Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p12
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 12/162)
Character Range: 14722496–14727738

clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
                                                                                                         (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
                                                                                                         All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
                                                                                                         The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
                                                                                                         An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
                                                                                                         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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                         If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
                                                                                                         If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
                                                                                                         A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
                                                                                                         Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats.
C13990              P13990         CN13990          Upadacitinib                                         Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                         Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                         Must be treated by a gastroenterologist (code 87); or
                                                                                                         Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                         Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                         Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                         Patient must have had a break in treatment of 5 years or