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

Early breast cancer

The treatment must be adjuvant to surgical resection; AND

Patient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; 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 not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing this drug; AND

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

The condition must be hormone receptor positive; AND

The condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system); AND

The treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 2 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression; AND

The treatment must not be in combination with any of the following: (i) olaparib, (ii) pembrolizumab, (iii) ribociclib; AND

Patient must be undergoing concurrent treatment with endocrine therapy where this drug is being prescribed as a PBS benefit; 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.

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

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).