Ankylosing spondylitis

The Pharmaceutical Benefits Scheme (PBS) subsidises a range of medicines for patients with active ankylosing spondylitis.

For patients with active ankylosing spondylitis, treatment with biological agents (adalimumab, certolizumab, etanercept, golimumab infliximab and secukinumab only) can be subsidised under the PBS  under sections 85 and 100 of the National Health Act 1953.

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.

Restriction details

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

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing adalimumab, certolizumab, etanercept, golimumab, infliximab and secukinumab to patients.

All applications must be completed by the treating rheumatologist, with expertise in the management of active ankylosing spondylitis.

The restrictions are:

  • initial PBS subsidised treatment with a biological agent
  • continuing PBS subsidised treatment with a biological agent
  • recommencement or change to an alternate biological agent, and
  • grandfathered PBS subsidised treatment with secukinumab

Notes on interchangeability

Patients are eligible for PBS subsidised treatment with only 1 of the biological agents for ankylosing spondylitis at any one time. Patients can start a biological treatment cycle to trial adalimumab, certolizumab, etanercept, golimumab, infliximab or secukinumab, and then swap to a different agent without the need to experience a disease flare. Within a single cycle, patients may receive long-term treatment with a biological agent as long as they sustain a response to therapy.

Patients who fail or cease to respond to treatment 3 times are deemed to have completed a single cycle. They must then have a minimum 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. If a patient fails to meet the response criteria for any biological agent, they must change to an alternative agent that they have not previously failed to respond to.

Schedule item details

Dose - Adalimumab (Humira®) is presented as:

  • a prefilled syringe containing 40 mg of adalimumab in 0.8 mL, or
  • a prefilled pen containing 40 mg of adalimumab in 0.8 mL

The dose for adult patients is 1 subcutaneous injection each fortnight.

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

Dose – Certolizumab pegol (Cimzia®) is presented as:

  • a prefilled syringe containing 200 mg of certolizumab in 1 mL

The dose for adult patients is 2 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 a week.

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

  • a pack of 4 single-use prefilled syringes containing 50 mg of etanercept in 1 mL
  • a pack of 4 single-use prefilled autoinjectors containing 50 mg of etanercept in 1 mL

The dose for adult patients is 1 subcutaneous injection once a week.

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

Dose - Golimumab (Simponi®) is presented as:

  • a prefilled syringe containing 50 mg of golimumab in 0.5mL, or
  • a prefilled pen containing 50 mg of golimumab in 0.5mL

The form of golimumab 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 6-weekly intervals.

Dose - Secukinumab (Cosentyx®) is presented as:

  • a prefilled pen containing 150 mg of secukinumab in 1 mL

The dose for adult patients is 1 subcutaneous injection at week 0, week 1, week 2 and week 3, then 1 injection every 4 weeks 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 consistency in determining response, the same indices of disease severity used to establish 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 one month of application.

  • prescribers should provide Erythrocyte Sedimentation Rate (ESR) and C-Reactive Protein (CRP) measurements with the initial application. Prescribers may choose to provide only 1 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
  • the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measurements must be completed by the patient. The patient must not have access to any previous BASDAI assessments when completing the new assessment

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, or no later than 4 weeks after stopping treatment. Failure to notify us of a 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 Ankylosing spondylitis Continuing PBS authority application Supporting information form (PB074).

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

Toxicity and severity descriptors

To make sure the eligibility of patients can be fully assessed, a comprehensive list of toxicity descriptors is available. This should be used in conjunction with the application when demonstrating a patient's inability to tolerate NSAID treatment. The intolerance must be of a severity to necessitate permanent treatment withdrawal.

