Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Early breast cancer

Initial treatment

The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND

Patient must have received neoadjuvant or adjuvant chemotherapy; AND

The treatment must be adjuvant to surgical resection; AND

The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene variant; AND

Patient must have received neoadjuvant chemotherapy, and residual invasive cancer is confirmed in the breast and/or resected lymph nodes (pathological complete response was not achieved); or

Patient must have received adjuvant chemotherapy for triple negative breast cancer, and has either: (a) node positive disease is present, (b) a primary tumour greater than 20 mm; or

Patient must have received adjuvant chemotherapy for hormone receptor positive breast cancer, and has at least 4 positive lymph nodes; AND

The treatment must not be a PBS-subsidised benefit beyond the following, whichever comes first: (i) a total of 52 weeks of treatment (including any non-PBS-subsidised supply), (ii) disease recurrence. Mark any remaining repeat prescriptions with the word 'cancelled' where (i)/(ii) has occurred; AND

The treatment must be commenced within 12 weeks of completing other therapy noting that other therapy can be any of the following therapy: (i) surgery, (ii) radiotherapy, (iii) chemotherapy; AND

The treatment must not in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab, (iii) ribociclib.

Retain all pathology imaging and investigative test results in the patient's medical records.

Treatment with this drug for this condition is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under metastatic disease is no longer available).