Actemra (Tocilizumab) - fantastic results in the first month

I can live with $38.30.....:-) 

I have it for free until September 2017, so we'll see how well I'm travelling by then. It *might* be available for PMR by then.

It isn't the cost to the patient that will pose the problem: it will be overall cost to the healthcare provider. It is the most common rheumatic disorder in over 65s and so far considerably less common amongst people of working age (despite what it may seem on the forums) - so justifying the cost immediately becomes far more difficult. It sounds harsh - but it is a reality and it is part of what is making ALL healthcare systems creak.

Even within the USA system, expensive medications often are blocked by the insurers. There are considerable co-pays in the US system - and the people who would really benefit from tcz are older and more often than not on limited incomes. And throughout the world - populations are ageing. The cost problem will only get worse, not better.

the Aus PBS (pharmaceutical benefits scheme) also publishes the DPMQ (dispensed price maximum quantity) which is price ex manufacturer plus all fees, markups and patient contributions.

Difficult to know which version of Actemra (there are several "injections" is relevant to PMR. DPMQ is about A$200 which if monthly is reasonable for some people. This is at odds with the price from .com drug sources of US$900 and may not be comparing apples.

The murky obfuscated world of health care costs is such that I ignore the cost to the health provider. Its their system, not mine. I cannot change it. If it were more transparent I might be able to see. Co-payments to help me see are, to me, just economists words on a page. Trying to extract an estimate prior to any procedure is like pulling hens' teeth.

The benefit to the health provider is in the hoped for remission in chronic conditions that hopefully translates to reduced future tests, fewer GP, Specialist and Hospital visits, reduced future complications, and more obscure the contribution of a more healthy person to society.

Whether the cost benefit analyses carried out by our PBS are sufficiently sophisticated or take the historic siloed approach of having a total budget limit on pharmaceuticals that suits a dominance of acute conditions I have no idea. The methodology will no doubt change over time to consider "total cost of patient" (or health). A bit like the computer "total cost of ownership", but harder to estimate.

My guess (or hope, it makes no difference) is that for a significant number of patients with an auto-immune condition which includes elevated IL-6 the treatment protocol may evolve to the extent that the condition may in future be considered acute rather than chronic. Remission may become quite rapid for the lucky ones. But really we are hardly past initial trials and advances are necessarily cautious. The language is of "steroid sparing". Actemra as an addition to existing treatment. Another view of the action of Actemra may emerge.

Actemra is really only 10 years old.

?

As my (Immunology educated) daughter points out to me, the body is not as mechanical as we sometimes are led to believe. The effect of blocking the receptors of something like IL-6 isn't quite the same as sticking a bung in the end of a hose to stop the flow of water.

Which all makes the cost benefit analysis more difficult for the bureaucrats.

The benefit to Flip is obvious. I nearly said "long may it continue" but even better would be remission, before September 2017. 

PS the smiley after "injections" shouldn't be there. Must be gremlins!

It will have been the combination of the close bracket and whatever you put around it - infuriates me!

"As my (Immunology educated) daughter points out to me, the body is not as mechanical as we sometimes are led to believe" - something I have spent the last 7+ years trying to explain to people who expect miracle cures for whatever it is they have wrong! And to doctors if it comes to that!

The crux with TCZ I think will be if it induces remission quickly and it is sustained for at least a year without treatment. If it requires sustained asministration it won't be cost effective - and unaffordable. However, at present it is being re-considered in the UK after a consultation this summer rejected it for GCA but approved its use fo Takayashu's which is much rarer. It was a trifle stupid as the consultaion was done just before the Phase 3 trial results were available! Now they are out - they are looking again. The talk I have heard for PMR is its use in resistant cases - but there are only small pilot studies thus far. 

