Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p67
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 67/381)
Character Range: 11948632–11955462

demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
                                                                                                                                                                    The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
                                                                                                                                                                    If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                                                    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.
                                                                                                                                                                    If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
                                                                                                                                                                    Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
C11606              P11606         CN11606          Adalimumab                                                                                                      Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 11606
                                                                                                                                                                    Subsequent continuing treatment, Face, hand, foot
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
                                                                                                                                                                    Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND
                                                                                                                                                                    The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                                                                                    Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction;
                                                                                                                                                                    Patient must be aged 18 years or older;
                                                                                                                                                                    Must be treated by a dermatologist.
                                                                                                                                                                    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; or
                                                                                                                                                                    (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
                                                                                                                                                                    The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
                                                                                                                                                                    The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
                                                                                                                                                                    If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not