Severe chronic plaque psoriasis for patients under 18 years

The PBS subsidises etanercept for patients under 18 with severe chronic plaque psoriasis.

Treatment with etanercept can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under section 85 of the National Health Act 1953 for patients under 18 years of age with severe chronic plaque psoriasis.

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions to be eligible for PBS subsidy.

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing etanercept.

There are separate restrictions for treatment for psoriasis affecting the whole body and 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

Applications

All applications must be completed by the treating dermatologist.

Initial treatment

Make all initial applications for authority approval to prescribe etanercept for the treatment of severe chronic plaque psoriasis in writing and:

All applications must include a completed:

All applications for treatment of this condition 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.

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.

Re-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 want 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 want 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

Recommencement of treatment

Patients who want to start a second or subsequent treatment cycle after a break in PBS subsidised etanercept of at least 12 months, must requalify for initial treatment and meet the relevant restriction criteria at that time. 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 treatment

After the initial treatment cycle of 12 weeks, patients who are currently responding to treatment and who want to have a break in treatment, for any reason, must demonstrate a response to current treatment by submitting a relevant PASI assessment form. This form must be faxed to the Complex Drugs Programs enquiry line.

If we are not notified of a response within 1 month of stopping treatment, the patient is deemed to have failed treatment with etanercept.

Rating scales

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.

Lodging an application

Make all applications for authority approval to prescribe etanercept for the treatment of severe chronic plaque psoriasis in writing and:

The treating dermatologist must use Severe chronic plaque psoriasis for patients under 18 years Initial PBS authority information Supporting information form 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

Toxicity and severity descriptors

To ensure the eligibility of patients can be fully assessed, a comprehensive list of toxicity descriptors is available. The intolerance must be of a severity to necessitate permanent treatment withdrawal.

Further information

For more information contact the PBS Complex Drugs Programs enquiry line.

Page last updated: 4 April 2017

This information was printed Saturday 29 April 2017 from humanservices.gov.au/health-professionals/enablers/severe-chronic-plaque-psoriasis-patients-under-18-years It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.