CapivasertibTruqap
Treatment of locally advanced or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer with a confirmed AKT pathway alteration (PIK3CA, AKT1, or PTEN) following recurrence or progression on or after aromatase inhibitor (AI) therapy, with or without a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor.
Decisions on record
- Meeting Mar 2025 Recommended HR+/HER2- locally advanced unresectable or metastatic breast cancer with AKT pathway alteration no PSD
- Meeting Nov 2024 Not recommended Hormone receptor-positive, HER2-negative locally advanced unresectable or metastatic breast cancer with AKT pathway alteration
Access path
- TGA registered · Truqap
TGA label narrower than the PBS population
- Nov 2024Recommended · restricted
vs fulvestrant monotherapy
- PBS listing
From the public summary
7.1 The PBAC did not recommend capivasertib for treatment of hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) locally advanced unresectable or metastatic breast cancer with evidence of a serine/threonine protein kinase (AKT) pathway alteration, following recurrence or progression on or after endocrine therapy.PSD · Nov 2024
7.2 The primary reason for this outcome was due to the economic evaluation.PSD · Nov 2024
6.51 The submission presented a modelled economic evaluation, based on the direct randomised trial, CAPItello-291, comparing the proposed test scenario (NGS tumour tissue testing for the detection of AKT pathway alterations [PIK3CA, AKT1, or PTEN]), with the comparator test scenario (no testing) in HR+/HER2- locally advanced or metastatic breast cancer patients who progressed on or after an ET with or without a CDK4/6 inhibitor.PSD · Nov 2024
6.52 Table 13 presents the summary of the economic model components.PSD · Nov 2024
6.41 The submission described CAPI+FULV as superior in terms of PFS and inferior but with a manageable safety compared to placebo + FULV in patients with HR+/HER2- locally advanced (unresectable) or metastatic breast cancer following progression on or after an ET with or without a CDK4/6 inhibitor, who have an AKT pathway alteration (PIK3CA, AKT1, or PTEN).PSD · Nov 2024
6.42 The ESCs agreed with the commentary that the claim of superior PFS in AKT pathway altered patients was adequately supported. However, the treatment benefit of CAPI+FULV compared to placebo + FULV in CAPItello-291 may have reduced applicability to Australian clinical practice and any clinical benefit compared to SOC in the Australian setting was potentially overestimated because:PSD · Nov 2024
6.2 The PBAC noted and welcomed the input from 3 organisations via the Consumer Comments facility on the PBS website. The input from Rare Cancers Australia described the impact of breast cancer on patients and the challenges of current treatments, including surgery, chemotherapy and hormone therapies.PSD · Nov 2024
6.3 The Medical Oncology Group of Australia (MOGA) also expressed its strong support for the capivasertib submission, categorising it as one of the therapies of “high priority for PBS listing” on the basis of the CAPItello-291 trial. The PBAC noted that the MOGA presented a European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) for capivasertib, which was limited to 3 (out of a maximum of 5, 13PSD · Nov 2024
Cost-effectiveness
ICER not stated in document. Economic analysis versus fulvestrant monotherapy was conducted but no numeric ICER value or band is presented in the PSD.
Decision context
Populationpatients with newly diagnosed locally advanced or progression to metastatic HR+/HER2- breast cancer
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | fulvestrant monotherapy | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| CAPItello-291 | Ph 3 | 818 | Progression Free Survival: Overall Population (Months) in the Global Cohort | active not recruiting |
Consumer voice
Three organisations provided consumer input on capivasertib, highlighting the impact of breast cancer and treatment challenges. The input emphasised the benefits of oral treatment for quality of life, the significance of progression-free survival gains, and concerns about high costs limiting equitable access to treatment.
The advantage of capivasertib being an oral treatment, potentially allowing patients to return to a more normal daily life while receiving treatment. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to confirmed AKT pathway alterations (PIK3CA, AKT1, or PTEN); TGA label has no biomarker requirement.