Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p177
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 177/381)
Character Range: 12685091–12694089

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, 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.
                                                                                                                                                                    Document each qualifying response measure in the patient's medical records for PBS compliance auditing purposes
C12495              P12495         CN12495          Acalabrutinib                                                                                                   Mantle cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                    Ibrutinib                                                                                                       The condition must have relapsed or be refractory to at least one prior therapy; AND
                                                                                                                                                                    Patient must have a WHO performance status of 0 or 1; AND
                                                    Zanubrutinib                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    Patient must be untreated with Bruton's tyrosine kinase inhibitor therapy.  or
                                                                                                                                                                    Patient must have developed intolerance to another Bruton's tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication.
C12497              P12497         CN12497          Dupilumab                                                                                                       Chronic severe atopic dermatitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment 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
                                                                                                                                                                    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 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