Table 1.
Access arrangements for biological agents for RA under the PBS
| 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) |
ESR = erythrocyte sedimentation rate
CRP = C-reactive protein
DMARDs = disease-modifying anti-rheumatic drugs