TucatinibTukysa
Metastatic (Stage IV) HER2-positive breast cancer in patients who have received two prior lines of HER2-directed therapy or who have progressed on trastuzumab deruxtecan, for use in combination with trastuzumab plus capecitabine.
Decisions on record
- Meeting May 2026 Noted Metastatic HER2-positive breast cancer no PSD
- Meeting Nov 2025 Recommended Metastatic HER2-positive breast cancer – combination with trastuzumab and capecitabine in patients with ≥2 prior HER2-directed therapies
- Meeting Mar 2021 Not recommended HER2-positive metastatic breast cancer with brain metastases
Access path
- TGA registered · Tukysa
TGA label narrower than the PBS population
- Mar 2021Not recommended
vs trastuzumab plus capecitabine
- ↻ resubmittedNov 2025Recommended · restricted
Comparator changed: trastuzumab plus capecitabine → trastuzumab plus capecitabine…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended tucatinib for use in combination with trastuzumab plus capecitabine for the treatment of metastatic (Stage IV) human epidermal growth factor receptor 2 positive (HER2+) breast cancer in patients who have received at least two prior lines of HER2-directed therapy or who have progressed on trastuzumab deruxtecan (T-DXd).PSD · Nov 2025
7.2 The PBAC was satisfied that tucatinib in combination with trastuzumab plus capecitabine provides, for some patients, a significant improvement in efficacy over trastuzumab plus capecitabine alone. 46 OFFICIALPSD · Nov 2025
6.48 The resubmission presented two economic evaluations: a CUA comparing tucatinib plus trastuzumab and capecitabine against placebo plus trastuzumab and capecitabine, similar to that considered by the PBAC at the March 2021 meeting, and a CMA comparing tucatinib plus trastuzumab and capecitabine against T-DM1, new to the resubmission due to the nomination of T-DM1 as a relevant comparator.PSD · Nov 2025
Cost-utility analysis versus trastuzumab and capecitabine alonePSD · Nov 2025
Efficacy: Superiority for tucatinib in combination with trastuzumab and capecitabine vs trastuzumab and capecitabine.PSD · Nov 2025
Safety: Inferior safety to trastuzumab and capecitabine, with this being regarded as tolerable and manageable T-DM1 Efficacy: Non-inferiority for tucatinib in combination with trastuzumab and capecitabine versus T-DM1 Safety: Tucatinib combination therapy has a different safety profile compared to T-DM1, with this being regarded as tolerable and manageable Source: Table 1.1.1, p22 of the submission.PSD · Nov 2025
6.2 The PBAC noted and welcomed the input from individuals (5), a health care professional (1) and organisations (4) via the Consumer Comments facility on the PBS website. The comments described the significant challenges faced by people living with metastatic HER2-positive breast cancer (third line and beyond) including pain, anxiety, fatigue and neurological symptoms, with a substantial impact on quality of life and ability to work.PSD · Nov 2025
6.3 Input emphasised the significant clinical benefits of tucatinib in improving progression-free and overall survival, particularly for those with brain metastases. The high cost of tucatinib means many patients cannot afford it or need to make the difficult decision to access superannuation to fund treatment. The comments stated that while adverse effects are expected, they are generally manageable.PSD · Nov 2025
Cost-effectiveness
Base case ICER vs trastuzumab plus capecitabine is $75,000 to <$95,000 per QALY gained (published in footnote 1 as redacted in main tables)
Decision context
PopulationPatients with HER2-positive metastatic (Stage IV) breast cancer, including those with brain metastases, who have received two prior anti-HER2-based regimens in the metastatic setting or who have progressed on trastuzumab deruxtecan, with WHO performance status 0 or 1.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended · restricted | trastuzumab plus capecitabine; trastuzumab emtansine (T-DM1) | $75k–95k | RCT · PFS |
| Mar 2021 | Not recommended | trastuzumab plus capecitabine | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| HER2CLIMB | Ph 2 | 612 | Progression-free Survival (PFS) Per RECIST 1.1 as Determined by Blinded Independent Centra… | completed |
Consumer voice
Consumers and healthcare professionals described significant challenges of metastatic HER2-positive breast cancer including pain, anxiety, fatigue, and neurological symptoms with substantial quality-of-life impact. They emphasized tucatinib's survival benefits, particularly for brain metastases, while highlighting unaffordability and the need for financial sacrifice to access treatment.
The comments described the significant challenges faced by people living with metastatic HER2-positive breast cancer (third line and beyond) including pain, anxiety, fatigue and neurological symptoms, with a substantial impact on quality of life and ability to work. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to two prior HER2-directed regimens or trastuzumab deruxtecan progression; TGA allows one or more prior regimens.