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TOPIC: All aboard the "Harvoni" Treatment Train


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RE: All aboard for the "Harvoni" Treatment Train , Enjoy the Ride for 8,12 or 24 weeks
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Thanks, Isiscat.  The doctor said 12 weeks since I am treatment naive.



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62 y/o F     Genotype 1b  for 40+ years    cirrhosis    Started Harvoni  on 11/23  for 12 weeks       UND  12/22/2014     Ended treatment on Feb 15th.

12 week's EOT viral load      <15 



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This is good news, Mugsy!  Your time for tx has arrived and you will have the next couple of weeks to look forward to it.   Very exciting; it will be like opening a long awaited gift.   Do you know yet whether you will be taking the 12 or the 24 week ride?

Good luck with your CT scan tomorrow.  Should be a piece of cake. 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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Trying not to get too giddy, but I just got a call from Karista @ OHSU and my PA was sent in today to Walgreens Specialty Pharmacy. After hearing it might be 6 months before I'd get Harvoni from the doctor at my appointment a week ago, I am surprised. She said if it all goes correctly, it may be only two weeks before the armored truck delivers the meds.

Now if I can just get good results from my CT scan tomorrow. My AFP has doubled from the level it was in March.   

 

Like Rosann Rosannadanna said, "It's always something"



__________________

62 y/o F     Genotype 1b  for 40+ years    cirrhosis    Started Harvoni  on 11/23  for 12 weeks       UND  12/22/2014     Ended treatment on Feb 15th.

12 week's EOT viral load      <15 



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Matt Chris wrote:

 

 

Hey all

Just a important reminder regarding getting help in obtaining "Harvoni" You might want to sign up with Gilead sponsored assistance program called  "Harvoni Support Path"

Link--- http://www.mysupportpath.com/

After signing up last week they called on Monday and told me that they checked into my BCBS health insurance coverage for my particular policy and said it would cover it. Then informed me to that they want to contact my medical team to help with prior authorization procedures, I told them I think its already sent in but gave them the contact info. Found out later that BCBS (Prime Therapeutics) received the info on Monday which is 4 day turn around from the day I saw my Hepatologist. In talking to Prime T. they said is 4 or 5 day process until determination of approval  or rejection. It shows again the importance of competence of the medical team.

matt     


 

Thanks very much for the reminder Matt.  I spent another hour on the phone(5 reps) with Express Scripts today getting the run around.  They basically told me my PA had been denied and that I would need to appeal the decision.  I asked them specifically the basis for the denial and they never gave me that.  Only that I must appeal the denial.  I had already registered with Harvoni but upon seeing your post I called them for assistance.  They were very helpful.  Took my information, and said they would contact Express Scripts and my doctor.  I should expect some response from the Harvoni Support Path by next Monday.  Sometimes we can't see the forest for the trees.  Appreciate it



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.



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I think I would rather be ahead of the curve and have to wait patiently or not, than be behind, late and have to endure waiting in a long line.

I know that if your in line for any reason and your near the front of the line it makes the waiting a lot easier on the psyche when you look back and see how long the line is.

matt

http://www.sherv.net/cm/emoticons/travel/train-goodbye-smiley-emoticon.gif



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Isiscat2011 wrote:

One thing is certain.  The passengers are certainly anxious for the Harvoni train to leave the station.  Let's try not to kill the conductor in the process of getting our boarding passes!    

 

 


Well put, Isiscat.  We are all just sitting in the depot, waiting!  I am sure the medical teams are just as frustrated as we are.



__________________

62 y/o F     Genotype 1b  for 40+ years    cirrhosis    Started Harvoni  on 11/23  for 12 weeks       UND  12/22/2014     Ended treatment on Feb 15th.

12 week's EOT viral load      <15 



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One thing is certain.  The passengers are certainly anxious for the Harvoni train to leave the station.  Let's try not to kill the conductor in the process of getting our boarding passes!    

