Severe chronic plaque psoriasis

The PBS subsidises biological agents for adult patients with severe chronic plaque psoriasis.

Treatment with some biological agents as systemic monotherapy and methotrexate for adult patients with severe chronic plaque psoriasis, can be subsidised through the PBS under sections 85 and 100 arrangements of the National Health Act 1953.

These biological agents are:

  • adalimumab
  • etanercept
  • infliximab
  • ixekizumab
  • secukinumab
  • ustekinumab

Section 100 arrangements for infliximab only

This item is available to a patient attending:

  • an approved private hospital
  • a public participating hospital, or
  • a public hospital

and is a:

  • day admitted patient
  • non-admitted patient, or
  • patient on discharge

You must include the hospital provider number on the application form.

Patient eligibility

Patients must meet the relevant criteria in the restrictions and be eligible for the PBS.

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for biological agents and methotrexate.

Interchangeability

Patients are eligible for PBS subsidised treatment with only as systemic monotherapy with only 1 biological agent at a time.

In a biological treatment cycle, patients can trial the following alternate drugs without experiencing a disease flare:

  • adalimumab
  • etanercept
  • infliximab
  • ixekizumab
  • secukinumab, and
  • ustekinumab

In a single cycle, patients can receive long term treatment with a biological agent if they continue to respond to treatment.

Once a patient has failed or stops responding to treatment 3 times, they have formally completed a single cycle. They must have a minimum 5 year break in PBS subsidised biological therapy before they can start the next cycle.

In the same cycle, patients cannot fail or stop responding to the same PBS subsidised biological agent more than once.

Toxicity criteria and severity descriptors

The toxicity criteria and severity descriptors should be used with the application when demonstrating a patient's inability to tolerate acitretin, methotrexate, cyclosporin or phototherapy.

PASI rating scales

The 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.

If your patient has:

Applications

All applications must be completed by a dermatologist.

Initial treatment

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

All applications must include a completed:

All applications for initial treatment are limited to a maximum of:

  • 16 weeks of treatment for adalimumab, etanercept, ixekizumab and secukinumab
  • 22 weeks of treatment for infliximab
  • 28 weeks of treatment for ustekinumab

Patients must be assessed for a response to an initial treatment course after at least 12 weeks of treatment.

Grandfathered patients for ixekizumab

You can make initial applications for patients who began treatment with ixekizumab for severe chronic plaque psoriasis before 1 February 2017. Grandfathered patients may start initial PBS subsidised treatment as continuing therapy under the relevant initial treatment restriction on the PBS website.

Grandfathered patients access PBS interchangeability arrangements in the same way as new patients who have not been treated with a biological agent prior to PBS listing that agent.

For a grandfathered patient who started non-PBS subsidised treatment with ixekizumab prior to 1 February 2017, lodge Severe chronic plaque psoriasis - ixekizumab initial grandfather PBS authority application form.

Applications for initial PBS subsidised treatment for ixekizumab grandfathered patients will be provided for a maximum of 24 weeks of treatment.

Continuing treatment

Make all applications for continuing authority approval to prescribe biological agents for systemic monotherapy for the treatment of severe chronic plaque psoriasis in writing and:

All applications must include a completed:

Continuing treatment with a biological agent consists of 24 weeks continuous treatment for patients who have demonstrated an adequate response.

Applications for continuing treatment should be made before the completion of the previous course to ensure stable treatment. If we are not notified, the patient is deemed to have failed treatment with that biological agent.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

Recommencement of treatment

Patients who want to start a second or subsequent treatment cycle after a break in PBS subsidised biological treatment of at least 5 years must requalify for initial treatment and meet the current criteria.

Stopping treatment

Patients who want to temporarily stop treatment with biological agents for systemic monotherapy need to submit a demonstration of response to current treatment within 1 month of stopping treatment.

To submit a demonstration of response, the following application must be completed:

You can:

Further information

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

Page last updated: 24 April 2017

This information was printed Friday 23 June 2017 from humanservices.gov.au/health-professionals/enablers/severe-chronic-plaque-psoriasis 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.