Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p167
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 167/191)
Character Range: 11193388–11203110

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 mannitol at a dose of 400 mg twice 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.
C9601               P9601          CN9601           Inotuzumab ozogamicin                                                                                                                                                      Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                                                                               Consolidation treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised induction treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have achieved a complete remission; or
                                                                                                                                                                                                                               Patient must have achieved a complete remission with partial haematological recovery; AND
                                                                                                                                                                                                                               The treatment must not be more than 5 treatment cycles under this restriction in a lifetime; AND
                                                                                                                                                                                                                               Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.
                                                                                                                                                                                                                               This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
                                                                                                                                                                                                                               The treatment must not exceed 0.5mg per m2 for all doses within a treatment cycle
                                                                                                                                                                                                                               Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.
C9603               P9603          CN9603           Peginterferon alfa-2a                                                                                                                                                      Chronic hepatitis C infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 9603
                                                                                                                                                                                                                               Must be treated in an accredited treatment centre;
                                                                                                                                                                                                                               Patient must be aged 18 years or older;
                                                                                                                                                                                                                               Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age;
                                                                                                                                                                                                                               Patient must have compensated liver disease; AND
                                                                                                                                                                                                                               Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
                                                                                                                                                                                                                               Patient must have a contraindication to ribavirin; AND
                                                                                                                                                                                                                               The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral 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