Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p160
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 160/191)
Character Range: 11128969–11139527

treatment cycle. 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.
C9488               P9488          CN9488           Baclofen                                                                                                                                                                   Severe chronic spasticity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 9488
                                                                                                                                                                                                                               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.
C9489               P9489          CN9489           Baclofen                                                                                                                                                                   Severe chronic spasticity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 9489
                                                                                                                                                                                                                               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 injury.
C9490               P9490          CN9490           Clozapine                                                                                                                                                                  Schizophrenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 9490
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient; AND
                                                                                                                                                                                                                               Patient must be non-responsive to other neuroleptic agents.  or
                                                                                                                                                                                                                               Patient must be intolerant of other neuroleptic agents.
                                                                                                                                                                                                                               Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.
                                                                                                                                                                                                                               The name of the consulting psychiatrist should be included in the patient's medical records.
                                                                                                                                                                                                                               A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised.
C9519               P9519          CN9519           Blinatumomab                                                                                                                                                               Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                                                                               Induction treatment - balance of supply
                                                                                                                                                                                                                               The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
                                                                                                                                                                                                                               The condition must not be present in the central nervous system or testis; AND
                                                                                                                                                                                                                               Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this agent for this condition under the Induction treatment restriction to complete a maximum of 2 treatment cycles in a lifetime.
                                                                                                                                                                                                                               According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or