Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p80
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 80/381)
Character Range: 12042444–12049187

(change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                                                                                                    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 received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                                                                    Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; 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) two completed authority prescription forms; and
                                                                                                                                                                    (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                                                                    Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.
                                                                                                                                                                    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 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.
C11761              P11761         CN11761          Adalimumab                                                                                                      Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                                                                                                    Patient must have a documented history of severe Crohn disease; AND
                                                                                                                                                                    Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND