Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p168
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 168/191)
Character Range: 11202435–11213013

load has decreased by at least a 2 log drop; AND
                                                                                                                                                                                                                               The treatment must be limited to a maximum duration of 48 weeks.
                                                                                                                                                                                                                               Evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
C9604               P9604          CN9604           Azithromycin                                                                                                                                                               Mycobacterium avium complex infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 9604
                                                                                                                                                                                                                               The treatment must be for prophylaxis; AND
                                                                                                                                                                                                                               Patient must be human immunodeficiency virus (HIV) positive; AND
                                                                                                                                                                                                                               Patient must have CD4 cell counts of less than 75 per cubic millimetre.
C9606               P9606          CN9606           Baclofen                                                                                                                                                                   Severe chronic spasticity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 9606
                                                                                                                                                                                                                               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 due to spinal cord disease.
C9614               P9614          CN9614           Ponatinib                                                                                                                                                                  Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               The condition must be expressing the Philadelphia chromosome; or
                                                                                                                                                                                                                               The condition must have the transcript BCR-ABL; AND
                                                                                                                                                                                                                               Patient must have failed prior treatment with PBS-subsidised dasatinib for this condition.  or
                                                                                                                                                                                                                               Patient must have developed intolerance to PBS-subsidised dasatinib of a severity requiring treatment withdrawal.
                                                                                                                                                                                                                               Failure of treatment with dasatinib is defined as either
                                                                                                                                                                                                                               1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with PBS-subsidised dasatinib for this condition; or
                                                                                                                                                                                                                               2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by PBS-subsidised dasatinib for this condition; or
                                                                                                                                                                                                                               3. Rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.
                                                                                                                                                                                                                               Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission; OR rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.
                                                                                                                                                                                                                               The authority application must be made in writing and must include
                                                                                                                                                                                                                               1. a completed authority prescription form; and
                                                                                                                                                                                                                               2. a completed Acute Lymphoblastic Leukaemia ponatinib PBS Authority Application - Supporting Information Form; and
                                                                                                                                                                                                                               3. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided; or
                                                                                                                                                                                                                               4. pathology reports documenting rising levels of BCR-ABL1 transcript