Arthritis - rheumatoid arthritis

The PBS subsidises biological agents for patients with severe active rheumatoid arthritis.

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 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

Biosimilars

Applying for initial treatment

Applications for initial authority approval to prescribe PBS-subsidised biosimilar brands of biological agents to treat severe active rheumatoid arthritis can be made either:

Applying for change or recommencement of treatment

Applications to change or recommence authority approval to prescribe PBS-subsidised biosimilar brands of biological agents to treat severe active rheumatoid arthritis can be made either:

Applying for continuing treatment

Application for continuing PBS-subsidised treatment with biosimilar brands of biological agents is Authority Required (Streamlined). You don’t need authority approval from us for the listed quantities and repeats.

Originators

Applying for initial treatment

Apply for initial authority approval to prescribe PBS-subsidised originator brands of biological agents to treat severe active rheumatoid arthritis in writing and either:

All written applications must include the completed:

Applying for change or recommencement of treatment

Apply to change or recommence authority approval to prescribe PBS-subsidised originator brands of biological agents to treat severe active rheumatoid arthritis in writing and either:

All written applications must include the completed:

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 the first continuing treatment

Apply for the first continuing authority approval to prescribe PBS-subsidised originator brands of biological agents to treat severe active rheumatoid arthritis in writing and either:

All written applications must include the completed:

Applying for subsequent continuing treatment - excluding infliximab s.c. and upadacitinib

After we approve the first application for continuing treatment, subsequent continuing treatments with PBS-subsidised biological agents (excluding infliximab s.c. and upadacitinib) are Authority Required (Streamlined). You don’t need authority approval from us for the listed quantity and repeats.

Applying for continuing treatment - infliximab s.c. and upadacitinib

Apply for continuing authority approval to prescribe PBS-subsidised infliximab s.c. and upadacitinib to treat severe active rheumatoid arthritis in writing and either:

All written applications must include the completed:

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:

All written applications must include the completed:

More information

Call the PBS Complex Drugs Programs enquiry line for more information.

Page last updated: 1 November 2023.
QC 32971