Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p444
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 444/476)
Character Range: 3697185–3703233

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.
                                                                                                                                            A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
                                                                                                                                            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.
                                                                                                                                            Details of the accepted toxicities including severity can be found on the Services Australia website.
                                                                       C14010                                                               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)].
                                                                                                                                            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 more from the most recently approved PBS‑subsidised biological medicine for this condition; 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