Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p71
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 71/162)
Character Range: 15023650–15031494

identifying number/code or provider number) of evidence that the patient has been diagnosed with giant cell arteritis with a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis.
                                                                                                         All reports must be documented in the patient's medical records.
                                                                                                         If the application is submitted through HPOS form upload or mail, it must include
                                                                                                         (i) A completed authority prescription form; and
                                                                                                         (ii) 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).
C14196              P14196         CN14196          Trabectedin                                          Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 14196
                                                                                                         Initial treatment
                                                                                                         Patient must have an ECOG performance status of 2 or less; AND
                                                                                                         Patient must have received prior chemotherapy treatment including an anthracycline; AND
                                                                                                         The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
                                                                                                         The condition must be one of the following subtypes for patients with liposarcoma:
                                                                                                          (i) dedifferentiated, (ii) myxoid, (iii) round-cell, (iv) pleomorphic.
                                                                                                         This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
C14197              P14197         CN14197          Trabectedin                                          Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 14197
                                                                                                         Continuing treatment
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                         The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.
                                                                                                         This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
C14202              P14202         CN14202          Mifepristone and misoprostol                         Termination of an intra-uterine pregnancy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 14202
                                                                                                         The condition must be an intra-uterine pregnancy of up to 63 days of gestation.
C14217              P14217         CN14217          Bimekizumab                                          Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                         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
                                                    Upadacitinib                                         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
                                                                                                         Patient must have received insufficient therapy with this drug for this condition under the