Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p180
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 180/381)
Character Range: 12709532–12718125

dermatitis affecting either of:
                                                                                                                                                                     (i) the whole body, (ii) face/hands; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND
                                                                                                                                                                    Patient must not have experienced an inadequate response to this biological medicine in this PBS indication; AND
                                                                                                                                                                    Must be treated by a dermatologist; or
                                                                                                                                                                    Must be treated by a clinical immunologist;
                                                                                                                                                                    Patient must be 12 years of age or older.
                                                                                                                                                                    State each of the 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) for
                                                                                                                                                                    (i) erythema,
                                                                                                                                                                    (ii) oedema/papulation,
                                                                                                                                                                    (iii) excoriation,
                                                                                                                                                                    (iv) lichenification
                                                                                                                                                                    (a) current scores; or
                                                                                                                                                                    (b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.
                                                                                                                                                                    Acceptable scores can be
                                                                                                                                                                    (a) current scores; or
                                                                                                                                                                    (b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.
                                                                                                                                                                    State the percentage face/hand surface area affected by the condition (must be at least 30%) where EASI symptom sub-scores are not provided. This percentage surface area can also be stated in addition to the EASI symptom sub-scores.
                                                                                                                                                                    The EASI/percentage surface area and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient's medical records.
                                                                                                                                                                    Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled are in the patient's medical records.
C12508              P12508         CN12508          Upadacitinib                                                                                                    Chronic severe atopic dermatitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment with this drug of the face and/or hands
                                                                                                                                                                    The condition must have at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub-scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; or
                                                                                                                                                                    The condition must have affected at least 30% of the face/hands surface area despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND
                                                                                                                                                                    Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND
                                                                                                                                                                    The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of:
                                                                                                                                                                     (i) the whole body, (ii) face/hands; AND
                                                                                                                                                                    Patient must not have experienced an inadequate response to this therapy; AND
                                                                                                                                                                    Must be treated by a dermatologist; or
                                                                                                                                                                    Must be treated by a clinical immunologist; AND