Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p141
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 141/162)
Character Range: 15376172–15383941

Abatacept                                            Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                         First continuing treatment - balance of supply
                                                    Adalimumab                                           Must be treated by a rheumatologist; or
                                                                                                         Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                    Baricitinib                                          Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                         The treatment must provide no more than the balance of up to 24 weeks treatment.
                                                    Certolizumab pegol

                                                    Etanercept

                                                    Golimumab

                                                    Infliximab

                                                    Tocilizumab

                                                    Tofacitinib

C14508              P14508         CN14508          Etanercept                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 14508
                                                                                                         Completion of course - treatment covering weeks 16 to 24 (Face, hand, foot)
                                                                                                         Must be treated by a dermatologist; AND
                                                                                                         Patient must be undergoing current PBS-subsidised treatment with this biological medicine, with the intention to complete the remainder of a 24-week treatment course with this biological medicine; AND
                                                                                                         The treatment must be as systemic monotherapy; or
                                                                                                         The treatment 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, but within 8 weeks of the last administered dose; AND
                                                                                                         Patient must have demonstrated an adequate response to treatment; AND
                                                                                                         Patient must not receive more than 8 weeks of treatment with etanercept under this restriction.
                                                                                                         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 documented in the patient's medical records.
                                                                                                         The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.
C14509              P14509         CN14509          Etanercept                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 14509
                                                                                                         Completion of course - treatment covering weeks 16 to 24 (Whole body)
                                                                                                         Must be treated by a dermatologist; AND
                                                                                                         Patient must be undergoing current PBS-subsidised treatment with this biological medicine, with the intention to complete the remainder of a 24-week treatment course with this biological medicine; AND
                                                                                                         The treatment must be as systemic monotherapy; or
                                                                                                         The treatment must be in combination with methotrexate; AND
                                                                                                         Patient must have been assessed for response to treatment after at