PBAC's latest decision on Lapatinib ditosylate monohydrate: Not recommended (2007). Considered for for use in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress HER2 (ErbB2) and who have received prior therapy including trastuzumab.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
$200k/QALY
Range: $110k/QALY–$200k/QALY
Submissions
1
first 2007
Submissions
1
2007 → 2007
Eligible population
patients with HER2 positive metastatic breast cancer who have failed trastuzumab in the metastatic setting or experienced disease progression while receiving adjuvant trastuzumab treatment
Therapy area
Oncology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
OS, TTP
Key trials
EGF100151
Comparator
capecitabine monotherapy
Economic model
CUA
Why PBAC said no
Reasons cited in the latest PSD: unacceptable cost-effectiveness ratio (AUD $110,000–$200,000 per LY/QALY), uncertain survival benefit (not statistically significant), inadequately supported assumptions regarding trastuzumab continuation cost offset