What's new?

September 2010

Health professionals can stay up-to-date with Forum. The spring edition is available online now.

Website Feedback

Send feedback about our website

photo of doctor and young patient

Juvenile chronic arthritis - under and over 18 years

Authority to supply etanercept (Enbrel®) for eligible patients through the Pharmaceutical Benefits Scheme (PBS) under Section 85 (Adults) and Section 100 (Juveniles) of the National Health Act 1953.

Etanercept is available on the PBS as an Authority required medicine for the treatment of:

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

Guide to prescribing biological agents

Section 100 arrangements

This item is only available to a patient who is attending either:

  • 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.

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

Restriction details

View a full transcript of the restriction detailsExternal link

Adults with severe active polyarticular course JCA restrictions (Section 85)

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

  • initial PBS subsidised treatment by a rheumatologist of patients aged 18 years or older, with a documented history of severe active polyarticular course JCA with onset before the age of 18 years
  • continuing PBS subsidised treatment by a rheumatologist of patients aged 18 years or older, with a documented history of severe active polyarticular course JCA with onset before the age of 18 years, who at the time of application demonstrate an adequate response to treatment with etanercept.

Juvenile restrictions (Section 100)

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

  • initial PBS subsidised treatment by a paediatric rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of patients under 18 years who have severe active polyarticular course JCA
  • continuing PBS subsidised treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of patients who have a documented history of severe active polyarticular course JCA and who have demonstrated an adequate response to treatment with etanercept. This includes patients who have turned 18 years since commencement of PBS subsidised treatment.

Item details

Dose

Etanercept (Enbrel®) 25 mg is presented as a set of four vials of powder for injection 25 mg and four prefilled syringes of solvent 1 mL.

Etanercept (Enbrel®) 50 mg is presented as either:

  • a pack of four single use prefilled syringes containing etanercept 50 mg in 1 mL
    or
  • a pack of four single use prefilled pens (autoinjectors) containing etanercept 50 mg in 1 mL.

The form of etanercept 50 mg required must be specified on the prescription as a pack of prefilled syringes or prefilled pens.

Juvenile patients aged less than 18 years at the time of initial application (Section 100).

The dose for children aged four to 17 years is 0.4 mg/kg (maximum 25 mg) subcutaneous injection given twice a week. These patients can only be approved for etanercept 25 mg injection set.

Patients who turn 18 years after starting treatment then become eligible to use etanercept 50 mg prefilled syringes or prefilled pens.

Adult patients aged 18 years or older at the time of initial application (Section 85).

The dose for adult patients is 25 mg subcutaneous injection given twice a week or 50 mg subcutaneous injection given once a week.

 Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive PBS subsidised medicines.

Who is eligible for the PBS?

 Test requirements

Juvenile chronic arthritis under 18 (Section 100)

The joint count must be within one month of the application.

To ensure consistency in determining response where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to a reduction in the total number of active joints. Where a patient has at least four active major joints and less than 20 total active joints assessment of the major joints only will be used for all continuing applications.

Juvenile chronic arthritis over 18 (Section 85)

Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and joint count must be within one month of the application.

To ensure consistency in determining response, the same indices of disease severity used to establish baseline at the start of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications.

  • Prescribers should provide both ESR and CRP measurements with the initial application. Prescribers may choose to provide only one acute phase reactant measurement with continuing treatment applications. Where only an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be provided to determine response.
  • Similarly, where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to a reduction in the total number of active joints. Where a patient has at least four active major joints and less than 20 total active joints assessment of the major joints only will be used for all continuing applications.

 Reciprocal Health Care Agreement (only applies to under 18s)

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

Lodgement

Send all written applications to:

Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
Hobart Tasmania 7001

(No stamp required if posted in Australia)

For more information please call 1800 700 270** (option 2) between 8.00am and 5.00pm EST Monday to Friday.

Toxicity criteria and severity descriptors

Only valid for adult patients with a documented history of severe active polyarticular course JCA (Section 85).

To make sure the eligibility of patients can be fully assessed a comprehensive list of toxicity criteria and severity descriptors which should be used in conjunction with the application when demonstrating a patient's inability to tolerate Disease Modifying Anti Rheumatic Drugs (DMARDs) is attached. This list has been prepared in consultation with the Australian Rheumatology Association.

Application forms

Adult with a documented history of severe active polyarticular course JCA forms (Section 85)

Juvenile forms (Section 100)

** Call charges apply from mobile or pay phones only.

Some documents on this page may require the free Adobe PDF reader.

Last updated: 19 March, 2010