Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p178
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 178/381)
Character Range: 12693184–12701003

EASI and (iii) DLQI scores in the authority application.
                                                                                                                                                                    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.
                                                                                                                                                                    The EASI 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 in the patient's medical records.
C12499              P12499         CN12499          Upadacitinib                                                                                                    Chronic severe atopic dermatitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment with this drug of the whole body
                                                                                                                                                                    Patient must have a Physicians Global Assessment (PGA) (5-point scale) baseline score of at least 4 as evidence of severe disease despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND
                                                                                                                                                                    Patient must have an Eczema Area and Severity Index (EASI) baseline score of at least 20 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
                                                                                                                                                                    Patient must be undergoing treatment with this drug as the sole PBS-subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication:
                                                                                                                                                                     chronic severe atopic dermatitis);
                                                                                                                                                                    Patient must be 12 years of age or older.
                                                                                                                                                                    State each of the qualifying (i) PGA, (ii) EASI and (iii) DLQI scores in the authority application.
                                                                                                                                                                    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.
                                                                                                                                                                    The EASI 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 in the patient's medical records.
C12500              P12500         CN12500          Acalabrutinib