Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p147
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 147/312)
Character Range: 16386455–16394018

practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders; this authority application must be sought by the same medical practitioner providing treatment.
                                                                                                                           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) a completed authority prescription form; 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).
                                                                                                                           Evidence of clinical findings to establish the diagnosis:
                                                                                                                           In this authority application, confirm that there is documented evidence of transthyretin precursor protein through either (1) alone, or, both (2) and (3), from the list below:
                                                                                                                           Confirm the following has been completed:
                                                                                                                           (1) amyloid expert centre histology findings derived via immunohistochemistry or mass spectrometry; OR
                                                                                                                           (2) bone scintigraphy with grade 2-3 finding
                                                                                                                           AND
                                                                                                                           (3) Confirm that there are negative results for monoclonal protein on each of the following three tests:
                                                                                                                           (a) serum immunofixation (also known as protein electrophoresis)
                                                                                                                           (b) urine immunofixation
                                                                                                                           (c) serum free light chains blood test
                                                                                                                           State which of (1) to (3) above has been completed, as well as the:
                                                                                                                           (i) date of the finding,
                                                                                                                           (ii) imaging/pathology report number/code that links the finding to the patient,
                                                                                                                           (iii) name of the amyloid expert centre in this authority application (if applicable).
                                                                                                                           For end-diastolic interventricular septal wall thickness (at least 12 mm), confirm that:
                                                                                                                           (i) imaging (echocardiogram or magnetic resonance imaging) has been undertaken; and
                                                                                                                           (ii) that the imaging report is stored in the patient's medical records.
                                                                                                                           State the date that the imaging was performed and the thickness (in mm) in this authority application.
                                                                                                                           Where this authority application is to transition a patient from non-PBS-subsidised to PBS-subsidised supply (i.e. a 'grandfathered' patient), confirm the following:
                                                                                                                           (i) the patient's heart failure has not worsened to persistent New York Heart Association Class III/IV heart failure while taking this drug.
C15363              P15363         CN15363          Melatonin                                                              Insomnia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Continuing
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have experienced/maintained a clinically meaningful response (as defined below) to the preceding supply of this drug - document the response improvement in the patient's medical records; AND
                                                                                                                           The treatment must have commenced between the ages of 2 to 17 years inclusive.
                                                                                                                           Must be treated by a medical practitioner identifying as at least one of: (i) a paediatrician, (ii) a sleep physician, (iii) neurologist, (iv) a psychiatrist, (v) a developmental specialist (see NOTE); this authority approval is being sought by