PMRGCAuk
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Tocilizumab for GCA

Someone has just posted on the patient.info forum that on October 4th 2016 tocilizumab (Actrema) was approved by the FDA in the USA for use in GCA.

I imagine it will be a while before it is approved in the UK - but it is on its way!!

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Yes, I kept meaning to post this, one GCAer I'm aware of in another group has done very well on it.

Cheers

reuters.com/article/us-roch...

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I think it is already approved. My rheumatologist has prescribed it for me and I'm waiting for the induction visit.

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Venezia1, I'm very pleased for you. Where do you live?

Cheers

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I should perhaps have said that I have both RA and GCA - presumably the prescription is for RA but hopefully it will also benefit my GCA!

I live in Cumbria, by the way.

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Venezia, thank you for clarifying ....and I'd never heard of Cumbria but looked it up so have learned something!....

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You have a very nice rheumy who is doing it on the RA ticket. I do hope it works well for the GCA.

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Thanks, PMRPro! It has been used for a while in Cumbria (actually Morecambe Bay Trust), I think, but I recently attended a support group meeting addressed by the head of rheumatology for the Trust, who explained that the cost was prohibitive and the CCG was not willing to endorse its use, so I feel doubly lucky that my rheumy is independant-minded!

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I just wrote an email about it, The cost is about £10K per year. If you don't use it in GCA where it seems likely it isn't a long term commitment (don't really know yet, the trial isn't published and there is no long term follow-up) - and a young person loses their sight - it costs far more than £10K to care for them until they are maybe 80. There is this insistence that only over 70s get it. But that isn't true, there are plenty in their late 50s and early 60s. Who still work and have a long lifetime ahead of them. But that is rarely mentioned...

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It isn't yet fully approved for GCA. It is already approved for RA and has been used for several years. There has been a Phase 3 clinical trial - and from what we know it is looking pretty good. But those results are not yet published.

If you read the Wiki definition of "breakthrough status", which is what it has been granted, you will see that sometimes drugs get this approval - but later real clinical studies show them not be as good as the drug company claims. I suspect it may mean that the company can get an extended patent - which will increase the money they can claw back in drug charges before other companies can make what are called bioidenticals and provide competition.

For most people in the UK though I don't think I would hold my breath - there has recently been an NHS consultation about funding its use in GCA and it has been turned down. Even if they do approve it view of the Phase 3 study results it will only be kept for the patients who have severe problems with pred. As with RA you will have to fail everything else first. They simply haven't got the money...

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Awesome. Even tho I got a negative biopsy result, I have continued to wish you all the best possible treatment. Prednisone is such a nightmare. Just two weeks on it while I was under scrutiny, proved too much for me. You guys are legends.

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As far as I am aware Tocilizumab is only available in UK on NHS for TAK not GCA. The NHS has deemed it too expensive (about £10k a year) for GCA treatment.

My cynical side suggests this is to do with age as TAK mainly affects younger people.

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TAK not only affects younger people - it is exceptionally rare so won't need many doses. I saw the consultation document, it was sent to me for comment. It was a piece of nonsense - and it was issued BEFORE the results of a major clinical trial.

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Yes you are right. Any age can have TAK but doctors (mine for example) will not diagnose it as such if you are over 50. It's either GCA or LVV. I have argued this and was told it doesn't matter because the treatment is the same. Well not now, if this med is only available for TAK.

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Absolutely. I wonder if it will be available for LVV that isn't responding to anything else? You don't actually have a GCA diagnosis do you - that needs a biopsy. Technicalities, technicalities...

What got me was someone on another forum saying she'd been diagnosed with TAK in her early 40s I think, but more recently she discovered the diagnosis on her notes had now been changed. To GCA. Solely on the basis of age.

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Not for pmr too I am guessing?

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There has been a pilot in the USA that is singing its praises - but as Caro12ine says - at £10k a year, what do you think! They won't even allow Lodotra at a maximum of £100 per month...

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I am in the US and looking at its side effects. Is this better than what is currently out there? Don't kmow much about steroid sparing medication but was mentioned to me (current medicines not the new one) by new rheumatologist I saw just in case I can't reduce to 10. Sorry but I am not taking something that causes me to lose my hair. That is my limit with this crazy disease! (I realize I am very vain) also I am at 15 and doing well

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Yes you are vain. Try diabetes and herpes and black and blue arms and legs and skin that rips open from a blade of grass. Now let's talk about eye diseases. No let's not. So I have wigs that are great. A little itchy and hot but this is the very least of my problems. You are very lucky. Appreciate what you do not have. Things can get very rough on prednisones. I am not being mean just realistic. Your hair could grow back especially if you use the men's strength of Rogaine. Good luck.

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england.nhs.uk/commissionin...

This link details NHS standpoint

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And the NHS standpoint on TAK.....

So if you have LVV affecting Aorta, subclavian, axillary etc etc. You have to have a diagnosis of TAK not GCA (or just LVV) to get it...

england.nhs.uk/commissionin...

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i am so thrilled to hear this good news. I pray it will soon be used all over the world for people with GCA.

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Hi

Good news

I believe read somewhere that this is likely to be approved by NICE in 2017, but if I understood Bhaskar Dasgupta correctly, it is expensive.

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I don't know where you may have read that - there has just been an NHS consultation that has ruled out recommending tocilizumab for GCA (see Caro12ine's comments above). It will be available for a disease called Takayashu's arteritis which is even more rare and only found in younger patients.

The irony is - as I understand it, the two diseases are pretty much identical but what you are diagnosed with depends greatly on your age. One lady had a diagnosis of Takayashu's originally but she noticed it had been changed to GCA. When she queried it - it was due to her age, in over 50s it is called GCA. So at 49 she had a TA diagnosis and could have been treated with tocilizumab but a year later it's a different matter. And that sounds very much like discrimination on grounds of age to me.

Oh yes - the drug costs about £10,000 per year. Well it did, it will now be something like 15% more expensive as it is imported and the slump in the pound will affect the cost. If it can be used as a one-off course, compared with the cost of caring for a person with loss of vision that is peanuts in the long term - but the long term side-effects of tocilizumab aren't known nor whether it must be used in an ongoing manner as it is in RA. The results of a Phase 3 clinical trial with 250 patients, about a third of them on tocilizumab, will be published early in November. It MIGHT change the NICE stance, it might not.

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I was told by my rheumy it was going to be approved next year by NICE for GCA

but at the moment only for RA

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See my response above - and its use is even discouraged for RA. Of course, approval doesn't mean it will be funded.

At least the last comment in the consultation document is that it will be reviewed if other evidence comes to light. What a waste of money - anyone could have told them they should wait until November when the results of the phase 3 trial will be available. No wonder the NHS is in a mess...

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