Severe chronic plaque psoriasis for patients under 18 years
Etanercept (Enbrel®) used for the treatment of severe chronic plaque psoriasis, for patients under 18 years, can be supplied through the Pharmaceutical Benefits Scheme (PBS) as authorised under Section 85 arrangements of the National Health Act 1953.
It’s important that all applications are completed by a dermatologist. There are separate restrictions for treatment for psoriasis affecting the whole body, versus psoriasis affecting the face, hands and feet.
Patients must meet one of two restrictions. These restrictions are:
- initial PBS subsidised treatment with etanercept as systemic monotherapy (other than methotrexate) of patients under 18 years with severe chronic plaque psoriasis.
- re-treatment with etanercept as systemic monotherapy (other than methotrexate) of patients under 18 years with a documented history of severe chronic plaque psoriasis.
You can view the full transcript of the Schedule of Pharmaceutical Benefits (the Schedule) restriction 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 either:
- a pack of four single use prefilled syringes containing etanercept 50 mg in 1 mL
- a pack of four single use prefilled autoinjectors containing etanercept 50 mg in 1 mL.
The form of etanercept 50 mg required must be specified on the prescription as either a pack of prefilled syringes or prefilled autoinjectors.
The recommended dose of etanercept is 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks as per the Product Information.
Primary initial application
Balance of initial
|Set of four vials of powder for injection 25 mg and four prefilled syringes of solvent 1 mL||2 sets||3||2 sets||1|
|Set of four syringes or autoinjectors containing etanercept 50 mg in 1 mL||1 pack||3||1 pack||1|
Patients must meet the relevant criteria, as indicated in the restrictions, and be eligible for PBS medicines.
All applications for intial treatment will be limited to a maximum of 24 weeks of therapy. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance, a further eight weeks treatment, will be authorised if the submitted Psoriasis Area and Severity Index (PASI) assessment demonstrates an adequate response to treatment.
Patients must be assessed for response to an initial treatment course after at least 12 weeks of treatment.
To make sure there is consistency in determining a response, the same body area assessed at the baseline PASI assessment, must be assessed for demonstration of response to treatment. This is for the purpose of gaining approval for the remainder of the 24 weeks of treatment.
A patient may fail to respond to PBS subsidised etanercept twice under this restriction. Once a patient has failed to respond to treatment two times, they must have, at a minimum, a 12 month break. The length of a treatment break is measured from the date the most recent treatment was stopped to the date of the first application for initial treatment.
Applications for re-treatment with etanercept should be made in the following situations for patients who have received prior PBS subsidised etanercept and:
- experience a disease flare, and who wish to start a second or subsequent treatment course with etanercept following a break of less than 12 months in PBS subsidised therapy
- failed to respond to prior PBS subsidised etanercept and who wish to start a second or subsequent treatment course following a break of less than 12 months in PBS subsidised therapy.
A disease flare is defined below:
Whole body patients:
- a 50% or greater change in the patient’s PASI score, or
- the current PASI score is greater than 15, compared to the most recent response assessment
Face/Hand/Foot (FHF) patients:
- a 50% or greater change in the patient’s FHF PASI score, or
- the current FHF PASI which is 30% or more, compared to the most recent response assessment, or
- 2 out of 3 parameters on the current FHF PASI assessment are scored as severe or very severe, or
- 3 out of 3 parameters on the current FHF PASI assessment are scored as moderate or severe
A patient who wishes to start a second or subsequent treatment course with etanercept following a break in PBS subsidised etanercept therapy of at least 12 months, must requalify for treatment under the initial treatment restriction. The PASI assessments must not be older than one month at the time of application.
Break in treatment for patients who are currently responding to PBS subsidised etanercept treatment
Patients who are currently responding to treatment and who wish to have a break in treatment for any reason, after the initial 12 weeks of treatment, must demonstrate a response to current treatment by submitting a relevant PASI assessment form, which must be faxed to Human Services on 1300 093 177. If we are not notified of a response within one month of stopping treatment, then the patient is deemed to have failed treatment with etanercept.
Written applications can be sent to:
Department of Human Services
Prior written approval of specialised drugs
Reply Paid 9826
Hobart TAS 7001
(No stamp required if posted in Australia)
For more information call us 1800 700 270** (option 3) between 8.00 am to 5.00 pm Eastern Standard Time, Monday to Friday.
To make sure that the eligibility of patients can be fully assessed, a comprehensive list of toxicity criteria which should be used in conjunction with the application when demonstrating a patient's inability to tolerate acitretin, methotrexate, or phototherapy is below
- Psoriasis Area and Severity Index (PASI) form 4178 [PDF, 132Kb] - (whole body)
The PASI is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
- Psoriasis Area and Severity Index (PASI) form 4177 [PDF, 159Kb] - (face, hand, foot)
The PASI is a quantitative rating scale for measuring the severity of psoriatic plaques based on area coverage and plaque appearance
Severe chronic plaque psoriasis forms
Initial PBS subsidised treatment [PDF, 404Kb] (form 8946)
The treating dermatologist must use this form for a patient under 18 years, with severe chronic plaque psoriasis, to start initial PBS subsidised treatment with etanercept. It includes the parent/guardian and prescriber acknowledgements which must be signed by the parent/guardian and the prescriber in the presence of an adult witness. The completed application form must be sent to Human Services with all relevant Psoriasis Area and Severity Index assessments.
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Last updated: 27 September, 2013