 

 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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Hey all

Just a important reminder regarding getting help in obtaining "Harvoni" You might want to sign up with Gilead sponsored assistance program called  "Harvoni Support Path"

Link--- http://www.mysupportpath.com/

After signing up last week they called on Monday and told me that they checked into my BCBS health insurance coverage for my particular policy and said it would cover it. Then informed me to that they want to contact my medical team to help with prior authorization procedures, I told them I think its already sent in but gave them the contact info. Found out later that BCBS (Prime Therapeutics) received the info on Monday which is 4 day turn around from the day I saw my Hepatologist. In talking to Prime T. they said is 4 or 5 day process until determination of approval or rejection. It shows again the importance of competence of the medical team.

matt     





__________________

"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Hi shadow10cats:

That's an interesting document from United Healthcare but I doubt it is the full criteria.  It establishes length of tx for various tx populations but does not distinguish patients at all based on medical need for tx.  An open policy for treating all HCV patients seems awfully generous.  There  is probably more to the approval process than this.  If not, United Healthcare is going to see a significant decrease in profits, and they have to know that.  

P.S.  Just glanced at that again and it looks like they have VL and prior Interferon tx as a requirement for some.  So that's how they are going to limit tx.  



-- Edited by Isiscat2011 on Thursday 23rd of October 2014 05:00:17 AM



-- Edited by Isiscat2011 on Thursday 23rd of October 2014 05:06:14 AM

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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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Miss B wrote:

 I think there is a small window of opportunity to try to get approved before the insurance companies are overwhelmed with claims.  

 


There is a small window of opportunity to get Harvoni because there is no other competition on the market yet.  The number of claims does not determine who gets treated, however.  The medical criteria determines outcome.  The payers  who were so inclined enacted prior authorization rules that mirror the AASLD guidelines. The number of claims won't change the outcome; it will simply slow the process.   

The AASLD guidelines set the standards for who and when to treat and the insurance companies are using the guidelines to deny claims.  Interestingly, the AASLD recently wrote a clarifying statement indicating that the guidelines were not intended to exclude patients, but that just doesn't fly.  The AASLD committee had to have understood the consequences when they specifically defined, categorized, and prioritized patient populations.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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I totally agree w/ you Isiscat (are you a cat lover too??)

I have tried treatment twice and failed and have now waited 3 yrs or so since my last try. For me, I am really symptomatic. I think that I've gotten about every possible other thing wrong with me that HepC can be responsible for! And it is time for me to get rid of it.  

Plus, for the first time since being diagnosed in 2004 my AST doubled since my last labs in May. My liver panel has always been in the mid-range of normal. AST usually around 20-28.  It was 53 this time, a bit outside the high end of the range. Now that may not alarm many who have levels in the hundreds but that tells me things are changing so I really do want to nip this quickly before the liver damage really starts to happen. 

However do I need to be the first in line? heck no. I can wait a bit but I do want to treat before the end of this year. Get started anyway. It's just a goal I set for myself. And I'm not getting any younger either wink

Here's an article I just found on the very subject of this "game"

 http://blogs.barrons.com/stockstowatchtoday/2014/10/20/will-high-price-hurt-gilead-sciences-new-hep-c-drug/

found this too: kind of interesting it's the criteria for United HealthCare - based on their criteria I would appear to have no problem being approve for the 12 wk regime (treatment exp w/o cirrhosis)

http://www.natap.org/2014/HCV/102214_01.htm

 

 

 

 



-- Edited by shadow10cats on Thursday 23rd of October 2014 03:58:23 AM



-- Edited by shadow10cats on Thursday 23rd of October 2014 04:05:10 AM



-- Edited by shadow10cats on Thursday 23rd of October 2014 04:05:47 AM



-- Edited by shadow10cats on Thursday 23rd of October 2014 04:44:21 AM

__________________

Diagnosed 10/04 / VL 12.7 M / Genotype 1b - Grade 2, Stage 1 / 2007 -Pegylated Interferon & Ribavirin - Stopped Due to Sides / 2011 - Telaprevir, Interferon & Ribavirin - Stopped Due to Sides / APR 2015 - COMPLETED HARVONI So Far Undetectable :) 



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Shadow10Cats,

I agree with both of your theories. I think there is a small window of opportunity to try to get approved before the insurance companies are overwhelmed with claims.  And, I agree the insurance companies & Gilead will continue to call each others' bluff at our expense. Very frustrating!



-- Edited by Miss B on Thursday 23rd of October 2014 03:44:18 AM

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Miss B
56 years old. Genotype 1B, previous treatment with interferon 1994. Started Harvoni 12/8/14. After 2 weeks, VL dropped from over 4 million to 496. At 4 weeks, undetected, but at 8 weeks, <15 mL (detected), at 12 weeks/EOT UND!  



