Severe chronic plaque psoriasis

The Pharmaceutical Benefits Scheme (PBS) subsidises biological agents for adult patients with severe chronic plaque psoriasis.

For adult patients with severe chronic plaque psoriasis, treatment with specific biological agents as systemic monotherapy (other than methotrexate), 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
  • secukinumab
  • ustekinumab

Authority is required to supply each biological agent.

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.

All applications must be completed by a dermatologist with expertise in the management of severe chronic plaque psoriasis.

 The Psoriasis Assessment Severity Index (PASI) assessment for continuing treatment must be performed on the same area assessed before initiation of biological agent treatment.

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing medicines to treat patients with severe chronic plaque psoriasis.

Interchangeability

Patients can start a biological treatment cycle (a cycle), where they may trial an alternative biological agent for which they are eligible, without having to meet the initial treatment criteria. These include:

  • adalimumab
  • etanercept
  • infliximab
  • secukinumab
  • ustekinumab

This means they will not need to experience a disease flare when swapping to the alternative agent.

Under these arrangements, within a single cycle, patients may receive long-term treatment with a biological agent as long as they respond to therapy.

Patients are eligible for PBS subsidised treatment with only 1 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 3 times, they are deemed to have completed a single cycle. After this, they must have a minimum 5 year break in PBS subsidised biological therapy before they are eligible to start another cycle.

Schedule item details

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 loading dose for adult patients is 80 mg (2 injections) for the first dose and then 40 mg (1 subcutaneous injection) fortnightly thereafter, starting 1 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.

Dose - Etanercept (Enbrel®) 25 mg is presented as a set of 4 vials containing 25 mg powder for injection and 4 prefilled syringes containing 1 mL solvent.

The dose for adult patients is 1 subcutaneous injection twice weekly.

Dose - Etanercept (Enbrel®) 50 mg is presented as:

  • 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 must be specified on the prescription as either a pack of prefilled syringes or prefilled autoinjectors.

The dose for adult patients is 1 subcutaneous injection per week.

Dose - Infliximab (Remicade®) is presented as:

  • a vial containing 100 mg of lyophilised powder

The dose for adult patients is 5 mg per kg given intravenously.

Initially patients are to be treated at weeks 0, 2 and 6. Subsequent infusions are at 8 week intervals.

Dose - Secukinumab (Cosentyx®) is presented as

  • a pack of 2 injection devices containing secukinumab 150 mg in 1 mL

The recommended dose is 300 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, and 3, followed by monthly maintenance dosing of 300 mg starting at week 4. Each 300 mg dose is given as 2 subcutaneous injections of 150 mg.

Dose - 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 0 and 4, then every 12 weeks thereafter. Alternatively, 90 mg may be used in patients with a body weight greater than 100 kg.

Drug name Presentation Initial or Change Continuing
Quantity Repeats Quantity Repeats
Adalimumab Prefilled syringe or prefilled pen 40 mg in 0.8 mL 2 4 2 5
Etanercept Set of 4 vials containing 25 mg powder for injection and 4 prefilled syringes containing 1mL solvent 2 sets 3 2 sets 5
Etanercept (pre-filled) Set of 4 prefilled syringes or autoinjectors containing etanercept 50 mg in 1 mL 1 pack 3 1 pack 5
Infliximab 100 mg vial x vials @
5 mg per kg
3 x vials @
5 mg per kg
2
Secukinumab 150 mg/1 mL injection device 1 pack 6 1 pack 5
Ustekinumab 45 mg vial (patients 100 kg or less in body weight) 1 vial 2 1 vial 1
45 mg vial (patients greater than 100 kg in body weight) 2 vials 2 2 vials 1

Calculating next assessment dates

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 date the patient was first dispensed the approved authority prescription.

Patients should then be assessed at 24 week intervals, assuming treatment is continuous.

Test requirements

The PASI assessment for continuing treatment must be performed on the same area assessed before initiation of biological agent treatment.

Treatment

Initial

All applications for initial treatment will be limited to a maximum of:

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

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

Continuing

Continuing treatment with a biological agent consists of 24 weeks of 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 continuity of 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.

Treatment for grandfathered patients for secukinumab

Applications can be made for patients who began treatment with secukinumab for chronic plaque psoriasis before 1 September 2015. Patients may commence initial PBS-subsidised treatment as continuing therapy under the relevant initial treatment restriction (Initial 3) as found 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 before it was listed on the PBS.

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

Break in treatment for patients currently responding to PBS subsidised treatment with a biological agent

Patients who are currently responding to treatment and want to have a break in treatment for any reason must complete a demonstration of response under the condition and criteria section of form PB113. The form must be faxed to us.

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

Recommencement of treatment after a 5 year break in PBS subsidised therapy

Patients who want to trial a second or subsequent biological treatment cycle must requalify for initial treatment according to the criteria of the relevant restriction and index of disease severity. In order to requalify, they must have had a break in PBS subsidised biological therapy of at least 5 years.

Patients must have had at least 1 prior treatment, as listed in the criteria, for a minimum of 6 weeks and must have a PASI assessment conducted. The assessment should occur preferably while still being treated, but no later than 1 month after stopping treatment.

An application must be made within 1 month of the PASI assessment.

Toxicity criteria and severity descriptors

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

Rating scales

A PASI is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.

Lodging an application

All applications must be completed by a dermatologist with expertise in the management of severe chronic plaque psoriasis.

Send all written applications to the complex drugs address on the contact us page.

To start initial PBS subsidised treatment with a biological agent for an adult patient with severe chronic plaque psoriasis, you must provide:

To continue, change or to demonstrate a response to PBS subsidised treatment with a biological agent for an adult with severe chronic plaque psoriasis, you must provide:

Further information

For more information contact us on the Complex Drug Enquiry line.

Page last updated: 27 January 2016

This information was printed Sunday 4 December 2016 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.