Arthritis - rheumatoid arthritis

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

Treatment with biological agents can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under sections 85 and 100 of the National Health Act 1953 for patients with severe active rheumatoid arthritis.

Where the term biological agent appears it refers to abatacept both intravenous and subcutaneous, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab both intravenous and subcutaneous and tofacitinib.

Section 100 arrangements

Abatacept (intravenous), infliximab, rituximab and tocilizumab (intravenous) are only available to a patient who is attending:

  • an approved private hospital
  • a public participating hospital, or
  • a public hospital

and is a

  • day admitted patient
  • non-admitted patient, or
  • patient on discharge

These items are not PBS-subsidised for in-patients of the hospital. You must include the hospital name and provider number on the authority application form.

Patient eligibility

Patients must be eligible for the PBS and meet the relevant restriction criteria. The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing biological agents.

Toxicity criteria and severity descriptors

Use the rheumatoid arthritis toxicity criteria and severity descriptors in conjunction with the authority application when demonstrating patient’s intolerance to prior systemic therapy.

Demonstration of a response

The same indices of disease severity used to establish the baseline must be used for all continuing treatment authority applications. This ensures consistency in demonstrating a response.

You can provide new baseline measurements when applying to change or recommence PBS subsidised treatment with biological agents.

If a patient has failed to demonstrate or sustain a response to treatment with a maximum of 5 different biological agents, they are no longer eligible for PBS subsidised biological agents for the treatment of rheumatoid arthritis.

Applications

Patients must be treated by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis.

Initial treatment

Make all initial applications for authority approval to prescribe biological agents for the treatment of rheumatoid arthritis in writing and:

All applications must include a completed:

Initial grandfather treatment

For patients who received non PBS subsidised tofacitinib treatment before 1 October 2015 for rheumatoid arthritis, make all initial grandfather applications in writing and:

All applications must include a completed:

Continuing, changing or recommencing treatment

Make all continuing applications for authority approval to continue, change or recommence PBS subsidised biological agents for the treatment of rheumatoid arthritis in writing and:

All applications must include a completed:

You can use this authority application form to submit a demonstration of response to the current PBS subsidised treatment.

Subsequent continuing treatment with the etanercept biosimilar as per the PBS restriction is Authority Required (Streamlined) and does not require prior authority approval from the Department of Human Services.

Further information

For more information call the PBS Complex Drugs Programs enquiry line.

Page last updated: 15 February 2018