Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p470
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 470/476)
Character Range: 3841414–3859146

must be made after the third dose of vedolizumab so there is adequate time for a response to be demonstrated. The assessment must be made prior to obtaining a PBS authority for continuing treatment from the dose at week 14.
                                                                                                                                            Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                                            Application for authorisation of initial treatment must be in writing and must include:
                                                                                                                                            (a) details of the proposed prescription; and
                                                                                                                                            (b) 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) which includes the details of prior biological medicine therapy for this condition [date of commencement and duration of therapy].
                                                                                                                                            The prescriber must have excluded secondary causes of pouchitis, for example:
                                                                                                                                            (a) Ischaemia;
                                                                                                                                            (b) Crohn's disease (CD) or CD of the pouch;
                                                                                                                                            (c) Irritable pouch syndrome;
                                                                                                                                            (d) Predominant cuffitis;
                                                                                                                                            (e) Pouch stricture or pouch fistula;
                                                                                                                                            (f) Active infection;
                                                                                                                                            (g) NSAIDs;
                                                                                                                                            (h) Coeliac disease.
Zidovudine                                                             C4454                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454
                                                                                                                                            Continuing
                                                                                                                                            Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents
                                                                       C4512                                                                HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512
                                                                                                                                            Initial
                                                                                                                                            Patient must be antiretroviral treatment naïve; AND
                                                                                                                                            The treatment must be in combination with other antiretroviral agents
Zoledronic acid                                                        C5605               P5605                                            Bone metastases                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 5605
                                                                                                                                            The condition must be due to breast cancer.
                                                                       C5703               P5703                                            Bone metastases                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 5703
                                                                                                                                            The condition must be due to castration‑resistant prostate cancer.
                                                                       C5704               P5704                                            Hypercalcaemia of malignancy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 5704
                                                                                                                                            Patient must have a malignancy refractory to anti‑neoplastic therapy.
                                                                       C5735               P5735                                            Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures ‑ Streamlined Authority Code 5735

                                                                       C9268               P9268                                            Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures ‑ Streamlined Authority Code 9268
                                                                       C9304               P9304                                            Bone metastases                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 9304
                                                                                                                                            The condition must be due to castration‑resistant prostate cancer.
                                                                       C9317               P9317                                            Hypercalcaemia of malignancy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures ‑ Streamlined Authority Code 9317
                                                                                                                                            Patient must have a malignancy refractory to anti‑neoplastic therapy.
                                                                       C9328               P9328                                            Bone metastases                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 9328
                                                                                                                                            The condition must be due to breast cancer.
                                                                       C14729              P14729                                           Adjuvant management of breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 14729
                                                                                                                                            Patient must be