Adverse event Brief description of minimum grade National Institutes of Health common toxicity criteria grade
Blood or bone marrow
Anaemia Haemoglobin <80 g per L 3 (or higher)
Haemolysis Evidence of red cell destruction and >20 g per L drop in haemoglobin, no transfusion required 2 (or higher)
Leukopaenia Total white cell count < 3 × 109 per L 2 (or higher)
Neutropaenia Neutrophils <1.0 × 109 per L 3 (or higher)
Thrombocytopaenia Platelets <50 × 109 per L 3 (or higher)
Cardiovascular
Arrhythmia Symptomatic and requiring therapy 3 (or higher)
Cardiac left ventricle function Congestive cardiac failure responsive to treatment 3 (or higher)
Hypertension Recurrent or persistent rise of >20 mmHg diastolic blood pressure or rise to >150/90 on 2 occasions if blood pressure previously normal 2 (or higher)
Myocardial ischaemia or infarction Unstable angina or myocardial infarction 3 (or higher)
Oedema Symptomatic, limiting function, unresponsive to therapy or requiring drug discontinuation 3 (or higher)
Coagulation
Prothrombin time Prothrombin time >2 × upper limit of normal 3 (or higher)
Dermatology or skin
Alopecia Pronounced hair loss 2 (or higher)
Photosensitivity Painful erythema or bullae 2 (or higher)
Pruritis Intense or widespread and poorly controlled despite treatment 3 (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 surface 2 (or higher)
Urticaria Requiring topical, oral or IV medication for <24 hours 2 (or higher)
Gastrointestinal
Abdominal pain Moderate pain, interfering with function 2 (or higher)
Anorexia Oral intake significantly decreased 2 (or higher)
Constipation Requiring use of laxatives and enemas 3 (or higher)
Diarrhoea Increase of 4-6 stools per day over pretreatment 2 (or higher)
Dyspepsia Moderate or severe, unresponsive to standard therapy, recurs on rechallenge 2 (or higher)
Nausea Oral intake significantly decreased 2 (or higher)
Pancreatitis Abdominal pain with pancreatic enzyme elevation 3 (or higher)
Peptic ulcer Requiring medical management 2 (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)
Haemorrhage
Melena or gastrointestinal bleeding Requiring transfusion 3 (or higher)
Purpura Generalised purpura 3 (or higher)
Hepatic
Bilirubin >1.5 × upper limit of normal 2 (or higher)
Transaminases Alanine aminotransferase or
aspartate aminotransferase >2.5 × upper limit of normal or
alanine aminotransferase or
aspartate aminotransferase >1.5 × upper limit of normal on 3 occasions over a 3-month period
2 (or higher)
Neurology or senses
Central nervous system cerebrovascular ischaemia Transient ischaemic attack or cerebrovascular accident 3 (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)
Inner ear or hearing Tinnitus or hearing loss not requiring hearing aid or treatment 2 (or higher)
Insomnia Frequent difficulty sleeping, interfering with activities of daily living 3 (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)
Vertigo Interfering with activities of daily living 3 (or higher)
Vision Symptomatic and interfering with function but not interfering with activities of daily living 2 (or higher)
Pulmonary
Asthma Moderate 2 (or higher)
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)
Renal
Haematuria Macroscopic haematuria 2 (or higher)
Hyperkalaemia >6.0 mmol per L 3 (or higher)
Proteinuria >1.0g per 24 hours, elevated urine protein:creatinine ratios >100 mg per mmol, dipstick protein ++ or greater, confirmed on 2 separate occasions 2 (or higher)
Renal impairment Creatinine >1.5 upper limit of normal or creatinine clearance <30 mL per min 2 (or higher)
Other
Allergic reaction or hypersensitivity Urticaria, drug fever >38 °C or bronchospasm 2 (or higher)
Fatigue, malaise Severe, loss of ability to perform some activities 3 (or higher)
Infection Severe, systemic infection, requiring IV antimicrobial treatment or hospitalisation 3 (or higher)

Lodging an application

All applications must be completed by the treating rheumatologist.

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 Sunday 4 December 2016 from humanservices.gov.au/health-professionals/enablers/ankylosing-spondylitis 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.