Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p30
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 30/312)
Character Range: 15634950–15641752

must be in combination with methotrexate; AND
                                                                                                                           Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND
                                                                                                                           Patient must have demonstrated an adequate response to treatment; AND
                                                                                                                           Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
                                                                                                                           The authority application must be made in writing and must include
                                                                                                                           (1) a completed authority prescription form; and
                                                                                                                           (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 adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing
                                                                                                                           (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
                                                                                                                           (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
                                                                                                                           The assessment of response to treatment must be provided in this application and documented in the patient's medical records.
C14629              P14629         CN14629          Etanercept                                                             Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 14629
                                                                                                                           First continuing treatment
                                                                                                                           Must be treated by a rheumatologist; or
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; 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 under this restriction;
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           An adequate response to treatment is defined as
                                                                                                                           an ESR no greater than 25 mm per hour or a 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 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 assessment of response to treatment must be documented