Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p29
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 29/476)
Character Range: 867978–872625

mg per week (ii) azathioprine 100 mg per day (iii)mycophenolate 1,000 mg per day, prior to commencing therapy with this drug for this condition unless contraindicated/intolerant necessitating treatment withdrawal; AND
                                                                                                                                            Patient must have been receiving prednisolone or equivalent of at least 7.5 mg per day for at least 4 weeks prior to commencing therapy with this drug for this condition unless contraindicated/intolerant necessitating treatment withdrawal; AND
                                                                                                                                            Patient must not have either: (i) severe active lupus nephritis, (ii) severe active central nervous system systemic lupus erythematosus.
                                                                                                                                            Must be treated by a specialist physician experienced in the management of this condition.
                                                                                                                                            If prednisolone or equivalent is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated of at least 7.5 mg per day, the patient must have received at least 12 weeks of continuous treatment with each of at least 2 of the following: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day.
                                                                                                                                            Where two of: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; or (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to prednisolone or equivalent: at least one of the remaining tolerated therapies must be trialled at a minimum dose as mentioned above.
                                                                                                                                            If the patient has a contraindication/severe intolerance to each of: (i) prednisolone or equivalent of at least 7.5 mg per day; (ii) hydroxychloroquine; (iii) methotrexate at a dose of at least 20 mg per week; (iv) azathioprine at a dose of at least 100 mg per day; (v) mycophenolate at a dose of at least 1,000 mg per day; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application.
                                                                                                                                            The authority application must be made in writing via HPOS form upload or mail and must include:
                                                                                                                                            (a) details of the ACR/EULAR SLE Classification Criteria 2019 confirming diagnosis of SLE;
                                                                                                                                            (b) details (date and score) of the completed SLEDAI-2K score sheet;
                                                                                                                                            (c) details of current systemic therapy used (dosage, date of commencement and duration of therapy including prior anifrolumab use);
                                                                                                                                            (d) details of contraindication/intolerances to prior therapies (drug name, the degree of toxicity and dose).
                                                                                                                                            All the reports must be documented in the patient's medical records.
                                                                                                                                            If the application is submitted through HPOS form upload or mail, it must include: