Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p7
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 7/312)
Character Range: 15513818–15521397

(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 for reasons other than the 2 mentioned above.
                                                                                                                           Recommencing therapy
                                                                                                                           If the patient is recommencing therapy, in relation to the last administered dose, state whether there was
                                                                                                                           (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 for reasons other than the 2 mentioned above.
                                                                                                                           The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient's medical records.
C14576              P14576         CN14576          Etanercept                                                             Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                           Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years
                                                                                                                           Must be treated by a dermatologist; AND
                                                                                                                           Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND
                                                                                                                           The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words 'whole body'; or
                                                                                                                           The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words 'face, hand, foot'; AND
                                                                                                                           Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; or
                                                                                                                           The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
                                                                                                                            (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
                                                                                                                           The treatment must be as systemic monotherapy; or
                                                                                                                           The treatment must be in combination with methotrexate; AND
                                                                                                                           Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction;
                                                                                                                           Patient must be under 18 years of age.
                                                                                                                           The most recent PASI assessment must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.
C14577              P14577         CN14577          Etanercept                                                             Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                           Initial 4 - Re-treatment (face, hand, foot)
                                                                                                                           Must be treated by a dermatologist; AND
                                                                                                                           The treatment must be as systemic