Rheumatoid Arthritis – Qualifying for Biological DMARDS (bDMARDS) in Australia

rheumatoid arthritis infusions
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Ok, bear with me. This is going to get confusing. Why?  Because I am going to try and explain why some people with severe RA cannot access expensive biological medications in Australia.

Why is it hard to get these drugs?  Because they are expensive.  I would think that the cost of supporting the disability that Rheumatoid Arthritis causes is more expensive than these treatments… treatments that offer hope of remission and a normal or near normal life…But hey, I don’t make the rules….

In Australia, eight biological medications are available under the Pharmaceutical Benefits Scheme (PBS) which means their cost is subsidised by the government.  IF you qualify.

I have been told that the cost of unsubsidised treatment with these drugs is between $1200 to $2000 per month.  Obviously out of reach of the mere mortal.

The medications are abatacept (Orencia), adalimumab (Humira), etanercept (Enbrel), golimumab (Simponi) and tocilizumab (Actemra),certolizumab pegol (Cimzia), infliximab (Remicade), rituximab (Rituxan/mabthera).

Over the course of your life you are allowed subsidised treatment with FIVE biologicals.  If the first five you try don’t help, you’ll have to pay for the others yourself.  As previously stated, pretty much impossible for the average person.

Additionally, methotrexate at a dosage of at least 7.5mg per week must be taken with abatacept (Orencia) , golimumab (simponi), infliximab (remicade) and rituximab (rituxan) therapy.  So too bad if you can’t tolerate methotrexate.  You’re down to four options now.

That’s if you even qualify for treatment.

As stated before, conclusive blood tests for rheumatoid arthritis don’t exist.  Blood tests are indicative and interpreted in context with other results.  See Rheumatoid Arthritis diagnosis for more info.

For me, the only ‘proof’ I have that I actually DO have rheumatoid arthritis is in my scans.  Synovitis is visible on nuclear bone scans and ultrasound.  Positive, physical evidence. Indisputable.  Relevant in the current diagnostic criteria for Rheuamtoid Arthritis.  But it’s not part of the qualifying criteria for biologics in Australia.

I clearly have rheumatoid arthritis, or at least a form of inflammatory arthritis, but the criteria only take blood work into consideration, not physical evidence.

Previously you needed a positive RF (Rheumatoid Factor).  This criteria was removed in 2005, possibly in deference to the fact that 30% of people with active and obvious rheumatoid arthritis do not have a positive RF.  This is often referred to as “Seronegative Rheumatod Arthritis”.

Seronegative Rheumatoid Arthritis is considered to be a milder, less serious form of the disease.  I have met enough people with severe Seronegative Rheumatoid Arthritis to realise this is not the case.  Equally I have met people with a positive RF who have no signs of disease whatsoever.

So removing RF from the disease criteria was a positive step.  Gives me hope – criteria can be changed!

So, the criteria for treatment are a count of tender and swollen joints – determined by the rheumatologist squeezing your joints and seeing how much you flinch.  I don’t flinch.  You can put a cigarette out on my hand and I won’t flinch.  I know someone that you could brush their hand lightly with a feather and they would flinch.  They would even cry on cue if you asked them to.  Pretty flawed test I think.

Then you need to submit a blood test.  Your CRP (C-reactive protein) or ESR (erythrocite sedimentation rate) are both indicators of inflammation in the body.

Sounds fine, right?  Except that they are not very accurate tests.  Something as simple as the common cold can cause an elevated ESR or CRP.  Conversely some people with severe and active inflammatory arthritis *always* have ESR and CRP in the normal range.  Mine is mildly elevated from time to time.

Also a pretty flawed test I think!

In addition to all of this you MUST have been on methotrexate for 3-6 months at the maximum dose of 20mg per week.  Except in the case of intolerance or toxicity.  Methotrexate can cause liver damage and lower your white cell count. This is considered toxicity.  Intolerance is experiencing severe side effects.  Again, there is a criteria and points system. Medicine is like that.  All about criteria and points.  Not at all about people and pain.

