Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p70
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 70/191)
Character Range: 10295996–10308932

Compliance with Authority Required procedures - Streamlined Authority Code 6585
                                                                                                                                                                                                                               Re-induction treatment
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               Patient must have progressive disease after achieving an initial objective response to the most recent course of ipilimumab treatment (induction or re-induction); AND
                                                                                                                                                                                                                               The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
                                                                                                                                                                                                                               An initial objective response to treatment is defined as either
                                                                                                                                                                                                                               (i) sustained stable disease of greater than or equal to 3 months duration measured from at least 2 weeks after the date of completion of the most recent course of ipilimumab; or
                                                                                                                                                                                                                               (ii) a partial or complete response.
                                                                                                                                                                                                                               The patient's body weight must be documented in the patient's medical records at the time treatment with ipilimumab is initiated.
C6621               P6621          CN6621           Filgrastim                                                                                                                                                                 Severe chronic neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 6621
                                                                                                                                                                                                                               Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; or
                                                                                                                                                                                                                               Patient must have neutrophil dysfunction; AND
                                                                                                                                                                                                                               Patient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months.  or
                                                                                                                                                                                                                               Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months.
C6628               P6628          CN6628           Ciclosporin                                                                                                                                                                Management of transplant rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 6628
                                                                                                                                                                                                                               The treatment must be used by organ or tissue transplant recipients.
C6631               P6631          CN6631           Ciclosporin                                                                                                                                                                Nephrotic syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 6631
                                                                                                                                                                                                                               Management (initiation, stabilisation and review of therapy)
                                                                                                                                                                                                                               Patient must have failed prior treatment with steroids and cytostatic drugs; or
                                                                                                                                                                                                                               Patient must be intolerant to treatment with steroids and cytostatic drugs; or
                                                                                                                                                                                                                               The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND
                                                                                                                                                                                                                               Patient must not have renal impairment; AND
                                                                                                                                                                                                                               Must be treated by a nephrologist.
C6636               P6636          CN6636           Paroxetine                                                                                                                                                                 Panic disorder

C6638               P6638          CN6638           Ciclosporin                                                                                                                                                                Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 6638
                                                                                                                                                                                                                               Management (initiation, stabilisation and review of therapy)
                                                                                                                                                                                                                               The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); or
                                                                                                                                                                                                                               The condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate); AND
                                                                                                                                                                                                                               Must be treated by a rheumatologist.  or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist.
C6640               P6640          CN6640           Filgrastim                                                                                                                                                                 Chronic cyclical neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 6640
                                                                                                                                                                                                                               Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND
                                                                                                                                                                                                                               Patient must