Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p154
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 154/162)
Character Range: 15442401–15447940

(v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);
                                                                                                         (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.
                                                                                                         Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment
                                                                                                         (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);
                                                                                                         (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.
                                                                                                         Where a patient has had a 12 month treatment break, the length of the break is measured from the date the most recent treatment was stopped to the date of the application to re-commence treatment.
C14556              P14556         CN14556          Golimumab                                            Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Written Authority Required procedures
                                                                                                         Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
                                                                                                         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 prior PBS-subsidised treatment with a biological medicine for this condition; or
                                                                                                         Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
                                                                                                         Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND
                                                                                                         Patient must not receive more than 16 weeks of treatment under this restriction; AND
                                                                                                         The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly;
                                                                                                         Patient must be at least 18 years of age.
                                                                                                         Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
                                                                                                         Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.
                                                                                                         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