Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p286
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 286/312)
Character Range: 17277738–17286077

to share care of the patient with a medical practitioner.
C16151              P16151         CN16151          Nivolumab with relatlimab                                              Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 16151
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
                                                                                                                           Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.
                                                                                                                           The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.
                                                                                                                           The prescription must include the amount of nivolumab with relatlimab (Opdualag) that is appropriate to be prescribed for the patient. For the purposes of PBS subsidy, the maximum amount requested is based on the nivolumab dose only. The prescribed amount of nivolumab must be expressed in milligrams.
C16152              P16152         CN16152          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 8 hours; AND
                                                                                                                           The treatment must not exceed a maximum daily dose of 80 mg of PBS-subsidised treatment with this drug.
                                                                                                                           Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive; OR
                                                                                                                           Patient must have had a diagnosis of ADHD prior to turning 18 years of age if PBS-subsidised treatment is continuing beyond 18 years of age; OR
                                                                                                                           Patient must have a retrospective diagnosis of ADHD if PBS-subsidised treatment is commencing after turning 18 years of age; OR
                                                                                                                           Patient must have had a retrospective diagnosis of ADHD if PBS-subsidised treatment is continuing in a patient who commenced PBS-subsidised treatment after turning 18 years of age.
                                                                                                                           A retrospective diagnosis of ADHD for the purposes of administering this restriction is:
                                                                                                                           (i) the presence of pre-existing childhood symptoms of ADHD (onset during the developmental period, typically early to mid-childhood); and
                                                                                                                           (ii) documentation in the patient's medical records that an in-depth clinical interview with, or, obtainment of evidence from, either a: (a) parent, (b) teacher, (c) sibling, (d) third party, has occurred and which supports point (i) above.
C16154              P16154         CN16154          Lisdexamfetamine                                                       Attention deficit hyperactivity disorder                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Patient must require continuous coverage over 12 hours; AND
                                                                                                                           The treatment must not exceed a maximum daily dose of 70 mg of PBS-subsidised treatment with this drug.
                                                                                                                           Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive; OR
                                                                                                                           Patient must have had a diagnosis of ADHD prior to turning 18 years of