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Harvoni approval process

Hello - I am genotype 1a, I had a liver biopsy in February 2014 that showed stage 2 grade 2-3. My IL28B is TT. I found out in Oct 2013 that I relapsed after 48 weeks of triple therapy with Incivek. Prior to that I was a twice non-responder to Interferon and Ribiviran. I've had this disease since 1987 as far as I know.

Today my GI is starting his efforts to get me approved for Harvoni. I'm not sure if I'm considered sick enough for approval or what. I guess I'll find out.  I would be interested in hearing from others in similar situations, thanks.
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Avatar universal
I keep giving Gilead all the info they ask for and they keep having me jump through more and more hoops.They asked for 2 letters of denial which they received along with everything else they needed.Now they want another denial to an appeal prior authorization.Its like the guy with the coin attached to the string.Every time the kid tries to pick up the coin the guy yanks the string and pulls it away from the kid,its very cruel.
Helpful - 0
Avatar universal
I got on the trial by constantly looking in the gov't trial site when I finally found one in my area I made copies of all the paper work and brought it to a gastro Dr. . Mind you this was the first time seeing him I told him why I came to see him and right then and there he started the paperwork for me to get the trial. Within in 4days they called me and said they submitted all the paperwork and I had to wait to hear if I can be in that trial. Well 2 wks later they called and said I would get paperwork for it. Then I had to get some tests done. The only scarey part was 1 week before I was to get the okay my viral load went down so they redid the test and that one made me eligible
I will keep good wishes that soon you too will be in a trial or find away to get the meds. I've been in my trial for 33 days.
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Avatar universal
If the referral had sent us to the same office I may already be receiving my Rx.
We are just so thankful my wife was approved so expeditiously.
She has had no major side effects and we are hoping her blood work on Thursday is the miracle we need.
Helpful - 0
Avatar universal
Hi,
My frustration is with our clinic. They have mishandled this from the start.
They sure were on the ball when I first went in so they could sell another colonoscopy, even though I saw the GE originally to plan for the Harvoni treatments. My colon is fine.
After the colonoscopy I was brushed off to a NP, that is when the confusion began. I may need to get another biopsy to verify tissue damage, since a recent ultra-sound should no liver mass, and they will most likely ask for a new metavir score. The clinic keeps screwing up getting results of my past biopsies. My scarring may be minimal, as a result of healthy lifestyle changes, but the other symptoms I have are proving to be quite overwhelming. ie: joint pain and total fatigue.
We have been living in the shadow of being diagnosed with this disease for over 20 years, and it has altered our life choices ever since. I am tired of being Sick and Tired. I originally waived treatment after my wife was non-responsive to interferon/ribavirin, and just toughed it out, but I can't/wont wait any longer. Need this gone so I can get healthy and live again.

Thanks for listening, I just needed to rant a little
Helpful - 0
Avatar universal
Mike are you going to same place where your wife got hers? Might be a good idea to do that if your not.
Helpful - 0
Avatar universal
Hi Mike,
You could be describing my clinic. It's the same. I was only able to get my prescription for S/O from the nurse practitioner. Then when insurance denied it I had to see the doctor to get him to do the appeal letter, making the insurance process last almost 3 months. They can certainly make it frustrating and very difficult but hang in there and chances are they're eventually come through.

Oh yeah, for me it wasn't the insurance but the clinic that made it all so difficult. Once the doctor sent in his letter I was approved within 3 days.
Helpful - 0
Avatar universal
Hi to all,
I have 1a and have had 2 biopsies over the years since diagnosis in 1997, but I am treatment naive to this point.
Going through a great deal of rhetoric from my Health provider in trying to get a Rx for Harvoni. Too many cooks and not enough bottle washers. And they keep blaming each other for missing information, already provided to them. I haven't heard from anyone from insurance or a Pharmacy and my Rx was filed 3 weeks ago.
This is in contrast to my wife who got her Harvoni approval within days of its approval and goes in for 1st blood draw on Friday. She was a non responder on Interfuron/ribo. We are cautiously optimistic.
She has a Nurse Prac. that seems to know how to get the ball rolling and keeps it rolling.
Some health systems just don't seem to be able to handle the nuances necessary to jump the hurdles for approval, while others do. Some don't even know what to do next.
I hate to jump ship and look for a new Dr. but if these professionals don't begin acting like professionals, I will be forced to.
Getting on this train may be easy, but getting your ticket can be a nightmare.
Don't let them push you to the bottom fight for treatment. I plan to.


Helpful - 0
Avatar universal
Congrats. I too have bcbs and express scrips with a Medco card. So happy for you.
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Avatar universal
Nice to hear from you Jules, has your doctor suggested you have cirrhosis or are you going by some of the parameters from your labs? I wouldn't even know what to look for as far as lab indicators beyond low platlet counts. Best of luck for you getting on this treatment as well!!
Helpful - 0
Avatar universal
I don't know about only getting approved if you're stage 3. Obviously I hope that's not the case, but I guess I haven't really seen enough evidence of Harvoni approvals on this site to counter that.  I am a stage 2 grade 2-3. I'm not even real sure what that means.  My biopsy was in Feb of 2014 and I've had the disease since 1987, maybe longer.  Best of luck to both of us.

Dee, I think Riba may be added for people with cirrhosis.
Helpful - 0
317787 tn?1473358451
Hi, not sure who to ask but wanted to know, is Harvoni supposed to be paired with Ribavirin?
I thought it was just the one drug.
Thank you
Helpful - 0
408795 tn?1324935675
I'm trying to get approved as well.  Last year I was seeing the head chingon over at the clinical trial site here in Sacramento.  It just so happened he retired a few months after I saw him, that was Dr. Lorenzo Rossaro and he was the liver guru here in Sactown but no more.  Anyways, long story short I tried to see his replacement but my BCBS denied my request.  See the clinical trial site is under UC Davis which is different insurance and doctors than I have.  So under my BS, I saw a Physicians Assistant, he's the person who treats all the people facing tx.  The doctors I see now are only Gastros and terrible ones to boot.  He told me that Blue Shield isn't approving anybody unless they are stage 3 minimum.  I don't know if that's the truth, but that's what he told me.  Well that *****!!  He told me that he will put in for approval but don't be surprised if I am denied.  Of course I could get on the interferon, Riba and whatever else, but I'll just wait this out.  The PA told me that if my insurance denies me twice he's going straight to Gilead.  I see my piece of sheet doctor in a month or so and I'm gonna give him a piece of my mind when I do. I guess he thought that since Dr. Rossaro retired then UCD lost their clout but he's wrong and now I'm stuck in limbo.  Anyways, just wanted you to know that you're not alone.  Lastly my IL28B was listed as C/T and T/G both, neither are good.  Hopefully we are both approved for Harvoni really soon, cause for once in my life I actually want to tx.  ~Cheers!
Helpful - 0
683231 tn?1467323017
Not sure where your treatice is. The long post about going to see your team?

Yes only Harvoni no Ribavirin pre the precsribing instructions.

Worried I will be on the wrong side of the stats again but hopeful it will work this time.

I guess I have made my decision Harvoni 24 weeks and fingers crossed

Lynn
Helpful - 0
6708370 tn?1471490210
Wow, Lynn, so happy for you! That's awesome that you just took charge and they said, all right already, let's get this woman off our backs!

They hate it when you shame them in public - I once got my web hosting company to provide me with excellent service by shaming them on Facebook

My docs are recommending that I take Riba too. But not for you? See the treatise I just posted

I am conflicted about what to do

~ Linda
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683231 tn?1467323017
Hi Penn

I posted on Express Scripts page on an article they wrote. They contacted me the next morning through the comment to email them at: [email protected]

I sent them a long email out lining my medical status and questioning their determination process with links supporting my arguments. And comments of how dissatisfied I am with their service. I provided my contact info and said I am availble by phone after 10 AM they called me at 10:01 to tell me I had been approved and where can they send the meds via Fed Ex overnight.

I received my first bottle 28 days this morning and will be starting treatment next Thursday.

Good luck everyone
Lynn
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Avatar universal
Did you get approval?
Helpful - 0
683231 tn?1467323017
Hi 48weeks

I just battled my way to approval. I also have BCBS but my prescription drug provider is Express Scripts. My prescription card says Medco but they were bought out by Express Scripts a few years back.

Anyway whoever is on your prescription drug card you can probably call the phone number on the back to find out any staus they may have for your request for coverage

Good luck
Lynn
Helpful - 0
Avatar universal
I have BCBS and I've had more trouble with the pharmacy getting their butt in gear than for BCBS to agree to cover it. I'm getting a $5 copay as far as I know so that's a HUGE relief!
I was supposed to start next week but the pharmacy screwed up and never sent it up to the specialty pharmacy. After waiting for a week to hear back from them I called to check the status and they had no idea what I was talking about. Oh well, at least now I've verified that they have received it and they say it takes 3-5 business days to get it through then they overnight the medication.
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Avatar universal
Hi 48!  Glad you are setting up for Harvoni.  I am right behind you.  I am GT1b, CT, G2S3 (prob cirrhotic now), relapsed 6 mo post on Vic, Riba, Inf.  So I am trying to get on the Harvoni train.  Also have hemochromatosis, high iron levels, so I am trying to get these phlebotomies in gear.  Waiting for the Dr to literally call me.  I have BCBS also and haven't had any problems yet. If they happen to deny you just have your Dr send in an appeal.

Best of luck and keep in touch!

Jules
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Avatar universal
Thanks Dee. I have bcbs through work and it's been a decent policy in the past so I guess we'll see if they try to wiggle out of this. I am not afraid to call my insurance company if I have too. I guess I'll wait for a couple of weeks to see how my GI's office is doing with their efforts before I unleash my inner beast on the insurance co. :)
Helpful - 0
317787 tn?1473358451
Hey there! I just wanted to say that I am sorry you have gone through 3 tx's.
As I have been searching for approvals of Harvoni I have seen people getting approved so that is a good thing.
I think it will depend on your health insurance.  It will also depend on your doctor submitting everything that your insurance requires.
I have had problems with approval in that past when my doctor did not include all information or gave the wrong information.
I would call the insurance to see how I was doing.  At that time they would tell me what the problem was and how I or my doctor could correct it.
The irritating part was when the insurance did not call to tell me what was missing.
It was as if they waited until I called and then told me.
I hope you will be approved
I have read where others have started with the Harvoni Path to get advice from the company and even help with getting approved.
Good luck,
Dee
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