Totally desperate and abandoned (sorry- this is a long rant)

[Suzita76]

I have not posted for a long time, mainly because I’ve been in excellent health.

In summary, I was diagnosed with GCA in May 2017, had terrible reactions to Prednisolone (severe psychosis being the worst- apparently 1 in 20 people suffer this) such that my husband had to call out the Crisis team.

After several relapses, and a PET-CT scan revealing I additionally had severe large vessel arteritis , my Consultant managed to get me on self-injected Ro-Actemra. This worked miraculously for me- no side effects, no illnesses (apart from a slight cold last year). I have been off Prednisolone, and all other medications for more than 3 years, after having been on it for 3 years (and made very ill by it, not to mention stacking up a very high accumulated dose).

The one year allocation allowed by NICE was extended because of Covid, and (entirely off my own bat) I decided to inject every 2 weeks, then 3 weeks, instead of weekly, to eke out my supply, with no reduction in its effectiveness.

I was thus able to be on Ro-Actemra (Tocilizumab) for nearly 4 years, but my last injection was in May this year, and a blood test last week shows I am having a major relapse 10 weeks after my last injection.

Now it seems my only option is to wait for a stroke or aneurysm to finish me off; my consultant, lovely though she is, says she cannot prescribe more because of NICE’s edict that for GCA, only one year is allowed.

I have tried to obtain it privately, and pay for it, but even this is not allowed! Why not?!

I know I am one of the lucky ones to have been given Tocilizumab in the first place, BUT it is totally reprehensible, and discriminatory (this condition after all, mainly affects elderly ladies).

When NICE can approve expensive biological drugs for Alziemers ( which affects far more people), not to mention drugs to treat obesity, and £1.89 million pounds per patient to slow down (not stop) certain very rare degenerative conditions, it cannot be justified.

My ( and our) only option seems to be a judicial review of NICE’s decision on this. I cannot be the only one in this situation, in the UK. It seems that the one year rule does not apply in all countries; and some countries (Australia for eg.) have done a deal with Roche so that patients can buy the drug themselves, but of course, the request has to be made through a Consultant. I mentioned this to my consultant, and she hadn’t heard of it, so it won’t happen.

If anyone has any ideas, I would love to hear them. Otherwise, I might not be around much longer!

[PMRpro Ambassador]

I know, don't get me started!!

I'm currently in the position that I can't move back to the UK because I would lose the 2 medications that work for my PMR after 18 years of it and 14 years of pred! Here I am on the Lodotra form of pred and Ro-Actemra, well over a year now but it wouldn't be an option in the UK for PMR.

Have you tried writing to Roche? The private restriction is a piece of nonsense. If I was down to a monthly jab I would happily pay for myself. My rheumy thinks the price will come down a lot soon - Humira was a similar price to RoActemra but is now about 800 euros a year,

There is someone else on the form who gets it because it is approved WITHOUT RESTRICTION for Takayasu's which is pathologically the same as GCA. It is also approved without restriction for RA, So why are we different?

[Suzita76 in reply to PMRpro]

Because both of those conditions most often affect younger people! It could be that I actually do have Takayasu’s- I have all the same pathology and it is hard to be definitive ( except that mostly affects under 40s, but certainly not exclusively). Trying to be positive, but I’m totally at a loss now. The family clubbed together and said they’ll buy it privately, but if that isn’t allowed, there really is no hope.

[PMRpro Ambassador in reply to Suzita76]

I said as much at a NICE meeting about developing treatments for PMR - that the refusal to approve TCZ for GCA was agist and they got VERY defensive.

Saw a very interesting article recently about that missing 10 years - what have patients with the pathology got when they are in their 40s? One lady on the forum told us she'd had a Takayasu's diagnosis and then noticed it was now GCA so asked - oh, when you are over 50, it is GCA. What utter twaddle ...

[piglette]

NICE’s remit is only to decide whether medicines can be made available on the NHS. If they do not recommend a medicine for use on the NHS a private company can still choose whether to provide a medicine or not. Contact Genentech (Roche) and ask them for their authorised distributor.

