Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p53
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 53/162)
Character Range: 14934776–14941206

prescription, whether it is to initiate or continue treatment, must be made out under the specialist's prescriber number.
C14097              P14097         CN14097          Finerenone                                           Chronic kidney disease with Type 2 diabetes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 14097
                                                                                                         Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of:
                                                                                                          (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND
                                                                                                         Patient must not have known significant non-diabetic renal disease, prior to initiating treatment with this drug; AND
                                                                                                         Patient must have an estimated glomerular filtration rate of 25 mL/min/1.73 m2 or greater, prior to initiating treatment with this drug; AND
                                                                                                         Patient must have a urinary albumin-to-creatinine ratio of 200 mg/g (22.6 mg/mmol) or greater, prior to initiating treatment with this drug; AND
                                                                                                         Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND
                                                                                                         Patient must be stabilised, for at least 4 weeks, on either:
                                                                                                          (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug; AND
                                                                                                         The treatment must be in combination with an SGLT2i unless medically contraindicated or intolerant; AND
                                                                                                         Patient must not be receiving treatment with another selective nonsteroidal mineralocorticoid receptor antagonist, a renin inhibitor or a potassium-sparing diuretic; AND
                                                                                                         Patient must not have established heart failure with reduced ejection fraction with an indication for treatment with a mineralocorticoid receptor antagonist.
C14103              P14103         CN14103          Tocilizumab                                          Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                         Initial treatment - Initial 1 (new patient)
                                                                                                         Must be treated by a paediatric rheumatologist; or
                                                                                                         Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND
                                                                                                         Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                         Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or
                                                                                                         Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens:
                                                                                                          (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months;
                                                                                                         Patient must be under 18 years of age.
                                                                                                         Severe intolerance to methotrexate is