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Hi shadow10cats:

I was about to tell you that the petition story (as well as some of the other information) was full of holes but decided against it. Looks like you have had a reality check.  I agree that medical professionals should always know what they are talking about and be entirely truthful with their patients, helping them to weigh their options wisely and realistically, but that is easier said than done.  You asked for opinions so here is mine:  If you don't need to be in this battle yet save your sanity and wait for the dust to settle.  

Nobody can predict the future but there is no question that tx will become easier to obtain in the future.  For people who don't have advanced liver disease getting tx now is going to be a crap shoot.  Do you really want to spend this much time and energy trying to get ahead in the line under the circumstances?  Is there an ethical question here or has that become irrelevant too?  There will be tx available over the next few years that is more effective and will probably be shorter in duration.  All this pushing to secure one's place in line seems a bit crazy to me unless there are no viable alternatives.  

This need for everyone to tx immediately has really been blown out of proportion, IMO.  While it is clearly wrong that everyone cannot tx as soon as they are diagnosed it just isn't going to happen right now.  The greedy have seen to that.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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A reality check for me today
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Checking in & Revising Previous Post:

I had mentioned in other emails that I was not all that happy with the Dr who I've been seeing since I was diagnosed. I did find another Gastro-Entro Dr that I've seen & was kind of playing back & forth trying to decide who to stick with. After my Drs appt on Monday, even tho I was not pleased with some of his comments in regards to my symptoms I thought I might stick w/ him - basically right now I'm sticking with whomever can get me this drug the fastest. And he (Dr Ben in Albany, NY) sure seemed to confident he was and he could.  He was telling me how lucky I was to have CDPHP as they have been great & have everything in place for distribution. I have the option every Nov to change my health ins provider & he said "don't do that! - you've got the one to keep".  I asked him about turn around time & getting approved. He said he had one patient approved already "had the drug in his hands within 48 hrs of being approved".  When I left his office Monday I expected my paperwork to be out in a day or 2 & I might hear something by next week & if approved be on the drug before the end of the month. That's based on the information he told me; not my perception.

Well I called today & spoke to Sandra, his nurse to make sure she had my new number & we had a nice little chat.  Seems there are 25 patients ahead of me.  She is the only one filling out the pre-auths. With any luck, she "may" get to mine by the end of next week!  We talked about approvals and I commented how "at least I had CDPHP and Dr Ben said I was lucky as they were the best to work with right now". She was like "what? I'm going to have to have a chat with him. He can't be telling patients that!"  Fact is, they have denied more claims then they approved!  I told her I felt like the rug just got pulled out from under me.  Here I am talking to my employer & making plans for some time off in 2 weeks - all based on what He told me Monday & then I find out he didn't have a freekin clue!   What a disappointing thing to find out.  

And to make matters worse, you gotta figure that in the next 2 weeks, these insurance companies are going to be swamped with pre-auths.  If, like most large companies they've had cut-backs that means less staff doing more work.  Now they have piles of pre-auths to go thru.  Due to the cost of the this drug I'm sure they have very strict criteria for  the review process; possibly more than one person to review or a very timely one at best.  As they pile up the further out you are going to wait.  And, since I'm not in the "advanced" category now I'll probably get denied & have to wait for him to appeal - pushing it out even further.  To go from thinking I was really in a good position with a great ins provider to I don't have a clue when or even IF! I will get the drug.  What kind of Dr intentionally does that to his patients?  Does Dr Ben have some personal agenda? Tomorrow I am calling the other liver Dr to see how his pre-auth process is going. If he can get mine out quicker; I'm dumping Dr Ben.  I understand all this takes time,  but he should have been honest, not let me walk out of there thinking I'll be taking Harvoni before next month.  And an office his size having only one person handling all the pre-auths, denials, appeals & re-subs is unacceptable.  You just know she's going to be going bonkers & make mistakes, it could all go downhill in a heartbeat.

So I have to re-nig on my previous post about CDPHP and how they have relaxed their criteria for pre-auths.  Now his story about the petition makes no sense at all!  Certainly did't seem to make it easier to get based on what Sandra tells me & she is the person handling all the pre-auths! 

Anyway.....  here's some food for thought...

Something I was thinking about:  Gilead is standing firm on it's $94k price - for now.  The ins companies, as a result, are making Gilead's drug difficult for patients to get bec they can't afford to dole it out to everyone w/ HepC.  Who is calling whose bluff?  Think about it. I don't know the percentage of HepC patients who fit into the category of advanced vs. those in early stages, newly diagnosed, or chronic but in decent health. But, there's a possibility that there are more of us then there are of those advanced.  "IF" that is the case then that means Gilead is not going to be selling as much of their drug as they had hoped. Investors will watch this closely.  If Gilead is not making huge sales investors will start dumping their stock in the company. Gilead will be forced to lower the price of Harvoni to make it more affordable for ins companies to provide to all of us so they can sell all the Harvoni they made. Is this the game that is going on?  Are the ins companies hoping they will be able to reject claims long enough to force Gilead's hand?  Or is Gilead putting its money on the hope that  Drs & patients who are not "advanced" will put so much pressure on the ins companies to make Harvoni available to all that they'll give  in to public demand & Gilead will not have to lower its price?  What do you think? 

 



__________________

Diagnosed 10/04 / VL 12.7 M / Genotype 1b - Grade 2, Stage 1 / 2007 -Pegylated Interferon & Ribavirin - Stopped Due to Sides / 2011 - Telaprevir, Interferon & Ribavirin - Stopped Due to Sides / APR 2015 - COMPLETED HARVONI So Far Undetectable :) 

Ro


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RE: All aboard for the "Harvoni" Treatment Train , Enjoy the Ride for 8,12 or 24 weeks
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OK first road block...changing specialty Pharmacies...not sure why.. doctor's office called and told me I would be getting my meds from Walgreen's Specialty Pharmacy... Taking a deep breath....

"Keep on swimming...keep on swimming..."



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Ro


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I am saving a seat for you, Isis :)  Thank you for your kind words and support!

Now waiting for the pills to arrive!  That is the ticket to go.....



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Excellent, Ro.  I know you have been waiting some time for this and I can't tell you how happy I am to see it materializing so well.  I'll be looking forward to reading about your progress and, naturally, to riding the Harvoni train along with you.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.

Ro


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Just got my doctor's call.  Prime Aid is the  speciality drug distributer located in NY.  We are just waiting for the pills to arrive.  I was approved by Highmark BCBS of PA for 24 weeks. The protocol for labs etc. is being worked on now by my doctor.  Will post when I have more news.



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Not much chance of getting aboard this train in the UK...still, our slippery,untrustworthy politicians ride the "Gravy train" at everyones expense!



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My doctor started working with Premier Pharmacy a week ago so I called them this morning to check on how it's going.  They told me I need to go through Briova Specialty Pharmacy.  I had also found this out yesterday from Catamaran so I contacted Briova yesterday, registered with them and they will start the process; I should know something in about 72 hours.  The strange thing is, Premier told me I do not require prior authorization for Harvoni, according to my plan.  Catamaran tells me Harvoni is excluded from my plan.  This just drives me crazy so I will take a deep breath, relax and deal with this on Friday.



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G1A, F3, prev. tx 2012 for 28 weeks vic/riba/int. Started Harvoni Oct. 29, 2014 for 24 weeks, 1.5 mil., und at 4 weeks. EOT: 4/14/15.  One week EOT labs: und; 4 wk EOT und, 7wk EOT labs: und



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Hey Bills 

Welcome aboard for the 24 week journey, its going to be a smooth trip.

Your medical teams prior authorization part of the procedure is the most important element in getting your insurance to approve "Harvoni"

 Your medical team (Doctor, nurses, etc) work up a prior authorization consisting of all the substantiating lab reports, liver biopsies, Fibroscans, history on prior relapses, etc. anything that proves you should qualify for the drugs. (most qualified will be cirrhotics and previous relapse patients) These are used to submit to the Specialty drugs request review broad.

Bill you will no doubt qualify for 24 weeks of Harvoni so don't worry.

matt 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Groupergetter wrote:

 I don't want to burn bridges, so some patience is warranted.  If after having a complete understanding of the criteria, and the basis for the denial doesn't wash, I can be VERY difficult.  I deal with these types of issues on a professional level.  I do know how to pursue the matter and if it becomes necessary won't hesitate to do so.  Hope it doesn't get to that, as it will further delay treatment.  I think it will work out, just may take a bit longer than I'd hoped.   


 Wow! Greg I'm very impressed with your spirit, keep up the positive thinking because it can make the difference in your future.

matt 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Isiscat2011 wrote:

Hi Groupergetter:

What is your liver status?  

The primary reasons I can think of for denial would be (1) don't meet medical criteria, (2) insufficient medical documentation, or (3) a policy limitation on re-treatment with Sovaldi.  

Hang in there.  You will get a letter stating the reason(s) for the denial.  Onward to the appeal.  


Isis, I am cirrhotic.  I got absolutely nowhere with Express Scripts,,,,except passed around to different people.   If I previously met the criteria for the S/O and relapsed, I should still meet the criteria for Harvoni.  The liver hasn't improved and my symptoms are worse.  The medical staff at the teaching hospital are professionals and deal with the submission of PA requests daily.  While it's possible they didn't submit the necessary documentation I doubt this is the case.  I suspect the insurance company is baulking at paying another round.  Will know better after I talk with the staff that submits the PA's.   I don't want to burn bridges, so some patience is warranted.  If after having a complete understanding of the criteria, and the basis for the denial doesn't wash, I can be VERY difficult.  I deal with these types of issues on a professional level.  I do know how to pursue the matter and if it becomes necessary won't hesitate to do so.  Hope it doesn't get to that, as it will further delay treatment.  I think it will work out, just may take a bit longer than I'd hoped.   



__________________

1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.



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Hi Groupergetter:

What is your liver status?  

The primary reasons I can think of for denial would be (1) don't meet medical criteria, (2) insufficient medical documentation, or (3) a policy limitation on re-treatment with Sovaldi.  

Hang in there.  You will get a letter stating the reason(s) for the denial.  Onward to the appeal.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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And so it begins.  Spent nearly an hour on the phone with Express Scripts today.  Spoke to 5 different people before being put on hold until I finally hung up.  Never could find out what was happening with the PA, only told it was in pending status. I called my doc's to see if they could shed any light.  They said the PA was denied so we begin the appeals process.  Glad others are having success.   Hoping I'll get on the train.



__________________

1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.

Ro


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I think it may be Prime, this time, but am not sure... Will find out tomorrow.  I have had curascript twice, And was supposed to have Burman(?)  last time, but never  received approval for the 2 meds so that is when I had to wait for this go around.

Today feels like a marathon day waiting for tomorrow......



-- Edited by Ro on Tuesday 21st of October 2014 10:31:20 PM

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Tig


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Hey Ro,

Did BCBS mention anything about the specialty pharmacy that will handle your medication? Prime Therapeutics handled mine and they did a great job. I guess that's hopefully something you'll hear tomorrow. Good luck!

Tig



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Tig

65 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 8+ years!

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Hi Bills:

Ignore the rumors.  People's situations are different.   Keep your eye on the ball now--your November 19th doc's appointment--they will know your insurance situation.

Watch a movie, read a book, etc, but don't pscyh yourself out.  You are right--it is going to be an awesome trip--maybe a little like a roller coaster for a while so just buckle up and enjoy it.  

smile



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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Hi Everyone,

The Long long awaited trip. I can't believe is really here. I'm here confused and butterfly's in my stomach. Not about the drugs but the insurance. I'll be on the non stop to 24th week ( I hope )

I don't like that plan of 1 week pills and then 3 week pills.  What if the insurance does change and co-pays go up. I need to assurance from my doc's this will be a go start to finish.

So I got an appt for Nov 19th. New doc in NJ.   But I just called back to my old Doc's in NYC see if working through them may make insurance easier to work up authorization substantiating lab reports. All the fine print on insurance limitations and exceptions is still a big question mark to me.  It makes my Brain Fogged head spin.  But I'm here.  So happy to see all the people who fought so hard and for so long. We're going to have a great trip and get to a great destination. I'll post as I get more info on my status.

BillS



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Bills

Harvoni started 12-12-14 for 24 wks PrevTX Geno 1 stage 3 cirrhosis - non resp Int/ ribv. Started Trial  in Aug 2011 -July 2012 into Incivek relapsed  Feb 2013 Had 72 weeks on interferon & Riba.

Ro


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RE: All aboard for the
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Matt, Blue cross approved the payment for 24 weeks! Will find out details tomorrow from doctor. Nurse called to tell me the good news.

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All aboard for the "Harvoni" Treatment Train , Enjoy the Ride for 8,12 or 24 weeks
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Hey Ro

Congrats on getting approved, what part of the process do you mean? (Doctors, Insurance, Medicare etc.)

matt

http://www.sherv.net/cm/emoticons/travel/train-goodbye-smiley-emoticon.gif



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Congratulations!!  Very exciting news.



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G1A, F3, prev. tx 2012 for 28 weeks vic/riba/int. Started Harvoni Oct. 29, 2014 for 24 weeks, 1.5 mil., und at 4 weeks. EOT: 4/14/15.  One week EOT labs: und; 4 wk EOT und, 7wk EOT labs: und

Ro


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Start the train!  I just got approved!  Will meet with doctor for details tomorrow!



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Thanks Maddie.  I will be following up on this tomorrow morning.



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G1A, F3, prev. tx 2012 for 28 weeks vic/riba/int. Started Harvoni Oct. 29, 2014 for 24 weeks, 1.5 mil., und at 4 weeks. EOT: 4/14/15.  One week EOT labs: und; 4 wk EOT und, 7wk EOT labs: und



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Justme50....If a drug is medically necessary and there aren't equally effective alternative drugs on the formulary, you should be allowed to appeal the decision.  I believe that you should be notified in writing that the drug is denied. 



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Dx. 2005-liver bx.: stg 2/gr 1. at that time  - GT 1a multiple transfusions in 1981.  Started Sovaldi and Olysio 1/16/14  (No prior treatments) Q80K present.  UND week 4,8 and at EOT.   UND at wk 4EOT, Und at wk 8EOT  SVR 12!!!..SVR 24 :-)



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Cinnamon Girl wrote:

Thanks for that Maddie, I was just coming back to correct what I said.  I`ve read about the phases of clinical trials many times before but my memory isn`t so good these days!  wink


 Right there with you Jill...smile



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Dx. 2005-liver bx.: stg 2/gr 1. at that time  - GT 1a multiple transfusions in 1981.  Started Sovaldi and Olysio 1/16/14  (No prior treatments) Q80K present.  UND week 4,8 and at EOT.   UND at wk 4EOT, Und at wk 8EOT  SVR 12!!!..SVR 24 :-)



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Hi Matt,

I have a county self-insured point of service plan through my employment.  It allows me to see physicians outside of the county in which I live.  When I use a physician outside my county, claims are submitted to Anthem Blue Cross.  I don't know about other insurance plans who use Catamaran.  All I know is, when I looked Harvoni up on the formulary it stated it may not be included in my plan.  I phoned Catamaran and they looked up my information and saw they had received a request from Premier Specialty Pharmacy for approval.  They then told me Harvoni is excluded from my plan.  I am prepared to file an appeal but because it's excluded from my plan I don't know if I can.  That is something I will work on. I hope others will not have this problem.



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G1A, F3, prev. tx 2012 for 28 weeks vic/riba/int. Started Harvoni Oct. 29, 2014 for 24 weeks, 1.5 mil., und at 4 weeks. EOT: 4/14/15.  One week EOT labs: und; 4 wk EOT und, 7wk EOT labs: und



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Hello Monica

Sorry about the depressing news, if I may ask what insurance provider do you have.

Also does having "Harvoni" in the catamarans formulary cause it to be excluded in all cases and in all insurance companies that use there services.

matt



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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I am so upset right now.  Looking at various information on the internet I saw that Harvoni is in Catamaran's formulary.  Yes, but of course it is excluded from my insurance plan.  They said I could get it but I would have to pay for it.



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G1A, F3, prev. tx 2012 for 28 weeks vic/riba/int. Started Harvoni Oct. 29, 2014 for 24 weeks, 1.5 mil., und at 4 weeks. EOT: 4/14/15.  One week EOT labs: und; 4 wk EOT und, 7wk EOT labs: und



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Matt Chris wrote:

Hey all

Very important article from Lucinda K. Porter on blogs.hepmag.com

Harvoni: Tips for Navigating Insurance Prior Authorizations for Hepatitis C Treatment 

Here is the Link 

http://blogs.hepmag.com/lucindakporter

 



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Thanks for that Maddie, I was just coming back to correct what I said.  I`ve read about the phases of clinical trials many times before but my memory isn`t so good these days!  wink



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



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Phase 4 refers to studies done just after approval and the med is in use by general public.  This link explains all four in brief summary.

http://academics.wellesley.edu/Chemistry/Chem101/testing/Phases%20of%20Trials.pdf



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Dx. 2005-liver bx.: stg 2/gr 1. at that time  - GT 1a multiple transfusions in 1981.  Started Sovaldi and Olysio 1/16/14  (No prior treatments) Q80K present.  UND week 4,8 and at EOT.   UND at wk 4EOT, Und at wk 8EOT  SVR 12!!!..SVR 24 :-)



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Thanks for the update, Isiscat, it all sounds very promising and how reassuring that your doctor is so well-informed and helpful. 

