This document outlines details of PBS-subsidised biological medicine for patients with non-radiographic axial spondyloarthritis (AXSPA).
For details on how to process a PBS Authority, see Processing Complex Authority Required Listings.
On this page:
Non-radiographic axial spondyloarthritis (AXSPA) quick reference
Contraindications to prior therapy
Delayed assessment
Non-radiographic axial spondyloarthritis (AXSPA) quick reference
Table 1
Restrictions | Authority level and section | PA assessment | Processing system | Prescriber type | Prescriber self-serve |
Initial PB255 form | Written Electronic S85: bimekizumab certolizumab pegol golimumab secukinumab upadacitinib | No | OPA | Must be treated by a:- rheumatologist
- clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis
| Yes - immediate or delayed assessment (delayed if any free text option used) |
Continuing | Telephone Electronic S85: bimekizumab certolizumab pegol golimumab secukinumab upadacitinib | No | OPA | Must be treated by a:- rheumatologist
- clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis
| Yes |
Change or: - Recommencement after a break (< 5 years), or
- Recommencement - after a break (> 5 years)
| Telephone Electronic S85: bimekizumab certolizumab pegol golimumab secukinumab upadacitinib | No | OPA | Must be treated by a:- rheumatologist
- clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis
| Yes |
Balance of supply | Telephone Electronic S85: bimekizumab certolizumab pegol golimumab secukinumab upadacitinib | No | OPA | Must be treated by a:- rheumatologist
- clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis
| Yes |
Contraindications to prior therapy
Table 2: 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
|
Delayed assessment
Delayed assessment due to:
- intolerance to prior therapies
- drug name of NSAID
- reason for non-elevated CRP
- other contraindication to prior therapies
Table 3: this table lists the details of what to check for the delayed assessment and common acronyms.
Service Officers to assess that the free text is: | Examples | Outcome |
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 AXSPA:
- ibuprofen (Nurofen)
- naproxen (Naprosyn)
- celecoxib (Celebrex)
- diclofenac (Voltaren)
- meloxicam (Mobic)
- piroxicam (Feldene)
- ketoprofen (Orudis, Oruvail)
- etoricoxib (Arcoxia)
| Approve |
Random text | - Happy Birthday
- Patient did not want to take
- Ikasditbn
| Reject |
Non-descriptive | - Toxicity (no details)
- Intolerance
- Ineffective
| Reject |
CRP not elevated | - Treatment with prednisolone (or equivalent steroid)
- Treatment with a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent)
| Approve |
CRP 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 and provided 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 not sure of the acronym, reason provided and/or drug name used.
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