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Table 1 Access arrangements for biological agents for RA under the PBS

From: The views of stakeholders on controlled access schemes for high-cost antirheumatic biological medicines in Australia

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