Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p181
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 181/381)
Character Range: 12717217–12727009

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 4 Eczema Area and Severity Index (EASI) symptom sub-score ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) for
                                                                                                                                                                    (i) erythema,
                                                                                                                                                                    (ii) oedema/papulation,
                                                                                                                                                                    (iii) excoriation,
                                                                                                                                                                    (iv) lichenification
                                                                                                                                                                    (a) current scores; or
                                                                                                                                                                    (b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.
                                                                                                                                                                    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.
                                                                                                                                                                    State the percentage face/hand surface area affected by the condition (must be at least 30%) where EASI symptom sub-scores are not provided. This percentage surface area can also be stated in addition to the EASI symptom sub-scores.
                                                                                                                                                                    The EASI/percentage surface area 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 are in the patient's medical records.
C12522              P12522         CN12522          Dasatinib                                                                                                       Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 12522
                                                                                                                                                                    Continuing treatment - third-line therapy
                                                    Nilotinib                                                                                                       Patient must have received initial PBS-subsidised treatment with this drug as a third-line therapy for this condition; AND
                                                                                                                                                                    Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; or
                                                                                                                                                                    Patient must have achieved a peripheral blood level of BCR-ABL of less than 1% in the preceding 18 months and thereafter at 12 monthly intervals; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                    A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records.
C12524              P12524         CN12524          Dasatinib                                                                                                       Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment - second-line therapy
                                                                                                                                                                    The condition must be in the chronic phase; or
                                                                                                                                                                    The condition must be in the