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Criteria for initiating
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• Severe active disease:
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treatment
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a) elevated levels of inflammatory markers (ESR > 25 mm/hour or CRP > 15 mg/L)
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b) swollen and tender joints – a total of > 20 joints, or > 4 major joints (elbow, wrist, knee, ankle, shoulder, hip)
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• A record of rheumatoid factor positive status (this requirement was removed as of June 2005)
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• Failure to achieve adequate response to a step-up sequence of treatment with conventional DMARDs:
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a) monotherapy with methotrexate (20 mg per week)
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b) a combination of methotrexate (> 7.5 mg per week) and 2 other DMARDs for at least 3 months
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c) leflunomide, leflunomide with methotrexate, or cyclosporin for at least 3 months
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• Evidence of intolerance or contraindication to DMARDs
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• Patients required to sign a 'patient acknowledgement form'
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• Treatment is approved for 16 weeks only (treatment of 22 weeks is approved for infliximab)
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A patient agreement process
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• A Patient Acknowledgement Form to be signed by patients to acknowledge that PBS subsidised treatment will only continue if the predetermined response criteria are achieved at 12 weeks
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Criteria for continuing treatment
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• Clinical outcomes are evaluated according to predetermined quantifiable criteria at 12 weeks:
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a) Reduction in levels of inflammatory markers, ESR < 25 mg/hour, or CRP < 15 mg/L, or 20% from baseline levels
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b) Reduction in the total number of joint count by 50%
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'Interchangeability' (introduced December 2004)
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• Patients approved to commence PBS subsidised biological treatment are allowed to switch to an alternate biological agent at any time
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Restricted prescribing rights
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• Prescription only by specialist rheumatologists initially. Prescribing rights were extended to clinical immunologists with expertise in the management of RA as of February 2004
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'Risk-sharing' arrangement
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• Annual PBS expenditure for the tumour necrosis factor inhibitors group was predicted to be up to A$140 million
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• Expenditure above this figure to be covered by the sponsoring pharmaceutical companies (details not clear from public documents)
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