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Hep C Discussion Forum -> On Treatment -> Dealing with delays, denials, and frustrations in getting Harvoni approval
Post Info TOPIC: Dealing with delays, denials, and frustrations in getting Harvoni approval
RudiRoo


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Dealing with delays, denials, and frustrations in getting Harvoni approval
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JLynch30 wrote:

I took solvaldi over the summer with interferon and ribrivirin.  I was undetected all the way through treatment but the dragon came right back.  he thinks seeing I was exposed to sovaldi my "best best" might be the abvie.  My other liver doc at kesier today she thinks mid november they will have harvoni.  Now I need to make a choice!

 Sovaldi continues to be efficacious and can be used to retreat per Gilead study:

http://www.gilead.com/news/press-releases/2014/4/gilead-announces-results-from-study-of-sovaldi-for-retreatment-of-chronic-hepatitis-c-in-patients-not-cured-with-prior-antiviral-therapy

 

The final study results are due October 2014 per www.clinicaltrials.gov (Study GS-US-334-0109).

 

 



__________________

Hep C since 1982, GT IL28b CC, tx naive, VL 2.5M, normal liver panel, Hepascore F-0, A-1. Sjogren's, Hashimoto's, Raynaud's, etc. SOT S/O 12 wk tx on 10.28.14. EOT 1.19.15. HEP C FREE AT LAST! 4.29.15
JLynch30


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I took solvaldi over the summer with interferon and ribrivirin.  I was undetected all the way through treatment but the dragon came right back.  he thinks seeing I was exposed to sovaldi my "best best" might be the abvie.  My other liver doc at kesier today she thinks mid november they will have harvoni.  Now I need to make a choice!



__________________

John   non-responder  

Undetected at week 2 on solvaldi/rib/interferon:  stayed through week 12 but virus came back as soon as I stopped.  on   Harvoni and ribravirin 24 weeks undetected after two. 8/2/15  12 week EOT  UNDETECTED!  SVR

1991-2015 RIP

 
Miss B


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JLynch30,

What did you mean when you said your doctor told you "I might need to wait for the others?"

Do you mean you might have to wait for new drugs to be approved? I would have thought that you would go on 24 weeks of Harvoni. Are you GT 1?  It would be nice if they had some written guidelines we could look at rather than getting bits of semi-information.

I called Kaiser today in California & was told Harvoni is on the KP Formulary in every region except Mid-Atlantic (where I am).  I'm hoping that it is just a matter of days before it is on the formulary here too.

I'm trying to be patient but would really like to get some real info.



__________________

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!  
shadow10cats


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Not yet. Just found out today when I called about something else. I will ask for that.

My Dr and numerous others are supposed to be meeting w/ CDPHP this Thursday so we'll see how that goes. 



__________________

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 :) 
Groupergetter


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BJ, if you don't already have it, make a formal request for the guidelines. policies, parameters, and limitations of your pharmacy provider for the provision of Harvoni.  That way you will have the criteria necessary documented.  If you meet their criteria, it will be difficult for them to turn you down.  Have you filed an appeal of the denial?



__________________

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.
shadow10cats


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As expected CDPHP denied my claim.

I hope that the list of other conditions that have flared up & all my symptoms/side effects may help on the appeal.

I have decided to be proactive & join in the fight for Harvoni  - as much as possible anyway:

Today I requested a report from CDPHP for the last 12 months showing how much they paid out in claims on my behalf. Since everyone seems to think that most if not all of my health issues / symptoms are from the HepC I wanted to know approx. how much it costs them each year to put a band aid on it vs. the current cost to cure it. And of course each year the symptoms will become worse & other problems will arise adding to the cost. I've had CDPHP for at least 17 years; if I could go back to 2004 when I was diagnosed I wonder how many thousands of dollars my health has cost them?  Now they have potential to cure me but seem to think that is not a good financial decision?

I was thinking that if they were being honest with themselves; in the end - if they don't cure me now, I will cost them a lot more over the next 5-10+ years in health costs then someone in late stages of liver disease who may die in a yr. or two if left untreated.  Not that I would ever want that but if all they care about is the bottom line it seems to me it would make better fiscal sense to cure those not too sick yet!  Of course I don't want anyone who needs this denied I'm just using their basis for deciding who gets what.   Not to mention my loss of work as I now have to take time off work because I can no longer function with the daily symptoms & all the other health issues that have cropped up since being diagnosed. That's less money I have to be spending supporting our economy & I am no longer being a productive member of society.

