Hep C Discussion Forum

Thanks all!  I will certainly chronicle this process for everyones perusal.  I am planned for 24 weeks assuming a response and will get my first viral load after two weeks.  It is also clear that the issue of drug resistance is a real one.  How my prior therapies will affect my current treatment is certainly unknown, but my hepatologist who has been instrumental in keeping me alive during the last 15 years believes this is the best shot for me at the present.

In regards to the comments of isiscat2011 and dzdayscomin, it is not profound to say that these issues are complex.  We as a society in the US do not discuss or deal with these issues openly or honestly.  We live in a society where an 80 yo with no hope of survival is kept on a ventilator and hundreds of thousands of dollars are spent because the family didn't want to give up....not the right thing to do but the rules.  Who has a more profound outcome, an F0, never treated who is 30 yo and lives a normal life b/o cure or an F4 who is 60+ irrespective of outcome.  Today, our society has not grappled with those issues and we are letting the market, insurance companies and politicians make these decisions indirectly without tackling these issues head on.  

In that context, (I am 60+ yo, infected for 40 yrs, F3/4 but compensated, don't drink or smoke, work out regularly and work full time) I will fight as hard as I can for myself.  I don't apologize for it and I want to be treated with the best treatment available yesterday.  Anybody who has confronted their own mortality and worried that they would not see their kids grow up understands that.  If you don't then ask if you are being honest with yourself.  And by the way, I remained on interferon for over five years and never missed a day of work because of my treatment!

-- Edited by darkstar on Saturday 1st of November 2014 07:41:46 AM

RE-Post from new member Whochman

I just started too--took my second dose an hour ago. I remembered the interferon/ribivirin "flu-like" feelings and have had a headachey day but I don't care. It's my last best chance to beat HCV. I've already been transplanted (five years ago) and my doc really is confident that I will "kick some viral butt." I feel so lucky to be starting this drug and believe SVR is now possible. (Gentype 1A, Null responder, diagnosed "non-a-non b" 25 years ago.)

Had to move this post to the train

matt

darkstar wrote:

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This has been a very interesting process and I just took my first dose of Harvoni about an hour ago.  I have ave had a lot of back and forth with the pharmacy folks and I would offer some of there perspectives.  Trying to step back and think objectively, some make sense and some do not.  The biggest question that I heard is whether Harvoni, Abbvie or BMS have the best product.  Abbvie filed on the same date as Gilead and they will be presenting data on November 9th at the liver meetings.  We do not know which combo will be most effective and certainly do not know which combo will be most cost effective.  Both of these issues are reasonable ones to consider in a system that is going bankrupt.  We also do not know as we discuss patients with prior failures +/- cirrhosis what the impact of sovaldi/olysio failures will be.  I fit into that category and it certainly worries me.

 

In talking to my people, I was told that my prior treatment is viewed as a negative in regards to providing the new drugs.  But my stage of disease/cirrhosis is the final reason that they will provide the drug.  In the final analysis, they understand that waiting for someone who has had HCV for about 40 years with late but compensated cirrhosis is not a situation where waiting works well.  So, the bottom line is that I have the drug, keeping my fingers crossed and hoping that I can report ongoing good news in regards to both efficacy and lack of side effects.

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Congratulations Bob, seeing you get started is music to my ears.  I suspect we have a number of similarities as it relates to our staging, symptoms, and history with this disease.  It will be good to follow your tx challenges (if any) and improvements that will most certainly come.  I was so excited to get started on the S/O that initially, it didn't sink in that I might relapse.  Who thinks they would be one of the 10% or so that don't find SVR?  A HUGE letdown would be an understatement.  I will certainly be much more reserved and cautiously optimistic if the opportunity for Harvoni presents.  (It is looking better)

Like you, I wonder if the previous S/O relapse would somehow affect the outcome of the new course of treatment?  So many factors come into play when making the decision of which, and when to start tx.  Certainly health (or lack thereof) is paramount.  Having had this for over 30 years it has taken its toll.  Most veterans in this war understand the battle scars... physical, mental, and emotional.   In my case insurance coverage is also a factor as there is a good possibility my office will close in the coming year.

Trying to aquire this new "miracle med" has certainly been an experience.  What started as an exercise in futility, morphed into an exercise of sensibility, and then to an exercise in humility.  I'm quite certain most in the hunt (including me) have become frustrated, aggravated, and maddened in dealing with what seems to be a never ending maze....then the dead ends.   I haven't received meds yet, but it appears as though I am about to be approved.  Please remember when talking on the phone with anyone at your insurance company, pharmacy, specialty pharmacy, or PA section of your pharmacy, you never really know which of these individuals is in a position to make your dream(or nightmare) a reality.  I have spent hours on hold, with 17 different people (I saved their names), numerous e-mails, and a written appeal.  As strange as it sounds, I believe a single person I was patient and respectful with (even after being on hold more than 20 minutes) may have been instrumental in helping me get approved.  I'm truly thankful for those here who continue to encourage and uplift others even in the midst their own trials.  Also extremely Thankful for those who have reached SVR and continue to support us "wannabees"   We should remember to be Thankful for this one day. 

I apologize if this is redundant but a buddy of mine (Paul) said something to the effect that "more than this we can rejoice in our suffering, because we know that suffering produces endurance, endurance builds character, character gives hope, and hope doesn't disappoint us because we know that God's love will be poured into our hearts through the Holy Spirit.  This forum is a special place, with special people, trying to help each other get through difficult times.  We should love each other like there is no tomorrow...........    There's a new train leaving the station every day, with always be room for more.   I Think I can, I Think I can, I Think I can..... I Thought I could. 

Keep us posted darkstar, hoping this train ride brings you to your journey's end.      congratulations!

Hey Bob

Yahoo! for you, not only have you boarded the train but your en route to your final destination.

Your situation will be very interesting having been a previously user of S&O,  but I assume you will be on the train for 24 weeks which will make all the difference on your outcome.

Because I am in somewhat a similar situation as you, would you mind relating how you got approved and what insurance you have.

matt     

Re: "This is all speculation, and with all due respect, fairly pointless at this stage.  We do not know BCBS's reasoning because we are not privy to it.  It could be that the lack of guidance from clinical guidelines and clinical trial results are forming the basis of BCBC's reasoning.  In other words, they have no affirmative evidence or guidance that retreatment would be effective so they might as well deny it." & "Alternatively, BCBS may have information concerning retreatment that the general public does not.  We know only what Gilead has made public and it is important to remember that."  

First I would like to give my opinion on this (I know, big surprise!): As paying clients or members we have RIGHT  to this information. since we purchased the policy we have a legal right to all aspects, criteria whatever to the policy we pay for. The insurance co. can not take your money for a policy then deny you access to the terms of your policy. 

In regards to BCBS concerning re-treatment info - I think thanks to the internet we all can pretty much find out what is going on.  After all we knew Harvoni was coming several years ago.  And, I believe Gilead has a vested interest in doing every thing possible to get their drug to people.  After all, if they hid info making it more difficult & less folks then projected get on Harvoni you can be sure their stock prices will fall.  They already are fluctuating quite a bit as news first shot out about this new cure then the news that ins companies were denying access.  So Gilead wants us on their drug. They need to make back all that R&D money - after all, if my Dr is correct; they did not get any Federal Grant money to develop Harvoni it was all private investors and they need to make good on that.  

I am hoping that very shortly the insurance companies & Gilead will close the gap between them.   Insurance will give to public, member, governmental pressure to make this drug available to their policy holders; for any sorts of reasons; legal or ethical.  I foresee Gilead re-thinking their pricing especially since we all know they can sell it for a lot cheaper based on what they are making it available for in other countries & as new competitive cures come down the pike they aren't going to want us to decide to wait & lose the money for the drug to another company.  I also see the potential for Gov intervention here possibly in subsidies. We need a healthy America & HepC is the biggest epidemic going on in our country right now - & there are possibly thousands who don't even know they have it yet. It's in everyone's best interest to knock the HepC monster out of the ball park.

