Head-to-head clinical trial puts Entyvio as more effective than Humira

Head-to-head clinical trials comparing two treatments of UC is as rare as hen's-teeth. Here's one!
https://www.empr.com/home/news/vedolizumab-tops-adalimumab-in-head-to-head-ulcerative-colitis-trial/

"Vedolizumab (Entyvio; Takeda), an integrin receptor antagonist, was found to be superior to adalimumab (Humira; AbbVie), a tumor necrosis factor-alpha (TNFα) antagonist, in achieving clinical remission in patients with moderately to severely active ulcerative colitis (UC), according to results from a phase 3b head-to-head trial."

"Results showed that a statistically significantly greater percentage of patients achieved clinical remission in the vedolizumab group vs the adalimumab group (31.3% vs 22.5%, respectively; P =.0061) at Week 52. In addition, 39.7% of vedolizumab-treated patients achieved mucosal healing (secondary endpoint defined as Mayo endoscopic subscore of ≤1 point) compared with 27.7% of patients treated with adalimumab (P =.0005). While not powered to compare safety, the study findings demonstrated a lower rate of infections in patients treated with vedolizumab compared with those who received adalimumab (33.5% vs 43.5%, respectively)."

Even if I wanted to take Entyvio at some point, my insurance won't pay for it. Doubt it's covered in countries with socialized healthcare either. Bummer.

Wow, that’s awesome. Too bad we still have to jump through hoops to get to Entyvio

USA gets treatments 1st, other countries follow in subsequent months. I am sure entyvio is available almost everywhere. Given there might be restrictions on when you can get it, much as there is here in the usa. Often insurance dictates you must have failed at least one tnf-alpha-blocker before trying entyvio. Maybe trial results like this will make Entyvio a first biologic to try *shrug* my hope at least. Biggest reason why entyvio is 2nd biologic here is because it costs multiple times that of humira.

I'm glad it is available to people outside of the U.S., although my brother-in-law in Canada (with Crohn's) can barely get Humira covered. He has to constantly fight with his prescription plan to get it covered and they have used all kinds of tricks to avoid/limit reimbursement which has cost him thousands out of pocket.
Honestly I'd be surprised if it's easy to get anywhere, which is a shame. Perhaps people who have actually obtained access to it can tell us what they had to do to get it rather than going off on political rants.

C_G_K said...
I'm glad it is available to people outside of the U.S., although my brother-in-law in Canada (with Crohn's) can barely get Humira covered. He has to constantly fight with his prescription plan to get it covered and they have used all kinds of tricks to avoid/limit reimbursement which has cost him thousands out of pocket.
Honestly I'd be surprised if it's easy to get anywhere, which is a shame. Perhaps people who have actually obtained access to it can tell us what they had to do to get it rather than going off on political rants.

If you make a sweeping generalization without the facts to back it up then it’s not a rant when someone points it out. It’s really hard to solve problems when one side makes fact-free statements (politics or not).

Not everyone can get a PPO insurance plan but it covers patients much better than standard HMO plans. I’ve had no problem getting off label coverage for Stelara with my PPO plan, Stelara costs $44k every 8 weeks. I didn’t even have to try Entyvio first before they covered it.

They’ve covered Cimzia, xifaxan, Entocort, Enteragam and Stelara without much hassle. The only thing that I’ve been rejected for is VSL-DS.

FlowersGal said...
I'm on Medicare and had no issue at all with getting Entyvio as my first biologic. Medicare doesn't require prior approval.

That's great. 50 is not too far off on the horizon for me, so I may just end up retiring here eventually. I really don't know that much about medicare but I'm glad it covers biologics.

As good as Entyvio is, it doesn't help much if it is not widely available to those who would benefit the most from it.

Flowers Gal, I am 71 and on medicare too. Been on Lialda for 3 yrs now (4 per day) and Canasa for around 10 yrs. Heading to My Gastro Dr later today due to what looks like a flare. I have also been on prednisone tapers (60 to 10). I am thinking he may suggest a biologic next? Reading your post you say medicare covers Entyvio when given in the hospital. Is it given like a chemo infusion?And if so, how long does the infusion take? And how often?
My current meds are costing me a small fortune due to insurance covering a small portion once in the medicare donut hole.
Thank you for your response, as well as anyone else on medicare.

Thank you for your response. I have another concern because I was in hospital in November last yr and as a result was put on Eliquis which is a blood thinner twice a day. Was told would have problems with bleeding if I got cut or bruised. So, the internal bleeding right now with my potential flare is making me nervous. But, I imagine both my GI doctor and my Hematologist will coordinste on this. Hope so anyway.

When i did my first two entyvio loading doses they did them in one hour and observed me for another hour afterwards, in case of an allergic or other reaction. So i was probably at the hospital 3 hours in total. But with the later infusions they would do 30 mins iv plus 10 mins observation. I sort of miss my infusions because I was put with other ibd patients and it was the first (and only) time I met Real People with colitis who were at the same stage as me in terms of their disease severity and treatment protocol - and i enjoyed talking with them.

iPoop said...

poopydoop said...
(i.e., the time I crapped in a trashcan because my wife was in our only bathroom and I had to go RIGHT NOW).

I hope there was a plastic bag lining it! ha ha ha ha ha ha

Oh the fun of an IBD disease huh!!!! 🤪😱🤡

Nana — Entyvio is a very quick infusion as the others have said. 30 minutes and it’s done so not as much wear and tear on veins , imho. I have really small veins that roll so the longer an IV is in the worse for me.

Medicare does not require pre-approval. It’s my understanding that some dr offices will administer Entyvio infusions? Mine is done by the chronic disease center which is part of our local hospital. Technically it is outpatient and the office is a block away from the hospital itself but since the hospital name is on the billing (?) Medicare considers it as a Medical procedure and any medications given in a hospital are covered under medical not prescription. I have the plan F supplemental which picks up the 20% that Medicare doesn’t pay.

I do worry often that Medicare will consider this a loophole that needs closing but consider myself very lucky that it works in my favor as it stands. Again key is that a hospital administers the infusion (I think that’s the key — it’s sometimes very hard to pin down Medicare rules).

I think Remicade would be under the same rules. Entyvio’s advantage for me and my touchy veins is the much shorter infusion time. I used to be in and out in 45 minutes but now it’s about an hour due to the “new improved” 🤨 computer and check-in system. Entyvio is slow-acting. I did see improvements right away tho and was in symptomatic remission at month 4. Steroids and Canasa helped bridge that time. A few minor hitches during the first 6 months maybe but nothing to raise a fuss over and I was able to successfully taper off prednisone by month 3 for the first time in a year.

In a month I will have my 16th infusion (I think tomorrow may be my 2 year anniversary on it). My colonoscopy 6 months ago showed no inflammation. No side effects or dietary restrictions. Life is once again good!

I have Kaiser (HMO) and it covers Entyvio.

We don't get to chat with others during infusions, though The clinic has spaces that are all separated by curtains, so you can't really chat. The infusion clinic also serves people receiving chemo, vitamins, etc.