Rheumatoid arthritis

Treatment with biological disease-modifying antirheumatic drugs (bDMARDs) 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.

Section 100 arrangements

Abatacept (intravenous), infliximab, rituximab and tocilizumab 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

You must include the hospital number on the application form.

These items aren't available as PBS benefits for hospital in-patients.

Patient eligibility

Patients must meet the relevant criteria in the restrictions and be eligible for the PBS.

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing bDMARDs.

Toxicity criteria and severity descriptors

The rheumatoid arthritis toxicity criteria and severity descriptors list was prepared in consultation with the Australian Rheumatology Association.

Use this list to make sure patient eligibility is fully assessed. Use the list in conjunction with the application when showing a patient's intolerance to bDMARDS.

Interchangeability

Interchangeability arrangements apply when prescribing the following under the PBS:

• tumour necrosis factor (TNFα) antagonists (adalimumab, certolizumab pegol, etanercept, golimumab and infliximab)
• interleukin-6 inhibitor (tocilizumab)
• chimeric anti-CD20 monoclonal antibody (rituximab)
• T-cell co-stimulation modulator (abatacept), and
• Janus-associated kinase (JAK) inhibitor (tofacitinib)

Patients are eligible for PBS subsidised treatment for only 1 of these bDMARDs at a time.

The arrangements for prescribing bDMARDs under the PBS allow patients to start a single lifetime cycle of treatment for trialling a number of bDMARDs.

Eligible patients don’t need to experience a disease flare to swap between alternate bDMARDs. Within a single treatment cycle, patients can continue long term treatment with a bDMARD while they sustain a response to therapy.

Demonstration of a response

We’ll assess if a response to treatment has been successful based on the baseline measurements of the indices of disease severity.

You can provide new baseline measurements when submitting an initial or change treatment authority. We then assess the response according to the revised baseline measurements.

The same indices of disease severity used to establish the baseline must be provided for all subsequent continuing treatment applications. This ensures consistency in determining a response. For example:

• where only an erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) level is provided at baseline, an ESR or CRP level must be provided in subsequent applications to determine a response
• where the baseline is for total active joints, a response is determined according to a reduction in the total number of active joints. Patients with less than 20 active joints, with at least 4 active major joints, are assessed on major joints only for continuing treatment

Failure to respond

If a patient doesn’t respond to a particular bDMARD, they aren’t eligible for further PBS subsidised treatment with that bDMARD for rheumatoid arthritis.

Once a patient has failed, or stopped responding to treatment with a maximum of 5 bDMARDs, they are no longer eligible for PBS subsidised bDMARDs for the treatment of rheumatoid arthritis.

Applications

All applications must be completed by the treating rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis.

Initial treatment

Applications for initial treatment should be made where the patient:

• has had no prior PBS subsidised bDMARD treatment, or
• has had more than 24 months break in bDMARD treatment

Make all initial applications for authority approval to prescribe bDMARDs for the treatment of rheumatoid arthritis in writing and post to the PBS Complex Drugs Programs address.

All applications must include a completed:

• authority prescription form, and
• Rheumatoid arthritis Initial PBS authority application and Supporting information form (PB109)

All applications for initial treatment are limited to a maximum of:

• 16 weeks of therapy with:
  • abatacept
  • adalimumab
  • etanercept
  • golimumab
  • tocilizumab, and
  • tofacitinib
• 18 to 20 weeks of therapy with certolizumab pegol depending on the dosing schedule
• 22 weeks of therapy with infliximab
• 2 infusions of rituximab

Patients must be assessed for response to any course of PBS subsidised initial treatment after at least 12 weeks of therapy. Submit this assessment no later than 4 weeks from the date the course stopped. Not notifying us of the response within these time frames means the patient is deemed as failing treatment with that bDMARD.

Continuing treatment

Applications to change, restart or continue PBS subsidised treatment is only considered after an initial treatment course.

Make all continuing applications for authority approval to prescribe bDMARDs for the treatment of rheumatoid arthritis in writing and post to the PBS Complex Drugs Programs address.

All applications for continuing PBS authority must include a completed:

• authority prescription form, and
• Rheumatoid arthritis Continuing PBS authority application Supporting information form (PB111)

Once a patient completes an initial treatment course with a specific bDMARD, they may qualify for up to 24 weeks of continuing treatment with that drug. Patients must be assessed after at least 12 weeks of initial treatment and show an adequate response to treatment.

Patients are eligible to receive continuing bDMARD treatment with the same drug in courses of up to 24 weeks as long as they continue to sustain the response. Applications for continuing treatment should be made after 20 weeks or within 1 month of stopping treatment.

Continuing treatment - rituximab

The assessment for each continuing application should be made 12 weeks after the first infusion of the patient’s most recent treatment with rituximab.

Swapping therapy - change of treatment

Applications for patients who want to swap to an alternate bDMARD should include the approved authority prescription(s), and remaining repeats for the bDMARD the patient is stopping.

Patients can swap to an alternate bDMARD once an authority for initial treatment with the first PBS subsidised bDMARD is approved.

If the break in treatment is less than 24 months, eligible patients don’t need to requalify for:

• indices of disease severity, erythrocyte sedimentation rate or C-reactive protein levels and active joint count, or
• prior therapy requirements

The requirement for concomitant treatment with methotrexate must be met for the relevant bDMARD as specified in the restrictions.

If a patient doesn’t respond to at least 1 course of treatment with a PBS subsidised TFNα antagonist they will receive PBS subsidised treatment with rituximab. Patients who don’t have a response assessment submitted to us within the required timeframes are deemed to have failed bDMARD treatment and no longer qualify for rituximab.

Patients who have had a break in PBS subsidised treatment of:

• less than 24 months, who demonstrated a response to that treatment and want to restart treatment, must submit a new baseline set of measurements
• more than 24 months must reapply as an initial patient and this assessment becomes the new baseline set of measurements

Patients can swap to an alternate bDMARD if they’re receiving initial or continuing therapy with a bDMARD. Patients can alternate, 1 at a time, with any bDMARD if they’re eligible for treatment with that bDMARD and:

• haven’t received PBS subsidised treatment with that bDMARD previously, or
• have demonstrated an adequate response to that bDMARD during a previous trial on the PBS

Patients must be assessed for response to every course of treatment approved within the timeframes specified in the relevant restriction. This is to maximise the bDMARD treatment options for patients.

Stopping treatment

If your patient wants to temporarily stop treatment with a bDMARD, you need to submit a demonstration of response to current treatment within 1 month of the treatment stopping.

Fax the completed form to the Complex Drugs Programs enquiry line so it can be included in the patient's treatment history.

Patients who have a break in PBS subsidised treatment of more than 24 months must reapply as an initial patient.

Further information

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