Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p66
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 66/312)
Character Range: 15839225–15846276

used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
C14727              P14727         CN14727          Pembrolizumab                                                          Stage II or Stage III triple negative breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 14727
                                                                                                                           The treatment must be initiated in combination with neoadjuvant chemotherapy; AND
                                                                                                                           The condition must not have progressed/recurred whilst on treatment with this drug; AND
                                                                                                                           Patient must not be undergoing treatment with this drug beyond 52 cumulative weeks under this restriction; AND
                                                                                                                           Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions.  or
                                                                                                                           Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 4 repeat prescriptions.
C14728              P14728         CN14728          Upadacitinib                                                           Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                           Continuing (maintenance) treatment
                                                                                                                           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 as their most recent course of PBS-subsidised biological medicine treatment for this condition; 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; or
                                                                                                                           The condition must have not met the improvements specified above due to the prescribed dose being too low - this authority application seeks higher dosing;
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           The authority application must be made in writing and must include
                                                                                                                           (1) a completed authority prescription form; and
                                                                                                                           (2) a completed authority application form relevant to the indication and treatment phase