Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p27
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 27/476)
Character Range: 856354–862317

and
                                                                                                                                            (c) Physician Global Assessment (PGA) of not greater than 1, and
                                                                                                                                            (d) Current prednisolone (or equivalent) dose of not greater than 7.5 mg daily, and
                                                                                                                                            (e) Well tolerated standard maintenance doses of anti-malarial and immunosuppressive drugs are allowed.
                                                                                                                                            Where retreatment with anifrolumab after a break in PBS-subsidised treatment with anifrolumab is being sought, the date of cessation of the previous treatment course with anifrolumab must be included in the application. Recommencement of treatment with anifrolumab for severe SLE is within 12 months from the date that treatment was ceased.
                                                                       C15388                                                               Systemic lupus erythematosus                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Patient must have 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; AND
                                                                                                                                            Patient must have persistent disease activity as supported by a SLE Disease Activity Index 2000 (SLEDAI-2K) score of at least 10 points; AND
                                                                                                                                            Patient must be currently receiving hydroxychloroquine, with treatment received for at least 12 weeks, unless contraindicated/intolerant necessitating treatment withdrawal; AND
                                                                                                                                            Patient must be currently receiving immunosuppressant medication, with treatment received 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 unless contraindicated/intolerant necessitating treatment withdrawal; AND
                                                                                                                                            Patient must be currently receiving prednisolone or equivalent of at least 7.5 mg per day, with treatment received for at least 4 weeks, 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