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

Locally advanced or metastatic breast cancer

Initial treatment

Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or

Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND

The condition must be hormone receptor positive; AND

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

The condition must be inoperable; AND

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

The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with a non-steroidal aromatase inhibitor; or

The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND

The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND

Must be treated by a medical practitioner; AND

Patient must not be premenopausal.

PBS-subsidised treatment with CDK 4/6 inhibitors 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 locally advanced or metastatic disease is no longer available).

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

Locally advanced or metastatic breast cancer

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while being treated with this drug for this condition; AND

The treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND

The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; 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; AND

Patient must not be premenopausal.

A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.

PBS-subsidised treatment with CDK 4/6 inhibitors 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 locally advanced or metastatic disease is no longer available).