Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p149
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 149/162)
Character Range: 15416111–15421982

treatment with no loading dose One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.
                                                                                                         An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
                                                                                                         Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                         If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
C14542              P14542         CN14542          Certolizumab pegol                                   Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                         Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply
                                                                                                         Must be treated by a rheumatologist; or
                                                                                                         Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                                                                         Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; 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 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; 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 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; AND
                                                                                                         The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions.
C14543              P14543         CN14543          Ustekinumab                                          Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Written Authority Required procedures
                                                                                                         Initial 1 treatment (Whole body) - biological medicine-naive patient
                                                                                                         Must be treated by a dermatologist; AND
                                                                                                         Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND
                                                                                                         The treatment must be as systemic monotherapy; or
                                                                                                         The treatment must be in combination with methotrexate; AND
                                                                                                         Patient must have lesions present for at least 6 months from the