Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p28
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 28/476)
Character Range: 862037–868401

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:
                                                                                                                                            (i) A completed authority prescription form; and
                                                                                                                                            (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                       C15426                                                               Systemic lupus erythematosus                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                                            Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                                                                            Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 July 2024; AND
                                                                                                                                            Patient must have had a confirmed and documented diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) SLE Classification Criteria 2019 prior to commencing therapy with this drug for this condition; AND
                                                                                                                                            Patient must have had persistent disease activity as supported by a SLE Disease Activity Index 2000 (SLEDAI-2K) score of at least 10 points prior to commencing therapy with this drug for this condition; AND
                                                                                                                                            Patient must have been receiving hydroxychloroquine for at least 12 weeks prior to commencing therapy with this drug for this condition; AND
                                                                                                                                            Patient must have been receiving immunosuppressant medication for at least 12 weeks with either (i) minimum dose of methotrexate 20 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