Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p60
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 60/381)
Character Range: 11892948–11900490

their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; 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
                                                                                                                                                                    The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND
                                                                                                                                                                    Must be treated by a dermatologist.  or
                                                                                                                                                                    Must be treated by a clinical immunologist.
                                                                                                                                                                    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.
C11377              P11377         CN11377          Dupilumab                                                                                                       Chronic severe atopic dermatitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Continuing or resuming treatment of the face and/or hands
                                                                                                                                                                    Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND
                                                                                                                                                                    Patient must have achieved an adequate response within the first 16 weeks of treatment; or
                                                                                                                                                                    Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; 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
                                                                                                                                                                    The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND
                                                                                                                                                                    Must be treated by a dermatologist.  or
                                                                                                                                                                    Must be treated by a clinical immunologist.
                                                                                                                                                                    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)