New medication approved for ANCA vasculitis.

[Susan B]

For anyone interested:

https://trialsitenews.com/chemocentryx-announces-fda-approval-of-tavneos-avacopan-for-treating-anca-vasculitis/ (https://trialsitenews.com/chemocentryx-announces-fda-approval-of-tavneos-avacopan-for-treating-anca-vasculitis/)

[Susan B]

Here is more about the clinical trial.

https://clinicaltrials.gov/ct2/show/NCT02994927?term=ADVOCATE&cond=ANCA+Associated+Vasculitis&draw=2&rank=1

[drz]

Is anyone on this drug? It has been approved for me to try but is very expensive even with my insurance coverage for most of the cost but there apparently is a program to help us retired people on Medicare get the drug at lower cost or free. List cost is over $17000. This makes RTX and Insulin look cheap.

[Pete]

Cleveland Clinic bills my insurance about $20k for rtx. None of the new drugs are cheap…

[Susan B]

Yes, it’s very expensive. 🙁 Since I achieved remission with Rituxan my rheumatologist and I don’t see a reason to change course, but it would be nice for others to have the option.

imwould be interested to hear from anyone who is getting it, too.

[drz]

Cleveland Clinic bills my insurance about $20k for rtx. None of the new drugs are cheap…

Most people only get RTX once or twice a year so it would cost $40000 year. Tavenos for $17000 is probably for a month or $204000 year or best cases if it is 90 day supply, probably unlikely since they are reluctant to get expensive drugs for more than 30 days, but if they did $68000 year. I think most insurance plans today will cover RTX as it is a recognized and typical treatment for GPA. Taveneos is so new that it is not on most approved drug formularies but that should improve in next year or two.

I am only the second patient my treating doctor has tried to get on Taveneos so no one has much experience with it so it will be nice to hear from those who have used it.

[drz]

I was approved to get the Tavneos (avacopan)drug free for a year but have not been able to start it. The bottle says the med should be stored at 68 to 77 but excursions from 59 to 86 are permitted. Our over night temps are well below zero like minus 28 and minus 18 that past couple days so our course the meds were frozen in transit and after several phone calls the company advised me not to use the meds. The pharmacy that ships the meds does not seem to have any idea or plan on how to safely ship the meds to keep it in the safe ranges. They just put the bottle in a plastic bubble wrap bag and throw it on the truck. The same day another resident got a package of pears that were were frozen solid and garbage which seems to confirm that the shipping companies do not and can not keep their packages at safe temperatures when our temps are below zero. What a waste of $17000 plus worth of meds.

[drz]

After several more phone calls and discussion the company changed their position and said it does not matter if the drug gets frozen and that it should be OK to take. It just seems strange though that they list temperatures for storage and safety on the bottle if they don't matter. So I guess i will start taking the med tonight.

The pharmacy said they don't take any precautions in shipping any of their meds to keep them at room temperatures so most meds will have excursions outside of normal room temperatures during shipping.

Anyone else using it?

[Susan B]

After several more phone calls and discussion the company changed their position and said it does not matter if the drug gets frozen and that it should be OK to take. It just seems strange though that they list temperatures for storage and safety on the bottle if they don't matter. So I guess i will start taking the med tonight.

The pharmacy said they don't take any precautions in shipping any of their meds to keep them at room temperatures so most meds will have excursions outside of normal room temperatures during shipping.

Anyone else using it?

I’d love to hear updates about how this is going from time to time. Thanks for posting!

[drz]

i have been on the Tavneos for three weeks. It does cause some upset stomach and diarrhea so far but often such initial symptoms decrease as the body adjusts to the new meds. it can cause elevation in liver enzymes so regular lab work is needed to monitor this issue.

[KathyTPA]

Virtual Summit: Current Treatments for GPA and MPA Including the Recently FDA-approved Avacopan
Saturday, March 26.
Join Dr. Peter Merkel and Dr. Tanaz Kermani for an online webinar discussion about current treatments for GPA And MPA, including the recently FDA-approved drug, avacopan. Dr. Merkel will give an overview of the medications and then Dr. Kermani will moderate a Q&A session with the attendees.
No cost, but you must register in advance.
Virtual Summit: Current Treatments for GPA and MPA Including the Recently FDA-approved Avacopan - Vasculitis Foundation (https://www.vasculitisfoundation.org/event/current-treatments-for-gpa-and-mpa-including-the-recently-fda-approved-avacopan/?event_date=2022-03-26)

[little sister]

I am on this drug! As soon as I started it in July they could take me off prednisone. It IS expensive. I'm on medicare with a PDP that I change pretty much every year. My insurance covered it with a deductible of $3,000 the first month. After that it is $773/month. My current insurance is dropping coverage for it in 2023 but I found another one that would cover it. Same terms as before, $3,000 first month and then $773/month. There is a way to get extra help to pay but you have to have a certain maximum income to qualify. The pharmacy company helps you apply for it if you qualify. This drug is one of the few positive things about my recent relapse.

[drz]

I am on this drug! As soon as I started it in July they could take me off prednisone. It IS expensive. I'm on medicare with a PDP that I change pretty much every year. My insurance covered it with a deductible of $3,000 the first month. After that it is $773/month. My current insurance is dropping coverage for it in 2023 but I found another one that would cover it. Same terms as before, $3,000 first month and then $773/month. There is a way to get extra help to pay but you have to have a certain maximum income to qualify. The pharmacy company helps you apply for it if you qualify. This drug is one of the few positive things about my recent relapse.

I was on for a few months but developed a couple infections and had to stop it to treat the infections. After wards my treating doctors didn't think it was was worth the risk to try restarting it. I got it free and ended up with two or three bottles of it that would cost $8000 at full price a month which went to waste. It made me feel bad but the laws and medical procedures don't allow you to return any such meds to the pharmacy for safety reasons.

My current treating doctor for Wegs said her patients have not generally had good results with it so I didn't feel bad about not trying it again. I will get RTX every six months instead. I never got off the prednisone meds either and am still on 71/2 mg daily.

[little sister]

I was on cytoxan and prednisone initially and then cytoxan and avacopan to get me into remission. Now I stay on the avacopan and get rtx every 6 months to stay in remission.