I find her comments about the Abbvie combo very interesting, and I must say I wasn`t aware of the existence of phase 4 trials either. 

Very pleased for you that your Harvoni tx is finally getting to be a reality,  Do keep us posted!



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 



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Thanks Isis...I was looking for your post -- I remembered you saying you had your appt. on the 16th.  This was very informative.  That's great -- you'll start treatment before year end!!!  Awesome!



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Me: 62 yr. old female, GT 1b, fibroscan 4.5; VL 650,975 as of 2/4/14;started Harvoni 3/6/15; SVR


Hubby: 59 yrs.; GT1b; fibroscan 25-cirrhotic; S/O for 12 weeks started tx 3/20/14; SVR56; fibroscan done 7-7-15 = 8.5



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Greetings fellow passengers on the Harvoni Train.  Just wanted to give you an update on my doctor's appointment yesterday.  My hepatologist is submitting the request for 24 weeks of Harvoni (no riba).  She told me that she submitted the preauthorization requests for 6 patients on the day Harvoni was approved and has been submitting even more requests daily since the the FDA approval; no one has started tx yet.  She expects it will take 3-4 weeks for me.

It appears that the length of time it will take to actually get on tx depends on a number of factors such as the length of tx duration requested, the quality and quantity of the supporting medical records, the number of requests that are being processed as well as the system in place in the medical provider's office, the specialty pharmacy, and the insurance company, and perhaps even the urgency for tx (with patients who are severely ill being prioritized).  In short, I would expect the length of time will vary among patients.  As I said before, as long as I know they are working on it, I don't mind waiting a while longer. 

Interestingly, my doc felt quite certain that 12 weeks should be sufficient in my case, although she did agree to request 24.  She indicated that within the tx experienced cirrhotic population there are variables that suggest a shorter or longer protocol such as degree of fibrosis, whether the patient was a prior rapid responder, a non-responder or a relapser, etc.  She said that insurance companies will be looking at these variables in the patient's supporting medical records.  Paradoxically, they will not be performing pre tx genetic testing.

She said the VL testing schedule planned is at 4 weeks and 12 weeks, and then EOT+4 and EOT+12.  She also said that she expects the price of the Abbvie combo to be in the same ballpark as Harvoni--perhaps 5K less.

She said that for she has been involved in the clinical trials of both the Harvoni and the Abbvie combos and is currently working on Abbvie's Phase 4. (I didn't even know there was a Phase 4 in clinical trials).  She has also treated a substantial number of patients with the Sovaldi/Olysio combo (all cirrhotics).  When I asked her which combo she preferred her answer surprised me:  Abbvie.  She said that while the relapse rates have been very low with the Sovaldi combos they have been even lower with the Abbvie combo.  She did say that the results varied, to some extent, among the facilities performing the clinical trials.  

She also noted that the Abbvie combo is expected to have potentially greater side effects particularly for those receiving Riba (which I believe will include all genotype 1as). 

So, that's it for now.  My doc is extremely well informed about HCV tx, and she is also very personable and open minded, so I'm feeling pretty fortunate with that.  She also told me she encourages patients to become their own advocates in their medical care.  Lastly, she told me that she advises all of her patients that there will be a small number of relapsers, but not to be discouraged by this reality.  In the unlikely event that happens we will be prepared for it.



-- Edited by Isiscat2011 on Friday 17th of October 2014 07:50:19 PM

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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.



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Matt, I specifically asked my doc about taking the riba with the S/L.  I told her I would be glad to take it, if it would improve my chances.  She didn't think it would help and didn't prescribe it.   I pray God she's right.   With the relatively small clinical study samples, and this all being so new I guess to some extent we have to rely upon our physicians recommendations. 

I got a call from Express Scripts yesterday. They confirmed the meds had been ordered and still awaiting final PA approval.  If all goes well it appears I will have the meds before long.  Odd the doc's didn't schedule viral load labs as they did the last go round? 

