PBAC's latest decision on Neratinib: Not recommended (2019). Considered for Extended adjuvant treatment of adult patients with HER2-positive, hormone receptor positive, early breast cancer who have completed prior adjuvant trastuzumab-based therapy within the past 12 months.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
2
first 2019
Submissions
2
2019 → 2019
Eligible population
Adult patients with HER2+, HR+, early breast cancer who have completed prior adjuvant trastuzumab-based therapy within the past 12 months.
Therapy area
Oncology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Invasive disease-free survival
Pivotal trial size
740 patients
Key trials
ExteNET, KATHERINE, APHINITY
Comparator
placebo/usual care
Economic model
CUA
ICER note
ICER not stated in this PSD; economics section was incomplete in provided text.
Why PBAC said no
Reasons cited in the latest PSD: unclear clinical place in therapy with emerging treatments (T-DM1, pertuzumab), no new clinical data or OS data as requested, substantial risk of severe diarrhoea versus small and uncertain benefit, economic analysis highly uncertain, overestimated uptake and financial estimates, inconsistencies between clinical algorithm, TGA indication, proposed restriction, and ExteNET trial population
Submission history
Mar 2019: Recommended with restriction · Authority Required