Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p170
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 170/191)
Character Range: 11221859–11232156

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 Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 18 to 20 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 18 to 20 weeks treatment; AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions; AND
                                                                                                                                                                                                                               Must be treated by a rheumatologist.  or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
C9635               P9635          CN9635           Ocrelizumab                                                                                                                                                                Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 9635
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not show continuing progression of disability while on treatment with this drug; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                                                                               Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND
                                                                                                                                                                                                                               Must be treated by a neurologist.
C9636               P9636          CN9636           Alemtuzumab                                                                                                                                                                Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 9636
                                                                                                                                                                                                                               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.
C9637               P9637          CN9637           Baclofen                                                                                                                                                                   Severe chronic spasticity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 9637
                                                                                                                                                                                                                               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.
C9638               P9638          CN9638