Severe chronic plaque psoriasis for patients under 18 years
The Pharmaceutical Benefits Scheme subsidises etanercept for patients under 18 with severe chronic plaque psoriasis.
For patients under 18 years of age with severe chronic plaque psoriasis, treatment with etanercept (Enbrel®) can be subsidised 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
The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions.
Schedule item details
Dose - Etanercept (Enbrel®) 25 mg is presented as a set of 4 vials of powder for injection 25 mg and 4 prefilled syringes of solvent 1 mL.
Etanercept (Enbrel®) 50 mg is presented as either:
- a pack of 4 single-use prefilled syringes containing etanercept 50 mg in 1 mL or
- a pack of 4 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 per kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks as per the product information.
|Drug name||Presentation||Initial or Change||Continuing|
|Etanercept||Set of 4 vials of powder for injection 25 mg, and 4 prefilled syringes of solvent 1 mL||2 sets||3||2 sets||1|
|Set of 4 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 the Pharmaceutical Benefits Scheme.
All applications for initial 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 2 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 or
- 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 1 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 us. If we are not notified of a response within 1 month of stopping treatment, then the patient is deemed to have failed treatment with etanercept.
A Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.
- PASI calculation and body diagram - whole body form (PB115) complete this section if your patient has severe chronic plaque psoriasis of the whole body
- PASI calculation and body diagram - face, hand and foot form (PB114) complete this section if your patient has severe chronic plaque psoriasis of the face, or a palm of a hand, or a sole of a foot
Lodging an application
Send all written applications to Complex drugs address on the contact us page.
- The treating dermatologist must use Severe chronic plaque psoriasis for patients under 18 years Initial PBS authority information Supporting information form (PB116) for a patient under 18 years, with severe chronic plaque psoriasis, to start initial PBS-subsidised treatment with etanercept. It includes the parent or guardian and prescriber acknowledgements, which must be signed by the parent or guardian and the prescriber in the presence of an adult witness. The completed application form must be sent to us with all relevant Psoriasis Area and Severity Index assessments
For more information contact us on the Complex Drug Enquiry line.