Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p69
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 69/381)
Character Range: 11961016–11969148

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.
C11635              P11635         CN11635          Adalimumab                                                                                                      Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 11635
                                                                                                                                                                    Subsequent continuing treatment, Whole body
                                                                                                                                                                    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 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
                                                                                                                                                                    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 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 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.
C11642              P11642         CN11642          Stiripentol                                                                                                     Severe myoclonic epilepsy in infancy (Dravet syndrome)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 11642
                                                                                                                                                                    Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND
                                                                                                                                                                    The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs; AND
                                                                                                                                                                    Must be treated by a neurologist if treatment is being initiated.  or
                                                                                                                                                                    Must be treated by a neurologist if treatment is being continued or re-initiated.  or
                                                                                                                                                                    Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued.  or
                                                                                                                                                                    Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.
C11644              P11644         CN11644          High fat formula with vitamins, minerals and trace elements