Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p58
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 58/162)
Character Range: 14959623–14966038

or
                                                                                                         Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre;
                                                                                                         Patient must be under 18 years of age.
                                                                                                         The following information must be provided by the prescriber at the time of application and documented in the patient's medical records
                                                                                                         (a) the date of assessment of severe active systemic juvenile idiopathic arthritis.
                                                                                                         The following reports must be documented in the patient's medical records where appropriate
                                                                                                         (a) pathology reports detailing C-reactive protein (CRP) level and platelet count.
                                                                                                         The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.
                                                                                                         An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to 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.
C14124              P14124         CN14124          Choriogonadotropin alfa                              Assisted Reproductive Technology                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 14124
                                                                                                         Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule; AND
                                                                                                         Patient must not be undergoing simultaneous treatment with this drug through another PBS program listing.
C14136              P14136         CN14136          Adalimumab                                           Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 14136
                                                                                                         Continuing treatment
                                                                                                         Must be treated by a rheumatologist; or
                                                                                                         Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND
                                                                                                         Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                         Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                         Patient must not receive more than 24 weeks of treatment per continuing treatment 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