Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p68
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 68/162)
Character Range: 15008615–15014460

and platelet count.
                                                                                                         An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
                                                                                                         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 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring 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 prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C14180              P14180         CN14180          Fluticasone propionate                               Asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 14180
                                                                                                         The treatment must not be a PBS benefit where this 50 microgram strength is being initiated in a patient over the age of 6.00 years.
C14182              P14182         CN14182          Tocilizumab                                          Systemic juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                         Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing less than 30 kg)
                                                                                                         Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND
                                                                                                         Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND
                                                                                                         Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                         Patient must be under 18 years of age;
                                                                                                         Must be treated by a rheumatologist.  or
                                                                                                         Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
                                                                                                         An adequate response to treatment is defined as
                                                                                                         (a) in a patient with polyarticular course disease
                                                                                                         (i) 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
                                                                                                         (ii) a reduction in the number of the following major active joints, from at least 4, by