Lastly, I don't blame what is happening completely on the ins companies or Gilead - As a prev business owner I see both sides of the issue.  However as a person needing this medication I really don't care about any of that I want this drug & the sooner the better.  

Hi Matt:

There is some information available concerning RAVs and the various new DAAs, but there is very little guidance from the medical community for the insurance companies to interpret and apply the data to retreatment; nor is there clinical trial data concerning retreatment (that we know of).  

For the most part, the FDA knows what Pharma discloses to them about their drugs.  They learn more when the drugs are released to the public.  

BCBS is a federation of a few dozen health insurance companies; some of those are publicly traded and others are private. They are regulated by state and federal agencies but that regulation is limited.  You can contact your state insurance commissioner's office, your elected representatives, etc. but ultimately if BCBS refuses to pay you have to sue them.  

Most claim disputes are settled through the insurance company's appeals process.  I expect yours will be too. The longer they can delay paying the better from their point of view because the tx should get cheaper.  They also know policy holders can't afford to take them on in Court and that the legal process takes time too. Insurance companies vs. patients is not a level playing field.  

Insurance companies are not going to deny HCV tx indefinitely but they may end up deciding who gets treated when and with what.  That is the direction this appears to be going in.  Not a big surprise, really.  

This is all speculation, and with all due respect, fairly pointless at this stage.  We do not know BCBS's reasoning because we are not privy to it.  It could be that the lack of guidance from clinical guidelines and clinical trial results are forming the basis of BCBC's reasoning.  In other words, they have no affirmative evidence or guidance that retreatment would be effective so they might as well deny it.

Alternatively, BCBS may have information concerning retreatment that the general public does not.  We know only what Gilead has made public and it is important to remember that.  

The insurance companies have a strategy and it is probably just to delay.  They can give any reason they want and unless it is successfully contested via the litigation process there is nothing you can do about it.  Their only master (aside from their shareholders) is the law--either Congress or the Courts--and unless they are held accountable there they can do whatever they want.  They can make it up as they go.  That's the way it works, folks.  Rave all you want but it won't change the structure of the systems in which they are operating.  Public opinion can sometimes create change but HCV tx is not a popular cause.  

Matt,

This is a messy situation and I definitely feel for you. I haven't even had the chance to get into the battle yet, but I can see the insurance companies are taking a stance to save their butts. So basically they are saying that even though you have not taken any Sovaldi based regimen, you have taken an NS5B inhibitor (ABT 333), an NS5A  inhibitor (ABT 267). Therefore they are trying to reason that it's "medically unnecessary" to try the same classes of drugs again which Sovaldi and Ledipisvar are. Then, by their current thinking, you are blocked from using Simeprevir  because you also used a protease inhibitor (ABT 450) in the Abbvie clinical.  But don't lose heart I don't think they have any other option but to let you get onboard the Harvoni train because there is no other train to ride so I think you will prevail on appeal. Looking at the Abbvie clinical data, their drugs were not as effective as Harvoni for cirrhotics, but much more effective for non-cirrothics. So that's telling me that they are assuming you can't use the same class of drugs again without looking at the facts.  

i know ins companies don't care.  I mentioned previously what the CEO of a major NYS ins company said to my Dr this month "we don't care about patients we only want to give the perception we care"

but I will politely disagree on the rest. I won't kick and scream but I will get my facts together and present my case. I am not going to sit quietly on the sidelines letting others decide about my quality of life. 

It may seem stupid and & maybe they will laugh at such an idle threat, but I have waited a long time for this, I did everything possible to stay healthy during the interim - I am not waiting until I am in end stage liver disease; which could be around the corner or years from now.  HepC has already cost me enough and I want my life back now, before I get any older and am too decrepit to enjoy it even if I am cured! :)

Matt; those other drugs/combos that you mentioned they are using as criteria for denial; is there some supporting documentation that these particular drugs lower the success rate of the Harvoni?  Did they mutate the virus so Harvoni is not effective? What is their basis for this criteria?

