Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p61
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 61/381)
Character Range: 11899909–11908844

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, 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
C11385              P11385         CN11385          Apomorphine                                                                                                     Parkinson disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 11385
                                                                                                                                                                    Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND
                                                                                                                                                                    The treatment must be commenced in a specialist unit in a hospital setting.
C11390              P11390         CN11390          Secukinumab                                                                                                     Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                                                                    Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
                                                                                                                                                                    Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patients) restriction to complete 20 weeks treatment; or
                                                                                                                                                                    Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or
                                                                                                                                                                    Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND
                                                                                                                                                                    The treatment must provide no more than the balance of up to 20 weeks treatment; AND
                                                                                                                                                                    Must be treated by a rheumatologist.  or
                                                                                                                                                                    Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.
C11391              P11391         CN11391          Ipilimumab                                                                                                      Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 11391
                                                                                                                                                                    Continuing combination treatment (with nivolumab) of first-line drug therapy
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must not exceed 24 months in total, measured from