The other problem I have is that people seem to imagine it has next to no side effects. I have no idea where people get the idea that biologics are much safer! Is it because "biologic" signifies "natural"? If they are going to go wrong they seem to do so on a grand scale!

yup - the reality is probably if it doesn't provide remission with no ongoing support or substantial prolonged relief in steroid resistant cases its probably not cost effective, even when considering "total cost of patient".

There are definitely possible side effects.

Regardless of the cost, from a patient perspective (though I'm not really very patient) for someone like myself on 5mg/day pred (having been down to 3.5mg/day) after 2 1/2 years of treatment and traveling reasonably smoothly, unless it provides earlier remission than otherwise there's little benefit and increased risk. Of course I would like the PMR to just go away, but, as you say, miracles are unlikely ....... but it is Christmas after all! 

Unfortunately, I suspect it will be some time before trials aimed at working out whether its useful for cases like me may be mounted. My perception is that so far the target group has been recently diagnosed. And I doubt there is much agreement on what "persistent" implies. The Aus Pharmaceutical Benefits Scheme (PBS) and Medical Benefits Scheme (MBS) can't even agree on "chronic".

It will probably take lots of results from new patients before much gets applied to those further down the track. Its a bit like all the special offers from banks and utilities to entice new customers while unavailable to the old. 

I'm fine with being on 5mg a day for the rest of my life. I'm even fine with the occasional foray into higher doses as I had this year - and I could have been lower sooner had I been more insistent with ny GP about the back problems. As soon as she did a needling session I have got down another 2mg!

Since many doctors claim PMR only lasts 2 years - anything over 5 years apparent PMR symptoms has to be regarded as "persistent" surely! I know and you know that 5 years is actually more like the truth - but what do we know 

Sorry I only just saw this! I've responed to you on another post about your travelling - we should PM as we are going to do the grey nomad thing in a couple of years when we retire. We go away in the van as much as we can! We are just back in Canberra after a month in the west of Qld and NSW - where are you?

So, about Actemra.

To get on Actemra here you have to be 'reclassified' as having Rhumatoid Arthritis (RA) in the system. I'm no longer on a trial as it's on the PBS now - as long as you have RA (which I don't of course lol)

I reckon it will depend on your Rhuemy and her/his attitude to 'bending the rules a little'. on the PBS it's less than $40 a month.

I don't have time for this thing either. Nobody does!

Yes, thank you, I saw your other post and I have responded. We are in Newcastle, we've had the RV for about 3 years but only do about 5 weekends a year and then 2 weeks each Xmas. We had our own large business with employees and planned to travel once we sold it and retired. We have now retired...a bit earlier than planned  thanks to this...but I'm so happy about retiring I don't care! It's like a huge weight has been lifted and I'm free!!!! 

I spoke to the Rheumatologist today about Actemra on my follow up visit and he said exactly as you said....I'd have to be reclassified for RA to get on it and he didint seem to think that was a good idea given my condition now with GCA and PMR. He does seem to be concerned about the GCA, even though most of the symptoms have gone ( I still have blurred vision in one eye and an occasional droopy eye lid, but not every day) but  the eye specialist confirms there is no permanent damage to my vision or associated problems at this stage. I'm also a very tiny person, having lost 9 kls since this began and I was only 49 kls to begin with, and I also have a black spot on my liver and I believe both of those things tend to be contraindicative to taking  Actemra. So... it's on the prednisone I stay, although he is reducing it to 37.5 mg for 2 weeks to see if I can cope on that dose or if I flare again. 

He is aware that it is now approved in several countries for GCA as a result of the GiACTA trial?

I don't think he does. Well...he might, I  just got the impression he doesn't want me on it. When I asked him if he had heard of it he said yes, so I asked him what he thought of it and if he has any patients on it. He asked me to treat what, and of course I said GCA and that's when he said it wasn't approved here for GCA,  there's wasn't enough evidence yet for treating GCA effectively. I said I thought it was on the PBA list and that's when he said only  for RA. And he won't reclassifynme due to the severity of my symptoms of HV and PMR prior to diagnosis and treatment. 

