Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p134
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 134/161)
Character Range: 14510852–14515133

biological medicines for this condition within this treatment cycle; AND
                                                                                   Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
                                                                                   The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                   Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                   Patient must be at least 18 years of age;
                                                                                   Must be treated by a dermatologist.
                                                                                   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.
                                                                                   An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
                                                                                   Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
                                                                                   To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.
                                                                                   Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                   The authority application must be made in writing and must include
                                                                                   (a) a completed authority prescription form(s); and
                                                                                   (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following
                                                                                   (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
                                                                                   (ii) details of prior biological treatment, including dosage, date and duration of treatment.
                                                                                   If a patient fails to demonstrate a response to treatment with this drug under this