[Suzita76 in reply to piglette]

I have tried to find a private consultant who could prescribe it, but so far, no success.

[piglette in reply to Suzita76]

Ah that is different. Roche would probably be happy to sell it. You are saying you need someone to write a private prescription? Have I understood you right?

A judicual review would be to get NICE’s approval to allow the NHS to prescribe it for a longer period.

[Suzita76 in reply to piglette]

No, a Judicial review would be to make them change their ruling as it is clearly discriminatory. After all, the symptoms are identical to Takayasu’s syndrome except for the age of the sufferer!

[piglette in reply to Suzita76]

Have you ever been through a judicial review? Judicial review is only really concerned with the question of whether a public authority has acted lawfully and not with the question of whether they have made a good decision. It is perfectly possible for a public authority to lawfully make a very bad decision! You could try discrimination as being unlawful. Let us know the result.

[Suzita76 in reply to piglette]

It is blatantly discriminatory.

[piglette in reply to Suzita76]

A judicial review can challenge the way a decision has been made, if you believe it was illegal, unreasonable, irrational, or unfair. It is not really about whether the decision was “right”, but whether the law has been correctly applied and the right procedures have been followed. Why not give it a go.

[Bcol in reply to Suzita76]

I suspect it wouldn't get far with discrimination, because, although, it may be more common in females, it does affect males and the same rules apply to them as well. I suspect your only hope would be on ageist grounds. Agree it is a totally wrong position for NICE to take.

[Suzita76 in reply to Bcol]

It is indeed blatant ageism when ( as PMRpro points out), sufferers from Takayasu’s syndrome can get continuous supplies. It seems., by definition, the same large vessel arteritis symptoms are called different names depending on your age.

[PMRpro Ambassador in reply to Suzita76]

I'm told it is possible - you need a consultant who does private work and is interested in GCA - such as Professor Baskhar Dasgupta whose name was mentioned

spirehealthcare.com/consult...

Although the resume is a bit out of date - he is no long at Southend - he appears to be still working and is available for virtual appointments.

A publication is in the pipeline - done by rheumies in their own time, TOC STOP is a multi site service evaluation of 336 GCA patients from 40 Trusts across England looking at relapse rates after stopping TCZ. It will hopefully be published in Rheumatology soon and has been done by clinicians worried about their patients relapsing and wanting them to have better access to TCZ. NHS England only accepts evidence from published papers.

The review of TCZ planned for 2021 was delayed by Covid but should happen in the next year or so. TCZ is now off patent and there are several “biosimilars” in development. One is probably going to be available within the year. It will be cheaper than RoActemra but not as cheap as the Anti TNF biosimilars such as etanercept and adalimumab as there are no other anti IL6 agents for them to compete with,

We live in hope.

[Suzita76 in reply to PMRpro]

Thank you, dear lady. I don’t feel quite so hopeless right now and will keep trying! X

[Rugger in reply to PMRpro]

That is really encouraging! I'm seeing my Rheumatologist next month and will ask her (SM) about it.

[Rugger]

I wrote to Steve Barclay, Secretary of State for Health & Social Care about all this and didn't even recieve an acknowledgement of my letter, let alone a considered response!

I am so sorry that pred has such severe side-effects for you. My 'ration' of TCZ finished more than a year ago (wish I had thought to spin it out!) and I'm now back on pred, having tried 6 months on MTX which didn't seem to do anything for me, allowing the inflammation to resurface.

I presume you've read all of LemonZest11's posts about her buying the TCZ from Roche in Australia - but it had to be with her Consultant's blessing? Just because your Consultant hadn't heard of that arrangement, doesn't mean to say they couldn't look into it for you.....!

[Suzita76 in reply to Rugger]

Thanks Rugger- of course, transporting from Australia (cold) might be a problem .

[PMRpro Ambassador in reply to Rugger]

"didn't even recieve an acknowledgement of my letter, let alone a considered response!"

Did you REALLY expect one?

[Rugger in reply to PMRpro]

🤡

[PMRpro Ambassador in reply to Rugger]

Have you seen my reply above? If you can manage on 2 weekly jabs, it immediately halves the cost. Lemonzest is on 3 or 4 weekly. You can do that when you are private ...

