Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p263
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 263/476)
Character Range: 2467500–2476824

educator.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (1) details of the proposed prescription; 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).
                                                                                                                                            The following must be provided at the time of application and documented in the patient's medical records:
                                                                                                                                            (a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and
                                                                                                                                            (b) if applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and
                                                                                                                                            (c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and
                                                                                                                                            (d) the eosinophil count and date; and
                                                                                                                                            (e) Asthma Control Questionnaire (ACQ-5) score.
Methadone                                                              C16083                                                               Opioid dependence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 16083
                                                                                                                                            The treatment must be within a framework of medical, social and psychological treatment.
                                                                                                                                            The prescriber must request a quantity (in millilitres) sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.
Methoxsalen                                                            C10971              P10971                                           Erythrodermic stage III‑IVa T4 M0 Cutaneous T‑cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 10971
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; OR
                                                                                                                                            Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication; OR
                                                                                                                                            The treatment must be in combination with peginterferon alfa‑2a only if used in combination with another drug; AND
                                                                                                                                            Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND
                                                                                                                                            Patient must not have previously received PBS‑subsidised treatment with this drug for this PBS indication.
                                                                                                                                            Must be treated by a haematologist; OR
                                                                                                                                            Must be treated by a medical physician working under the supervision of a haematologist.
                                                                                                                                            Patient must be aged 18 years or over.
                                                                       C10985              P10985                                           Erythrodermic stage III‑IVa T4 M0 Cutaneous T‑cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 10985
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; OR
                                                                                                                                            Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one