Severe depression is not considered a bad enough side effect to class as intolerance.  It is classed instead as non-compliance.

In addition to having failed methotrexate you need to have failed two other DMARDs – sulfasalazine, leflunomide, azathioprine, plaquenil or intra muscular gold.

Do all of that and then you win the prize – a new medication with a whole host of dangerous side effects that *might* put you in remission.  If that one fails you can try four more.  Then what?  Five strikes and you’re out, apparently.

Too bad if one of the other three was the magic combination for you.

Now I’m not 100% sure that all of the above is completely correct.  Try googling – you will find not a lot of information.  Try asking a rheumatologist..they will likely um and ahh…they will not discuss it.  I have heard other RA patients say that the criteria is so complicated that even most doctors don’t understand them.

This is the best information I have been able to get.  The actual application form is here.

Click to access 4139-rheumatoid-arthritis-pbs-authority-application-initial.pdf


On reading through this, I think I have qualified.  I have failed methotrexate and another DMARD after 3 months of treatment (sulfasalazine).  I can explain my normal CRP with my prednisone use.

It could be done.  Some rheumatologists do it.  I love my rheumatologist – he has been great to me.  And his registrar has done her best.  But I now have an appointment booked with someone else.  A rheumatologist who is known for fudging the system.  Cheating?  Maybe.

Sometimes you have to.

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  1. I personally would call the second rheumy, one that cares enough about their patients to do whatever it takes to get them the very best treatment and quality of life. Best of luck I hope he/she can get you a shot at the good stuff.

    • Thanks Gillian. I am looking forward to the appointment. In the meantime I am doing lots of research so that I am well informed. Or as well informed as we can be…in the end its the luck of the draw, isn’t it? 🙂

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  2. Hi,

    Your info is really helpful, I am going to take it to my next appoint.

    I have been on methotrexate,prednisone,Salphazalzine and pain meds ranging from panadol to OxyContin for my ra and psoracic arth for three years. I am 44 and have six kids, and am at my wits end, my drs keep telling me I do not qualify for the new medications!

    I have gone from fit business owner,wife,and mum to mad couch potato(thanks prednisone) living with constant pain and increasing immobility.

    Educated is armed, so maybe like you I will research and hit my dr with it, and if he still says no then I will really hit him with it- haha

    • Good for you, Sarah. My rheumy told me that I need to be on 20mg of methotrexate for at least 3 months. I couldn’t tolerate 10mg, so that’s clearly ridiculous. Education is definatley the best ammunition we have – but be warned, my rheumy has dumped me now. He has referred me to the Pain Clinic and didn’t make another appointment for me. After five years, he has given up. Keep your rheumy on your side! Good luck 🙂

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  3. Hi Everyone,

    Yesterday I had an appoint with my rheumy- after a long discussion he told me that he is one of the head people on the Biological trials and criteria. He also told me that the criteria was updated as of 1/8/12- so here is what he said you need to have to get on the biologicals.

    1- 20 small joints or four large joints effected by the RA.
    2-A CRP greater than 15mg/l or a ESR greater than 25mm/l
    3- Have active desease after a minium of 6 months triple therapy- this dosn’t include pred.

    There are also two critical points that make the decision- First FAILED in the criteria means that your desease stays active whilst on the medication- not that you are unable to tolerate the meds or the side effects.
    And second- if you are unable to tolerate methotraxate- YOU CAN NOT HAVE THE BIOS- this is due to that fact that double blind studies show that if you have the bios without methotrex there is NO IMPROVEMENT in RA.

    The five rule nolonger stands as a stead fast rule as such- just that although there are 9 differant bios- there are only really 5 differant bios- several are the same strain.

    I hope that all makes sense.

    • Thanks Sarah – great information. NOT good news though! Does triple therapy mean taking three DMARDs simulataneously? Or failing three DMARDs? As I said in the other post, there are plenty of studies that show biologics can work without methotrexate…I really will dig those out!

