Kickas.org Forums Ankylosing Spondylitis General Discussion #1 AS Web Support Group No Remicade

Hi All,
Just a post to update you on the unfairness of Australian PBS!!!
I had an application submitted for Remicade that included grade 2 sacroillitis on right (from xrays 12months old) nothing on the left, limited range of movement, no elevated CRP or ESR (although ferrotin levels well above normal). Currently on Mobic, Plaquenil, Methotrexate, Arava, Prednisalone (hospitalised when off Pred), two docs saying I should be on it (that I have seen). I sent a letter to Davo's contact and recieved the following reply:

Dear Rosemary
I am sorry to hear of the problems you are having with AS. If your CRP level is elevated and you have grade 3 sacroiliitis on one side then you would qualify for Remicade provided certain other criteria are met. Unfortunately the current rules from the Pharmacetical Benefits Advisory Committee are strictly applied, although it is possible that changes may occur in the future.
I would suggest further discussion with your Rheumatologist, who may wish to talk directly to Schering Plough.
Best wishes
Jim Bertouch
Chairman. Therapeutics Committee

It seems that it is not likely for many AS suffers in Australia will get Remicade before the disease has put them in a wheelchair!!

My Rehumy has today told me she is going to keep fighting for me and we will get the drug, hopefully sooner rather than later.

Trying to keep a happy face (struggling a bit at the moment!).
Take care and keep smiling,
Rose

Hi Rose,
what a bummer! I find the fact thet you cant get Remicade absolutely ridiculous! If you dont qualify, who exactly will??? This must be so frustrating for you! At least your Rhuemie hasn't given up on you. You never know, things could change - they might find there guidelines too strict. You would think that you would qualify especially considering what medication you have been taking and its effectiveness.
Just keep hanging in, hopefully you will get a break.
How's work going, did you get a new job?
Debra

Keep fighting, they will eventually cave in, I'm sure.

I do understand the need for elevated ESR and CRP, as this is how they are measuring the success of Remicade, if I remember right, after 2 or 3 months on Remicade if your ESR and CRP have not dropped, you will be denied Remicade. This could actually be worse, as many people here have said that if you come off Remicade for an extended period, then your body developes antibodies, reducing the effect of Remicade.

Take Care
Wayne

Debra,
I have started working full time again but I'm doing shift work (kinda). So it means that some days I don't start til 1:30 pm. Gives me a bit of a chance to catch up on sleep and exercise. My new boss is also really good about my arthritis. My stress levels have dropped dramatically which I think has also helped. My prednisalone has not been less than 10mg a day for a couple of months which may also contribe to managing full time work. I dropped it to 5mg the other day (I think this is day 3) and will have to put it back up, my right foot can't fit shoes on, right shoulder has jammed and right SI very painful. Today back to 10mg I think. Maybe alternate for a while.

Anyway hope all is well for you.
Take care and keep smiling,
Rose

Hi Wanye,
My rehmy has a friend that is starting a trial in a few months that she will get me on if nothing else eventuates.
I can see that they need something to measure progress but it is know that 25% of AS suffers do not have elevated ESR's ever. Mine went to 25 when I was hospitalised cause I couldn't walk, at that point my ferrotin levels were over 400 (150 is the upper limit of normal) and have not gone back into a normal range since then (May/June last year). The other thing that really bugs me is that I have more recent CT's than the xray that show significant changes in the 6 weeks after the xray, they won't accept these results and want me to have more xrays. My rehumy is quite concerned that I'm only 25 and not had kids yet and my ovaries have had a signifcant amount of radiation.
Anyway enough whinging!!! Finally we are getting some spring weather down here so hopefully they warmer weather will give me a bit of a break!!
Take care and keep smiling,
Rose

Hi Rose,

Sorry to hear that you are in flare & have been denied remicade. I don't know why the PBS would even bother developing such restricted criteria when it appears that virtually no one will qualify. How frustrating. Thank heavens that you have a good rheumy - hopefully lobbying efforts are underway to have some changes made to the criteria.