 Once I get the info on my health costs, I am going to write to the CEO of CDPHP , John Bennett, and let him know my story & plead with him to reverse their stance on Harvoni & make it available for everyone who is a member. He can look for himself how much Ive cost them. Im sure hed like me off the books!

In addition; I will let CDPHP know that as of the date of my denial I will be holding CDPHP liable for any health issues:  existing issues that had the potential to be eliminated had I access to Harvoni or future issues that may have been avoided had I access to Harvoni & cured of this disease. And, that I will sue them for loss of work, mental & emotional strain, loss of quality of life and anything else a good lawyer can come up with. 

 I will also let them know I believe them to be in violation of my health insurance contract with them whereby they have been contracted to provide me with quality care & the medications I need for which we (me & my employer) pay a hefty sum for.   I will also be contacting my union PEF / NYS who contracts with CDPHP for our insurance coverage & let them know that CDPHP is not providing the services we are paying for.

Lastly, I plan to contact a couple local newspapers such as the Times Union & the Metroland to see if they wont do a story on this.
I encourage everyone on my HepC forums to do likewise & get the word out there that both Gilead & the insurance companies are playing God with peoples lives; basically making the decision of who is going to live & who may die & neither has the right to do so.  It probably wouldnt hurt, should I have the energy, to contact some of my local constituents or even the Governor.   

It's too bad it's come down to this but the insurance companies have known for a long time this drug & others were in development.  It is not any of our fault if they did not make sound decisions to prepare for this event.

ps: I know you want to chill & be Zen my dear IsisCat & I get that I really do. Everyone has the right to deal with this as they see fit.  

But after the comment the one CEO made I really don't think the insurance companies give a crap about us.  It's all $$$$$$$. I pay a lot for good coverage & I expect to get what I paid for. To me that is just how I need to deal with this. I need to get on with my life -  If Harvoni wasn't available in the US that might be different but it is. 

 



-- Edited by shadow10cats on Wednesday 29th of October 2014 01:30:23 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 :) 
JLynch30


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Now my kasier doctor is saying that since I was already exposed to solvaldi I might need to wait for the others.... bull!



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John   non-responder  

Undetected at week 2 on solvaldi/rib/interferon:  stayed through week 12 but virus came back as soon as I stopped.  on   Harvoni and ribravirin 24 weeks undetected after two. 8/2/15  12 week EOT  UNDETECTED!  SVR

1991-2015 RIP

 
Groupergetter


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Isiscat2011 wrote:

I decided to take the Zen approach to the approval process.  Too many aggravating phone calls might mess with my Chakra.    

I just asked my doc to call me when the drugs are ready and if I don't hear from  somebody in 3 weeks I'll dial her number.  yawn 

    

I figure they need some time to work it out and having me in the mix at this stage will only waste everyone's time including mine.  

 

I'm trying to be patient about this. My doc's got the Harvoni PA denial last Monday.  I received my denial letter today. The letter indicated I could file a verbal appeal so I called Express Scripts.  The representative I spoke with told me I could not file a verbal appeal even though the letter stated I could???  I also spoke to the folks at the Harvoni Support Path.  They called Express Scripts to inquire about the denial and were told there was NO denial.  This with the denial case # I had given them???  I did an email to my doctor this evening to see if they had appealed the decision.  Yes my blood pressure is probably high and I am pissed.  Sorry for the rant.  

Isis you are right, trying to talk to these people is an exercise in futility.



-- Edited by Groupergetter on Tuesday 28th of October 2014 02:07:31 AM

__________________

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.
Miss B


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Great news! Enjoy!



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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!  
justme50


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I'm approved.  Delivery is set for this Wednesday, Oct. 29; $5 with coupon.  I will be receiving a 28 day supply so my doctor will need to send in another prescription for more.



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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
Isiscat2011


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I decided to take the Zen approach to the approval process.  Too many aggravating phone calls might mess with my Chakra.    

I just asked my doc to call me when the drugs are ready and if I don't hear from  somebody in 3 weeks I'll dial her number.  yawn

    

I figure they need some time to work it out and having me in the mix at this stage will only waste everyone's time including mine.  

 

 



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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.
Miss B


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justme50,

That is a crazy story! Just keep on them. Keep a paper trail for documentation. 

