Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p32
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 32/312)
Character Range: 15646512–15653082

is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.
                                                                                                                           An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.
                                                                                                                           Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
                                                                                                                           The authority application must be made in writing and must include
                                                                                                                           (1) a completed authority prescription form; and
                                                                                                                           (2) a completed Measurable residual disease positive Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and
                                                                                                                           (3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; and
                                                                                                                           (4) the percentage blasts in bone marrow count that is no more than 4 weeks old at the time of application.
                                                                                                                           Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
C14636              P14636         CN14636          Ustekinumab                                                            Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                           Initial 1 treatment (Face, hand, foot) - 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 the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND
                                                                                                                           Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments:
                                                                                                                            (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
                                                                                                                           Patient must not receive more than 28 weeks of treatment under this restriction;
                                                                                                                           Patient must be under 18 years of age.
                                                                                                                           Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.
                                                                                                                           Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
                                                                                                                           Details of the accepted toxicities including severity can be found on the Services Australia website.
                                                                                                                           The authority application must be made in writing and must include
                                                                                                                           (1) a