This document outlines details of PBS-subsidised biological medicines for patients with ankylosing spondylitis (AS).
For details on how to process a PBS Authority, see Processing Complex Authority Required Listings.
On this page:
Ankylosing spondylitis (AS) quick reference
Ankylosing spondylitis (AS) authority level comparison
Ankylosing spondylitis (AS) authority level comparison for rest of the biological medicines
Response to baselines
Contraindications to prior therapy
Application assessment
Ankylosing spondylitis (AS) quick reference
Table 1
Restrictions | Authority level and section | PA assessment | Processing system | Prescriber type | Prescriber self-serve |
Initial: originators PB073 form | Written Electronic S85: adalimumab bimekizumab certolizumab pegol etanercept golimumab infliximab s.c. ixekizumab secukinumab tofacitinib upadacitinib S100: infliximab i.v. | No | OPA | Must be treated by a: - rheumatologist
- clinical immunologist with expertise in the management of ankylosing spondylitis
| Yes - delayed assessment (due to exercise program attachment and any free text option used) |
Initial: biosimilars | Telephone Electronic S85: adalimumab etanercept S100: infliximab i.v. | No | OPA | Must be treated by a: - rheumatologist
- clinical immunologist with expertise in the management of ankylosing spondylitis
| Yes |
Change or recommencement: originators PB251 form | Written Electronic S85: adalimumab bimekizumab certolizumab pegol etanercept golimumab infliximab s.c. ixekizumab secukinumab tofacitinib upadacitinib S100: infliximab i.v. | No | OPA | Must be treated by a: - rheumatologist
- clinical immunologist with expertise in the management of ankylosing spondylitis
| Yes - immediate or delayed assessment (delayed if any free text option used) |
Change or recommencement: biosimilars | Telephone Electronic S85: adalimumab etanercept S100: infliximab i.v. | No | OPA | Must be treated by a: - rheumatologist
- clinical immunologist with expertise in the management of ankylosing spondylitis
| Yes |
Continuing | Streamlined S85: infliximab s.c. | No | N/A | Must be treated by a: - rheumatologist
- clinical immunologist with expertise in the management of ankylosing spondylitis
| N/A |
First continuing: originators PB074 form | Written Electronic S85: adalimumab bimekizumab certolizumab pegol etanercept golimumab ixekizumab secukinumab tofacitinib upadacitinib S100: infliximab i.v. | No | OPA | Must be treated by a: - rheumatologist
- clinical immunologist with expertise in the management of ankylosing spondylitis
| Yes |
First continuing: biosimilars | Streamlined S85: adalimumab etanercept S100: infliximab i.v. (Telephone for increased quantities of infliximab i.v. for patients >100kg) | No | N/A | Must be treated by a: - rheumatologist
- clinical immunologist with expertise in the management of ankylosing spondylitis
| N/A |
Subsequent continuing: originators PB074 form | Written Electronic S85: adalimumab bimekizumab certolizumab pegol etanercept golimumab ixekizumab secukinumab tofacitinib upadacitinib S100: infliximab i.v. | No | OPA | Must be treated by a: - rheumatologist
- clinical immunologist with expertise in the management of ankylosing spondylitis
| Yes |
Subsequent continuing - biosimilars | Streamlined S85: adalimumab etanercept S100: infliximab i.v. (telephone for increased quantities of infliximab i.v. for patients >100kg) | No | N/A | Must be treated by a: - rheumatologist
- clinical immunologist with expertise in the management of ankylosing spondylitis
| N/A |
Balance of supply (top-up): originators and biosimilars | Telephone Electronic S85: adalimumab bimekizumab certolizumab pegol etanercept golimumab infliximab s.c. ixekizumab secukinumab tofacitinib upadacitinib S100: infliximab i.v. | No | OPA | Must be treated by a: - rheumatologist
- clinical immunologist with expertise in the management of ankylosing spondylitis
| Yes |
Ankylosing spondylitis (AS) authority level comparison
Table 2: adalimumab, etanercept and infliximab i.v.