 



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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!  
justme50


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Justme again.  Just by chance, I looked on Catamaran's website regarding prior authorization history.  Looks like my prior authorization was approved from 10/16/14 through 4/16/15.  Out of all the people I have spoken to, not one person has told me about this.  Now I think they, my "Plan" doesn't know if they are going to pay, or if they do, how much they are going to pay.  On Wed., Oct. 22, I did get a phone call in response to an email I had sent.  Juan from Catamaran phoned and said there is a limit on my "Plan" of $1,248 per claim.  The cost for the Harvoni for 28 days is $32,000.00  I could request a one time override of up to $2,000.00 but that is not going to help me.  He then told me to call a different ph. number to initiate a prior authorization process and I would know a decision in 72 hours.

In the meantime I get a call from Lisa, Premier pharm. telling me I had been approved for Harvoni but it is distributed through Catamarans Specialty pharm., Briova.  She asked if they had contacted me regarding delivery.  I just chalked this up to she didn't know what she was talking about.

This is where I'm at.  Approved authorization has been halted by my "Plan".



__________________

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
justme50


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From what this guy is telling me (I can see him in person), I was not denied or approved, just halted.  Lol, lol!!  I was so tired of talking to people Friday...will take this up again with my "Plan" again on Monday.  Thank you, I know you are correct in saying they should let me know if I am approved or denied and if approved, how long it will take before I can start the treatment.  December is not acceptable; open enrollment for another plan comes and goes and I become cirrhotic.



__________________

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
Isiscat2011


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Hi justme50:

This is one of the many problems with phone calls to insurance companies, pharmacies, etc.  Talk to 3 different people and get 3 different answers.  These phone calls can easily become an exercise in frustration and futility.

You need to know if you have actually been denied.  If you have you should be getting a letter identifying the reasons for the denial and you SHOULD APPEAL (regardless of what some numskull tells you).  

If you have not been denied then the question is how long should you have to wait for a decision.  Your insurance policy may define time frames for approval decisions.  December seems unreasonable to me for an initial decision but who knows if the info you received is even accurate.

If you have been approved for HARVONI then don't sweat it.  You will get it.   

The first question is whether you are approved, denied, or a decision is pending (and how long that decision should take).  That is all you need to know for the moment.  



__________________

Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
justme50


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Part of my problem is I don't understand the approval process and my insurance has not been helpful in explaining it.  Dr. submitted script and supporting doc. to Premier pharm.  Premier sent to Briova (this is the specialty pharm my plan uses), Briova sent request to Catamaran, (my plan's PBM), then it was halted because of the high cost and I was told I should file an appeal.  All along they (my plan) was telling me Harvoni was excluded from my plan and there was no appeal process for prescriptions.  Yesterday, my plan told me there is no need to file an appeal at this time.  The problem has been that my plan's system has not set up guidelines for Harvoni and said Catamaran's clinical team will be meeting in December to hammer out the guidelines.  He told me he believes I will be approved and to wait until they get the system set up.  Crazy!

 



__________________

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
Isiscat2011


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Hi Groupergetter:

I was just thinking that Gilead might be especially interested in Sovaldi relapsers because they can use the data.  

The bottom line is that cirrhotics will get tx sooner rather than later.  Whether it is via an appeal, or approval of the Abbvie combo in December, it is going to happen, IMO.  Some insurance companies are delaying and using whatever justification they can find to do so.  Ultimately, they can't lawfully deny necessary tx, and they know it.

Imagine if a patient was prescribed a course of antibiotics and the infection persisted.  Of course the patient would be given another round of the same or the Rx would be changed and tx would be continued.  Same thing from a medical point of view.  

The healthier will also get tx although it may take longer.  The triage system is in place for HCV tx for the time being.  The question isn't if but rather when people will be treated.  Harvoni was only approved 2 weeks ago.

Excellent thread topic, btw. 



__________________

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


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So it appears there are going to be delays, denials, and problems in Harvoni approvals.  Having already been denied an approval after relapsing on S/O I understand the frustrations folks are having to deal with.  I thought this thread might be a good place to discuss things we could do to give support and lend ideas that might prove helpful in working to get approval for Harvoni.

In another thread Matt talked about using the Harvoni Support Path for assistance.  I did this and am awaiting a response.  They were very helpful.   I have spent nearly 2 hours on the phone with Express Scripts with no answer to a straightforward question "what is the basis for my PA denial"???  I went to their website and did emails to make sure the problem is documented.  I hadn't contacted my insurance carrier but will do that by email today.  I am awaiting a response from my physician before taking other actions already in the "game plan"  No this isn't a game. cry    If you have other thoughts, ideas, or information that might help others get approved for Harvoni, please share.



-- Edited by Groupergetter on Saturday 25th of October 2014 08:42:59 AM

__________________

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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