Biosimilar

[SoccerMom47]

I received notice from my insurance yesterday that my son's Remicade is not approved. The insurance wants to switch him to a biosimilar. Anyone have experience with this? He was diagnosed last May, started Remicade in June and was symptom free within 3 days. Since last year he gained 30 lbs and has had zero symptoms. He actually ran in the Track States qualifier last night. A year ago I could barely get him out of bed. Why mess with something that works? He is 17 with mod/severe Crohns/colitis. Had fistula at diagnosis that seems to have healed.

 

[my little penguin]

Biosimilars are cheaper
Most only put new patients on them
And DO NOT switch patients from remicade to the biosimilar
But that was a year or two ago
A few adults on here in the UK were made to switch
Some did ok woth the switch
Some did not
Assume your Gi is appealing the decision ????

 

[crohnsinct]

Congrats on the state qualifier! I have a runner to!

Everything I read has said that the biosimilars are just as good as the originals. However, their success has only been proven when used in a bionaive patient. So, if you are newly diagnosed and your insurance won't approve Remicade it would be totally acceptable to try the biosimilar. However, similar means just that. SIMILAR. They are not exactly the same and for this reason, GI's prefer to stay with the same drug once initiated and working. They don't want to risk that the slight change would create an antibody situation. The GI's (mostly adult GI's) I follow on social media have had great success fighting insurance companies on these switches and the ones who had have had positive results.

I would call your GI and start the appeals process.

Glad your son is doing well!

 

[SoccerMom47]

I spoke with his infusion nurse when I received the letter. She said she is talking to the GI because he is a pediatric. Apparently pediatric use for Crohns is approved but not colitis. He has both so she is hoping the appeal works. He goes to an adult practice, and they have already been switching the adults over.

 

[SoccerMom47]

Honestly I feel like this is a breach of contract. I have to choose a new insurance or renew each fall. We stayed with the company bc they paid for all of this. Now halfway through they changed what they will pay for...but I am stuck with them until the end of this year. Nurse said once he's off he can't go back.
Crohnsinct - I just read your post - sorry your O is not well.

 

[crohnsinct]

Thanks for your well wishes!

Not exactly true that they can't go back once they are off. Quite a few kids here (paging Maya142) have gone back and successfully used a biologic. However, chances are way higher that you will build antibodies to a biologic when you take a break and come back so it isn't a guaranteed option and something to consider when making switches. Our GI is telling us that there is research that shows if the break is at least a year long the return to a biologic is much more successful, so at least there is that.

I would appeal. I think as a pediatric patient you will have a lot more success. Not sure about the Crohn's vs. UC consideration as I haven't extensively researched the biosimilars but most have a similar success rate as the original in treated both diseases.

I am curious as to why they say your son has both Crohn's and Colitis. Are they saying both small bowel and colonic disease? They don't mean Crohn's and UC do they? Because as far as I understand (and we will be going down that rabbit hole with surgery discussions) If you have small bowel involvement then you have Crohn's. Now you can have Crohn's in the colon that behaves exactly like UC (like O) but it is still Crohn's. There is some stuff being written about UC that does extend into the terminal ileum but not ready for prime time.

 

[SoccerMom47]

So he has small bowl and colonic disease. They call it Crohn's colitis. I don't know what the difference really is with UC as he had ulcers, bloody stool, and tenesmus at dx which is pretty similar to UC as I understand it. The granulomas were found in the colon. Interesting that UC can be in the small intestine. His was at the terminal ileum, not anywhere else. Fistula was in colon.

 

[my little penguin]

Crohn's disease has many forms: Involvement of the large intestine (colon) only is called Crohn's colitis or granulomatous colitis, while involvement of the small intestine alone is called Crohn's enteritis. The most common part of the small intestine to be affected by Crohn's disease is the last portion, called the terminal ileum. Active disease in this area is termed Crohn's ileitis. When both the small intestine and the large intestine are involved, the condition is called Crohn's enterocolitis (or ileocolitis). Other descriptive terms may be used as well.

From

https://www.medicinenet.com/script/main/art.asp?articlekey=2865


So still “ crohns”
Just mainly large intestine
Ds has Crohn enteritis - mainly small intestine
End of the day only crohns

 

[pdx]

Hope the appeal works. I have also heard anecdotal evidence about people having trouble when they switch from Remicade to the biosimilar.

 

[crohnsinct]

Interesting that UC can be in the small intestine.

Well not really. That isn't quite ready for prime time. There are some VERY early papers saying that if just a little of the TI is involved etc the disease can still be UC.

So his disease is similar to O. She has disease now in colon and TI. Same symptoms and her loud symptoms are all the colonic ones.

I just don't get what the nurse was saying then about Remicade and Crohns vs. colitis (I will go back and read it). Remicade works equally as well in both diseases as do the biosimilars. Insurance doesn't really look at Crohn's colitis as a dx to approve or deny meds. They pretty much look at IBD. They will sometimes look at location or a UC vs Crohns dx for particular meds such as the 5 ASA topicals or certain biologics as those that are only approved for UC. I know this now because O needed rectal topicals and they are used much more widely in UC. Her insurance said , "No UC dx" ..yeah don't get me started. So we had to go to steroid topicals.

I honestly think the best shot for appeal is the switch opens him up for reaction to a different formulation. As a matter of fact, our GI explained that Remicade is a large molecule (correct me here MLP) drug and as such it is constantly changing ever so slightly. But it is these changes that over time can lead some people to lose response. So in y mommy opinion, if you can lose response to the same med that is going through slight changes I would assume you leave yourself oen for lack of response when changing to a bio similar.

I am sure your GI can put it in terms they will understand...

Incremental cost of Remicade vs cost of hospitalization due to uncontrolled disease.

 

[SoccerMom47]

Thanks - we will see what the response is of the appeal.

 

[crohnsinct]

Ahhhh just reread your thread. The biosimilar isn't approved for Crohn's? Well there you have it! He can't switch!

Good luck. Keep us posted. There are many layers to appeal! Don't give up!

 

[Jonny84]

I received notice from my insurance yesterday that my son's Remicade is not approved. The insurance wants to switch him to a biosimilar. Anyone have experience with this? He was diagnosed last May, started Remicade in June and was symptom free within 3 days. Since last year he gained 30 lbs and has had zero symptoms. He actually ran in the Track States qualifier last night. A year ago I could barely get him out of bed. Why mess with something that works? He is 17 with mod/severe Crohns/colitis. Had fistula at diagnosis that seems to have healed.

I understand your concern but in my experience the biosimilars work the same as the original medications. I was on infliximab for over a year when they switched me to Inflectra. I never noticed a single difference - its the same thing, just cheaper now that the original formula is no longer protected by a patent.

 

[Maya142]

I have no info on biosimilars, but my daughter did go back onto Remicade several times. It can be done. She didn't have antibodies and didn't have any reactions to it. Remicade worked better the second time she was on it (probably because she was put on a baby dose the first time and a normal dose the second time).

Both my daughters have re-tried biologics without issues. So it is possible to switch back to Remicade. But Remicade is also the biologic you're most likely to have a reaction to - due to the mouse protein.

Because of that, I would try your best to stay on Remicade - get your GI to appeal, do a peer to peer phone call etc. Also, I'd want him to stay on Remicade simply because Remicade is working WELL for your son and it would be a shame if he flared due to insurance.

I cannot believe insurance companies are allowed to dictate treatment - drives me NUTS!!

 

[Scipio]

So he has small bowl and colonic disease. They call it Crohn's colitis. I don't know what the difference really is with UC as he had ulcers, bloody stool, and tenesmus at dx which is pretty similar to UC as I understand it. The granulomas were found in the colon. Interesting that UC can be in the small intestine. His was at the terminal ileum, not anywhere else. Fistula was in colon.

UC doesn't really occur in the small bowel except for the occasional case of what the GIs call "backwash ileitis" - UC that just leaked slightly across the border into the ileum of the small bowel. But normally any degree of IBD inflammation to speak of found in the small bowel indicates Crohn's.

In fact that's one of the mysteries of IBD - the sharp dividing line of inflammation between the large and small bowel in UC. UC normally starts at the rectum and proceeds "upstream" in a continuous fashion as the disease progresses, until the eventually the entire large bowel is inflamed. But the spread of the inflammation stops dead in its tracks at the border between the large and small bowel. Why? No one knows.

And that points out another key distinction, besides granulomas, between Crohn's and UC - the continuous nature of the UC lesion. Crohn's by contrast is patchy. The Crohn's inflammation starts and stops and restarts farther on, and can occur anywhere from mouth to anus. UC focuses solely on the large bowel.

 

[SoccerMom47]

Insurance agreed with the appeal! He is set for 6 months, but likely that's it as he will have passed the imaginary line between pediatric and adult. I'll take a look at my insurance options though as I can change plans in the fall. Thanks everyone!

 

[SoccerMom47]

UC doesn't really occur in the small bowel except for the occasional case of what the GIs call "backwash ileitis" - UC that just leaked slightly across the border into the ileum of the small bowel. But normally any degree of IBD inflammation to speak of found in the small bowel indicates Crohn's.

In fact that's one of the mysteries of IBD - the sharp dividing line of inflammation between the large and small bowel in UC. UC normally starts at the rectum and proceeds "upstream" in a continuous fashion as the disease progresses, until the eventually the entire large bowel is inflamed. But the spread of the inflammation stops dead in its tracks at the border between the large and small bowel. Why? No one knows.

And that points out another key distinction, besides granulomas, between Crohn's and UC - the continuous nature of the UC lesion. Crohn's by contrast is patchy. The Crohn's inflammation starts and stops and restarts farther on, and can occur anywhere from mouth to anus. UC focuses solely on the large bowel.

Good info. Thanks.

 

[Maya142]

Insurance agreed with the appeal! He is set for 6 months, but likely that's it as he will have passed the imaginary line between pediatric and adult. I'll take a look at my insurance options though as I can change plans in the fall. Thanks everyone!

I'm confused - is he with a pediatric GI now? If so, are you staying with his pediatric GI once he is 18? If so, it might be possible to appeal again once he is 18 and argue that he has done so well on Remicade that a switch to Inflectra might be risky. It might help to point out that he has pediatric onset aggressive disease and therefore the switch to Inflectra could possibly cause loss of response. Biosimilars are similar, but not exactly the same drug, since they are made from living cells. Generally trials have shown good results though, but if it were my kiddo, I would also be worried about loss of response, considering how much Remicade has helped him.

 

[crohnsinct]

In our experience, the crossing over that age line hasn't really affected the insurance company approvals/denials they are really just going to follow the case. As a matter of fact, crossing over to adult world has actually opened up more options for O as they are more conservative about approved treatments for meds and don't like you using drugs off label as much.

Good luck! Hopefully he continues to do well and the next approval is an easy one.

 

[Lisa]

Glad to see the appeal was approved. I know on my approval, it clearly states NO biosimilar.....