Biologicals | Initial | Balance of supply: initial | First continuing | Subsequent continuing | Balance of supply: continuing |
Originator | Written Electronic | Telephone Electronic | Written Electronic | Written Electronic | Telephone Electronic |
Biosimilar | Telephone Electronic | Telephone Electronic | Streamlined | Streamlined | N/A |
Ankylosing spondylitis (AS) authority level comparison for rest of the biological medicines
Table 3:
Biologicals | Initial | Balance of supply: initial | Continuing | Balance of supply: continuing | Balance of supply: all |
Originator (excluding infliximab s.c.) | Written Electronic | Telephone Electronic | Written Electronic | Telephone Electronic | N/A |
Originator infliximab s.c. (Remsima®) | Written Electronic | N/A | Streamlined | N/A | Telephone Electronic |
Response to baselines
Table 4
Item | Action |
1 | Erythrocyte Sedimentation Rate (ESR) Where ESR has been provided: - ESR must be either 25 or less, or reduced by 20% from the baseline level
- a response cannot be assessed against ESR if ESR is not documented at baseline
- if both ESR and CRP are provided at baseline, either can be used to demonstrate a response to treatment
|
2 | C-Reactive Protein (CRP) Where CRP has been provided: - CRP must be either 10 or less, or reduced by 20% from the baseline level
- a response cannot be assessed against CRP if CRP is not documented at baseline
- if both ESR and CRP are provided at baseline, either can be used to demonstrate a response to treatment
|
3 | Response to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) - The BASDAI must be either 2 or less, or reduced by 2 units compared to the baseline score
- If the patient is not responding on their BASDAI, the application must be rejected
|
Contraindications to prior therapy
Table 5: this table lists the details of contraindications to prior treatment with non-steroidal anti-inflammatory drugs (NSAIDs) according to the relevant Therapeutic Goods Administration (TGA) approved Product Information.
| Prior therapy | Contraindication |
| NSAID | - Known hypersensitivity to aspirin or other NSAIDs
- Asthma or other allergic-type reactions that are aspirin or NSAIDs sensitive
- Active, or a history of, peptic or gastrointestinal ulceration, bleeding or perforation
- Active, or history of, haemorrhage, chronic dyspepsia, or conditions involving an increased tendency or active bleeding
- Active inflammatory bowel disease
- Previous myocardial infarction or stroke
- Unstable ischaemic heart disease
- Congestive heart failure or severe heart failure
- Severe renal impairment
- Severe liver impairment
- Undergoing treatment of perioperative pain in a setting of coronary artery bypass surgery (CABG)
- Pregnancy or planned pregnancy
- Breastfeeding
- Other contraindications based on TGA-approved PI
|
Application assessment
Delayed assessment due to:
- exercise program attachment
- intolerance to prior therapies
- drug name of NSAID
- reason(s) for non-elevated bloods
- other contraindication to prior therapies
Table 6: this table lists the details of what Service Officers should check for all assessments (including delayed) and common acronyms.
Delayed assessment checks for uploaded document / free text | Examples | Outcome |
Uploaded document | - A completed exercise program self-certification attached which must include the following details:
- Dates and relevant ticks to indicate exercise(s) undertaken, and
- Patient’s declaration including full name, signature and date, and
- Prescriber’s declaration including full name, signature and date, and
- It is for the correct patient on the application
| Approve |
| - An incomplete exercise program with any of the details listed above missing, and/or it is for the incorrect patient on the application
| Reject |
| - Unrelated document(s) attached
| Reject |
Free text - relevant to the question | - Intolerances to prior therapies:
- Heart condition
- Worsened renal failure
- Nausea and vomiting
- Elevated or deranged etc. liver function test
- Gastrointestinal toxicity
- Common NSAIDs (originator brands in the bracket) to treat AS:
- ibuprofen (Nurofen)
- naproxen (Naprosyn)
- celecoxib (Celebrex)
- diclofenac (Voltaren)
- meloxicam (Mobic)
- piroxicam (Feldene)
- ketoprofen (Orudis, Oruvail)
- etoricoxib (Arcoxia)
| Approve |
Free text - random | - Happy Birthday
- Patient did not want to take
- Ikasditbn
| Reject |
Free text - non-descriptive | - Toxicity (no details)
- Intolerance
- Ineffective
| Reject |
Bloods not elevated | - Treatment with prednisolone (or equivalent steroid)
- Treatment with a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent)
| Approve |
Bloods not elevated | - When prescriber has provided a reason other than the 2 steroid-related reasons listed above
| Escalate to PA |
Contraindications to prior NSAID therapy | - When prescriber has used written application form with contraindication(s) other than the list of contraindications in OPA
- When prescriber has used the online self-serve system to provide contraindication(s) and select free text other than ticking the box of listed contraindications in OPA
| Escalate to PA |
Common acronyms
- LFT - Liver function tests
- GI toxicity - Gastrointestinal
- N+V - Nausea and vomiting
Escalate to a Pharmaceutical Adviser (PA) by phone (delayed assessment only) if unsure of the acronym, reason provided and/or drug name used.
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