[Suzita76 in reply to PMRpro]

Thanks again, dear lady- it’s so long since I posted anything that I’m finding it difficult to negotiate it ( so haven’t found Lemonzest’s messages), but no doubt will when I am less stressed/ have some sleep .

I was on 3-weekly injections for the last 6 months, with no problems at all (- no doubt helped by low body weight). My family are clubbing together to pay for the stuff, if only I can find a consultant who will write me a prescription….. whatever happened to “ First do no harm” , I wonder.

[DorsetLady PMRGCAuk volunteer in reply to Suzita76]

Hi Lemonzest’s profile - and you can always Chat/Meassage her if you want..

healthunlocked.com/user/Lem...

[Suzita76 in reply to DorsetLady]

Thank you! Xxx

[DorsetLady PMRGCAuk volunteer in reply to Suzita76]

You’re welcome….hope she can give you some advice…

[Suzita76 in reply to DorsetLady]

Maybe I will just have to emigrate to Oz!

[DorsetLady PMRGCAuk volunteer in reply to Suzita76]

Maybe! 😉

[PMRpro Ambassador in reply to Suzita76]

Cheaper to have a day trip to Southend and see Dasgupta!

[Rugger in reply to PMRpro]

I "went by the book" for the majority of the time I was on TCZ and only took it fortnightly for the last couple of months. My Rheumatologist knew, but didn't put it on record! This was before LemonZest and others had written about 3 or 4-weekly intervals, otherwise I might have have tried that.

[Hoofprints in reply to Rugger]

That's appalling that you did not even receive a reply from the minister! Why does it seem they only respond when media-shamed and worried about losing votes?

Perhaps you and Suzita76 should consider taking your story to the newspapers initially? It will be far more affordable than judicial review (which the government at one stage tried to 'reform' i.e. water down to make challenging public bodies decisions even more difficult).And the angle of ageism is a very pertinent one. With a general election not that far off, maybe they will take more notice?

At the very least, people should be informed of how decisions about their health are being made. Many people who have never been chronically sick cruise along thinking that you can always just go to a doctor and get treated and fixed by a tablet or procedure if you become ill. If only!

Perhaps this issue of people missing out on appropriate drug therapy needs to be addressed publicly all round.

There's such a drive generally by politicians to save money where the NHS budget is concerned, partly by obfuscating how much is actually needed to run it properly in the first place. Holding back effective drug therapy because of cost seems to be a part of this drive.

Just wish money didn't come into it where medicine is concerned.

[Raewynne]

Hi Suzita76Interesting about your psychosis issue.I was talking to my counsellor at lunch time and she wasn't even ware that prednisolone can cause such things.I know prednisolone has given me anxiety issues.Just another gift from it.What did they give you instead.I am recovering 2nd time round from temporal arteritis.A few months ago I got a perforated bowel on top of everything else.Getting stronger slowly but it has been terrible.Im in Australia.

[Suzita76 in reply to Raewynne]

I still had to take prednisone, and be watched closely in case I tried to jump in front of a train or off the multi-storey car park, until the dose could be reduced below 20mg. Terrible hallucinations too, even when “awake”, the more terrifying, and recurring one being trying to fight my way out of a filthy ( occupied) coffin as the lid was being screwed down.

[Raewynne in reply to Suzita76]

Gosh.How terrible.No wonder they were keeping an eye on me when I was on 100mg.You would think that professional counsellors would have some knowledge about these things.I haven't been as out of it as you.Do the people who make this know these things can happen to people?

[Suzita76 in reply to Raewynne]

Apparently, about 1 in 20 people suffer psychosis on higher doses of Prednisolone.

[Suzita76 in reply to Raewynne]

They should do, if the medics ever get round to reporting it on the so-called “ Yellow card” system .

[DorsetLady PMRGCAuk volunteer in reply to Suzita76]

Patients report adverse effects on the yellow card system -

yellowcard.mhra.gov.uk

[Suzita76 in reply to DorsetLady]

Yes, (and I did, eventually)…. my pharmacy had never heard of it! …plus you need to be tech-savvy to go online y too report it, and not everyone is, (or certainly wasn’t 6 years ago). They shouldn’t really call it a “card” system when no physical card seems to exist.

