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January 2012

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January 2012

Revised provider percentile charts
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Juvenile idiopathic arthritis - under and over 18 years

Interchangeability between biological Disease Modifying Antirheumatic Drugs (bDMARDs).  Where the term bDMARDS appears it refers only to adalimumab and etanercept.

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

bDMARDs are available on the PBS as an Authority required medicine for the treatment of:

  • juvenile patients (under 18 years of age), with severe active juvenile idiopathic arthritis 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 juvenile idiopathic arthritis 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

These items are 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.

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.

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

  • initial PBS subsidised treatment by a rheumatologist of patients aged 18 years or older, with a documented history of severe active 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 juvenile idiopathic arthritis who started treatment with non PBS subsidised adalimumab prior to 1 March 2010 and who, at the time of application, have demonstrated an adequate response to treatment.
  • change to an alternate bDMARD treatment, for which the patient is eligible, by a (paediatric) rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of patients under 18 years who have a documented history of severe active juvenile idiopathic arthritis, where the patient has already received PBS subsidised bDMARD treatment within this interchangeability cycle.
  • continuing PBS subsidised treatment by a rheumatologist of patients aged 18 years or older, with a documented history of severe active juvenile idiopathic arthritis (JIA) with onset before the age of 18 years, who at the time of application demonstrate an adequate response to treatment with etanercept.

Adult restrictions (Section 85)

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 four restrictions before approval will be granted to prescribe a bDMARD. The restrictions are:

  • initial PBS subsidised treatment by a rheumatologist of patients aged 18 years or older, with a documented history of severe active juvenile idiopathic arthritis with onset before the age of 18 years
  • initial PBS subsidised treatment by a rheumatologist,  for continuing treatment of patients aged 18 years or older with a documented history of severe active juvenile idiopathic arthritis with onset before the age of 18 years who started treatment with non PBS subsidised adalimumab prior to 1 March 2010 and who, at the time of application, have demonstrated an adequate response to treatment.
  • change to an alternate bDMARD treatment, for which the patient is eligible, by rheumatologist of patients aged 18 years or older who have a documented history of severe active juvenile idiopathic arthritis with onset before the age of 18 years, where the patient has already received PBS subsidised bDMARD treatment within this interchangeability cycle. 
  • continuing PBS subsidised treatment by a rheumatologist of patients aged 18 years or older, with a documented history of severe active juvenile idiopathic arthritis with onset before the age of 18 years, who at the time of application demonstrate an adequate response to treatment.

Information relevant to all patients

Notes on interchangeability

From 1 November 2010, the following applies:

  • 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 is considered to be in the same treatment cycle
  • a patient who has received PBS subsidised bDMARD treatment and who has had a break in treatment of greater than 12 months 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, and
  • fail to respond, or sustain a respnse to, one PBS subsidised bDMARD twice and the other PBS subsidised bDMARD once only, and
  • may swap to the alternate bDMARD without having to experience a disease flare. 

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

  • For juvenile patients (S100) the break must be a minimum of 12 months from the date treatment was ceased.
  • For adult patients (S85) the break must be a minimum of 5 years from the date of the last approval

Initial applications

Applications for initial treatment should be made where patients:

  • have received no prior PBS subsidised treatment with a bDMARD, or
  • have had a break in PBS subsidised bDMARD treatment of greater than 12 months.

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

Patients must be assessed for a response after a minimum of 12 weeks of PBS subsidised initial bDMARD treatment:

This assessment must be submitted to Medicare Australia no later than four weeks from the date that the course completed. Where a response assessment is not submitted to Medicare Australia within these time frames, patients will be deemed to have failed to respond to treatment with that bDMARD.

Continuing applications

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

Patients must be assessed for a response to each course of continuing therapy. The assessment must be submitted to Medicare Australia no later than four weeks from the date that the course is completed. Where a response assessment is not submitted to Medicare Australia within these time frames, patients will be deemed to have failed to respond to treatment.

Swapping therapy—change applications;

Once an authority for initial treatment with a bDMARD is approved, patients may swap to the alternate treatment, providing they are eligible, and providing the break in PBS subsidised treatment is less than 12 months without having to requalify with respect to either the:

  • indices of disease severity or
  • prior therapy requirements.

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

  • less than 12 months and who demonstrated a response to that treatment and who wish to recommence treatment may submit a new baseline set of measurements.
  • greater than 12 months must reapply as an initial patient

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

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

Patients may alternate between bDMARD therapy, providing they have:

  • not received PBS subsidised treatment with that particular bDMARD previously
    or
  • not trialled and failed, or cease to respond to, the same PBS subsidised bDMARD more than twice

Therefore, to maximise the choice of bDMARDs patients may alternate between, it is important that they are assessed for 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 the alternate bDMARD should be accompanied by the approved authority prescription, or remaining repeats for the bDMARD the patient is ceasing.

Baseline measurements to determine response

Medicare Australia 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.

Where applicable, any one of the baseline criteria may be used to determine 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.

The lodgement of application must be made within one month of the date of all assessments.

Item details

Adalimumab (Humira®) is presented as either:

  • a prefilled syringe containing 20 mg adalimumab in 0.4mL, or
  • a prefilled syringe containing 40 mg adalimumab in 0.8 mL, or
  • a prefilled pen containing 40 mg adalimumab in 0.8 mL

Prescriptions for adalimumab must specifiy both the strength required (either 20 mg or 40 mg) and the form of adalimumab required (either prefilled syringes or prefilled pens).

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.

Dose

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

Adalimumab

The dose for patients aged four years and who weigh;

  • less than 30 kg is 20 mg fortnightly
  • 30 kg, or more, is 40 mg fortnightly

Etanercept

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 given once a week.

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

Adalimumab

The dose for adult patients is 40 mg fortnightly.

Etanercept

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 (for JIA over 18 only)

Only valid for adult patients with a documented history of severe active juvenile idiopathic arthritis (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 juvenile idiopathic arthritis forms (Section 85)

Juvenile forms (Section 100)

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

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Last updated: 1 November, 2011