Lapatinib Ditosylate MonohydrateTykerb
Treatment of patients with advanced or metastatic breast cancer whose tumours overexpress HER2 (ErbB2) and who have received prior therapy including trastuzumab, used in combination with capecitabine.
Decisions on record
- Meeting Mar 2021 Noted Metastatic breast cancer no PSD
- Meeting Nov 2015 Recommended Metastatic (Stage IV) HER2 positive breast cancer no PSD
- Meeting Jul 2007 Not recommended Metastatic HER2 positive breast cancer
Access path
- TGA registered · Tykerb
TGA label narrower than the PBS population
- Jul 2007Not recommended
unacceptable cost-effectiveness ratio (AUD $110,000–$200,000 per LY/QALY), uncertain survival benefit (not…
- Jul 2007Not recommended
unacceptable cost effectiveness ratio, uncertain overall survival benefit (not statistically significant despite…
Cost-effectiveness
The PBAC thus considered that the most reliable current estimate of the cost-effectiveness of lapatinib per discounted cost per additional discounted life-year gained (LYG) or per discounted quality adjusted life year (QALY) over 5 years fell in the range $110,000 - $200,000. These were considered unacceptably high by the Committee. PBAC · 2007
Decision context
PopulationPatients with HER2-positive locally advanced or metastatic breast cancer that had progressed after treatment with regimes including an anthracycline, a taxane, and trastuzumab
Why it was knocked back
- unacceptable cost effectiveness ratio, uncertain overall survival benefit (not statistically significant despite trending towards significance), higher incidence of diarrhoea, rash and dyspepsia compared to capecitabine alone
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2007 | Not recommended | capecitabine monotherapy | $110k–200k | RCT · OS, TTP |
| Jul 2007 | Not recommended | capecitabine monotherapy | $110k–200k | RCT · TTP |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line use in metastatic setting or progression during adjuvant trastuzumab; TGA label permits any prior progression after anthracycline, taxane, and trastuzumab.