I do imagine this drug will be available - but when?  A lot of us have put off treatment for years waiting for something like this to come along.  I've paid my dues - I'm not waiting any longer! They owe me that much - it's why I paid for insurance all these years. I am paying them go have access to the care I need and I expect to get a medication SPECIFICALLY developed to cure my disease! 

None of us should  take these denials quietly.  We spend a lot of time on the forums talking among ourselves - why not take 10-15 min of that time & put it into making our voice heard. Write the insurance company & tell them why you deserve Harvoni.  That it's NOT just about a "stage" or a "grade" or "cirrhosis".  Let them know you will hold them liable for all ensuing health issues that arise from not curing this virus because they withheld medication specifically for you.  Contact you constituents; local, state & federal / contact your local paper, especially if you have a more radical type paper that loves these types of stories.

I think too that it is very narrow minded of the ins companies to base criteria for treatment on how damaged your liver is.  Altho I am lucky that I have maintained a pretty healthy liver since being diagnosed in 2004; I am highly symptomatic.  I have all sorts of other issues that have cropped up that may or may not be a result of HepC but probably are that I am continually being treated for. I have Excessive Chronic Fatigue, COPD (I don't smoke or am around it), Arthritis, Fibromylagia, Gall Bladder issues, Hormonal imbalance, Stomach problems;ulcers, I must have ultrasounds every 6 mos - these have increased stress & depression so I see a therapist monthly.  I see at least 2 of my Drs every month plus a Chiropractor. As a result, my Dr is now putting me out on medical leave for at least 6 weeks for rest & try to focus on my health vs burning all my energy just trying to crawl my way into work. And, I have done everything right yet I still got this disease: I am a vegetarian, don't smoke or drink, a very active outdoor person & active in my community.

 I tried 2 of the other treatments & I didn't fail, I just can't take Interferon or Ribavirin I get way too sick.  So I didn't cost them thousands of dollars for 3 mos of treatment only to relapse.  I stopped as soon as I knew the drug was not for me.   I don't appreciate being punished:  for Gilead's decision to charge so much, the insurance companies failure to budget accordingly or the Gov's ineptness at having health care available to all.  

I guess it really shines the light on what motivates insurance companies when the very CEO of one says to my Dr "  "we don't care about patients - we just want to give them the perception we care"

Hey All

Thanks for all the kind and warm encouraging words, I am disgusted with short sightedness of BCBS insurance they have no grasp of the new DAA's on the market, unfortunately they have been led down a road where its criteria for treatment is unsubstantiated by any worthy Liver health organization. IDIOTS !

matt

P.S. will post some of there thinking later and ask for input on how to respond.    

I am stunned, Matt.  I thought for sure you would get it on the first try.  Medically unnecessary?  Are they friggin serious?  That decision will be reversed. They are stalling for time and hoping some patients will give up and/or the tx will get cheaper.   

I know you must feel completely devastated but take heart in knowing you WILL get treatment.  This is a temporary setback only.   

Matt,

That is staggering news! I'm so sick of these insurance companies and the direction health care is going in general. Maybe this is something Gilead will pony up and help you with? It's worthy try and worked for me when I got Sovaldi. UHC has been worthless in my pursuit of SVR.

Good luck and keep us posted.

-Rob

Matt, sorry to hear this.  I suspect many will have early disappointments with the cost of these meds.  I thought with my medical history the Harvoni would be a slam dunk.  While I got what appears to be good news tonight, I'll believe it when I see it.  Still hoping to be on board in the next couple weeks. 

Hey All

My Doctors request for me to be treated for 24 weeks on Harvoni had been denied.

