Imatinib MesylateGlivec
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).
Decisions on record
- Meeting Mar 2009 Recommended Acute lymphoblastic leukaemia no PSD
- Meeting Mar 2008 Recommended Imatinib-sensitive rare diseases
- Meeting Jul 2007 Recommended Acute lymphoblastic leukaemia (ALL)
- Meeting Jul 2007 Not recommended Imatinib-sensitive rare diseases
- Meeting Nov 2006 Recommended Chronic myeloid leukaemia no PSD
- Meeting Jul 2004 Recommended A protein-tyrosine kinase inhibitor used to treat chronic myeloid leukaemia and gastrointestinal stromal tumours. no PSD
- Meeting Sep 2002 Recommended Treatment for certain forms of cancer no PSD
- Meeting Sep 2001 Recommended An anti-cancer drug no PSD
Access path
- TGA registered · Glivec
TGA label narrower than the PBS population
- Jul 2007Recommended · restricted
Comparator changed: chemotherapy → standard medical management
- Jul 2007Not recommended
uncertain clinical benefit with only very weak evidence of greater efficacy over standard care, particularly regarding…
- ↻ resubmittedJul 2007Recommended · restricted
Comparator changed: chemotherapy → standard medical management
- Mar 2008Recommended · restricted
ICER rose $45,000 → $75,000 (+67%)
- PBS listing · Authority Required
From the public summary
Newly diagnosed Ph+ ALL Imatinib + Chemotherapy Lee S et al (2005) with SCT p- value chemotherapy (N=29) (N=33) After consolidation therapy • Sustained CR1 22/23 (95.7%) 16/27 (59.3%) 0.003PSD · Jul 2007
• Relapse 1/23 (4.3%) 11/27 (40.7%) Pre-transplantation status • CR1 25/29 (86.2%) 17/33 (51.5%) • CR2 0/29 (0%) 9/33 (27.3%) 0.004PSD · Jul 2007
Cost-effectiveness
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.
The PBAC agreed the incremental costs per life-year gained in these patient groups were acceptable overall, though in the case of those patients who do not progress to a stem cell transplant, the incremental cost effectiveness ratio was noted to be high. PBAC · 2007
Decision context
PopulationAdult 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2008 | Recommended · restricted | standard medical management; radiotherapy (for DFSP); standard chemotherapy (for HES/CEL); best supportive care or chemo | $15k–75k | Single-arm · ORR |
| Jul 2007 | Recommended · restricted | chemotherapy | $15k–45k | Single-arm · OS, PFS |
| Jul 2007 | Not recommended | standard medical management | — | Case series | Other |
| Jul 2007 | Recommended · restricted | chemotherapy alone | $15k–45k | Single-arm · OS |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to later-line treatment and adds biomarker requirements (FIP1L1-PDGFRA fusion, absence of D816V c-kit mutation) not specified in TGA label.