Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p56
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 56/312)
Character Range: 15781011–15787050

course authorised under this restriction.
                                                                                                                           An adequate response to treatment is defined as
                                                                                                                           (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
                                                                                                                           (b) a reduction in the number of the following active joints, from at least 4, by at least 50%
                                                                                                                           (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                                                           (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
                                                                                                                           The assessment of response to treatment must be documented in the patient's medical records.
                                                                                                                           Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
                                                                                                                           The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
                                                                                                                           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 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 they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
C14698              P14698         CN14698          Upadacitinib                                                           Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                           Balance of supply for the Continuing (maintenance) treatment phase
                                                                                                                           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
                                                                                                                           The treatment must have been prescribed in a quantity in the most recent prescription which did not seek the full quantity available in regards to any of:
                                                                                                                            (i) the quantity per dispensing, (ii) repeat prescriptions; AND
                                                                                                                           The treatment