Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p134
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 134/312)
Character Range: 16299712–16305937

Patient must be at least 18 years of age.
                                                                                                                           Must be treated by a dermatologist.
                                                                                                                           The most recent PASI assessment must be no more than 4 weeks old at the time of application.
                                                                                                                           The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (1) a completed authority prescription form(s); and
                                                                                                                           (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition.
                                                                                                                           To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                                                           Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                           If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
C15242              P15242         CN15242          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