Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p179
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 179/381)
Character Range: 12700514–12710289

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                                                                                                   Mantle cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                    Ibrutinib                                                                                                       The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                    Zanubrutinib                                                                                                    Patient must not have developed disease progression while being treated with this drug for this condition.

C12504              P12504         CN12504          Upadacitinib                                                                                                    Chronic severe atopic dermatitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Dose change (increasing up to the 30 mg dose, or, decreasing back down to the 15 mg dose) - whole body, or, face/hands
                                                                                                                                                                    Patient must not be undergoing each of:
                                                                                                                                                                     (i) commencing treatment through this treatment phase listing, (ii) treatment accessed through this treatment phase on more than 2 consecutive occasions; AND
                                                                                                                                                                    Patient must be undergoing existing PBS-subsidised treatment with this therapy where each of the following is true:
                                                                                                                                                                     (i) there is a change in daily dose, (ii) any remaining PBS repeat prescriptions for the strength that the patient is changing from, is marked as 'cancelled'; 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).
C12507              P12507         CN12507          Dupilumab                                                                                                       Chronic severe atopic dermatitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment 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
                                                                                                                                                                    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