PalbociclibIbrance
Treatment of patients with locally advanced (stage IIIB/IIIC) or metastatic (stage IV) hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have received previous endocrine therapy, in combination with fulvestrant.
Decisions on record
- Meeting Mar 2022 Recommended Breast cancer
- Meeting Jul 2021 Recommended HR+ HER2- advanced/metastatic breast cancer
- Meeting Mar 2018 Recommended Hormone receptor- positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) advanced or metastatic breast cancer
- Meeting Nov 2017 Not recommended Indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; fulvestrant in patients who have received prior therapy.
- Meeting Mar 2017 Not recommended Hormone receptor positive, human epidermal growth factor receptor 2 (HER2)- negative advanced breast cancer
Access path
- TGA registered · Ibrance
TGA label narrower than the PBS population
- Mar 2017Not recommended
vs NSAI alone (letrozole or anastrozole)
- Nov 2017Not recommended
Comparator changed: NSAI alone (letrozole or anastrozole) → non-steroidal aromatase…
- ↻ resubmittedMar 2018Recommended
Comparator changed: non-steroidal aromatase inhibitor (letrozole or anastrozole) →…
- Jul 2021Recommended · restricted
Evidence: RCT → Other
- Mar 2022Recommended · restricted
Evidence: Other → RCT
- PBS listing · Restricted
From the public summary
The PBAC recommended the listing of palbociclib, in combination with fulvestrant, for the treatment of patients with locally advanced (stage IIIB/IIIC) or metastatic (stage IV) hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have received previous endocrine therapy.PSD · Mar 2022
The PBAC noted that the Medical Oncology Group of Australia supported the listing of palbociclib plus fulvestrant on the PBS for the treatment of breast cancer.PSD · Mar 2022
The submission adopted a cost-minimisation approach (CMA) on the basis that palbociclib plus fulvestrant is non-inferior to ribociclib plus fulvestrant in terms of efficacy and similar in terms of safety. 22PSD · Mar 2022
The submission proposed that the equi-effective doses for the existing listing of palbociclib in combination with a NSAI and ribociclib in combination with a NSAI be applied to the CMA for palbociclib in combination with fulvestrant and ribociclib in combination with fulvestrant.PSD · Mar 2022
The submission described palbociclib plus fulvestrant as non-inferior in terms of efficacy to ribociclib plus fulvestrant and to abemaciclib plus fulvestrant, in patients with HR+/HER2− inoperable locally advanced or metastatic breast cancer previously treated with endocrine therapy.PSD · Mar 2022
The PBAC considered that the claims of non-inferiority in terms of comparative clinical effectiveness between palbociclib plus fulvestrant and (i) ribociclib plus fulvestrant and (ii) abemaciclib plus fulvestrant were supported, noting that:PSD · Mar 2022
The Medical Oncology Group of Australia (MOGA) expressed its support for palbociclib for use in combination with fulvestrant. The PBAC noted that the MOGA presented a European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO- MCBS) for palbociclib, which was limited to 4 (out of a maximum of 5, where 5 and 4 represent the grades with substantial improvement)6, based on a comparison with fulvestrant in the PALOMA-3 trial.PSD · Mar 2022
The submission requested that the proposed extended listing of palbociclib, for use in combination with fulvestrant, be included in the existing RSA that palbociclib currently shares with ribociclib and abemaciclib. The ESC considered that this would be 27PSD · Mar 2022
Cost-effectiveness
Cost-minimisation analysis adopted; no ICER calculated by design.
The submission adopted a cost-minimisation approach (CMA) on the basis that palbociclib plus fulvestrant is non-inferior to ribociclib plus fulvestrant in terms of efficacy and similar in terms of safety. PSD · 2022
Decision context
PopulationPre-/peri- or postmenopausal patients (but restricted to not premenopausal) with HR+/HER2- locally advanced inoperable or metastatic breast cancer who have received previous endocrine therapy, experienced disease progression, developed endocrine resistance, and have not previously been treated with a CDK4/6 inhibitor or developed intolerance to one necessitating withdrawal, with WHO ECOG status ≤2.
Risk sharingExtended listing would be included within the existing Risk Sharing Agreement that palbociclib currently shares with ribociclib and abemaciclib.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended · restricted | ribociclib in combination with fulvestrant | — | RCT · PFS |
| Jul 2021 | Recommended · restricted | — | — | Other |
| Mar 2018 | Recommended | non-steroidal aromatase inhibitor (letrozole or anastrozole) alone | $105k–200k | RCT · PFS |
| Nov 2017 | Not recommended | non-steroidal aromatase inhibitor (letrozole or anastrozole) | — | RCT · PFS |
| Mar 2017 | Not recommended | NSAI alone (letrozole or anastrozole) | — | RCT · PFS |
Clinical evidence
Consumer voice
The Medical Oncology Group of Australia expressed support for palbociclib in combination with fulvestrant, presenting an ESMO-MCBS score of 4 based on the PALOMA-3 trial comparison with fulvestrant alone.
The Medical Oncology Group of Australia (MOGA) expressed its support for palbociclib for use in combination with fulvestrant. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to prior endocrine therapy failure and CDK4/6-inhibitor-naive patients; TGA label permits initial AI therapy without these prerequisites.