PBAC's latest decision on Lipegfilgrastim: Noted (2016). Considered for Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy.
PBAC outcome
Noted
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
Adult patients treated with cytotoxic chemotherapy for malignancy, specifically breast cancer patients receiving doxorubicin 60 mg/m² and docetaxel 75 mg/m² every 3 weeks in the pivotal trials.
Therapy area
Oncology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Duration of severe neutropenia
Pivotal trial size
410 patients
Key trials
XM22-02, XM22-03
Comparator
pegfilgrastim
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; numeric pricing and cost comparisons are redacted (commercial-in-confidence). The PBAC did not proceed to recommend based on ICER.
Why PBAC said no
Reasons cited in the latest PSD: Uncertainty regarding efficacy in patients weighing >80 kg; clinical evidence limited to breast cancer only, while requested listing was for multiple indications; lack of head-to-head trial evidence versus filgrastim (a relevant comparator); unclear whether flow-on approval to other indications is justified when efficacy established only in breast cancer; no recommendation made by PBAC.