Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p14
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 14/161)
Character Range: 13904677–13910627

medicine; AND
                                                                                   Patient must be undergoing treatment with this benefit where:
                                                                                    (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved;
                                                                                   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 (the latest version is located on the website specified in the Administrative Advice).
                                                                                   The PBS administrator will confirm that
                                                                                   (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;
                                                                                   (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.
C13079              P13079         CN13079          Infliximab                     Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                   Continuing treatment (whole body, or, face/hand/foot) with subcutaneous form or switching from intravenous form to subcutaneous form
                                                                                   Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                   The treatment must have both:
                                                                                    (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; AND
                                                                                   The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                   Patient must not receive more than 24 weeks of treatment under this restriction;
                                                                                   Patient must be at least 18 years of age;
                                                                                   Must be treated by a dermatologist.
                                                                                   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 (the latest version is located on the website specified in the Administrative Advice).
                                                                                   Where the condition is affecting the whole body, an adequate response to treatment is defined as
                                                                                   A Psoriasis Area and Severity Index (PASI) score which is reduced by at least 75%, or, is sustained at this level, when compared with the baseline value for this treatment cycle. State the qualifying PASI score in the authority application.
                                                                                   Where the condition is affecting the face/hand/foot, an adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing
                                                                                   (i) A reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or, sustained at this level, as compared to the baseline values. Indicate the rating (0=none, 1=slight) for each of these 3 observations in the authority application for each affected area; or
                                                                                   (ii) A reduction by at least 75% in the skin area affected, or, sustained at