Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p64
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 64/476)
Character Range: 1187810–1199407

no deterioration in FEV1 compared to baseline; AND
                                                                                                                                            (2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
                                                                                                                                            Further reassessments must be undertaken and documented at six‑monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.
Doxorubicin ‑                                                          C6234                                                                Kaposi sarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures ‑ Streamlined Authority Code 6234
Pegylated Liposomal                                                                                                                         The condition must be AIDS‑related; AND
                                                                                                                                            Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
                                                                                                                                            The condition must include extensive mucocutaneous involvement.
                                                                       C6274                                                                Kaposi sarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures ‑ Streamlined Authority Code 6274
                                                                                                                                            The condition must be AIDS‑related; AND
                                                                                                                                            Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
                                                                                                                                            The condition must include extensive visceral involvement.
                                                                       C9223                                                                Kaposi sarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures ‑ Streamlined Authority Code 9223
                                                                                                                                            The condition must be AIDS‑related; AND
                                                                                                                                            Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
                                                                                                                                            The condition must include extensive visceral involvement.
                                                                       C9287                                                                Kaposi sarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures ‑ Streamlined Authority Code 9287
                                                                                                                                            The condition must be AIDS‑related; AND
                                                                                                                                            Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
                                                                                                                                            The condition must include extensive mucocutaneous involvement.
Dupilumab                                                              C15348                                                               Uncontrolled severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.
                                                                                                                                            Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND
                                                                                                                                            Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                            The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment under this restriction.
                                                                                                                                            Patient must be aged 12 years or older.
                                                                                                                                            An adequate response to this biological medicine is defined as:
                                                                                                                                            (a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,
                                                                                                                                            OR
                                                                                                                                            (b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.
                                                                                                                                            All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the