Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p211
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 211/312)
Character Range: 16809882–16819361

prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.
C15800              P15800         CN15800          Ganciclovir                                                            Cytomegalovirus infection and disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 15800
                                                                                                                           Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.
                                                    Valganciclovir

C15801              P15801         CN15801          Migalastat                                                             Fabry disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record; AND
                                                                                                                           Patient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by migalastat.
                                                                                                                           Must be treated by a physician with expertise in the management of Fabry disease.
C15803              P15803         CN15803          Crizotinib                                                             Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
                                                                                                                           The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
                                                                                                                           Patient must have a WHO performance status of 2 or less; AND
                                                                                                                           Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.
                                                                                                                           Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
                                                                                                                           If the application is submitted through HPOS form upload or mail, it 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).
                                                                                                                           The following must be documented in the patient's medical records:
                                                                                                                           (a) evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.
C15804              P15804         CN15804          Lorlatinib                                                             Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND
                                                                                                                           The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
                                                                                                                           Patient must have a WHO performance status of 2 or less; AND
                                                                                                                           Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