Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p143
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 143/162)
Character Range: 15388818–15394832

withdrawal, details of the degree of this toxicity must be documented in the patient's medical records.
                                                                                                         Details of the accepted toxicities including severity can be found on the Services Australia website.
                                                                                                         The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy
                                                                                                         (a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy.
                                                                                                         (i) the name of each prior therapy trialled that meets the above requirements - state at least 2;
                                                                                                         (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);
                                                                                                         (iii) the PASI score that followed each prior therapy trialled;
                                                                                                         (iv) the date the PASI scores were determined.
                                                                                                         A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. Provide in this authority application, and document in the patient's medical records, each of
                                                                                                         (i) the name of each prior therapy trialled that meets the above requirements - state at least 2;
                                                                                                         (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);
                                                                                                         (iii) the PASI score that followed each prior therapy trialled;
                                                                                                         (iv) the date the PASI scores were determined.
                                                                                                         Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine.
C14515              P14515         CN14515          Infliximab                                           Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Written Authority Required procedures
                                                                                                         Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form
                                                                                                         Must be treated by a rheumatologist; or
                                                                                                         Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                                                                         Patient must have received this drug (in any form) as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                         Patient must have demonstrated an adequate response to treatment with this drug; or
                                                                                                         Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND
                                                                                                         The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND
                                                                                                         Patient must not receive more than 24 weeks of treatment under this restriction;
                                                                                                         Patient must be at least 18 years of age.
                                                                                                         An adequate response to treatment is defined as
                                                                                                         an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either