Good luck to you and may your flare be short-lived,
Cat

Lytton Hazel

Hi Rose,

I am so sorry thay denyed your application for remicade.

You should be the ideal person to get Remicade, your young, still working, not to bent over yet (I would think).
I showed the PBS application form to my GP and he was shocked he said it should be called an exclusion form not an application form.

I am going to apply for it in 3 months as I have to complete the stupid exercise program and try and get my ESR up. I had my si joints x-rayed about 3 weeks ago I don't know if thay are grade 11, grade 111 or fused yet I am not gamed to ask.

I think the only way we are going to change the PBAC rules is to get as many people as possible to apply for remicade and when no one meets there rules thay will have to change.

Keep your chin up Rose,

Adriaan

Hi,
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Seriously though:

I am so glad that we are having this discussion. as I've said before this is the impression I've had talking on the "dog and bone" to the bodies/corporations.

The patients are saying they do n't want to let the condition get that bad if they can stop or reverse it.

I'm not as uptight as I may sound....but I really am having an attack of goat horns at the moment regarding how these "exclusion criteria work".......

There are indexes which can determine prognosis, some are from the Bath AS which highlight certain things such as othe SpA related condition peripheral and Axial onset othe family memebers etc which seem to be well thought out, high ESR/CRP maybe these are more appropriate for early aggessive use of biologics.....no doub all rheummies will have an opinion
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I like to see both sides of an argument though and there are some opinions in the rheummy World which say AS'ers should be left to fuse, no nsaids, the dmards are useless and both can be dangerous (liver kidneys GI) and the TNF inhibitors are unknown and potentially dangerous......

Against this you have large regional bodies such as EULAR, and other national rheummy Bodies trying to get biologics out as first line drugs and use them early and agressively and putting forward financial reasons for doing it.
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As for the PBS there was an article in the Media just last week saying that the PBS would blow by $110 million, this was expected due to a single item recently added. Not sure if that is remicade for AS.........if it is that's about approx 3000+ patients at $30,000 per year. By my maths that's about $90,000,000......

The PBS Site has a tool for checking out what drugs how many users per state. For Enbrel the number I remember was 657 in NSW 2002-2003 that would be for RhA or the young persons arhtirits. NSW was the highest state for prescriptions by far. I'll see if I can still find that tool and get some more info on remicade.
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As for elevated ESR and CRP there are contradictions in the studies regarding these markers as a sign of a good responser or a non responder in individually or together.

Even the representation to the FDA for Enbrel stated that it is well known that ESR and CRP are not good indicators of disease in AS....
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As for exercise programs I posted the link from the hiv.goc.au site a short time back. it's not that bad......in fact got to say that I need to walk and move alot just to keep the pain down. So again I just do n't think the people who set these criteria actually understand the disease.
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David

Hi Rose,

I'm so sorry you're not going to be able to start on Remicade.

What a crazy country (world?!) we're living in!!! I'm as mad as David about this, being B27- as well. If a person has an illness/disease that's not repsonding to any other available treatment, what right does some (presumably) ignorant beaurocrat have to say they can't have access to something that might actually help them, simply on the grounds that they don't have a particular gene?????
It's absolutely ridiculous.....Grrrrrrrrr!!!!
Surely, we're just as entitiled to at least give Remicade/Enbrel, or anything else that comes along, a try? If it doesn't work, then we stop taking it, just the same as anyone else :(

Let's hope that some kind of sense comes out of all this mess, sooner rather than later, and you get your turn.

Good luck,

Sue

Rose,

Part of the problem is that the anti-TNF therapy is relatively new and quite expensive. There is little evidence yet to support early intervention. Nonetheless, some is appearing, e.g., Enbrel especially helpful for early arthritis.

An ally in the battles with the third party payors and the pharmaceutical companies that make the drugs. They can help your rheumatologist with information that supports use of their drugs.

Best regards,

jcwinnie