Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p161
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 161/191)
Character Range: 11139290–11150134

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 more hours), supervision by a health care professional or hospitalisation is recommended.
                                                                                                                                                                                                                               An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.
                                                                                                                                                                                                                               Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
C9523               P9523          CN9523           Ocrelizumab                                                                                                                                                                Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 9523
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or
                                                                                                                                                                                                                               The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                                                                               Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                                                                               Patient must be ambulatory (without assistance or support); AND
                                                                                                                                                                                                                               Must be treated by a neurologist.
                                                                                                                                                                                                                               Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C9524               P9524          CN9524           Baclofen                                                                                                                                                                   Severe chronic spasticity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 9524
                                                                                                                                                                                                                               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.
C9525               P9525          CN9525           Baclofen                                                                                                                                                                   Severe chronic spasticity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 9525
                                                                                                                                                                                                                               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 multiple sclerosis.
C9527               P9527          CN9527           Mannitol                                                                                                                                                                   Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9527
                                                                                                                                                                                                                               The treatment must be as monotherapy; AND
                                                                                                                                                                                                                               Patient must be intolerant or inadequately responsive to dornase alfa;
                                                                                                                                                                                                                               Patient must be 6 years of age or older.
                                                                                                                                                                                                                               Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.
                                                                                                                                                                                                                               Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience