Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p160
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 160/381)
Character Range: 12555295–12563400

a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                                                                    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.
                                                                                                                                                                    At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient doses for up to 24 weeks treatment. Up to a maximum of 5 repeats will be authorised.
                                                                                                                                                                    Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.
C12225              P12225         CN12225          Lacosamide                                                                                                      Idiopathic generalised epilepsy with primary generalised tonic-clonic seizures                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 12225
                                                                                                                                                                    Dose titration at the start of therapy, during therapy or to gradually cease treatment
                                                                                                                                                                    Must be treated by a neurologist; or
                                                                                                                                                                    Must be treated by a paediatrician; AND
                                                                                                                                                                    The condition must have failed to be controlled satisfactorily by at least two anti-epileptic drugs prior to when the drug is/was first commenced; AND
                                                                                                                                                                    The treatment must be (for initiating treatment)/have been (for continuing treatment) in combination with at least one PBS-subsidised anti-epileptic drug at the time the drug is/was first commenced; AND
                                                                                                                                                                    The treatment must be for dose titration purposes.
C12228              P12228         CN12228          Adalimumab                                                                                                      Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                                                                    First continuing treatment
                                                                                                                                                                    Must be treated by a gastroenterologist (code 87); or
                                                                                                                                                                    Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                                                                                    Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must have demonstrated an adequate response to treatment with this drug for this condition.
                                                                                                                                                                    An adequate response is defined as