Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p248
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 248/312)
Character Range: 17029757–17036001

25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
                                                                                                                           either of the following:
                                                                                                                           (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 major 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 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 authority application must be made in writing and must include:
                                                                                                                           (a) details of the proposed prescription; and,
                                                                                                                           (b) 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).
                                                                                                                           (c) the date of commencement of this drug; and
                                                                                                                           (d) results of the baseline patient assessment prior to initiation of non-PBS-subsidised therapy with this drug.
                                                                                                                           The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all continuing treatment applications.
                                                                                                                           The assessment of the patient's response to this PBS-subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course.
                                                                                                                           An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
                                                                                                                           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.
C15918              P15918         CN15918          Aflibercept                                                            Subfoveal choroidal neovascularisation (CNV)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
                                                                                                                           The condition must be due to age-related macular degeneration (AMD); AND
                                                                                                                           The condition must be diagnosed by optical coherence tomography; OR
                                                                                                                           The condition must be diagnosed