Psoriatic arthritis

The PBS subsidises a range of medicines for patients with severe active psoriatic arthritis.

For patients with severe active psoriatic arthritis, treatment with the following biologic agents can be subsidised through thePBS under sections 85 and 100 of the National Health Act 1953:

  • adalimumab (Humira®)
  • certolizumab pegol (Cimzia®)
  • etanercept (Enbrel®)
  • golimumab (Simponi®)
  • infliximab (Remicade®)
  • secukinumab (Cosentyx®)
  • ustekinumab (Stelara®)

Section 100 arrangements only for infliximab

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

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

and is either a

  • day admitted patient
  • non-admitted patient, or
  • 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 for this drug.

Restriction details

Adult patients must satisfy the initial treatment criteria to be eligible to commence an interchangeability cycle. Applications to change, recommence or continue PBS subsidised treatment will only be considered after an initial course of treatment.

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

All applications must be completed by the treating rheumatologist or clinical immunologist with expertise in managing psoriatic arthritis.

The restrictions for an interchangeability cycle are:

  • initial PBS subsidised treatment with a biological agent
  • continuing PBS subsidised treatment with a biological agent
  • change to an alternative PBS subsidised treatment with a biological agent
  • demonstration of a response to the current PBS subsidised treatment, or
  • grandfathered PBS subsidised treatment with secukinumab (Cosentyx®)

Interchangeability

Patients are eligible for PBS subsidised treatment with only 1 biological agent for psoriatic arthritis at a time.

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

  • adalimumab (Humira®)
  • certolizumab pegol (Cimzia®)
  • etanercept (Enbrel®)
  • golimumab (Simponi®)
  • infliximab (Remicade®)
  • secukinumab (Cosentyx®), or
  • ustekinumab (Stelara®)

Within a single cycle, patients may receive long term treatment with a biological agent as long as they continue to sustain a response.

Once patients have either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a single cycle. They must have, at a minimum, a 5 year break in PBS subsidised biological therapy before they are eligible to start another cycle.

Within the same cycle, patients cannot fail or cease to respond to the same PBS subsidised biological agent more than once.

Item details

Dose - Adalimumab (Humira®) is presented as either:

  • a prefilled syringe containing 40 mg adalimumab (Humira®) in 0.8 mL, or
  • a prefilled pen containing 40 mg adalimumab (Humira®) in 0.8 mL

The dose for adult patients is 1 subcutaneous injection fortnightly.

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

Dose - Certolizumab pegol (Cimzia®) is presented as a prefilled syringe containing 200 mg certolizumab in 1 mL.

The dose for adult patients is 2 subcutaneous injections at week 0, week 2 and week 4; then, 1 injection every 2 weeks, or 2 injections every 4 weeks.

A prescription should be included with the initial application for the loading doses (quantity of 3 packs of 6 prefilled syringes and nil repeats). The initial balance of supply can be applied for by phone or by including a prescription with the initial application (quantity of 1 pack of 2 prefilled syringes and 2 repeats).

Dose - Etanercept (Enbrel®) 25 mg is presented as a set of:

  • 4 vials of powder for injection (25 mg), and
  • 4 prefilled syringes of solvent (1 mL)

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 (Enbrel®) (50 mg in 1 mL), or
  • pack of 4 single-use prefilled autoinjectors containing etanercept (Enbrel®) (50 mg in 1 mL)

The form of etanercept (Enbrel®) 50 mg required must be specified on the prescription as a pack of either prefilled syringes or prefilled autoinjectors.

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

Dose - Golimumab (Simponi®) 50 mg is presented as a:

  • prefilled syringe containing 50 mg golimumab (Simponi®) in 0.5 mL, or
  • prefilled pen containing 50 mg golimumab (Simponi®) in 0.5 mL

The form of golimumab (Simponi®) 50 mg required must be specified on the prescription as a pack of either prefilled syringes or prefilled pens.

The dose for adult patients is 1 subcutaneous injection every 4 weeks.

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 week 0, week 2 and week 6. Subsequent infusions are at 8 week intervals.

Dose – Ustekinumab (Stelara®) is presented as a single use vial containing ustekinumab (Stelara®) 45 mg/0.5 mL solution for injection

Ustekinumab (Stelara®) is administered as a subcutaneous injection.

