Systemic juvenile idiopathic arthritis

The Pharmaceutical Benefits Scheme subsidises tocilizumab for patients with systemic juvenile idiopathic arthritis.

For patients with systemic juvenile idiopathic arthritis, treatment with tocilizumab can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under section 100 of the National Health Act 1953.

Section 100 Arrangements

Tocilizumab is only available to a patient in:

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

Tocilizumab is not available as a PBS medicine for in-patients of the hospital. The hospital provider number must be included on the application form.

Restrictions

A patient must satisfy one of the four restrictions before approval will be granted to prescribe tocilizumab. The restrictions are:

  1. initial PBS subsidised treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of patients aged under 18 years, with a documented history of severe active systemic juvenile idiopathic arthritis
  2. initial PBS subsidised treatment by a paediatric rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, for continuing treatment of patients under 18 years with a documented history of severe active systemic juvenile idiopathic arthritis who started treatment with non PBS subsidised tocilizumab before 1 November 2011 and who, at the time of application, have shown an adequate response to treatment
  3. retrial or recommencement of treatment after a break of less than 12 months, by a rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of patients with a documented history of severe active systemic juvenile idiopathic arthritis who have received PBS subsidised treatment with tocilizumab in the previous 12 months and who have not failed PBS subsidised therapy with tocilizumab more than once in the current treatment cycle
  4. continuing PBS subsidised treatment, by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre of patients with a documented history of severe active systemic juvenile idiopathic arthritis, who at the time of application show an adequate response to treatment with tocilizumab

Information for all patients

If a patient continues to show a response to treatment, they can continue to receive long term treatment with PBS subsidised tocilizumab within a single treatment cycle.

Once a patient has failed or ceased to respond to treatment twice, they have completed a single treatment cycle. The patient must have a 12 month break in PBS subsidised tocilizumab treatment from the date the last PBS subsidised treatment was stopped and the date of the first application under a new treatment cycle.

Initial treatment

Applications for initial treatment should be made when a patient has had:

  • no prior PBS subsidised tocilizumab treatment, or
  • a break in PBS subsidised tocilizumab treatment of more than 12 months

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

Patients must be assessed for a response after a minimum of 12 weeks of PBS-subsidised initial tocilizumab treatment. This assessment must be submitted to us no later than 4 weeks after the course is completed. If a response assessment is not submitted within these time frames, patients will be deemed to have failed to respond to treatment.

Continuing treatment

After completing an initial treatment course with PBS-subsidised tocilizumab, patients may qualify to receive up to 24 weeks of continuing treatment if they show an adequate response to treatment. Patients can have further continuing treatment in courses of up to 24 weeks if they continue to respond.

Patients must be assessed for a response to each course of continuing therapy. The assessment must be submitted to us no later than 4 weeks after the course is completed. If a response assessment is not submitted within this time, patients will be deemed to have failed to respond to treatment.

Once a patient has failed or ceased to respond to treatment twice, they have completed a single treatment cycle. The patient must have a 12-month break in PBS-subsidised tocilizumab treatment from the date the last PBS-subsidised treatment was stopped and the date of the 1st application under a new treatment cycle.

Baseline measurements to determine response

We will use the baseline measurements of the indices of disease severity submitted with the first authority application to determine if there has been response to treatment.

Any of the baseline criteria can be used to determine a 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 response must have been supplied with the initial application.

Applications must be made within 1 month of all assessments.

Schedule item details

Dose - Tocilizumab (Actemra®) is presented as:

  • 80 mg per 4 mL intravenous solution
  • 200 mg per 10 mL intravenous solution
  • 400 mg per 20 mL intravenous solution

The dose for patients who weigh:

  • <30 kg is 12 mg per kg every 2 weeks
  • ≥30 kg is 8 mg per kg every 2 weeks

Prescribers should request the appropriate quantity of vials of appropriate strength, based on the weight of the patient, to provide for 2 infusions, 1 month's supply. A separate authority prescription is needed for each strength. The most cost-effective combination of vials must be prescribed.

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.

Test requirements

The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than four weeks following cessation of the most recent prior treatment.

Reciprocal Health Care Agreement

If an eligible patient is a visitor from a country with which Australia has entered into a Reciprocal Health Care Agreement, the supply is limited to the original prescription only. Repeat prescriptions for these patients are not permitted.

Lodging an application

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

Further information

For more information contact us on the Complex Drug Enquiry line.

Page last updated: 28 January 2016

This information was printed Sunday 4 December 2016 from humanservices.gov.au/health-professionals/enablers/systemic-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.