Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p34
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 34/312)
Character Range: 15657435–15664501

(must be at least 30%) prior to treatment with biological medicine.
                                                                                                                           Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment
                                                                                                                           (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);
                                                                                                                           (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.
C14643              P14643         CN14643          Ustekinumab                                                            Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                           Initial 2 treatment (Whole body) - Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years
                                                                                                                           Must be treated by a dermatologist; AND
                                                                                                                           Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                           Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND
                                                                                                                           Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND
                                                                                                                           The treatment must be as systemic monotherapy; or
                                                                                                                           The treatment must be in combination with methotrexate; AND
                                                                                                                           Patient must not receive more than 28 weeks of treatment under this restriction;
                                                                                                                           Patient must be under 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).
                                                                                                                           Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application.
                                                                                                                           Response to preceding supply
                                                                                                                           An adequate response to treatment is defined as
                                                                                                                           A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
                                                                                                                           Change in therapy
                                                                                                                           If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because
                                                                                                                           (i) there is an absence of an adequate response to that treatment; or
                                                                                                                           (ii) there was an intolerance to that treatment; or
                                                                                                                           (iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above
                                                                                                                           (i) an absence of an adequate response; or
                                                                                                                           (ii) an intolerance to that treatment; or
                                                                                                                           (iii) an adequate response, but a break in therapy was necessary