The initial dose for adult patients is 45 mg (1 vial) administered at week 0 and week 4, then every 12 weeks thereafter.

Subsequent continuing injections are administered at 12 week intervals.

Dose – Secukinumab (Cosentyx®) 150 mg is presented as a pre-filled pen containing 150 mg secukinumab in 1 mL.

The dose for adult patients is 1 subcutaneous injection at week 0, week 1, week 2, and week 3, followed by a monthly maintenance dose of 1 subcutaneous injection starting at week 4.

Patients who are anti-TNFα inadequate responders (IR), the recommended dose is 2 subcutaneous injections at week 0, week 1, week 2 and week 3, followed by monthly maintenance dose of 2 subcutaneous injections starting at Week 4.

A prescription should be included with the initial application for the loading doses (quantity of 4 packs of 1 prefilled pen and nil repeats). The initial balance of supply can be applied for by phone or by including a prescription with the initial application (quantity of 1 pack of 1 prefilled pen and 2 repeats).

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.

Test requirements

To ensure the response is determined consistently, the same indices of disease severity that were used to establish the baseline at the start of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications. All assessments must be within 1 month of application.

Prescribers should provide both Erythrocyte Sedimentation Rate (ESR) and C-Reactive Protein (CRP) measurements with the initial application. Prescribers may choose to provide only one acute phase reactant measurement with continuing treatment applications. Where only an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be provided to determine response.

Similarly, where the baseline active joint count is based on total active joints — that is 20 or more active joints — response will be determined according to a reduction in the total number of active joints. Where a patient has at least 4 active major joints and less than 20 total active joints, assessment of the major joints only will be used for all continuing applications.

Demonstration of a response

It is recommended that patients who have had a minimum of 12 weeks of treatment, and who wish to have a temporary break in treatment for any reason, be reviewed immediately before stopping treatment. If this is not possible, they should be reviewed no later than 4 weeks after stopping treatment. Failure to notify us of response means that this patient is deemed to have failed that particular biological agent.

To demonstrate a response to treatment, prior to a break in treatment, please use the Psoriatic arthritis Continuing PBS authority application and Supporting information form (PB106).

Fax your completed form to the Complex Drugs Programs enquiry line so it can be included in the patient's treatment history.

Recommencement of treatment

Patients who wish to commence a second or subsequent treatment cycle following a break in PBS subsidised biological therapy of at least 5 years must requalify for initial treatment and meet the relevant criteria at that time.

Toxicity criteria and severity descriptors

The following table shows Disease Modifying Anti Rheumatic Drug (DMARD) toxicity criteria and severity descriptors for the listing of biological agents for psoriatic arthritis on the PBS.

  • ALT - alanine aminotransferase
  • AST - aspartate aminotransferase
  • BP - blood pressure
  • ECG - electrocardiogram
  • IV - intravenous
  • LV - left ventricle
  • NIH - National Institutes of Health
  • PT - Prothrombin time
  • ULN - upper limit of normal
  • WCC - white cell count
Adverse event Brief description of minimum grade NIH common toxicity criteria grade
Blood or bone marrow
Anaemia Haemoglobin < 80 g per L 3 (or higher)
Leukopenia Total WCC < 3 x 109 per L 2 (or higher)
Thrombocytopenia Platelets < 50 x 109 per L 3 (or higher)
Neutropenia Total neutrophils < 1.0 x 109 per L 3 (or higher)
Cardiovascular
Arrhythmia Symptomatic and requiring therapy 3 (or higher)
Cardiac LV function Congestive cardiac failure responsive to treatment 3 (or higher)
Fluid retention Symptomatic, limiting function, unresponsive to therapy or requiring drug discontinuation 3 (or higher)
Hypertension Recurrent or persistent rise of > 20 mmHg diastolic BP or rise to > 150 over 90 on 2 occasions if BP previously normal 2 (or higher)
Pericardial effusion or pericarditis Pericarditis (pericardial rub, ECG changes or chest pain) 2 (or higher)
Thrombosis or embolism Requiring anticoagulant therapy 3 (or higher)
Coagulation
Prothrombin time PT > 2 x ULN 3 (or higher)
Dermatology or skin
Alopecia Pronounced hair loss 2 (or higher)
Rash or desquamation Scattered macular or papular eruption or erythema with pruritis or other associated symptoms covering < 50% of body surface or localised desquamation or other lesions covering < 50% of body 2 (or higher)
Gastrointestinal
Diarrhoea Increase of 4-6 stools per day over pretreatment 2 (or higher)
Nausea Oral intake significantly decreased, and where the causative DMARD is methotrexate, symptoms that do not respond to at least 2 of the following:
  • reduction of the methotrexate dose
  • folinic acid or folic acid supplementation
  • switching from oral to intramuscular dosing
  • dividing the methotrexate dose over 12 hours

