Severe chronic plaque psoriasis
Authority to prescribe biological agents (efalizumab, etanercept and infliximab only) for adults under Section 85 and Section 100 of the National Health Act 1953
Biological agents are available on the PBS as an authority required benefit for adult patients with severe chronic plaque psoriasis as systemic monotherapy (other than methotrexate).
Section 100 arrangements for infliximab only
These items are only available to a patient who is attending:
- an approved private hospital
- public participating hospital
or:
- public hospital
and is either a:
- day admitted patient
- non-admitted patient
or:
- patient on discharge
These items are not available as a PBS benefit for in-patients of the hospital. The hospital provider number must be included on the application form
Schedule restriction details
Adult patients must satisfy the relevant criteria before approval will be granted to prescribe a PBS subsidised biological agent.
All applications must be completed by a dermatologist with expertise in the management of severe chronic plaque psoriasis.
The restrictions are:
- Initial PBS subsidised treatment with a biological agent as systemic monotherapy (other than methotrexate) of adults with severe chronic plaque psoriasis.
- Initial PBS subsidised, continuing treatment for adult patients who started treatment with infliximab before 7 March 2007 and who wish to start PBS subsidised treatment with the same biological agent as systemic monotherapy (other than methotrexate) and who have a documented history of severe chronic plaque psoriasis and who are currently demonstrating a response to that treatment.
- Continuing PBS subsidised treatment with a biological agent as systemic monotherapy (other than methotrexate) of adults with a documented history of severe chronic plaque psoriasis, and who, at the time of application has demonstrated an adequate response to that treatment.
- Change to PBS subsidised treatment with an alternate biological agent.
- Recommencement of PBS subsidised treatment with a biological agent.
Please note the Psoriasis Assessment Severity Index (PASI) assessment for continuing treatment must be performed on the same area assessed before initiation of biological agent treatment.
Notes on interchangeability
From 1 December 2007, all patients will be able to start a 'biological treatment cycle' (cycle), where they may trial efalizumab, etanercept and infliximab without having to meet the initial treatment criteria. That is they will not need to experience a disease flare, when swapping to the alternate agent. Under these interchangeability arrangements, within a single cycle, patients may receive long-term treatment with a biological agent as long as they sustain a response to therapy.
Patients are eligible for PBS subsidised treatment with only one biological agent, as systemic mono-therapy (other than methotrexate), at any one time.
Once patients have either failed or ceased to sustain a response to treatment three times, they are deemed to have completed a single cycle and they must have, at a minimum, a five year break in PBS subsidised biological therapy before they are eligible to start another cycle.
Within the same cycle, patients are not allowed to trial and fail, or cease to respond to, the same PBS subsidised biological agent.
Schedule item detail
Dose
Efalizumab (Raptiva®) is presented as an injection set containing four vials of powder for injection 125 mg and four pre-filled syringes of solvent 1.3 ml.
Etanercept (Enbrel®) 25 mg is presented as a set of four vials of powder for injection 25 mg and four pre-filled syringes of solvent 1 mL. The dose for adult patients is one subcutaneous injection twice weekly in cycles of 12 weeks.
Etanercept (Enbrel®) 50 mg is presented as:
- a set of four vials of powder for injection 50 mg and four pre-filled syringes of solvent 1 mL
- a pack of four single use pre-filled syringes containing etanercept 50 mg in 1 mL.
The dose for adult patients is one subcutaneous injection once weekly in cycles of 12 weeks.
Infliximab (Remicade®) is presented as:
- a vial containing 100 mg of lypholised powder
The dose for adult patients is 5 mg per kg given intravenously.
Initially patients are to be treated at week zero, week two and then week six. Subsequent infusions are eight weekly intervals.
| Drug name | Initial/Change | Continuing and grandfather | |||
|---|---|---|---|---|---|
| Presentation | Quantity | Repeats | Quantity | Repeats | |
| efalizumab | Set of four vials of powder for injection 125 mg and four pre-filled syringes of solvent 1.3 mL | 1 set | 3 | 1 set | 5 |
| etanercept | Set of four vials of powder for injection 25 mg and four pre-filled syringes of solvent 1 mL | 2 sets | 2 | 2 sets | 2 |
| etanercept | Set of four vials of powder for injection 50 mg and four pre-filled syringes of solvent 1 mL | 1 set | 2 | 1 set | 2 |
| etanercept pre-filled | Set of four single use pre-filled syringes containing etanercept 50 mg in 1 mL | 1 pack | 2 | 1 pack | 2 |
| infliximab | 100 mg vial | x vials @ 5 mg/kg |
3 | x vials @ 5 mg/kg |
2 |
Note: The form of etanercept 50 mg required must be specified on the prescription as either an injection set or pre-filled injections.
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
Test requirements
Please note the PASI assessment for continuing treatment must be performed on the same area assessed before initiation of biological agent treatment.
Demonstration of response
Initial treatment
Efalizumab
Initial treatment with efalizumab consists of 16 weeks of therapy. Patients must be assessed after a minimum of 12 weeks of initial treatment and no later than four weeks after the stopping treatment. Assessments before 12 weeks have been completed will not be considered. If Medicare Australia is not notified of a response the patient is deemed to have failed efalizumab.
