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Patient eligibility
The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with biological agents under the National Health Act 1953, section 85 and section 100 for adult patients with severe active rheumatoid arthritis.
Where the term ‘biological agent’ appears it refers to:
- abatacept
- adalimumab
- baricitinib
- certolizumab
- etanercept
- golimumab
- infliximab
- tocilizumab
- tofacitinib
- upadacitinib.
Patients must be eligible for the PBS and meet the relevant restriction criteria.
The Schedule of Pharmaceutical Benefits on the PBS website outlines the restrictions for prescribing biological agents.
Section 100 arrangements
Abatacept i.v., infliximab i.v., and tocilizumab i.v.
These items are only PBS-subsidised for non-admitted patients, day admitted patients or patients on discharge who are attending:
- an approved private hospital
- a public participating hospital
- a public hospital.
These items aren’t PBS-subsidised for public hospital in-patients. You must include the hospital name and provider number on the authority application form.
Toxicity and severity descriptors
When demonstrating a patient’s intolerance to prior treatment, use the rheumatoid arthritis toxicity and severity descriptors with the authority application.
Treatment specifics
To be eligible for PBS-subsidised treatment with biological agents, patients must be treated by either a:
- rheumatologist
- clinical immunologist with expertise in the management of rheumatoid arthritis.
Authority applications
Applying for initial treatment
Apply for initial authority approval to prescribe PBS-subsidised biological agents to treat severe active rheumatoid arthritis in writing and either:
- use HPOS Form upload
- mail to PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- rheumatoid arthritis - initial authority application form
- relevant attachments.
Applying for change of treatment after resolution of critical shortage of tocilizumab
Apply for change of treatment after resolution of critical shortage of tocilizumab to treat patients with severe active rheumatoid arthritis in writing and either:
- use HPOS Form upload
- mail to PBS Complex Drugs Program.
All written applications must include the completed:
- authority prescription form or forms
- rheumatoid arthritis - change of treatment after resolution of critical shortage of tocilizumab authority application form
- relevant attachments.
Applying for change or recommencement of treatment
Apply to change or recommence authority approval to prescribe PBS-subsidised biological agents to treat severe active rheumatoid arthritis in writing and either:
- use HPOS Form upload
- mail to PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- rheumatoid arthritis - change, recommencement or demonstration of response authority application form
- relevant attachments.
You can use this authority application form for patients who received PBS-subsidised treatment for either:
- paediatric severe active juvenile idiopathic arthritis
- systemic juvenile idiopathic arthritis.
These patients must have had their condition reclassified to severe active rheumatoid arthritis.
You can also use this authority application form to submit a demonstration of response to the current PBS-subsidised treatment.
Applying for continuing treatment
Apply for continuing authority approval to prescribe PBS-subsidised biological agents to treat severe active rheumatoid arthritis in writing and either:
- use HPOS Form upload
- mail to PBS Complex Drugs Programs.
All written applications must include the completed:
- authority prescription form or forms
- rheumatoid arthritis - continuing authority application form
- relevant attachments.
After we approve the first application for continuing treatment, subsequent continuing treatment with PBS-subsidised biosimilar brands of biological agents are Authority Required (Streamlined). You don’t need authority approval from us for the listed quantity and repeats.
More information
Call the PBS Complex Drugs Programs enquiry line for more information.