Extremely Thankful to have another opportunity.  Hope all on this train reach their journey's end.  Can I get a window seat?  Looking forward to the view.   smile

 



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.



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Hey All

The question of whether or not to include Ribavirin with Harvoni needs to be discussed.

Most the trial studies (Ion 1,2,3,) had some arms of trials include Ribavirin, the final SVR 12 percentage did not show any real advantage including Ribavirin with L&S (Harvoni). Reading the New England Journal of Medicine article on L&S on a Phase 3 trial study on 440 patients the article shows very little case made for including Ribavirin in either 12 or 24 weeks.

Most Hepatologist reason that Ribavirin can help in controlling polymorphisms (Ravs) so if you happen to know that you have baseline NS5A Ravs it might be wise, or if you happen to know what Ravs if any caused your relapse you could consider it. Most of us don't unless you were on a trial or paid for a deep gene sequencing lab test. In my case I did final receive the information upon my many requests to Abbvie to reveal if I relapsed because of or with Ravs, well final they said that I had no detectable Ravs at time of relapse. So both my Hepatologists agreed that including Ribavirin was not worth the extra side effects.

Obviously Gilead and the FDA have concluded the same thing, but if you happen to know you have a problem with Ravs from your previous HCV treatments then you may want to read up and then talk to your Doctor about it. The side effects are quite detailed and long on Ribavirin but they are mostly tolerable.

matt



-- Edited by Matt Chris on Friday 17th of October 2014 05:24:02 AM



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 



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Miss B wrote:

Thank you for all the welcome messages. It's great to see that some of you are cured and are still on here helping others!


Welcome Miss B, that is part of what makes this such a great forum. Really tremendous folks here, helping each other to get through difficult times.  Hoping you get on the Harvoni train.

Looks like I'm gonna have a ticket for the ride.  My doc prescribed the Harvoni today.  The PA hasn't been approved as yet, but they have sent in the packet with all the necessary documentation.  Trying for the whole enchilada, 24 weeks.  Apparently there will be some delay but she thought if all goes well it may be under 10 days.  Will call the pharmacy tomorrow and try to get their estimates on the time frame.  Trying to stay realistic with this...until the Harvoni is in my hands won't get the hopes too high.



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1b  Int/Riba relapse @ 48 weeks.  Stop tx Peg Int/Riba 12 weeks ill. Relapse S/O 6/23/14 :(   Started Harvoni 11/12/14  EOT 4/28/15.  EOT+4 UND :)  SVR! 8/4/15  :)     Thankful for every morning.



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Hey Matt,

Very happy news for sure! Your face is going to cramp up from all that smiling!



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"hrsetrdr"=Tim

Treatment halted on Aug.8,2012 due to vision problem.  6 month post tx labs

Aug.2013 SVR

Be strong when you are weak, brave when you are scared, and humble when you are victorious.
- Unknown

 

 



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Hey BJ

I understand how you feel about the hassle of waiting for Harvoni to be delivered to your home. I am waiting as well

Its really a three part process than can not be avoided with an additional problem of it being just released and not on many of the current specialty drug list yet.

1st process = Your Doctor agrees to prescribe the 12 or 24 week duration of Harvoni.

2nd process = Your medical team (Doctor, nurses, etc) work up a prior authorization consisting of all the substantiating lab reports, liver biopsies, Fibroscans, etc. anything that proves you should qualify for the drugs. (most qualified will be cirrhotics and previous relapse patients) These are used to submit to the Specialty drugs request review broad.

3rd process = Most health insurance companies have a designated paid third party company like "Prime Therapeutics" or "Express Scripts" to review and sift through the insurance customers requests and make recommended approvals or rejections.  Which can be appealed and should be appealed.

The advantage we have now is that the FDA and Gilead have agreed on many of the things that would have cause problems in getting the drugs and are taken off the table.

So now the insurance companies will try to find other minor loopholes to reject claims, don't give up because many of our Hep-C friends got approved on other off label combos (Simeprevir & Sofosbuvir) so this should be easy than that. 

matt       

 



-- Edited by Matt Chris on Thursday 16th of October 2014 05:49:25 AM



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"And in the end, the love you take is equal to the love you make"

61 year old Geno type A1, F4 Cirrhotic, started 24 weeks on Harvoni 12-17-14 ,EOT-5 week = UND, 8-31-15 =UND , SVR-24 Baby YES! 

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