Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p176
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 176/381)
Character Range: 12678191–12685532

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).
                                                                                                                                                                    For the purposes of this restriction, an adequate response to treatment is defined as
                                                                                                                                                                    (a) An improvement/maintenance in the Eczema Area and Severity Index (EASI) score of at least 50% compared to baseline; and
                                                                                                                                                                    (b) An improvement/maintenance in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline
                                                                                                                                                                    Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above.
                                                                                                                                                                    State each of the current EASI and DLQI scores for this authority application.
C12494              P12494         CN12494          Upadacitinib                                                                                                    Chronic severe atopic dermatitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Continuing or resuming treatment with this drug of the face and/or hands
                                                                                                                                                                    Patient must have received PBS-subsidised treatment with this therapy for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND
                                                                                                                                                                    Patient must have achieved an adequate response prior to this first continuing treatment authority application; or
                                                                                                                                                                    Patient must have maintained an adequate response to their most recent supply of this therapy for this PBS indication if this is any Continuing treatment authority application other than the first; or
                                                                                                                                                                    Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; 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).
                                                                                                                                                                    For the purposes of this restriction, an adequate response to treatment of the face/hands is defined as
                                                                                                                                                                    (a) (i) A rating of either mild (1) to none (0) on at least 3 of the assessments of erythema, oedema/papulation, excoriation and lichenification mentioned in the Eczema Area and Severity Index (EASI); or
                                                                                                                                                                    (ii) At least a 75% reduction in the skin area affected by this condition compared to baseline; and
                                                                                                                                                                    (b) An improvement in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline
                                                                                                                                                                    Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial,