Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p116
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 116/312)
Character Range: 16195055–16202302

(ii) quality of life, (iii) exercise capacity, (iv) peak left ventricular outflow tract (LVOT) gradient.
                                                                                                                           Must be treated by a cardiologist; OR
                                                                                                                           Must be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy.
C15190              P15190         CN15190          Risankizumab                                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                           Continuing treatment, Whole body
                                                                                                                           Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                                           Patient must have demonstrated an adequate response to 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 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.
                                                                                                                           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 completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
                                                                                                                           The most recent PASI assessment must be no more than 4 weeks old at the time of application.
                                                                                                                           Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
                                                                                                                           An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
                                                                                                                           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.
                                                                                                                           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.
C15193              P15193         CN15193          Ondansetron                                                            Nausea and vomiting                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with