The reason: Drug is considered medically un-neccessay

Bottom line reason BCBS is excluding any patient that has had prior treatment on another regimen containing any of the following : Sofosbuvir, Ledipasvir, paritaprevir (ABT-540), ritonavir, ombitasvir (ABT-267) or dasabuvir (ABT-333) either individually or as part of any combination therapy.

My Doctor is very mad about this outcome and will have a Doctor to Doctor/BCBS medical people disscusion about this with BCBS 

will elaborate more about this later

matt 

Ro- I hear you. My nickname at work is Zen and it looks like I'm be needing a little of that before it's over.

I did file an written "urgent appeal" today.  Though my denial letter stated I could file a verbal appeal, when the attempt was made I was told it must be done in writing?   My insurance states they have 30 days to respond to a "routine" appeal with a 2nd level appeal after that.  The urgent appeal requires they respond within 72 hours.  I have also requested all policy, parameters, protocols, limitations and or exclusions related to the provision of Harvoni.  I contacted my Dr. by email requesting her continued support in helping to get Harvoni approved.  If I felt better and had fewer health problems, I would be less inclined to push this.  Hoping I don't have to pursue legal remedy.  Ironic my pharmacy coverage is carved out of the primary insurance company.  When I contacted their pharmacy section for assistance they looked at the request and documentation and told me they would have approved the Harvoni request.  Needless to say I take very good notes, and document all people and times/dates I speak with.  Glad to see others already getting on board.  This train will be leaving the station on different dates and times.     Hope all in need get their tickets punched.     

Matt, I kind of agree, you are almost there..why make waves that may jeopardizie your place on line... In 4 days if nothing, then begin making waves;)

Hey All

Update on the process of getting "Harvoni" through the insurance companies review process via "Prime Therapeutics". After calling directly to Prime T. last week they said it takes 4-5 business days to process a approval. So I called today (day 6) they said its still going through the process and that they are half way through (lamb excuse) and that according to  company policy they have a full 10 business days to complete the review and render a decision. (stalling) 

IMO - Because of the enormous amount of dollars/money that is to be doled out on one patient times hundreds that they could be liable for they are going to take there full time have every dept. ( bean counters, lawyers, medical experts and every other executive branch of the insurance company give there two cents) Like they have not done this already.

One interesting side note that the person I talked to said was I could ask my Doctor to escalate the PA request to URGENT! and that they would supposedly have to have a decision in two days.

The question in my mind is, should I push them into making a decision or wait it out?  What's a better strategy ? 

Any Thoughts?

matt

Beacon, It is just a bump in the road.. There will be a seat waiting for you....Hang in there!

I agree, shadow10cats, and I didn't mean the word "rant" in a pejorative sense at all.  Sorry if it came across that way.

I was serious too about the ideas you touched on being a good idea for a thread of their own.  

Hi Mugsy:

Thank goodness; these tests are always scary especially for us cirrhotics.  My AFP has been elevated for a few years, and is going up not down, so I know how you feel.  Onward to SVR. 

Mugsy wrote:

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Hey Matt   My doctor had said there were two lists; one for F3/4 and one for those not needing immediate medication and I was in the top 10/15 of the A list.  I'm sure the reason he said 6 months was because OHSU hadn't set their protocol yet and they just had that meeting earlier this week. I have great faith in Karista's skills at PA writing because I think that is what her job is, to compile the info and put together the priors. My insurance is through Regence UMP  which is BCBS.

Thanks for the moral support on the AFP level. I am trying not to think too much about it. 

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 No cancer, just cirrhosis the nurse said. Never thought hearing  'just cirrhosis' would make me so happy.  Best of all, my CT scan was @ 2:30 and she made the phone call with the results @ 5:30. Two hours before I even got home!

Prime Aid Pharmacy just called me.  They do not participate with my insurance plan, but the script was sent to Accredo Specialty pharmacy.  I called them.  They have the script, it is being processed, my insurance covers with my copay 24 weeks 1 pill daily 30 day supply monthly.  Just waiting for a call to arrange delivery times etc!