I think the evidence has been available since last autumn - the FDA gave it breakthrough status last summer on the basis of the results of the GiACTA trial. But he has the final say of course...

I'd googled it and read all about it as soon as a friend of mine told me about it and I'm almost sure it  said it had some great results overseas for treating GCA. I still think he doesn't want me on it, or maybe he wants to see how I go on prednisone for a bit longer...it's only been 8 weeks I guess. He is willing to try to reduce the dose to 37.5 mg so I guess I should be happy for small steps moving forward. 

must be fairly difficult for doctors charting an ethical course between the medicare/pbs bureaucracy, patient care, and professional insurance. Perhaps he was saying that the current diagnosis is so clear it would be difficult to justify a change of diagnosis to access a different treatment.

Its difficult for patients in a different way. Different risks for doctor and patient.

I can't find anything about whether it is covered in Aus. It isn't generally approved in the UK yet but can be used on the basis of individual funding requests in the meantime - mostly I imagine by the people who were involved in the Phase 3 trial who will have seen how their patients who were on it did. I think it started with a 1 or 2 years double blinded part with pred plus Actemra, pred plus placebo and just pred and then everyone got it afterwards (though I might be wrong about that). 

I think the idea of seeing if a patient does OK with just pred initially is a good one - and I'm a bit concerned about the people in the US who are sticking PMR patients who are already on fairly low doses of pred onto it to get them off it. I think I'd be happier with a low dose of pred as I am at present than being on Actemra with its potential downsides - because there ARE some nasty aspects to biologics and I can't see a justification for the patient who is doing well and happy enough with pred.

That's what I understood him to be saying. He was quite certain that with me he wanted  to stick to his currennt plan. Maybe if it  it was further down the track    and not just 8 weeks in, he may look at other courses of action but in reality from where I was to where I am now  I have had a massive improvement so far. I can walk, sometimes,  I can drive, I can move my arms and legs. Yes, I am still in a lot of pain most days, but I'm no longer bedridden. And there is no permanent GCA damage. And that is the thing he is most concerned about, 

I agree. I believe his idea is, as I mentioned to Julian, it's only been 8 weeks for me on pred, and although not as well as he'd like, t's working, It had taken a long time  to diagnose PMR, longer still to diagnose GCA, (I only had the biopsy 2 weeks ago). The symptoms started after sinus  surgery Jan 2016 which ended with a staph infection and blood clot in the cannula site. Although I recovered well ( always was a good healer) things started happening one by one after that, but I didn't run to the GP except when my lower back discs bulged last August and then  I was under an excercise physiologist. When the lower "back" pain started April this year I went back to the physiologist and we modified my excercises. When the headache stared we thought it was from my neck/back/core related management and saw the remedial massage specialist. When I continued to get rapidly worse and the pain from head to ankles and everywhere in between became unbearable and crippling and the muscles disappeared "overnight" I stopped trying to cope and saw my GP. He had seen me in Feb this year as I couldn't eat, sleep, and had started losing weight which I couldn't afford to lose at 49kls. He thought it was good old stress, which it was no doubt, as we were planning to wind down or sell our business to retire. I didn't have any other symptoms then so PMR  or GCA wasn't  even a consideration. It all happened in the next few months but it happened quickly and severely from then on, I just didn't link the symptoms and treated them all myself individually till it just got too severe. I didn't see the GP again till 31st May and he was horrified at how much I had deteriorated in those months. Pred was immediate and high dose, and the tests began. As I said, I think the rheumatologist is thinkung, it's only been a short 8 weeks, you've come a lingbway in that time, let's not rock the boat just yet. 

I find stable is good ... and change one thing at a time - probably my industrial experience..

Not much help but I can recall when I didn't know how far I could walk along our street and be certain I could walk back. It wasn't far. There came a time when I could walk up steep hills for long distances again.