Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p123
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 123/161)
Character Range: 14459919–14465467

condition must be stabilised following a decompensation event that required at least one of:
                                                                                    (i) hospitalisation in the past 6 months, (ii) intravenous diuretic therapy in the past three months; AND
                                                                                   Patient must not have clinical signs of fluid overload; AND
                                                                                   Patient must not have received intravenous treatment for fluid overload in the previous 24 hours; AND
                                                                                   Patient must not have a systolic blood pressure less than 100 mmHg; AND
                                                                                   The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND
                                                                                   The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated.  or
                                                                                   The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated.  or
                                                                                   The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated.
C13593              P13593         CN13593          Etanercept                     Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Written Authority Required procedures
                                                                                   Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                   Must be treated by a rheumatologist; or
                                                                                   Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND
                                                                                   Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                   Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                   The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or
                                                                                   The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
                                                                                   The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
                                                                                   Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                   Patient must be at least 18 years of age.
                                                                                   Major joints are defined as (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).
                                                                                   All measures of joint count and ESR and/or CRP must be no