PBS Criteria to access TNF inhibitors for Ankylosing Spondylitis in Australia

A steady trickle of patients with ankylosing spondylitis (AS) are coming to our clinic and asking how they may get access to the TNF inhibitor medications.

Sometimes, they have relatives on these medications who are doing well and they’re curious why they aren’t on the same medications.

Sometimes, it’s from searching the web and stumbling on a forum or a blog site like this.

I’m glad awareness of these agents seems to be trickling into the community. It’s still very slow however. These TNF inhibitor medications are not new after all.

They’ve been subsidised by the government’s pharmaceutical benefits scheme (PBS) since 2003, the year I started in clinical practice as a rheumatologist. More than a decade in Australia!

I then usually explain the process. When you’re trying to access medications which costs in excess of A$20,000 a year, there’s going to be quite a few hoops to jump through. 

Here’s a short spiel on some of these requirements to access TNF inhibitor:

So, you have an idea of the PBS criteria in more detail:

• The AS has to be reported on X-rays by a radiologist with the damage reported to be at least Grade 2 sacroiliitis on both sides.

• The patient has a level of spinal restriction of sufficient severity. For examples of the measures used, check out these Youtube videos.

• Patients with AS need to have trialled 2 different non-steroidal anti-inflammatory (NSAIDs) or Cox-2 inhibitor medications for at least 3 months each. Examples include Diclofenac, Celecoxib or Naproxen.

• Patients need to be on an appropriate exercise program concurrently with this documented on the application form for 12 weeks.

• At the end of the 3 months of NSAID/Cox-2 inhibitor medication with the exercise program, the disease needs to still be unfortunately active for TNF inhibitor therapy to be considered.

• The bars set for a “suitable” degree of activity in the Australian context include:
1. Raised inflammatory markers with a CRP of >10 and/or an ESR of >25
2. The BASDAI (a reasonably useful, validated measure of disease activity) needs to be at least 4 (out of 10, higher score implies higher disease activity).

In addition to this, we need to take into account a patient’s other medical conditions and infection risk, while attempting to reduce this with appropriate screening procedures and some vaccinations.

Yes, complex but necessarily so. And worthwhile to be given the opportunity to use these effective medications in people who are otherwise having a very hard time with their ankylosing spondylitis.

Have you had any issues with access to TNF inhibitor therapy due to the PBS criteria?