A minimum of 3 doses of methotrexate should have been trialled

2 (or higher)
Pancreatitis Abdominal pain with pancreatic enzyme elevation 3 (or higher)
Stomatitis Painful erythema, oedema or ulcers but able to eat or swallow 2 (or higher)
Vomiting 2 or more episodes per 24 hours over pretreatment 2 (or higher)
Weight gain or loss 20% or more weight gain or loss 3 (or higher)
Hepatic
Bilirubin > 1.5 x ULN 2 (or higher)
Transaminases ALT or AST > 2.5 x ULN, or ALT or AST > 1.5 x ULN on 3 occasions over a 3-month period 2 (or higher)
Ç Serum alkaline phosphatase 2.5 x ULN 2 (or higher)
Neurology or senses
Ataxia (incoordination) Mild symptoms interfering with function but not interfering with activities of daily living 2 (or higher)
Decreased level of consciousness Somnolence or sedation interfering with function but not interfering with activities of daily living 2 (or higher)
Headaches (severe) Severe pain; pain or analgesics severely interfere with activities of daily living 3 (or higher)
Hearing Tinnitus or hearing loss not requiring hearing aid or treatment 2 (or higher)
Mood alteration Moderate mood alteration interfering with function but not interfering with activities of daily living 2 (or higher)
Neuropathy - sensory Objective sensory loss or paraesthesia interfering with function but not interfering with activities of daily living 2 (or higher)
Seizure(s) Seizures in which consciousness is altered 3 (or higher)
Vision Symptomatic and interfering with function but not interfering with activities of daily living 2 (or higher)
Pulmonary
Cough (severe) Severe cough or coughing spasm, poor control or unresponsive to treatment. Evidence of reversal on cessation of treatment 3 (or higher)
Pneumonitis or pulmonary infiltrates Radiographic changes, respiratory function test abnormalities and requiring steroids or diuretics 2 (or higher)
Pulmonary fibrosis Respiratory function test abnormalities and requiring steroids or diuretics 2 (or higher)
Pulmonary symptoms
new or worsening (probable drug-induced pneumonitis)
Development of syndrome consistent with drug-induced pneumonitis (for example, cough, dyspnoea, fever, hypoxaemia) with lung infiltrates on imaging
(refer Searles McKendry criteria)
 
Renal
Haematuria Macroscopic (or dipstick +++) confirmed on 2 separate occasions 2 (or higher)
Proteinuria > 1.0 g per 24 hours, elevated urine protein-creatinine ratios, (dipstick protein ++ or greater), confirmed on 2 separate occasions 2 (or higher)
Renal impairment Creatinine > 1.5 ULN or creatinine clearance < 30 mL per min 2 (or higher)
Other
Allergic reaction Urticaria, drug fever > 38 °C or bronchospasm 2 (or higher)
Fatigue, malaise Severe, loss of ability to perform some activities 3 (or higher)
Fever (in the absence of neutropenia) Body temp > 39 °C (oral or tympanic) 2 (or higher)
Infection Severe, systemic infection, requiring IV antimicrobial treatment or hospitalisation 3 (or higher)
Nodulosis (following introduction of methotrexate therapy) Development of multiple new nodules causing significant local pressure symptoms and distress to patient  
Secondary malignancy Secondary malignancy present 4

Lodging an application

For a patient:

Further information

For more information contact us on the Complex Drugs Programs enquiry line. Send all written applications to the Complex Drugs Programs address on the contact us page.

Page last updated: 4 October 2016

This information was printed Friday 9 December 2016 from humanservices.gov.au/health-professionals/enablers/psoriatic-arthritis 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.