Juvenile idiopathic arthritis

The Pharmaceutical Benefits Scheme subsidises biological disease-modifying antirheumatic drugs for patients with severe active juvenile idiopathic arthritis.

Biological disease-modifying antirheumatic drugs (bDMARDs) are available through the Pharmaceutical Benefits Scheme (PBS) as an Authority Required medicine for the treatment of:

  • juvenile patients, under 18 years of age with severe active juvenile idiopathic arthritis (JIA) who are either being treated by a rheumatologist or are under the supervision of a paediatric rheumatology treatment centre, and
  • adult patients, over 18 years of age with a documented history of severe active JIA who are either being treated by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis

Section 100 arrangements

These items are only available to a JIA patient who is under 18 or a JIA patient who is over 18 (tocilizumab only) and is attending:

  • an approved private hospital
  • a public participating hospital, or
  • a public hospital
    and is either a
  • day admitted patient
  • non-admitted patient, or
  • patient on discharge

These items are not available as a PBS benefit for in-patients of the hospital. The hospital provider number must be included on the application form.

Initial treatment

All applications for initial treatment are limited to a maximum of 16 weeks of treatment.

Juvenile patients

Juvenile patients must satisfy 1 of the 3 restrictions before approval is granted to prescribe a bDMARD.

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

All applications must be completed by the treating paediatric rheumatologist for a patient under 18 years of age.

The restrictions for juvenile patients are:

  1. initial PBS-subsidised treatment for new patients or patients recommencing treatment after a break of more than 12 months or
  2. change or recommencement of treatment after a break of less than 12 months, or
  3. continuing PBS-subsidised treatment for patients who qualify to receive up to 24 weeks of continuing treatment

Adult patients

Adult patients must have a documented history of severe active juvenile idiopathic arthritis before the age of 18 years.

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

Adult patients must satisfy 1 of the 3 restrictions before approval is granted to prescribe a bDMARD.

The restrictions are:

  1. initial PBS-subsidised treatment for new patients or patients recommencing treatment after a break of more than 24 months
  2. change or recommencement of treatment after a break of less than 24 months, or
  3. continuing PBS-subsidised treatment for patients who qualify to receive up to 24 weeks of continuing treatment

Continuing treatment

Following the completion of an initial treatment course with a bDMARD, patients may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. Patients are eligible to receive continuing treatment with the same drug in courses of up to 24 weeks providing they continue to sustain a response.

Patients must be assessed for a response after a minimum of 12 weeks of initial treatment.

This assessment must be submitted to us no later than 4 weeks from the date that the course was completed.

If a response assessment is not submitted to us within this time, patients will be deemed to have failed to respond to treatment with that bDMARD.

Baseline measurements to determine response

We will determine whether a response to treatment has been demonstrated based on the baseline measurements of the indices of disease severity submitted with the first authority application for bDMARD treatment.

The joint count must be within 1 month of the application. To ensure consistency in determining the response where the baseline active joint count is based on total active joints, that is, more than 20 active joints, the response is determined according to a reduction in the total number of active joints. Where a patient has at least 4 active major joints and less than 20 total active joints, only assessment of the major joints is used for all continuing applications.

Where applicable, any 1 of the baseline criteria may be used to determine the response to an initial course of treatment and eligibility for continued therapy, according to the continuing treatment restriction. To determine eligibility for continuing PBS-subsidised therapy, any criterion used to demonstrate the response must have been supplied with the initial application.

Applications must be lodged within 1 month of the date of all assessments.

Changing treatment

Once an authority for initial treatment with a bDMARD is approved, patients may swap to an alternative treatment, providing they are eligible.

All applications for alternative treatment are limited to a maximum of 16 weeks of treatment.

Patients may swap to an alternative treatment at any time, regardless of whether they are receiving initial or continuing therapy at the time of the application.

Patients may alternate between bDMARD therapies, providing they have:

  • not received PBS-subsidised treatment with that particular bDMARD previously, or
  • not trialled and failed, or ceased to respond to, the same PBS-subsidised bDMARD

To maximise the choice of bDMARDs that patients may alternate between, it is important they are assessed for a response to every course of treatment approved within the timeframes specified in the relevant restriction.

To avoid confusion, applications for patients who wish to swap to an alternative bDMARD should include the approved authority prescription, or remaining repeats for the bDMARD that the patient is ceasing.

From 1 April 2014, the following apply:

  • a patient receiving current PBS-subsidised bDMARD treatment is considered to be in a treatment cycle
  • a patient who has received PBS-subsidised bDMARD treatment and who has had a break in treatment of less than 12 months (juvenile) or 24 months (adult) is considered to be in the same treatment cycle, and
  • a patient who has received PBS-subsidised bDMARD treatment and who has had a break in treatment of greater than 12 months (juvenile) or 24 months (adult) must meet all initial criteria and is considered to be in a new treatment cycle

Within a single treatment cycle, a patient may:

  • continue to receive long-term treatment with a PBS-subsidised bDMARD while they continue to show a response to treatment
  • fail to respond, or sustain a response to, each bDMARD once only, and
  • swap to an alternative bDMARD without having to experience a disease flare

Once a patient has either failed or ceased to respond to treatment 3 times, they are deemed to have completed a single treatment cycle and must have a break in PBS-subsidised bDMARD treatment.

A break is defined as the minimum amount of time from the date treatment was ceased:

  • 12 months for juvenile patients, and
  • 24 months for adult patients

Toxicity criteria and severity descriptors (for adult patients only)

To make sure patients' eligibility can be fully assessed, we have developed, in consultation with the Australian Rheumatology Association a comprehensive list of juvenile idiopathic arthritis toxicity criteria and severity descriptors to be used in conjunction with the application when demonstrating a patient's inability to tolerate bDMARDs.

Lodging an application

Send all written applications to the Complex Drugs Programs address on the contact us page.

Further information

For more information contact us on the Complex Drugs Programs, enquiry line.

Page last updated: 10 November 2016

This information was printed Friday 9 December 2016 from humanservices.gov.au/health-professionals/enablers/juvenile-idiopathic-arthritis It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.