      Interestingly I got a letter in the mail today…and appointment in January at the Biologicals Clinic at Canberra Hospital. Interesting times! I will post a blog about it soon.

      Thankyou so much for contributing to the blog and updating the information – knowledge is power! All the best too you, and I hope you’re doing OK.

      • Hi All,

        I think triple therapy means that you have tried 3 differant types, not three at the same time.

        He said that the 3 orginal centres that have been monitering the use and effectiveness of the treatment, which mostly would be still unpublished data are indicating that the four types best for treating RA have minimal effect without methotraxate- less than 20% improvement vs 80% improvment.
        Another thing that he said is that since the orginal studies for the treatment were carried out that the effectivness of the therapy had been decreasing and after further reaseach they belive this is due to two things- first- often people are given the drug prior to proof of RA ( so for reactive or psoricac arth)
        The second thing is that they are seeing eveidance that if the meds are started before the disease has reached a certain level- then the meds are less effective. He said that is due to the mechanism of how the biologicals work. So if you take the drug to early you have very little success.
        I am not a doctor so I might not have it 100% explained correctly- Cheers Sarah

        • Also not sure what level of methotraxate you were on but to get on the bios you need tio have been taking 20m- but when on the bios you only need to take 7.5 per week- can you tolerate the lower dose?

          • Thanks Sarah – lots there for me to look into. My rheumy told me that for four of the biologicals, you need mtx 7.5mg. For the other four, you don’t. But I’m not up to date…so I will look into it. I fall apart on 10mgs of mtx. Maybe I could do 7.5mg. But I’m not keen to try!

  4. Wow, that’s a lot of hoops to jump through. Hope your new doc gets you on a biologic soon. Within a week of the first shot I could snap my fingers. I miss it so much. Very sad I had to quit taking it (breast cancer).

    • oh I’m so sorry, Elizabeth. I hope you have beaten the cancer! And so very unfair that you had to stop taking a therapy that was working so well 🙁 (Sorry, I saw your other comment first, and replied before I read this one). What treatments are you able to take now? I hope you’re doing OK.

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  5. I did not take the biological with mx. In fact I’ve never taken mx. You could always say you are taking it when you get there and don’t.

    • Hi Elisabeth, are you in Australia? Which biological are you taking? I hope it is working for you 🙂 And you know I have considered this as well…I’ve read a few studies that say that teaming meth with a biological is no better than the biological alone, depending on which one. If it comes down to it and its the only way I can get the treatment, it will be my only option. It would be hard to lie to my Rheumy tho…she has been wonderful!

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  6. A friend of mine not on computer at present has been on Orencia for 3 months. Last week after her blood test showed 1 marker was down and the other wasn’t , she was told that she could be withdrawn from Orencia. Has anyone heard of such a fast move surely 12 months should be given to see if success is likely. I would appreciate knowing if there are support groups that she could access in Sydney NSW Australia. She has just started study because she thought her life could change now feeling thrown. It seems so unfair. cheers Janey

    • Hi Janey, no its not fair, but medicare rules are that you need to requalify every three months…in effect prove to them that the drug is working, so that they will continue to subsidise the cost. Its very unfair, because blood tests are not a reliable indicator of inflammation (or pain) in many people, and biologics can take up to six months to reach full effect. There *are* ways around the rules though, if her rheumy is willing to be creative. Not all are. Is she feeling better on Orencia?

  7. Hi
    I found your site while Googling Biologics, as they’re starting to look like options for me. I’m on 15mg Mexthotrexate and 10 Leflunomide -higher doses affect my liver results. Meanwhile the symptoms creep forward.
    Your site is excellent, and very heplful. I was trying to find out the subsidised cost of biologics (assuming I get that far)

    • Hi Irvine, thank you for your kind words. I’m sorry that your disease is progressing but I really hope that you can get onto a biologic. I believe the subsidised cost is around $40 a month, similar to most medications on the PBS. I am on DSP, and have a health care card so I now pay about $6 for my medications. Once you hit the safety net (which I always do) all medications are free. Good luck!!!


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