Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p164
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 164/191)
Character Range: 11166017–11175033

initial application, the same marker will be used to determine response.
                                                                                                                                                                                                                               The authority application must be made in writing and must include
                                                                                                                                                                                                                               (1) completed authority prescription form(s); and
                                                                                                                                                                                                                               (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form.
                                                                                                                                                                                                                               Where the most recent course of PBS-subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
                                                                                                                                                                                                                               An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
                                                                                                                                                                                                                               Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
                                                                                                                                                                                                                               If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                                                                                                               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.
                                                                                                                                                                                                                               If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
C9560               P9560          CN9560           Rifabutin                                                                                                                                                                  Mycobacterium avium complex infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 9560
                                                                                                                                                                                                                               Patient must be human immunodeficiency virus (HIV) positive.
C9562               P9562          CN9562           Baclofen                                                                                                                                                                   Severe chronic spasticity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 9562
                                                                                                                                                                                                                               Patient must have failed to respond to treatment with oral antispastic agents; or
                                                                                                                                                                                                                               Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
                                                                                                                                                                                                                               Patient must have chronic spasticity of cerebral origin.
C9571               P9571          CN9571           Trastuzumab                                                                                                                                                                Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 9571
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not have progressive disease; AND
                                                                                                                                                                                                                               The treatment must not