Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p437
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 437/476)
Character Range: 3661069–3666645

more than 4 weeks old at the time of application; AND
                                                                                                                                            Patient must have evidence of intestinal inflammation; OR
                                                                                                                                            Patient must be assessed clinically as being in a high faecal output state; OR
                                                                                                                                            Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND
                                                                                                                                            The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.
                                                                                                                                            Patient must be aged 18 years or older.
                                                                                                                                            Applications for authorisation must be made in writing and must include:
                                                                                                                                            (a) two completed authority prescription forms; and
                                                                                                                                            (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
                                                                                                                                            (i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
                                                                                                                                            (ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
                                                                                                                                            (iii) the date of the most recent clinical assessment.
                                                                                                                                            Evidence of intestinal inflammation includes:
                                                                                                                                            (i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
                                                                                                                                            (ii) faeces: higher than normal lactoferrin or calprotectin level; or
                                                                                                                                            (iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
                                                                                                                                            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 2 vials of 45 mg and no repeats.
                                                                                                                                            A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
                                                                                                                                            Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
                                                                                                                                            Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
                                                                                                                                            Any one of the baseline criteria may be used to determine response