Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p171
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 171/191)
Character Range: 11231200–11243115

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           Baclofen                                                                                                                                                                   Severe chronic spasticity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 9638
                                                                                                                                                                                                                               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.
C9639               P9639          CN9639           Interferon gamma-1b                                                                                                                                                        Chronic granulomatous disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 9639
                                                                                                                                                                                                                               Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents.
C9651               P9651          CN9651           Golimumab                                                                                                                                                                  Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment - balance of supply
                                                                                                                                                                                                                               Must be treated by a gastroenterologist (code 87); or
                                                                                                                                                                                                                               Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                                                                                                                                               Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 24 weeks treatment available under this restriction.
C9655               P9655          CN9655           Ustekinumab                                                                                                                                                                Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                                                                                                                                                               Must be treated by a gastroenterologist (code 87); or
                                                                                                                                                                                                                               Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                                                                                                                                               Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                                                                                                                                               Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                                                                                                                               Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
                                                                                                                                                                                                                               The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction;
                                                                                                                                                                                                                               Patient must be aged 18 years or older.
                                                                                                                                                                                                                               Applications for authorisation must be made in writing and must include
                                                                                                                                                                                                                               (a) two completed authority prescription forms; and
                                                                                                                                                                                                                               (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form, which includes the following
                                                                                                                                                                                                                               (i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
                                                                                                                                                                                                                               (ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome,