Table 1 Access scheme for biological agents for the treatment of RA under the PBS
Main features | Prior-approval requirements |
|---|---|
Criteria for initiating treatment | • Severe active disease: a) elevated levels of anti-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 is 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 with their physicians 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 anti-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 (an agent that the patient has responded adequately or has not trialed previously) |
Restricted prescribing rights | • Prescription only by specialist rheumatologists initially. Prescribing rights were extended to clinical immunologists with expertise in the management of rheumatoid arthritis as of February 2004 |
'Risk-mitigation' arrangement | • Annual PBS expenditure for the TNF 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) |