Etanercept
Initial treatment with etanercept consists of 12 weeks of active therapy followed by a treatment free period of at least 12 weeks. Response to treatment must be assessed at the completion of the 12 week active etanercept treatment course. This assessment, which will be used to determine eligibility for future treatment must be submitted to Medicare Australia no later than one month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to Medicare Australia within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept.
Infliximab
Initial treatment with infliximab consists of 22 weeks of therapy. Patients must be assessed after a minimum of 12 weeks of initial treatment and no later than four weeks after the stopping. Assessments before 12 weeks have been completed will not be considered. If Medicare Australia is not notified of a response the patient is deemed to have failed infliximab.
Continuing treatment
Efalizumab and infliximab
Continuing treatment of efalizumab and infliximab consists of 24 weeks of continuous active treatment. Applications for continuing treatment should be made before the completion of the previous course to ensure continuity of treatment for those patients who meet the continuation criteria. If Medicare Australia is not notified of a response the patient is deemed to have failed efalizumab or infliximab.
Etanercept
In the case of etanercept, continuing treatment consists of 12 weeks of active therapy followed by a treatment free period of at least 12 weeks. Patients must be assessed for response to each course of continuing treatment and are eligible to receive continuing treatment with etanercept on this cyclical basis, for as long as they continue to sustain a response.
Patients who have completed 12 weeks of active treatment and are responding must complete a demonstration of response form, and this form must be faxed to Medicare Australia on (03) 6215 54 74 within one month of stopping.
Continuing applications must be submitted at least 12 weeks after stopping the most recent course of etanercept treatment.
Break in treatment for patients who are currently responding to PBS subsidised treatment with a biological agent
Patients who are currently responding to treatment and who wish to have a break in treatment for any reason (or as required in the case of etanercept) must complete a demonstration of response form and this form must be faxed to Medicare Australia (03) 6215 5474. If Medicare Australia is not notified of a response within one month of stopping treatment means that this patient is deemed to have failed that particular biological agent.
Recommencement of treatment after a five year break in PBS subsidised therapy
Patients who wish to trial a second or subsequent biological treatment cycle following a break in PBS subsidised biological therapy of at least five years, must requalify for initial treatment according to the criteria of the relevant restriction and index of disease severity. Patients must have had at least one prior treatment, as listed in the criteria, for a minimum of six weeks, and must have a PASI assessment conducted preferably whilst still on treatment, but no later than one month after stopping treatment. The PASI assessment must be no older than one month at the time of application.
Lodgment
The postal address for all written applications is:
Medicare Australia
Prior written approval of specialised drugs
Reply paid 9826
GPO Box 9826
Hobart TAS 7001
(No stamp required if posted in Australia)
For more information please call 1800 700 270** and select option 3 (8 am to 5 pm EST Monday to Friday).
**Call charges apply from mobile or pay phones only.
Toxicity critieria and severity descriptors
To ensure 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, cyclosporin or phototherapy is attached.
Additional information
- Psoriasis Area and Severity Index (PASI) form 4178 [PDF, 85Kb]
- (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, 114Kb] - (face, hand, foot)
The PASI is a quantitative rating scale for measuring the severity of psoriatic plaques based on area coverage and plaque appearance
Application forms
Severe chronic plaque psoriasis forms
- Initial PBS subsidised treatment [PDF, 321Kb] (form 4173)
This document contains the form the treating dermatologist must lodge for an adult patient, with severe chronic plaque psoriasis, to start initial PBS subsidised treatment with a biological agent. It includes the patient acknowledgement which must be signed by the patient and the prescriber in the presence of an adult witness. The completed application form must be sent to Medicare Australia with all relevant Psoriasis Area and Severity Index assessments and an authority prescription. - Initial PBS subsidised treatment of adults who were started on treatment with infliximab before 7 March 2007 [PDF, 313Kb] (form 4175)
This document contains the form the treating dermatologist must lodge for an adult patient, with a documented history of severe chronic plaque psoriasis, to start initial PBS subsidised treatment and who were started on treatment with infliximab before 7 March 2007. It includes the patient acknowledgment which must be signed by the patient and the prescriber in the presence of an adult witness. The completed application form must be sent to Medicare Australia with all relevant Psoriasis Area and Severity Index assessments and an authority prescription. - Continuing PBS subsidised treatment [PDF, 311Kb] (form 4174)
This document contains the form the treating dermatologist must lodge for an adult patient, with a documented history of severe chronic plaque psoriasis, for continuing PBS subsidised treatment with a biological agent. The completed form, a current Psoriasis Area and Severity Index assessment and an authority prescription must be sent to Medicare Australia. - Change to the alternate PBS subsidised treatment [PDF, 311Kb] (form 4174)
This document contains the form the treating dermatologist must lodge for an adult patient who has qualified under initial PBS criteria for a biological agent for severe chronic plaque psoriasis and who wishes to apply for a change to an alternate biological agent. - Demonstration of a response to PBS subsidised treatment [PDF, 311Kb] (form 4174)
This document contains the form the treating dermatologist must lodge for an adult patient demonstrating a response to PBS subsidised biological agent treatment. This form must be submitted before any break in treatment as patients who do not document a response will not be eligible to restart treatment.
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Last updated: 15 September, 2008