Trastuzumab DeruxtecanEnhertu
Treatment of adult patients with hormone receptor positive (HR-positive) human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow unresectable and/or metastatic breast cancer who have received at least one prior line of endocrine therapy in the metastatic setting and are no longer suitable for further endocrine therapy.
Decisions on record
- Meeting Mar 2026 Not recommended Breast cancer, hormone receptor positive (HR-positive) human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow metastatic breast cancer
- Meeting Nov 2025 Not recommended Metastatic HER2-positive gastric or gastroesophageal junction cancer following trastuzumab therapy no PSD
- Meeting May 2025 Deferred Metastatic HER2-positive gastric/gastroesophageal junction cancer post-trastuzumab
- Meeting Mar 2024 Recommended HER2-low unresectable or metastatic breast cancer
- Meeting Nov 2023 Not recommended HER2-low unresectable locally advanced or metastatic breast cancer
- Meeting Jul 2023 Recommended Breast Cancer no PSD
- Meeting Mar 2023 Recommended Breast Cancer; HER2 positive metastatic breast cancer no PSD
- Meeting Dec 2022 Deferred HER2 positive metastatic breast cancer in patients who have progressed following prior HER2-directed therapy or relapsed during/within 6 months of adjuvant HER2-directed therapy no PSD
1 earlier decision
- Jul 2022 Not recommended Breast cancer, HER2 positive metastatic with progression on prior HER2-directed therapy
Access path
- TGA registered · Enhertu
TGA label narrower than the PBS population
- Jul 2022Recommended · restricted
vs trastuzumab emtansine (T-DM1)
- Nov 2023Not recommended
Comparator changed: trastuzumab emtansine (T-DM1) → For HR positive/HER2 low: physician's…
- ↻ resubmittedMar 2024Recommended · restricted
Comparator changed: For HR positive/HER2 low: physician's choice of chemotherapy…
- Nov 2025Not recommended
Comparator changed: Treatment of physician's choice (TPC) comprising capecitabine…
- Mar 2026Not recommended
Comparator changed: Standard of care chemotherapy (paclitaxel, irinotecan, docetaxel, or…
From the public summary
7.1 The PBAC deferred making a recommendation for trastuzumab deruxtecan (T-DXd for treatment of metastatic human epidermal growth factor receptor 2-positive (HER2+) gastric or gastroesophageal junction (G/GOJ) cancer following trastuzumab therapy to allow for further consultation with the sponsor regarding a pathway forward.PSD · May 2025
7.2 The PBAC advised that it would be willing to recommend PBS listing of T-DXd in this indication with a price reduction that would reduce the ICER to an acceptable level. The PBAC considered that based on the data available in the submission, a significant price reduction would be required to reduce the ICER to an acceptable level.PSD · May 2025
6.38 The submission presented a cost-utility analysis based on the Phase 2 randomised controlled trial DG-01 comparing T-DXd to SoC, measuring outcomes in terms of life- years (LYs) gained and quality-adjusted life years (QALYs) gained.PSD · May 2025
OFFICIAL Public Summary Document – May 2025 PBAC Meeting with November 2025 Addendum Table 8: Summary of model structure, key inputs and rationale Component Description Type of analysis Cost-utility analysis Outcomes Life years and quality-adjusted life years gainedPSD · May 2025
6.33 The clinical claim proposed in the submission was that T-DXd has superior efficacy and an inferior but manageable safety profile compared to chemotherapy in patients with metastatic HER2-positive G/GOJ adenocarcinoma who have received a prior trastuzumab-based regimen. The ESC considered that a claim of superior efficacy was reasonable on the basis of ORR and OS in the DG-01 study.PSD · May 2025
6.34 The superior efficacy claim was adequately supported by evidence included in the submission but the magnitude of the improvement in PFS and OS in the proposed Australian population is considered to be uncertain. Key issues were:PSD · May 2025
6.2 The PBAC noted and welcomed the input from health care professionals (1) and organisations (3) via the Consumer Comments facility on the PBS website. The comments from Rare Cancers Australia and the Pancare foundation highlighted the poor prognosis for HER2+ G/GOJ adenocarcinoma and the benefits of increased choice of treatment for the population.PSD · May 2025
Consumer input also noted the potential for significant side effects from T-DXd, and the health professional described the importance of educating clinicians regarding monitoring and early intervention for pneumonitis.PSD · May 2025
Cost-effectiveness
ICER values are redacted (commercially sensitive content marked 'redacted content' in the document)
The pre-PBAC response proposed a vial price of $ which resulted in an ICER of $55,000 to < $75,000 per QALY gained. PSD · 2024
Decision context
PopulationAdult patients with HR-positive HER2-low (IHC 1+ or IHC 2+/ISH-negative) or HER2-ultralow (IHC 0 with membrane staining) unresectable and/or metastatic breast cancer who have received at least one prior line of endocrine therapy in the metastatic setting and are no longer suitable for further endocrine therapy
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Not recommended | investigator's choice of chemotherapy (ICC) consisting of capecitabine, paclitaxel and nab-paclitaxel | — | RCT · PFS |
| Nov 2025 | Not recommended | Standard of care chemotherapy (paclitaxel, irinotecan, docetaxel, or FOLFIRI) | — | RCT · OS |
| Mar 2024 | Recommended · restricted | Treatment of physician's choice (TPC) comprising capecitabine, gemcitabine, eribulin, nab-paclitaxel, or paclitaxel | $55k–75k | RCT · OS |
| Nov 2023 | Not recommended | For HR positive/HER2 low: physician's choice of chemotherapy (capecitabine, gemcitabine, eribulin, paclitaxel, nab-pacli | — | RCT · OS |
| Jul 2022 | Recommended · restricted | trastuzumab emtansine (T-DM1) | — | RCT · PFS |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| HER2 ISH testing for trastuzumab-deruxtecan eligibility in metastatic gastric/gastroesophageal junction adenocarcinoma | HER2 gene amplification | supported with conditions | 2025 |
Consumer voice
Health care professionals and organisations highlighted the poor prognosis of HER2+ G/GOJ adenocarcinoma and emphasised the benefits of T-DXd treatment, including improved response rates and overall survival compared to chemotherapy, along with potential for reduced financial burden and equitable access if PBS listed. Consumer input also noted potential for significant side effects and the importa
the poor prognosis for HER2+ G/GOJ adenocarcinoma and the benefits of increased choice of treatment for the population Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line and WHO performance status ≤1; TGA label has no performance status restriction or line-of-therapy limitation.