Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p20
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 20/38)
Character Range: 60930–65665

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 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