Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p124
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 124/312)
Character Range: 16246649–16253686

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.
                                                                                                                           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 following:
                                                                                                                           (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
                                                                                                                           (ii) details of prior biological treatment, including dosage, date and duration 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.
                                                                                                                           A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
                                                                                                                           At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.
C15218              P15218         CN15218          Abemaciclib                                                            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.
                                                                                                                           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).
C15219              P15219         CN15219          Abemaciclib                                                            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)