Juvenile chronic arthritis - under and over 18 years
Authority to supply etanercept (Enbrel®) through the Pharmaceutical Benefits Scheme (PBS) under Section 85 (Adults) and Section 100 arrangements (Juveniles) of the National Health Act 1953.
Etanercept (Enbrel®) is available on the PBS as an authority required benefit:
- for the treatment of juvenile patients (under 18 years of age), with severe polyarticular course juvenile chronic arthritis who are either being treated by a rheumatologist or are under supervision of a paediatric rheumatology treatment centre:
- for adult patients with a documented history of severe active polyarticular course juvenile chronic arthritis who are being treated by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis.
Guide to prescribing biological agents
Schedule restriction details
Adults with severe active polyarticular course juvenile chronic arthritis restrictions (Section 85)
There are three restrictions, one of which a patient must satisfy before approval will be granted to prescribe etanercept (Enbrel®). These 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 juvenile chronic arthritis 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 juvenile chronic arthritis with onset before the age of 18 years, who at the time of application demonstrate an adequate response to treatment with etanercept; and
- initial PBS subsidised supply for continuing treatment by a rheumatologist of patients aged 18 years or older, with a documented history of severe active polyarticular course juvenile chronic arthritis with onset before the age of 18 years, who were receiving treatment with etanercept before 1 December 2002.
Juvenile restrictions (Section 100)
There are three restrictions, one of which a patient must satisfy before approval will be granted to prescribe etanercept (Enbrel®). These restrictions are:
- initial PBS subsidised treatment by paediatric rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of patients under 18 years who have severe active polyarticular course juvenile chronic arthritis;
- 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 juvenile chronic arthritis 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);
- continuing PBS subsidised treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of patients under 18 years who have a documented history of severe active polyarticular course juvenile chronic arthritis and who have been receiving treatment with etanercept before 1 December 2002.
Etanercept (Enbrel®) will be available for patients who are attending an approved private hospital, participating public hospital or public hospital and is only a benefit for a day admitted, non-admitted or discharge patient. This will not be a PBS benefit for in-patients of the hospital.
Schedule item details
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:
- a set of four vials of powder for injection 50 mg and four prefilled syringes of solvent 1 mL
- a pack of four single use, prefilled syringes containing etanercept 50 mg in 1 mL.
The form of etanercept 50 mg required must be specified on the prescription as either an injection set or a pack of prefilled injections.
Dose
Juvenile patients aged less than 18 years at the time of initial application (Section 100).
The dose for children four to 17 years is 0.4 mg/kg (maximum 25 mg) subcutaneous injection given twice weekly. 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 only.
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 weekly or 50 mg subcutaneous injection given once weekly.
Patient eligibility
Patients must meet the relevant restrictions as indicated in the criteria and be eligible to receive pharmaceutical benefits.
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 erythrocyte sedimentation rate (ESR) and C-reactive protein (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)
Please note, 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.
Lodgment
The postal address for all written applications is:
Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
GPO Box 9826
Hobart Tasmania 7001
(No stamp required if posted in Australia)
For more information please call 1800 700 270** and select option 2. (8am to 5pm EST Monday to Friday).
** Call charges apply from mobile or pay phones only.
Toxicity and Contra-indication Descriptors
Only valid for adult patients with a documented history of severe active polyarticular course juvenile chronic arthritis (section 85).
To ensure that the eligibility of patients can be fully assessed a comprehensive list of toxicity and contra-indications 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.
Adult with a documented history of severe active polyarticular course juvenile chronic arthritis forms (Section 85)
- Etanercept Enbrel®) PBS authority application supporting information form—initial PBS subsidised treatment—juvenile onset before the age of 18 years [PDF, 288Kb]
Lodge this form for patients aged 18 years or older, with a documented history of severe active polyarticular course juvenile chronic arthritis with onset before the age of 18 years and undergoing initial treatment by a rheumatologist. - Etanercept Enbrel®) PBS authority application supporting information form—continuing PBS subsidised treatment—juvenile onset before the age of 18 years [PDF, 283Kb]
Lodge this form for patients aged 18 years or older, with a documented history of severe active polyarticular course juvenile chronic arthritis with onset before the age of 18 years and undergoing continuing treatment by a rheumatologist. - Etanercept (Enbrel®) PBS adult (juvenile onset before the age of 18 years) patient declaration form [PDF, 57Kb]
Include this document with the supporting information form for initial and continuing treatment of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset before the age of 18 years who were receiving treatment with etanercept by a rheumatologist before 1 December 2002. It must be signed by the patient and the prescriber in the presence of an adult witness. The completed declaration must be sent to Medicare Australia together with the completed application and authority prescription.
Juvenile forms (Section 100)
- Etanercept (Enbrel®) PBS authority application supporting information form—initial PBS subsidised treatment—juveniles [PDF, 295Kb]
Lodge this form for patients under 18 years of age with severe active polyarticular course juvenile chronic arthritis undergoing initial treatment by a paediatric rheumatologist, or under the supervision of a paediatric rheumatology treatment centre. - Etanercept (Enbrel®) PBS authority application supporting information form—continuing PBS subsidised treatment - juveniles [PDF, 276Kb]
Lodge this form for patients with a documented history of severe active polyarticular course juvenile chronic arthritis undergoing continuing treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre. Patients must have first been approved under the age of 18 as juveniles; but may have since turned 18. - Etanercept (Enbrel®) PBS juvenile patient declaration form [PDF, 57Kb]
Include this document with the supporting information form for initial treatment of juveniles and continuing treatment of juveniles who were receiving treatment with etanercept before 1 December 2002. It must be signed by the parent/guardian of the patient and the prescriber in the presence of an adult witness. The completed declaration must be sent to Medicare Australia together with the completed application and authority prescription.
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Last updated: 15 September, 2008