Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p169
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 169/191)
Character Range: 11212493–11222334

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 on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. The date of the relevant pathology report(s) need(s) to be provided
C9622               P9622          CN9622           Rifabutin                                                                                                                                                                  Mycobacterium avium complex infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 9622
                                                                                                                                                                                                                               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.
C9623               P9623          CN9623           Deferiprone                                                                                                                                                                Iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 9623
                                                                                                                                                                                                                               Patient must have thalassaemia major; AND
                                                                                                                                                                                                                               Patient must be unable to take desferrioxamine therapy.
C9624               P9624          CN9624           Dornase alfa                                                                                                                                                               Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9624
                                                                                                                                                                                                                               Patient must be 5 years of age or older.
                                                                                                                                                                                                                               Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
                                                                                                                                                                                                                               Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.
                                                                                                                                                                                                                               Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.
                                                                                                                                                                                                                               To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment
                                                                                                                                                                                                                               (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
                                                                                                                                                                                                                               (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
                                                                                                                                                                                                                               Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.
C9625               P9625          CN9625           Certolizumab pegol                                                                                                                                                         Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the