RibociclibKisqali

7.1 The PBAC did not recommend the listing of ribociclib, as combination therapy with adjuvant endocrine therapy (ET), for the treatment of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), resected early breast cancer (eBC) with stage II or III disease with 1−3 positive axillary lymph nodes (ALNs) meeting specific histological and tumour size criteria, stage IIB or III disease with no positive lymph nodes or …PSD · Jul 2025

In the context of the increase in the number of adverse events reported with the addition of ribociclib to ET, and that patients treated in the adjuvant setting forego treatment with a CDK4/6 in the metastatic setting, the PBAC considered the overall benefit associated with adding ribociclib to ET in node negative/low patients had not been demonstrated to be clinically meaningful.PSD · Jul 2025

6.33 The submission presented a stepped economic evaluation comparing adjuvant ribociclib plus ET with ET alone, based on a subgroup of patients in the NATALEE trial in line with the proposed PBS population. The key components of the economic evaluation are summarised in Table 9. 21 OFFICIALPSD · Jul 2025

OFFICIAL Public Summary Document – July 2025 PBAC Meeting Table 9: Summary of model structure, key inputs and rationale Component Description Treatments Adjuvant treatment with ribociclib + ET vs ET Time horizon 30 years in the base case versus a median follow-up of 49.6 months in the NATALEE trial Outcomes LYs and QALYs Methods used to Cohort expected value analysis (Markov model) generate results Health states 6 health states: iDF, NMR, remission, SPM, …PSD · Jul 2025

6.26 The submission described ribociclib plus adjuvant ET as superior in terms of effectiveness compared to adjuvant ET alone.PSD · Jul 2025

6.27 The ESC considered the claim was adequately supported for iDFS, however considered that the absolute benefit was modest. In the PBS subgroup of the NATALEE trial, treatment with ribociclib + ET, in comparison to ET alone, resulted in an absolute benefit of iDFS of 1.3% at 3 years and 3.7% at 4 years and an absolute benefit of DRFS of 1.3% at 3 years and 2.8% at 4 years.PSD · Jul 2025

6.5 The PBAC acknowledged the input from health professionals discussed the treatment of early breast cancer, which aims to reduce the risk of recurrence and increase the proportion of cured individuals. The input also noted the importance of ribociclib as an additional treatment option to reduce recurrence rates, whilst noting that ribociclib had side effects, but that they were usually able to be managed.PSD · Jul 2025

6.6 The PBAC also acknowledged the input from individuals who would like access to ribociclib but have not used the medicine. The input discussed the devastating impact of a breast cancer diagnosis and the difficult side effects associated with current treatments, including fatigue, pain, brain fog, mobility issues and significant emotional impacts. The input also described the fear and anxiety related to the risk of recurrence.PSD · Jul 2025