Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p126
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 126/161)
Character Range: 14473347–14478704

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.
                                                                                   The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
                                                                                   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 and face, hand, foot area diagrams 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 restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
                                                                                   A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C13599              P13599         CN13599          Adalimumab                     Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                                                   Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
                                                                                   Must be treated by a rheumatologist; or
                                                                                   Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                                                   Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                   Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; or
                                                                                   Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND
                                                                                   The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or
                                                                                   The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
                                                                                   The condition must have either (a) a total active joint count of at least