Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p287
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 287/312)
Character Range: 17285620–17293349

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 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.
C16155              P16155         CN16155          Nirmatrelvir and ritonavir                                             SARS-CoV-2 infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 16155
                                                                                                                           Patient must have received a positive nucleic acid test result; OR
                                                                                                                           Patient must have received a positive rapid antigen test (RAT) result; AND
                                                                                                                           Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
                                                                                                                           The treatment must be initiated within 5 days of symptom onset; OR
                                                                                                                           The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic.
                                                                                                                           Patient must be at least 70 years of age.
                                                                                                                           Access to this drug through this restriction is permitted irrespective of vaccination status.
                                                                                                                           Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
                                                                                                                           Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
                                                                                                                           This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.
C16156              P16156         CN16156          Nirmatrelvir and ritonavir                                             SARS-CoV-2 infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 16156
                                                                                                                           Patient must have received a positive nucleic acid test result; OR
                                                                                                                           Patient must have received a positive rapid antigen test (RAT) result; AND
                                                                                                                           Patient must have at least one sign or symptom attributable to COVID-19; AND
                                                                                                                           Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
                                                                                                                           The treatment must be initiated within 5 days of symptom onset.
                                                                                                                           Patient must be both: (i) at least 50 years of age, (ii) at high risk.
                                                                                                                           For the purpose of administering this restriction, high risk is defined as either a