Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p114
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 114/312)
Character Range: 16182892–16189992

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.
                                                                                                                           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).
C15186              P15186         CN15186          Abemaciclib                                                            Early breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                           The treatment must be adjuvant to surgical resection; 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.
                                                                                                                           Patient must be undergoing concurrent treatment with endocrine therapy where this drug is being prescribed as a PBS benefit.
                                                                                                                           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).
C15188              P15188         CN15188          Mavacamten                                                             Symptomatic obstructive hypertrophic cardiomyopathy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                           First continuing treatment (until at least 6 months on optimal dose is achieved)
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction; OR
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition under the grandfather treatment restriction if dose titration or 6 months on optimal dose is yet to be achieved; AND
                                                                                                                           Patient must be undergoing concomitant treatment with at least one of: (i) a beta-blocker (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: