Arthritis - rheumatoid arthritis

Patient eligibility

The PBS subsidises treatment with biological agents under the National Health Act 1953, sections 85 and 100 for patients with severe active rheumatoid arthritis.

Where the term biological agent appears, it refers to:

• abatacept
• adalimumab
• baritcitinib
• certolizumab
• etanercept
• golimumab
• infliximab
• rituximab
• tocilizumab
• tofacitinib.

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, infliximab, rituximab and tocilizumab

These items are only available for a day admitted patient, non-admitted patient, or patients on discharge attending either:

• an approved private hospital
• a public participating hospital
• a public hospital.

These items aren't PBS subsidised for 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

Patients must be treated by a rheumatologist or clinical immunologist with expertise managing severe active rheumatoid arthritis to be eligible for PBS subsidised treatment with these medications.

Applications

Initial treatment

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

• upload through Health Professional Online Services (HPOS), or
• post to the PBS Complex Drugs Programs.

All applications must include the completed:

• authority prescription form or forms
• rheumatoid arthritis - initial PBS authority application form
• relevant attachments.

Initial grandfather treatment

For patients who received non-PBS subsidised baricitinib treatment before 1 September 2018 for severe active rheumatoid arthritis, apply for all initial grandfather authority approval in writing and either:

• upload through HPOS, or
• post to the PBS Complex Drugs Programs.

All applications must include the completed:

• authority prescription form or forms
• rheumatoid arthritis - initial PBS grandfather authority application form
• relevant attachments.

Changing or recommencing treatment

Apply for authority approval to change and recommence PBS subsidised biological agents to treat severe active rheumatoid arthritis in writing and either:

• upload through HPOS, or
• post to the PBS Complex Drugs Programs.

All applications must include the completed:

• authority prescription form or forms
• rheumatoid arthritis - change or recommencement PBS authority application form
• relevant attachments.

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

Continuing treatment

Apply for authority approval to continue PBS subsidised biological agents to treat severe active rheumatoid arthritis in writing and either:

• upload through HPOS, or
• post to PBS Complex Drugs Programs.

All applications must include the completed:

• authority prescription form or forms
• rheumatoid arthritis - continuing PBS authority application form
• relevant attachments.

After we approve the first application for continuing treatment with infliximab, subsequent continuing applications for biosimilar brands are:

• S100 - HSD (Public) - Authority Required (Streamlined) and don’t need authority approval from us
• S100 - HSD (Private) - Authority Required (Telephone) - you can call the PBS authority approvals line to request authority approval.

After we approve the first application for continuing treatment with etanercept, subsequent continuing applications for biosimilar brands are Authority Required (Streamlined). They don’t need prior authority approval from us.

More information

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