Systemic Juvenile idiopathic arthritis
Tocilizumab can be supplied to eligible patients through the Pharmaceutical Benefits Scheme (PBS) as authorised under Section 100 of the National Health Act 1953.
Guide to prescribing biological agents
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.
A patient must satisfy one of the four restrictions before approval will be granted to prescribe tocilizumab. The restrictions are:
- 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.
- 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.
- 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.
- 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 applications
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 Department of Human Services (Human Services) no later than four 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 applications
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 Human Services no later than four 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.
Baseline measurements to determine response
Human Services 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 one month of all assessments.
Item details
Tocilizumab (Actemra®) is presented as:
- 80 mg/4 mL I.V. solution
- 200 mg/10 mL I.V.solution
- 400 mg/20 mL I.V. solution
Dose
The dose for patients who weigh:
- < 30 kg is 12 mg/kg every 2 weeks
- ≥ 30 kg is 8 mg/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 two infusions (one 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 restrictions and be eligible for the PBS.
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.
Lodgement
Send all written applications to:
Department of Human Services
Prior written approval of specialised drugs
Reply Paid 9826
Hobart Tasmania 7001
For more information please call 1800 700 270** (option 2) between 8.00am and 5.00pm EST Monday to Friday.
Application forms
- Systemic Juvenile idiopathic arthritis PBS authority application supporting information - initial PBS subsidised treatment [PDF, 314Kb]
Use this form for a patient starting initial PBS subsidised treatment with tociluzumab. The patient (or guardian) and prescriber acknowledgements must be completed. - Systemic Juvenile idiopathic arthritis PBS authority application supporting information - continuing, change or demonstration of response to PBS subsidised treatment [PDF, 264Kb]
Use this form for a patient continuing, applying for a second course or demonstrating a response to PBS subsidised treatment with tocilizumab.
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Last updated: 3 May, 2012