Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p39
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 39/312)
Character Range: 15685490–15692903

date of assessment of severe active juvenile idiopathic arthritis; and
                                                                                                                           (b) details of prior treatment including dose and duration of treatment.
                                                                                                                           The assessment of the patient's response to the initial course of treatment 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 this 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.
C14653              P14653         CN14653          Upadacitinib                                                           Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                           Balance of supply for Initial (induction) treatment phases
                                                                                                                           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 must provide no more than the balance available under the treatment phase from which the immediately preceding supply was obtained under.
C14655              P14655         CN14655          Adalimumab                                                             Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                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)
                                                    Etanercept                                                             Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                           Patient must not have already failed/ceased to respond to PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
                                                    Golimumab                                                              Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                                           Patient must be at least 18 years of age;
                                                    Ixekizumab                                                             Must be treated by a rheumatologist.  or
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
                                                    Secukinumab                                                            The authority application must be made in writing and must include
                                                                                                                           (1) a completed authority prescription form; and
                                                    Tofacitinib                                                            (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).
                                                                                                                           An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment