Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p25
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 25/162)
Character Range: 14788063–14795568

and the date of the first application under a new cycle under the initial 3 treatment restriction.
                                                                                                         A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
C14015              P14015         CN14015          Daratumumab                                          Newly diagnosed systemic light chain amyloidosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                         Initial treatment from week 0 to week 24
                                                                                                         The condition must have histological evidence consistent with a diagnosis of systemic light-chain amyloidosis; AND
                                                                                                         The condition must be untreated with drug therapy, including this drug, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); AND
                                                                                                         Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND
                                                                                                         Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND
                                                                                                         Patient must be undergoing concomitant treatment limited to each of:
                                                                                                          (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug's approved Product Information.
                                                                                                         The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include
                                                                                                         Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to (i) the name of pathologist/pathology provider, (ii) the site of biopsy
                                                                                                         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).
C14017              P14017         CN14017          Ozanimod                                             Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 14017
                                                                                                         Dose escalation occurring at initial treatment or re-initiation of treatment
                                                                                                         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)].
C14018              P14018         CN14018          Ustekinumab                                          Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                         Continuing treatment
                                                                                                         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 this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                         Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater