Biosimilar - Humira

[CherryClift]

I have been on humira injections every two weeks for 10 years. It has been life changing and stopped the development of the disease. My doctor has said I will shortly be asked if I would like to be transferred to a new Biosimilar drug. Has anyone transferred to a Biosimilar? If so was there any difference in effect - I have never had any side effects on Humira and am very happy with it but realise it is expensive and if an use a Biosimilar it will save the Health Service quite a lot of money. Any comments please?

[Neonkittie17]

I'm not wanting to change from Rituximab to the biosimilar. I received a letter telling me to phone and register my name if I had concerns. I did. I have also told the registrar in the hospital when I had a steroid shot and will tell my rheumatologist officially on November when my clinic review is due.

[CherryClift in reply to Neonkittie17]

I tend to agree. I've been in on Humira for 10 years - why change - just in case......

Thanks for your post. Would welcome some more comments.

[Ailsa-NRAS Partner NRAS in reply to Neonkittie17]

Hi

Whilst we are aware that people on Infliximab, Etanercept and Rituximab are being switched to their biosimilar, I am concerned to hear that it is being suggested that you switch from Humira to clearly what has to be another originator product biosimilar (i.e. to Etanercept biosimilar - Benepali, or Rituximab biosimilar - Truxima) because the Humira biosimilar is not going to be available until 2018. I sit on the NHSE National Biosimilar Programme Board and we want to hear about any issues regarding biosimilar switching. In principle, for people who are well controlled on an originator such as those listed above, where there is a biosimilar available, we support properly carried switching programmes because it is incumbent on everyone to take care with precious NHS resources and the data indicates that they are as effective and safe as their biologic originators. See more information at nras.org.uk/biosimilars. Please let us know if I am understanding you correctly that it has been proposed to switch you from Humira to another originator Biologic's biosimilar given the Humira biosimilars (more than one coming down the line) aren't available till some time next year?

BW

Ailsa (NRAS CEO)

[CherryClift in reply to Ailsa-NRAS]

Hi Ailsa

Yes - the my consultants assistant who conducted my 6 monthly review told me it would be a biosimilar which would be available soon, to Humira and gave me a leaflet from Biogen about biosimilars. She gave me the name but I cant remember it - could have started with letter I ?? May be by soon she meant 2018 which could be before my next review? She said I would receive a letter saying they would be changing to prescribing the biosimilar but I could opt out if I wanted to. Thank you for your concern.

[Ailsa-NRAS Partner NRAS in reply to CherryClift]

OK that makes sense. We don't know exactly when the first Humira biosimilar will be launched but there will be more than one coming. If you have a look at the video on our website I interview our Chief Medical Advisor about biosimilars and this may reassure you. the best candidates for switching are those who are doing well on the originator.

Best wishes

Ailsa

[Birthdaygirl]

My view of the guidelines are that if you are in remission you should not be asked or forced to change to a bio similar. If a biosimilar drug is offered, the patient, after a full assessment and being told all possible risks by a doctor, has to consent to a change.

A clue to these drugs is in the naming convention in that the drugs are similar but not the same. I am in a similar situation to you but with Enbrel. I have not consented to a change to a 'bio similar'. My fear of losing my remission and mobility and fear of having further damage to my joints is greater than saying no to the doctors and the clinical commissioning group. I have also asked to have a copy of the technological appraisal, which was due to be released at the end of 2016, for those who have changed to a biosimilar. It appears to have been delayed! I think, as patients taking dangerous drugs, we need all the facts in order to make an informed decision.

I too understand the need for the NHS to save money but I really think that if the biosimilar drug takes away my remission it will cost the NHS more than if I stay on Enbrel.

I wish you well with your decision making. Let us all know how you get on.

BG

[Neonkittie17 in reply to Birthdaygirl]

I absolutely agree with everything you say. No they are not bio-identicals and "similar" could be a long way off beam. I plummeted so quickly when I had to wait for changing from Enbrel to Humira and Humira to Rituximab. I got joint damage in my fingers and further damage in my ankles. All in a few weeks It comes on very very quickly for me so I'm terrified of a biosimilar not working and being left in no man's land, so I'm saying no.

I asked this question last week but no one has replied so far ... Do you have to wait for several months to be able to return to have your original medication infusion just as you have to wait a minimum of several months before you can repeat it? What happens meds wise in that waiting time? Steroids and shots?

[Birthdaygirl in reply to Neonkittie17]

I understand the fear of plummeting into a world of agony and no mobility again.

None of us should' be threatened with that possibility if we are doing well on the biologic.

My understanding is that a 'round robin' letter should not be used by hospitals and/or doctors to inform patients of a blanket decision to change treatments. The decision has to be clinical only and made by a doctor after a full rheumy assessment, consultation with the patient, any carer and the patients wishes must be taken into account.

My understanding is that as long as the doctor continues to sign the prescription for the biologic, which still remains authorised under NICE guidelines, then NHS England/ the local ccg are legally obliged to pay.

I really wish NRAS would obrain a legal opinion on this situation for its members and others as many of us are finding ourselves being exposed to an unacceptable risk of losing our remission.

Hope your decision is listened to by your doctors.

BG

[CherryClift in reply to Birthdaygirl]

Thanks for you reply. Until the biosimilars have been in common usage for some years we will not know if they are as good as the originals (or may be better in some cases?), I think I will stick with Humira for the time being

[Birthdaygirl in reply to CherryClift]

Hi Cherry

Thanks for posting your concerns. It has helped me to feel stronger about my own position,

If I was being offered a biosimilar because DMARDS had failed I would not think twice about a biosimilar. I would say yes.

However I think there is a big difference between those in remission or nearly in remission and those whose DMARDS are not halting the disease.

To have the evidence that your drug is keeping you well but a doctor is going to unilaterally change your treatment to something that, as yet, there is no published evidence that patients are not being put at risk is wrong to me.

Thanks again for posting.

BG

[Neonkittie17]

Hi again Cherry, forgot to say that when I got the letter re the Biosimilar it never asked me if I would change .. Or said for definite I was being changed ... Just said the hospital would be moving patients onto them.

The Rheumatology Registrar I spoke to recently at the injection clinic who was doing my knee, said she agreed that I had had a very bad time settling to a medication that worked for two years during 2012/14 and sustained joint damage and the past three years have been very good on Rituximab so why threaten that.

Someone here on the Board said there were some guidelines on Biosimilars and reference to not having to switch if you didn't want to on the NICE website but I couldn't find them.

[CherryClift in reply to Neonkittie17]

I have been told I will get a letter changing me to the biosimilar but I can opt out. At that time I will ask what happens if I change and then there are problems and want to go back on humira. I will post details on this forum. However I don't think I will be changing, at least at this point in time.

[Birthdaygirl in reply to CherryClift]

Hi Cherry

Someone on the forum has failed Benepali and been put back on to enbrel. Hope she posts to let us know how it is going. I really wish her well.

I was told I would not be able to go back to enbrel if Benepali failed as enbrel would not work. I was informed I would have to have a more expensive biologic. I was appalled the nurse said this to me in a way that made it sound as if I should be grateful that they would be spending more money on me and couldn't seem to understand how I didn't want any extra money spent on me. I just wanted to be well and stay well on enbrel and never see a doctor again!

There are definitely problems with the way this is being handled and implemented by NHS staff at all levels and as usual patients are suffering.

[Neonkittie17 in reply to Birthdaygirl]

Interesting and distressing re that you wouldn't be able to go back on Enbrel if Benepali failed as it wouldn't work after the biosimilar. 😕

I was told on the "response line" I contacted after receiving the letter, I could go back to Rituximab if a biosimilar failed. Maybe as it is such a different drug.

I'm loathe to upset the apple cart too when something is working so well. 😐

[Birthdaygirl in reply to Neonkittie17]

Thank you Neonkittie for that information. I think it supports the view that the hospitals and/ or consultants are all doing and saying different things all over the country possibly! One thing I do believe is that doctors are not trained by the NHS to harm patients. They are there to help us get better and stay well. Not to take away what health and strength the medication has miraculously given us.

Hope all goes well for you in your decision making process and discussions with doctors.

BG

[Neonkittie17 in reply to Birthdaygirl]

I hope you stay on your med and don't get any pressure to change. Yes it seems many of us have been given differing info. I feel stressed of knowing how I plummeted in the past few years when between treatments and delayed treatment. I cannot go there again as a result of a biosimilar.

[Birthdaygirl in reply to Neonkittie17]

Thanks for your response. I was 'ambushed' by a rheumatology nurse who unexpectedly told me that it was benepali or nothing. Three months before this the rheumatologist had authorised that as I was in remission I would stay on enbrel. I was told the ccg had made the decision to stop paying for enbrel and there was nothing the hospital could do. I immediately told her that I do not consent to an arbitrary change of medication. I have told the ccg I do not consent. I am still appealing this decision and the way I have been treated. The ccg currently say it is nothing to do with them and that the rheumatologist makes the clinical decision. It is appalling the way patients are being treated and very stressful. My GP encouraged my appeal but powerless as he says no one listens to them either. The reality for me is nothing like the NRAS position statement or what is recommended by the British Society of Rheumatologists.

I wish you well. I wish myself well and anyone who has found themselves in a similar situation.

[Neonkittie17 in reply to Birthdaygirl]

I hope you get to stay on it and hope I'm not pushed as I will resist all the way. Good luck.

[Birthdaygirl in reply to Neonkittie17]

Thank you. Keep strong. X

[Neonkittie17 in reply to CherryClift]

No me neither for mine. My clinic review is November and next infusion booked for March.

[Hidden]

Dear all please take a look at the nras.org.uk/biosimilars section of the website as this contains our position paper and a short film with Professor Peter Taylor and our CEO discussing biosimilars. Many rheumatology units are being put under huge pressure to do blanket switching which we strongly oppose for all the reasons many of you have spoken about here. CCGs are trying to save money ( which we all fully appreciate needs to be done) but it should NOT be at the expense of PATIENT care and Clinical decision making. I would encourage you to stand your ground and refuse to switch if you really don't want to however I would also say that of the many thousands of people who have switched from originator to biosimilars there have been relatively few problems or loss of efficacy that we have been made aware of. RA is a very complex and diverse condition - it will never be a "one size" fits all solution hence the need for such a range of treatments and likewise each person's disease profile will differ. So for the majority of people switching may hold no problems but for those with complex disease that has taken many years to get under control most rheumatologists would prefer to keep stable on the existing treatment regime and not change. Putting your concerns in writing to your department as well as voicing your request to not change would bolster your physicians position to respect your decision

NO DECISION ABOUT ME WITHOUT ME. (Dept of Health consultation response 2012)

[Neonkittie17 in reply to Hidden]

Thank you Clare and everyone from NRAS. 😀

[Birthdaygirl in reply to Hidden]

Dear Clare,

Your post is welcome. Strong words and some good advice. Your last paragraph, which I have read before, made me weep. I wish my ccg, hospital doctors and nurses had read it and practised the DoH sentiment. I wish they too would follow the correct guidelines in order to reach individual clinical assessments and not the 'blanket approach'. What I have seen and experienced I believe is an unsafe programme and process driven by unknown and unaccountable people.

I wish NRAS could do more to sort out this mess for everyone.

It is wrong for anyone to blame RD patients for lack of money in the NHS. We cannot have that burden laid on our shoulders. No one asks to be ill.

I am not responsible for the lack of money in the NHS and so I will continue to fight to keep my remission, mobility and pain control so that I can spend time with my young grandchildren.

I will phone the helpline and update on my situation, as promised, when the appeal process is completed.

BG

Ps ....you mentioned that many 1000's of people have been switched successfully. Has the technical appraisal been published? If so could NRAS post the link to the report for us to see please.

[CherryClift]

Thank you, I have read the article and it has been very helpful.