Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p121
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 121/312)
Character Range: 16228000–16235497

breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).
C15209              P15209         CN15209          Ribociclib                                                             Locally advanced or metastatic breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                           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 one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; 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
                                                                                                                           Patient must require dosage reduction requiring a pack of 42 tablets.
                                                                                                                           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).
C15210              P15210         CN15210          Mavacamten                                                             Symptomatic obstructive hypertrophic cardiomyopathy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Written Authority Required procedures
                                                                                                                           Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements
                                                                                                                           Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 May 2024; AND
                                                                                                                           Patient must have had confirmed left ventricular hypertrophy due to hypertrophic cardiomyopathy prior to commencing non-PBS-subsidised treatment; AND
                                                                                                                           Patient must have had maximal end-diastolic left ventricular wall thickness, prior to commencing non-PBS-subsidised treatment, which is at least one of either: (i) no less than 15 mm; (ii) no less than 13 mm if patient has familial hypertrophic cardiomyopathy (at least one first degree relative with a diagnosis of hypertrophic cardiomyopathy); AND
                                                                                                                           Patient must have had confirmed peak left ventricular outflow tract (LVOT) gradient, prior to commencing non-PBS-subsidised treatment, of no less than 50 mm Hg which is measured either: (i) at rest; (ii) after provocation with at least one of: (a) Valsalva manoeuvre; (b) exercise; AND
                                                                                                                           Patient must have had left ventricular ejection fraction (LVEF) of no less than 55% prior to commencing non-PBS-subsidised treatment; AND
                                                                                                                           Patient must have had prior treatments with each of a (i) beta-blocker and (ii) non-dihydropyridine calcium channel blocker, unless contraindication/ intolerance present, prior to