Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p178
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 178/191)
Character Range: 11281209–11295898

renal allograft rejection; AND
                                                                                                                                                                                                                               The treatment must be under the supervision and direction of a transplant unit.
C9692               P9692          CN9692           Mycophenolic acid                                                                                                                                                          Prophylaxis of renal allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 9692
                                                                                                                                                                                                                               Management
                                                                                                                                                                                                                               The treatment must be under the supervision and direction of a transplant unit.
C9693               P9693          CN9693           Everolimus                                                                                                                                                                 Management of cardiac allograft rejection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 9693
                                                                                                                                                                                                                               Management (initiation, stabilisation and review of therapy)
                                                    Mycophenolic acid                                                                                                                                                          Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
                                                                                                                                                                                                                               The treatment must be under the supervision and direction of a transplant unit.
C9694               P9694          CN9694           Ciclosporin                                                                                                                                                                Nephrotic syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 9694
                                                                                                                                                                                                                               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.
C9695               P9695          CN9695           Ciclosporin                                                                                                                                                                Severe atopic dermatitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 9695
                                                                                                                                                                                                                               Management (initiation, stabilisation and review of therapy)
                                                                                                                                                                                                                               Must be treated by a dermatologist; or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist; AND
                                                                                                                                                                                                                               The condition must be ineffective to other systemic therapies.  or
                                                                                                                                                                                                                               The condition must be inappropriate for other systemic therapies.
C9696               P9696          CN9696           Desferrioxamine                                                                                                                                                            Disorders of erythropoiesis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 9696
                                                                                                                                                                                                                               The condition must be associated with treatment-related chronic iron overload.
C9697               P9697          CN9697           Tacrolimus                                                                                                                                                                 Management of rejection in patients following organ or tissue transplantation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 9697
                                                                                                                                                                                                                               The treatment must be under the supervision and direction of a transplant unit; AND
                                                                                                                                                                                                                               The treatment must include initiation, stabilisation, and review of therapy as required.
C9705               P9705          CN9705           Golimumab                                                                                                                                                                  Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                                                                                                                                               Must be treated by a gastroenterologist (code 87); or
                                                                                                                                                                                                                               Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                                                                                                                                               Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                                                                                                               Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                                                                                                                               Patient must have a Mayo clinic score greater than or equal to 6; or
                                                                                                                                                                                                                               Patient must have a partial Mayo clinic score greater