Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p111
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 111/312)
Character Range: 16161660–16170520

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.
                                                                                                                           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).
C15165              P15165         CN15165          Ribociclib                                                             Locally advanced or metastatic breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                           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
                                                                                                                           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).
C15167              P15167         CN15167          Palbociclib                                                            Locally advanced or metastatic breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                           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.
                                                                                                                           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).
C15169              P15169         CN15169          Mavacamten                                                             Symptomatic obstructive hypertrophic cardiomyopathy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment (covering the first 12 weeks of therapy)
                                                                                                                           Patient must have confirmed left ventricular hypertrophy due to hypertrophic cardiomyopathy; AND
                                                                                                                           Patient must have maximal end-diastolic left ventricular wall thickness 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