Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p67
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 67/312)
Character Range: 15845660–15854455

Patient must be at least 18 years of age.
                                                                                                                           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).
                                                                                                                           In relation to the immediately preceding supply of this biological medicine, provide at least one of the following which is not more than 4 weeks from the last administered dose
                                                                                                                           (i) the Crohn Disease Activity Index (CDAI) score, including the date the score was calculated on; or
                                                                                                                           (ii) the unique serial/identifying number and date(s) of pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant.
C14729              P14729         CN14729          Zoledronic acid                                                        Adjuvant management of breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 14729
                                                                                                                           Patient must be post-menopausal;
                                                                                                                           Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months.
C14730              P14730         CN14730          Adalimumab                                                             Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                           Continuing treatment - balance of supply
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or
                                                                                                                           Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) 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 restrictions; AND
                                                                                                                           Must be treated by a rheumatologist.  or
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
C14734              P14734         CN14734          Upadacitinib                                                           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
                                                                                                                           The treatment must not have on a previous occasion failed to provide the patient with an adequate response during the current treatment cycle;
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           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