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:
- upload through Health Professional Online Services (HPOS), or
- post to the PBS Complex Drugs Programs
All applications must include a completed:
- authority prescription form, and
- Rheumatoid arthritis Initial PBS authority application and Supporting information form (PB109)
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:
- upload through Health Professional Online Services, or
- post to the PBS Complex Drugs Programs address
All applications must include a completed:
- authority prescription form, and
- Rheumatoid arthritis Initial PBS grandfather authority application (PB110)
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:
- upload through Health Professional Online Services, or
- post to PBS Complex Drugs Programs
All applications must include a completed:
- authority prescription form(s), and
- Rheumatoid arthritis Continuing PBS authority application Supporting information form (PB111)
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.