Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p310
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 310/312)
Character Range: 17453680–17461792

shared with a medical practitioner.
C16270              P16270         CN16270          Selpercatinib                                                          Locally advanced or metastatic non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 16270
                                                                                                                           The condition must have evidence of rearranged during transfection (RET) gene fusion in tumour material - this evidence has been obtained prior to commencing treatment with this drug; 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
                                                                                                                           The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND
                                                                                                                           Patient must be initiating treatment with this drug. or
                                                                                                                           Patient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.
                                                                                                                           Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.
C16273              P16273         CN16273          Methyldopa                                                             Hypertension                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                           Patient must be pregnant;
                                                                                                                           Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, an endorsed midwife who is each of: (a) sharing patient care with a medical practitioner for the current pregnancy episode, (b) continuing existing treatment with this drug that was initiated by a medical practitioner.
C16274              P16274         CN16274          Methylphenidate                                                        Attention deficit hyperactivity disorder                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND
                                                                                                                           Patient must require continuous coverage over 12 hours; AND
                                                                                                                           The treatment must not exceed a maximum daily dose of 72 mg of PBS-subsidised treatment with this drug;
                                                                                                                           Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.
C16276              P16276         CN16276          Oxycodone                                                              Severe pain
                                                    Tramadol                                                               The treatment must be for short term therapy of acute severe pain; AND
                                                                                                                           Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics; or
                                                                                                                           Patient must be unable to use non-opioid analgesics due to contraindications or intolerance; AND
                                                                                                                           Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife who is sharing the post-operative care of the patient with a medical practitioner.
C16279              P16279         CN16279          Temazepam                                                              For prescribing by certain health practitioners
                                                                                                                           Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a