Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p442
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 442/476)
Character Range: 3686233–3691568

to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
                                                                                                                                            Patient must have a Mayo clinic score greater than or equal to 6; OR
                                                                                                                                            Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
                                                                                                                                            The treatment must not exceed a single dose to be administered at week 0 under this restriction.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (1) a completed authority prescription form; and
                                                                                                                                            (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:
                                                                                                                                            (i) the completed current Mayo 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