Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p169
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 169/381)
Character Range: 12619919–12626318

as joint destruction or bony overgrowth).
                                                                                                                                                                    To demonstrate a response to treatment the application 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 biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                                                                                                    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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                                                    A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months 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.
C12405              P12405         CN12405          Tocilizumab                                                                                                     Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)
                                                                                                                                                                    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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
                                                                                                                                                                    Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
                                                                                                                                                                    Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    The authority application must be made in writing and must include
                                                                                                                                                                    (1) a completed authority prescription form; and
                                                                                                                                                                    (2) a completed authority application