Table 1 Access arrangements for biological agents for RA under the PBS
| Â | 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: |
| Â | a) monotherapy with methotrexate (20 mg per week) |
| Â | b) a combination of methotrexate (> 7.5 mg per week) and 2 other DMARDs for at least 3 months |
| Â | 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: |
| Â | a) Reduction in levels of inflammatory markers, ESR < 25 mg/hour, or CRP < 15 mg/L, or 20% from baseline levels |
| Â | 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) |