Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p276
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 276/312)
Character Range: 17201138–17211837

of Mental Disorders, Fifth Edition (DSM-V) or ICD-10 international classification of mental and behavioural disorders.
C16050              P16050         CN16050          Buprenorphine                                                          Opioid dependence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 16050
                                                                                                                           Must be treated by a health care professional; AND
                                                                                                                           The treatment must be within a framework of medical, social and psychological treatment; AND
                                                                                                                           Patient must be stabilised on sublingual buprenorphine or buprenorphine/naloxone prior to commencing treatment with this drug for this condition.
                                                                                                                           The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs.
C16051              P16051         CN16051          Buprenorphine                                                          Opioid dependence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 16051
                                                                                                                           Must be treated by a health care professional; AND
                                                                                                                           The treatment must be within a framework of medical, social and psychological treatment.
                                                                                                                           The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs.
C16053              P16053         CN16053          Avelumab                                                               Stage IV (metastatic) Merkel Cell Carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 16053
                                                                                                                           Initial treatment
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           The treatment must not exceed a total of 9 doses at a maximum dose of 10 mg per kg every 2 weeks under this restriction. or
                                                                                                                           The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.
                                                                                                                           The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C16054              P16054         CN16054          Chlormethine                                                           Mycosis fungoides cutaneous T-cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must be treated by at least one of the following prescriber types (i) dermatologist, (ii) haematologist; AND
                                                                                                                           The treatment must be approved for 1 unit if the condition is no more than 10% of the patient's body surface area to provide 4 weeks of treatment per script. or
                                                                                                                           The treatment must be approved for 2 units if the condition is no more than 25% of the patient's body surface area to provide 4 weeks of treatment per script.
C16055              P16055         CN16055          Lanreotide                                                             Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16055
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The condition must be active; AND
                                                                                                                           Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
                                                                                                                           The treatment must be after failure of other therapy including dopamine agonists; or
                                                                                                                           The treatment