Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p155
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 155/191)
Character Range: 11088982–11101064

AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
C9429               P9429          CN9429           Golimumab                                                                                                                                                                  Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
                                                    Ixekizumab                                                                                                                                                                 Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 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 16 weeks treatment; or
                                                    Secukinumab                                                                                                                                                                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 16 weeks treatment; AND
                                                                                                                                                                                                                               The treatment must provide no more than the balance of up to 16 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.
C9431               P9431          CN9431           Certolizumab pegol                                                                                                                                                         Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment - balance of supply
                                                    Golimumab                                                                                                                                                                  Patient must have received insufficient therapy with this drug 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 the above restriction; AND
                                                    Ixekizumab                                                                                                                                                                 Must be treated by a rheumatologist.  or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
                                                    Secukinumab

                                                    Tofacitinib

                                                    Upadacitinib

C9443               P9443          CN9443           Mesalazine                                                                                                                                                                 Crohn disease

C9444               P9444          CN9444           Mesalazine                                                                                                                                                                 Ulcerative colitis

C9462               P9462          CN9462           Trastuzumab                                                                                                                                                                Metastatic (Stage IV) HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 9462
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
C9465               P9465          CN9465           Ponatinib                                                                                                                                                                  Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition.
C9470               P9470          CN9470           Inotuzumab ozogamicin                                                                                                                                                      Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Induction treatment
                                                                                                                                                                                                                               The condition must be relapsed or