Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p268
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 268/312)
Character Range: 17140279–17148434

cycle under the Initial 3 treatment restriction.
C15952              P15952         CN15952          Aflibercept                                                            Subfoveal choroidal neovascularisation (CNV)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                           Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements
                                                                                                                           Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
                                                                                                                           Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication for the same eye prior to 1 October 2024; AND
                                                                                                                           The condition must be due to age-related macular degeneration (AMD); AND
                                                                                                                           The condition must be diagnosed by optical coherence tomography; OR
                                                                                                                           The condition must be diagnosed by fluorescein angiography; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                           The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
                                                                                                                           (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.
                                                                                                                           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).
                                                                                                                           All reports must be documented in the patient's medical records.
C15955              P15955         CN15955          Lanreotide                                                             Functional carcinoid tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 15955
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The condition must be causing intractable symptoms; AND
                                                                                                                           Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
                                                                                                                           Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
                                                                                                                           The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.
                                                                                                                           Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.
C15956              P15956         CN15956          Auranofin                                                              For prescribing by certain health practitioners
                                                                                                                           Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
                                                    Chlorpromazine

                                                    Digoxin

                                                    Disopyramide

                                                    Isoniazid

                                                    Lidocaine

                                                    Penicillamine

                                                    Periciazine

                                                    Zuclopenthixol decanoate

C15964              P15964         CN15964          Cefazolin                                                              Infection where positive bacteriological evidence confirms that this antibiotic is