); standard chemotherapy (for HES/CEL); best supportive care or chemotherapy (for MDS/MPD and ASM)
Economic model
CEA
ICER note
ICER expressed as incremental cost per extra responder (not per QALY or LY). Range varies by disease: DFSP $15,000–$45,000; HES/CEL $45,000–$75,000; MDS/MPD $45,000–$75,000; ASM $45,000–$75,000.
ICER basis
Range aggregates 2 submissions (2007–2008) — not a single base case.