Severe chronic plaque psoriasis

Through the Pharmaceutical Benefits Scheme (PBS), under Section 85 and Section 100 arrangements of the National Health Act 1953, authority to supply biological agents (adalimumab, etanercept, infliximab and ustekinumab only) is required for the treatment of:

• adult patients with severe chronic plaque psoriasis as systemic monotherapy (other than methotrexate).

Section 100 arrangements for infliximab only

This item is only available to a patient who is attending either:

• an approved private hospital
• a public participating hospital

or:

• a public hospital

and is either:

• a day admitted patient
• a non-admitted patient

or:

• a patient on discharge

This item is 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.

Important: 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.
• 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 have 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.

Important: 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 March 2010, all patients will be able to start a 'biological treatment cycle' (cycle), where they may trial an alternate biological agent (adalimumab, etanercept, infliximab and ustekinumab only) for which they are eligible, without having to meet the initial treatment criteria. This means 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 monotherapy (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 a five year break (at minimum) in PBS subsidised biological therapy before they are eligible to start another cycle.

Item detail

Dose

Adalimumab (Humira®) is presented as either:

• a prefilled syringe containing 40 mg adalimumab in 0.8 mL

or

• a prefilled pen containing 40 mg adalimumab in 0.8 mL.

The dose for adult patients is a loading dose of 80 mg (two injections) for the first dose, then 40 mg (one injection) subcutaneous fortnightly thereafter, starting one week after the loading dose.

The form of adalimumab 40 mg required must be specified on the prescription as either prefilled syringes or prefilled pens.

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.

The dose for adult patients is one subcutaneous injection twice weekly.

Etanercept (Enbrel®) 50 mg is presented as either:

• a pack of four single use prefilled syringes containing etanercept 50 mg in 1 mL

or

• 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 dose for adult patients is one subcutaneous injection per week.

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 week six. Subsequent infusions are at eight week intervals.

Ustekinumab (Stelara®) is presented as:

• a vial containing 45 mg in 0.5 mL

The recommended dose is 45 mg administered by subcutaneous injection at weeks zero and four, then every 12 weeks thereafter.  Alternatively, 90 mg may be used in patients with a body weight greater than 100 kg.

Note: the form of etanercept 50 mg required must be specified on the prescription as either prefilled syringes or autoinjectors and the form of adalimumab must be specified as either prefilled syringes or pens.

Calculating next assessment dates

To assist with calculating the next assessment for patients continuing on the same biological agent:

• The first assessment of the patient after starting treatment must be after the patient has had at least 12 weeks of treatment. This date can be calculated by adding 12 weeks to the patient’s first dispensing of the approved authority prescription.
• Patients should then be assessed at 24 week intervals (assuming continuous treatment).

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.

Who is eligible for the PBS?

Reciprocal Health Care Agreement

Where an eligible patient is a visitor from a country with which Australia has entered into a Reciprocal Health Care Agreement, the supply of infliximab will be limited to the original prescription only. Repeat prescriptions for infliximab are not permitted.

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

All applications for intial treatment will be limited to a maximum of 17 weeks of therapy in the case of adalimumab, 16 weeks in the case of etanercept, 22 weeks in the case of infliximab and 28 weeks in the case of ustekinumab.

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

Continuing treatment

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

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

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 must complete a demonstration of response form, which must be faxed to Medicare Australia on 1300 093 177. If Medicare Australia is not notified of a response within one month of stopping treatment, then the patient is deemed to have failed treatment with 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.

Lodgement

The address for all written applications is:

Medicare Australia
Prior written approval of specialised drugs
Reply Paid 9826
Hobart TAS 7001

(No stamp required if posted in Australia)

For more information call 1800 700 270** (option 3) between 8:00am and 5.00pm EST - Monday to Friday.

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.

• Toxicity criteria and severity descriptors [PDF, 217Kb]

Additional information

• Psoriasis Area and Severity Index (PASI) form 4178 [PDF, 71Kb] - (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, 112Kb] - (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, 309Kb] (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 and prescriber acknowledgements 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.
• Continuation, change or demonstration of a response to PBS subsidised treatment [PDF, 300Kb] (form 4174)
  This document contains the form the treating dermatologist must lodge for an adult patient continuing, changing to an alternate agent, or demonstrating a response to PBS subsidised treatment with a biological agent.

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Last updated: 17 October, 2012

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