Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p74
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 74/312)
Character Range: 15896509–15904341

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 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)].
C14806              P14806         CN14806          Ustekinumab                                                            Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                           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)].
                                                                                                                           The authority application must be made in writing and must include
                                                                                                                           (1) a completed authority prescription form; and
                                                                                                                           (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                           An adequate response is defined as
                                                                                                                           (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
                                                                                                                           (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
                                                                                                                           The most recent fistula assessment must be no more than 1 month old at the time of application.
                                                                                                                           At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks.
C14808              P14808         CN14808          Ipilimumab                                                             Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 14808
                                                                                                                           Induction treatment
                                                                                                                           Patient must not have received prior treatment with nivolumab plus relatlimab, ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
                                                                                                                           Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
                                                                                                                           The condition must not be ocular or uveal melanoma; AND
                                                                                                                           The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
                                                                                                                           Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
                                                                                                                           Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every