Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p106
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 106/381)
Character Range: 12205958–12214153

be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
C11906              P11906         CN11906          Adalimumab                                                                                                      Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment - balance of supply
                                                                                                                                                                    Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; or
                                                                                                                                                                    Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND
                                                                                                                                                                    The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
                                                                                                                                                                    Must be treated by a rheumatologist.  or
                                                                                                                                                                    Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
C11910              P11910         CN11910          Infliximab                                                                                                      Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                                                    Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form
                                                                                                                                                                    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)]; AND
                                                                                                                                                                    Patient must have received this drug (in any form) as their most recent course of PBS-subsidised biological medicine treatment for this condition; or
                                                                                                                                                                    Patient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab intravenous form continuing treatment restriction; AND
                                                                                                                                                                    Patient must not receive more than 24 weeks of treatment under this restriction; AND
                                                                                                                                                                    Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or
                                                                                                                                                                    Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by:
                                                                                                                                                                     (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND
                                                                                                                                                                    Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    Applications for authorisation must be made in writing and must include