FulvestrantFulvestrant Accord

The PBAC recommended the listing of fulvestrant for the treatment of patients with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) unresectable advanced or metastatic breast cancer (ABC). The PBAC was satisfied that first line treatment with fulvestrant provides, for some patients, an improvement in efficacy over NSAIs. The PBAC also considered, on balance, fulvestrant 37PSD · Jul 2020

The PBAC recalled that it, along with the BCNA and MOGA Breast Cancer Expert Group, had requested that the sponsor provide a submission for fulvestrant. The PBAC considered that the main clinical need for fulvestrant monotherapy was:  In the first-line setting: older or frail patients who wish to avoid CDK4/6 inhibitors or who are intolerant to CDK4/6 inhibitors, or patients who progressed on NSAIs in the adjuvant setting, and  In the second-line and …PSD · Jul 2020

The submission presented a cost-effectiveness model comparing fulvestrant to anastrozole as first-line treatment for HR+ HER2- ABC, based on the FALCON and FIRST trials. This is consistent with the clinical claim of superior efficacy and non-inferior 24PSD · Jul 2020

Table 13 summarises the key components of the economic evaluation for first-line therapy.PSD · Jul 2020

In HR+, HER2- ABC, fulvestrant has superior efficacy in terms of OS and non-inferior safety compared with non-steroidal aromatase inhibitors. Second-line:PSD · Jul 2020

In HR+, HER2- ABC, fulvestrant is non-inferior in terms of OS and has superior safety compared with everolimus in combination with exemestane HR+, hormone receptor positive; HER2-, human epidermal growth factor receptor 2 negative; ABC, advanced breast cancer; ORR, overall response rate; OS, overall survival; PFS, progression free survival Source: Table 1.1, p14 of the submission, p143 of submissionPSD · Jul 2020

The PBAC noted the advice received from Breast Cancer Network Australia (BCNA) in support of PBS listing of fulvestrant. BCNA reported that while the combination use with CDK4/6 inhibitors is currently the main area of need, having fulvestrant available through the PBS as a monotherapy and for other combination therapies would also be a welcome outcome.PSD · Jul 2020

One consumer comment was also received from a medical oncologist, who noted that fulvestrant is used regularly overseas, and is associated with better quality of life than chemotherapy. Without PBS access to fulvestrant, patients may be treated with chemotherapy earlier in their treatment.PSD · Jul 2020