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

Metastatic breast cancer

Initial treatment

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

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

Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND

Patient must have received chemotherapy in the neoadjuvant, adjuvant or metastatic setting; AND

Patient must not have received PBS-subsidised treatment with this drug in any earlier line of treatment for breast cancer; AND

The condition must be triple negative breast cancer; or

The condition must be hormone-receptor positive breast cancer and the patient has either: (i) progressive disease after receiving endocrine therapy, (ii) been considered inappropriate for endocrine therapy; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND

Must be treated by a medical practitioner.

Retain all pathology imaging and investigative test results in the patient's medical records. Do not submit copies of these as part of the authority application.

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).

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

Metastatic breast cancer

Continuing treatment

Patient must have received previous PBS-subsidised treatment with this drug in the metastatic setting; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND

Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND

Must be treated by a medical practitioner; or

Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.