Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p163
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 163/381)
Character Range: 12577179–12589822

be undergoing current PBS-subsidised treatment with this biological medicine, but has received insufficient therapy with this biological medicine to complete 16 weeks treatment available under any of the initial treatment phases (regardless of the affected body area):
                                                                                                                                                                     (i) Initial 1, (ii) Initial 2, (iii) Initial 3, (iv) Initial 4; AND
                                                                                                                                                                    The treatment must be as systemic monotherapy; or
                                                                                                                                                                    The treatment must be in combination with methotrexate; AND
                                                                                                                                                                    The treatment must provide no more than the balance of up to 16 weeks treatment.
C12270              P12270         CN12270          Teriparatide                                                                                                    Severe established osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 12270
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously been issued with an authority prescription for this drug; AND
                                                                                                                                                                    The treatment must not exceed a lifetime maximum of 18 months therapy; AND
                                                                                                                                                                    Must be treated by a specialist.  or
                                                                                                                                                                    Must be treated by a consultant physician.
C12271              P12271         CN12271          Durvalumab                                                                                                      Unresectable Stage III non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 12271
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
                                                                                                                                                                    The treatment must not exceed 12 months in total for this condition under the initial and continuing restriction combined; AND
                                                                                                                                                                    The treatment must be once in a lifetime with this drug for this condition.
C12285              P12285         CN12285          Ustekinumab                                                                                                     Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                    Balance of supply - Continuing treatment (Whole body, or, face/hand/foot)
                                                                                                                                                                    Must be treated by a dermatologist; AND
                                                                                                                                                                    Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but the full number of repeats available under the continuing treatment phase was not prescribed.
C12334              P12334         CN12334          Ustekinumab                                                                                                     Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                    Balance of supply - Initial 1, 2 or 3 treatment (Whole body, or, face/hand/foot)
                                                                                                                                                                    Must be treated by a dermatologist; AND
                                                                                                                                                                    Patient must be undergoing current PBS-subsidised treatment with this biological medicine, but has received insufficient therapy with this biological medicine to complete 3 doses available under any of the initial treatment phases (regardless of the affected body area):
                                                                                                                                                                     (i) Initial 1, (ii) Initial 2, (iii) Initial 3; AND
                                                                                                                                                                    The treatment must be as systemic monotherapy; or
                                                                                                                                                                    The treatment must be in combination with methotrexate; AND
                                                                                                                                                                    The treatment must provide no more than the balance of 3 doses available under any of the initial treatment phases.
C12336              P12336         CN12336          Adalimumab                                                                                                      Moderate to severe hidradenitis suppurativa                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 1 (new patient)
                                                                                                                                                                    Patient must have, at the time of application, a Hurley