Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p8
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 8/312)
Character Range: 15519808–15526627

be documented in the patient's medical records.
C14577              P14577         CN14577          Etanercept                                                             Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                           Initial 4 - Re-treatment (face, hand, foot)
                                                                                                                           Must be treated by a dermatologist; AND
                                                                                                                           The treatment must be as systemic monotherapy; or
                                                                                                                           The treatment must be in combination with methotrexate; AND
                                                                                                                           Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND
                                                                                                                           Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following:
                                                                                                                            (i) all PASI sub-measures (redness, thickness, scaling) are rated as 'moderate' to 'severe', (ii) at least 2 of the 3 PASI sub-measures are rated as 'severe' to 'very severe', (iii) the skin area affected has increased by at least 50% since the last administered dose, (iv) the skin area affected is at least 30% of the total skin area of the face/hand/foot; AND
                                                                                                                           Patient must not have failed more than once to achieve an adequate response with etanercept; AND
                                                                                                                           Patient must not receive more than 16 weeks of treatment with etanercept under this restriction;
                                                                                                                           Patient must be under 18 years of age.
                                                                                                                           Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.
C14581              P14581         CN14581          Etanercept                                                             Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Initial 1 (new patient)
                                                                                                                           Must be treated by a rheumatologist; or
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                                                                                           Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following:
                                                                                                                            (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or
                                                                                                                           Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to