Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p120
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 120/312)
Character Range: 16219487–16229474

(i) a drug from the same pharmacological class as this drug (ii) inclisiran; AND
                                                                                                                           The treatment must be in conjunction with dietary therapy and exercise; AND
                                                                                                                           Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran, for this PBS indication.
C15204              P15204         CN15204          Upadacitinib                                                           Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                           First Continuing treatment - balance of supply
                                                                                                                           Must be treated by a rheumatologist; OR
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                                           The treatment must provide no more than the balance of up to 24 weeks treatment.
C15205              P15205         CN15205          Dostarlimab                                                            Advanced, metastatic or recurrent endometrial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 15205
                                                                                                                           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 receiving PBS-subsidised treatment with this drug for this condition.
                                                                                                                           Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 36 cumulative months from the first administered dose, once in a lifetime.
C15206              P15206         CN15206          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.
                                                                                                                           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).
C15209              P15209         CN15209          Ribociclib                                                             Locally advanced or metastatic breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           Patient