Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p181
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 181/191)
Character Range: 11307774–11315375

Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy.  or
                                                                                                                                                                                                                               Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.  or
                                                                                                                                                                                                                               Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
                                                                                                                                                                                                                               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) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
                                                                                                                                                                                                                               (iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
                                                                                                                                                                                                                               (iv) the date of the most recent clinical assessment.
                                                                                                                                                                                                                               Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following
                                                                                                                                                                                                                               (a) patient must have evidence of intestinal inflammation;
                                                                                                                                                                                                                               (b) patient must be assessed clinically as being in a high faecal output state;
                                                                                                                                                                                                                               (c) 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.
                                                                                                                                                                                                                               (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.
                                                                                                                                                                                                                               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