AbemaciclibVerzenio
Adjuvant treatment of hormone receptor positive, HER2-negative, lymph node positive, invasive, resected early breast cancer at high risk of disease recurrence, in combination with standard endocrine therapy.
Decisions on record
- Meeting Nov 2023 Recommended HR+ HER2- lymph node positive invasive resected early breast cancer at high risk of recurrence
- Meeting Mar 2023 Recommended HR+, HER2-, lymph node positive, invasive, resected early breast cancer at high risk of disease recurrence
- Meeting Mar 2022 Not recommended HR+ HER2- lymph node positive early breast cancer at high risk of recurrence
- Meeting Mar 2021 Recommended HR+ HER2- inoperable locally advanced or metastatic breast cancer
- Meeting Nov 2019 Recommended Advanced breast cancer no PSD
- Meeting Mar 2019 Deferred Advanced breast cancer
Access path
- TGA registered · Verzenio
TGA label narrower than the PBS population
- Mar 2019Recommended · restricted
vs ribociclib plus NSAI
- Mar 2021Recommended · restricted
Comparator changed: ribociclib plus NSAI → ribociclib in combination with fulvestrant
- Mar 2022Not recommended
Comparator changed: ribociclib in combination with fulvestrant → endocrine therapy alone
- ↻ resubmittedMar 2023Recommended · restricted
Comparator changed: endocrine therapy alone → Adjuvant endocrine therapy alone
- Nov 2023Recommended · restricted
Comparator changed: Adjuvant endocrine therapy alone → standard adjuvant endocrine…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the General Schedule Authority Required listing of abemaciclib, in combination with standard adjuvant endocrine therapy (ET), for the treatment of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), lymph node positive, invasive, resected early breast cancer (EBC) at high risk of disease recurrence.PSD · Nov 2023
The PBAC noted the consumer comments emphasising the clinical need for reducing the risk of recurrence for patients diagnosed with high risk EBC and emphasising the likely clinical benefit associated with access to cyclin-dependent kinase (CDK)4/6 inhibitor therapy for these patients. The PBAC noted the consumer comments outlining the disease free survival benefits associated with abemaciclib, based on the results of the monarchE trial.PSD · Nov 2023
The current submission presented a modelled economic evaluation comparing ABE + ET to ET alone based on the monarchE randomised control trial. The type of economic evaluation presented was a cost-utility analysis (CUA). The approach remained unchanged from the March 2023 resubmission.PSD · Nov 2023
The economic model presented in the submission was a cohort state transition model (Markov) with five health states. The health states were IDFS, non-metastatic recurrence, remission, metastatic recurrence, and death. Death and metastatic recurrence were modelled as absorbing health states. The structure of the economic model including health states remained unchanged from the March 2023 resubmission.PSD · Nov 2023
• ABE + ET provides monitorable and manageable safety to ET alone Source: Table 11, p24 of the submission.PSD · Nov 2023
Bold text indicates changes from previous submission. The current submission included the word “standard” to “adjuvant ET alone” and the word “monitorable” to “manageable safety to ET alone”.PSD · Nov 2023
The organisations outlined the clinical benefits associated with the treatment of abemaciclib based on the monarchE trial and emphasised the need for additional therapy options for patients with HER2-/HR+ breast cancer. The organisations also emphasised the psycho-social benefits associated with reducing the fear of disease recurrence and the likely associated improvements to overall wellbeing and quality of life.PSD · Nov 2023
The PBAC previously noted that there was significant risk in use outside the proposed restriction to patients with lower risk of recurrence than seen in the monarchE trial (para 7.14, abemaciclib, PSD, March 2022 PBAC meeting). The current submission proposed a Risk Sharing Agreement with annual subsidisation caps (SCs) with a rebate of % for use exceeding the financial caps.PSD · Nov 2023
Cost-effectiveness
ICER value is redacted (commercially sensitive); document indicates PBAC previously considered an ICER of up to $30,000/QALY gained would account for uncertainty regarding modelled OS.
The submission presented a cost-minimisation analysis on the basis that abemaciclib and ribociclib are clinically equivalent in terms of effectiveness and safety. PSD · 2019
Decision context
PopulationAdult patients with hormone receptor positive (HR+), HER2-negative, lymph node positive, invasive, resected early breast cancer (stages 1-3) at high risk of recurrence, defined as either ≥4 positive axillary lymph nodes or 1-3 positive axillary lymph nodes plus either tumour size ≥5 cm or grade 3 tumour histology.
Risk sharingRisk sharing arrangement (RSA) with annual subsidisation caps and rebate for use exceeding financial caps.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended · restricted | standard adjuvant endocrine therapy (ET) alone | — | RCT · IDFS |
| Mar 2023 | Recommended · restricted | Adjuvant endocrine therapy alone | — | RCT · IDFS |
| Mar 2022 | Not recommended | endocrine therapy alone | — | RCT · Invasive disease-free survival |
| Mar 2021 | Recommended · restricted | ribociclib in combination with fulvestrant | — | RCT · PFS |
| Mar 2019 | Recommended · restricted | ribociclib plus NSAI | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| monarchE | Ph 3 | 5,637 | Invasive Disease Free Survival (IDFS) | active not recruiting |
Consumer voice
Healthcare professionals and patients reported that abemaciclib provides improved disease-free survival and quality of life benefits for high-risk early breast cancer, with manageable side effects. Five organizations supported PBS listing, noting that private cost is currently a barrier to access.
disease recurrence for these patient is often incurable and life-limiting Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to first-line use and defines high risk by specific lymph node and tumor criteria; TGA label does not specify these restrictions.