[PMRpro Ambassador in reply to Suzita76]

There are obviously paper forms

"Please note that the where possible, the MHRA asks and encourages all Yellow Card reports to be sent electronically instead of paper forms."

but like everything else - they create more work for them so they prefer online reporting now.

yellowcard.mhra.gov.uk/reso...

has forms to be downloaded,

Recently the local rheuma charity has gone from email and post notifications and bank payments to asking everyone to create an online account because they can't cope with the clerical work involved. They do actually say in the bumpf that "we are sure everyone will have someone they can turn to for help". I'm internet-savvy - I took one look and filed it for later! I don't have family to help me, and a lot of it is in Italian. I will have to have a go but it involves making payments too - and THAT is the biggest hurdle.

[DorsetLady PMRGCAuk volunteer in reply to Suzita76]

It obviously did start life as a card -but as usual technology moves on -and names don’t always get changed to reflect such things…,

Nil points to pharmacy …. they of all people should be aware- even the counter assistant if handing over drugs.

[PMRpro Ambassador in reply to Raewynne]

It is listed as an uncommon adverse effect - so yes, they know. But it isn't them who need to know - it is the doctors.

[Devoid in reply to Suzita76]

Hi I think I’ve responded to you before I am back on Toc having had a ct pet scan that revealed active vasculitis. My nhs consultant didn’t appear to have any problems prescribing it for a relapse , so I’m not sure why others are. Nice at the end of the day is guidance. As we are treated by rheumatologist and they are used to having patients on it long term for RA I think they can prescribe it for other conditions that have not been well controlled

[Rugger in reply to Devoid]

A year ago you mentioned that your Consultant had discharged you. I'm wondering if they managed to prescribe TCZ again for you as a 'new episode / new patient'? That would be a way round for those that finish with pred for a while, then 'relapse'!

[Devoid in reply to Rugger]

That might be the case, in which case he’s got far more about him than I ever gave him credit for . I didn’t go 3 months from being discharged to being back, can’t quite remember how long I’d been off Toc for but I think it was about 5 months. I did have to start steroids but it didn’t take me too long to get off them once the Toc was reintroduced, I think the other thing in my favour was that they can never get the inflammation under control with steroids alone

[Rugger in reply to Devoid]

That's the same for many of us - I'm back on pred after 2 years of TCZ and 6 months off pred, but as I'm still under the care of my Rheumatologist, I can't have TCZ again. I'm seeing her next month - maybe I'll ask to be discharged.....(for a while)! 🤣

PMR: 2016

GCA-LVV: 2019

[WaltzG]

I am in a similar position, have GCA and PMR, steriods caused psychosis now on Actemra which finishes in bout 5 month's and like you in the UK. Very scary to think what may happen when it finishes

[TheMoaningViolet]

I wonder whether this organisation may be interested in getting involved with your struggle. ilcuk.org.uk

I hope things work out for you.

[Suzita76]

Here in the UK, we don’t yet have the option to keep taking Tocilizumab as long as we like, or need it. The regulatory body, NICE, made a ruling that for GCA, only certain people could have it, and only for one year, which is why I chose to increase the intervals between my injections eventually to 3 weekly ( but with no ill effects), until it ran out. 10 weeks later, I am having a “flare”, (relapse) which is why I’m trying so desperately to get my scripts reinstated.

It is also not yet allowed here for treatment of PMR.

As PMRpro says, there are several companies vying to get their ( hopefully cheaper) copies/ Biosimilars accepted by the regulators. Roche’s patent ran out in 2012 but making antibodies like Tocilizumab is not easy or cheap, so no “ generic” cheaper versions have yet made it to the market (except in China, earlier this year, and hopefully other countries will soon follow).

[Bramble2000]

It will happen, eventually. Unfortunately it’s a slow moving beast, NICE. The anti obesity meds are extremely important. There are allot of genes implicated in obesity. It’s something I’ve struggled with since age 11. I don’t choose to be fat. I wish you all the very best. X