Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p39
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 39/191)
Character Range: 9902186–9914001

CN5572           Ponatinib                                                                                                                                                                  Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               Patient must be expressing the T315I mutation; AND
                                                                                                                                                                                                                               Patient must have failed treatment with chemotherapy, with or without another tyrosine kinase inhibitor; AND
                                                                                                                                                                                                                               Patient must have failed allogeneic haemopoietic stem cell transplantation (where appropriate).
                                                                                                                                                                                                                               Failure of treatment is defined as either
                                                                                                                                                                                                                               1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy, with or without another tyrosine kinase inhibitor;
                                                                                                                                                                                                                               2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy, with or without another tyrosine kinase inhibitor;
                                                                                                                                                                                                                               3. Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation.
                                                                                                                                                                                                                               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.
                                                                                                                                                                                                                               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 Initial PBS authority application form; and
                                                                                                                                                                                                                               3. a signed patient acknowledgement; and
                                                                                                                                                                                                                               4. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript.; and evidence of the T315I mutation. The date of the relevant pathology report(s), which should be within the previous 6 months, need(s) to be provided
C5589               P5589          CN5589           Ponatinib                                                                                                                                                                  Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously been issued with an authority prescription for this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               Patient must not have progressive disease.
C5593               P5593          CN5593           Ciprofloxacin                                                                                                                                                              Chronic suppurative otitis media                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                                                                                                               Patient must be an Aboriginal or a Torres Strait Islander person;
                                                                                                                                                                                                                               Patient must be aged 1 month or older.
C5597               P5597          CN5597           Mycobacterium bovis (Bacillus Calmette and Guerin (BCG)) Danish 1331 strain                                                                                                Primary and relapsing superficial urothelial carcinoma of the bladder

                                                    Mycobacterium bovis (Bacillus Calmette and Guerin), Tice strain

C5600               P5600          CN5600           Mycophenolic acid                                                                                                                                                          Management of cardiac allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 5600
                                                                                                                                                                                                                               Management (initiation, stabilisation and review of therapy)
                                                                                                                                                                                                                               Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
                                                                                                                                                                                                                               The treatment must be under the supervision and direction of a transplant unit.
C5605               P5605          CN5605