Did you know re appeals for HCV Meds...

[Dbzc2]

Di you guys know that a website: HCVguidelines.org is being touted as the place for online "expert" medical advice for clinicians treating hepatitis C is being used as evidence and as guideline for medical appeals regarding insurance and new or non-FDA approved hep C treatments?

I didn't until I read a "Notice of External Review Determination" for an appeal I didn't initiate regarding me being able to extend my 12-week sovaldi & olyssio treatment I completed June 27th.  An internal review organization used ONE doctor with "expertise in hepatology," but NOT an actual hepatologist to make the decision. One internal med doc who is a board certified internal med doc. Who besides citing a website as a place for "expert" advice (managed by the AASLD and  ISDA association for liver disease), and two abstracts or talks at the recent April European Assoc. for the Study of The Liver this past April 9-13, 2014.

Back story, this was a waste of time since the review was done after I had already finished the first 12 weeks.  If approved, it would not have mattered because you can NOT have a break in medication.  The only thing I am appalled about is the lack of effort by a doctor that I would never go to for my disease being the single deciding factor for whether or not I get treatment.  Additionally, this so-called "expert" used dated info from the Cosmos trial data, which never went beyond the actual study....ergo, dated material not even relevant or up-to-date with any of the six recent studies that all call for a 24 week treatment plan with sovaldi.  That was the issue! Sovaldi, 12 or 24 weeks?  What a joke!  I am so glad this means nothing to me now.  

However, when Mike and Lynn warned everyone to be prepared and fully research your options, this was no joke!  You all need to know what is being said, studied, and discussed regarding YOUR options! If ever you are faced with an appeal, you must be a part of the process.  Some of the dates and labs were incorrect in is dumb document!  So, check out the website, and all of us interested in future options need to really get to the nuts and bolts of our options and assist in saving our own lives.  If not, you could get an appeal letter like I just did, which is unconscionable!  I'm upset for the future and for the unprofessional process my insurance company employed.  They paid this person for a report chalk full of errors!

Any comments?

[Dbzc2]

You make a great point and what got to me! The new treatments due to start recruiting patients who did NOT sustain a response! Those trials, which are in the midst of trying to get published, all advocate 24 week treatment plans.  Two using sovaldi! So this dumb reviewer relied on abstracts presented at a meeting using two year old data. This report I got was written a week ago.  This means this looser used a website and two abstracts to make a medical opinion that could have been life or death.  What's crazier, I have no idea what the appeal was done? I didn't ask for one? Yet the list says they have a letter from me? No they do not!  Then, when the appeal was begun, it was already too lat--I had finished my last two pills a week before the appeal was in full bureaucratic crud!  What a waste of time!

The bigger issue:  I should fight it to make an issue with why and how this appeal was done. This Appeal is uneducated and the "MD" who did it, is too lazy to being doing ANY appeals!  This is obscene that he/she did not bother looking at why the hell there are changes already being made to deal with the FACT not everyone is sustaining a zero viral load. It really makes me mad that un-educated people are getting paid a lot of money to write up a report that is not based on "relevant" facts.  Guys, gals, this is important for anybody who needs medical help outside the scope of normal insurance...which leads right to the second response about money.  

I am personally mortified that money is more important than saving lives! Yes Gilead has been helping, but really, to the tune of a NET profit of nearly 2 billion dollars a MONTH! That more than pays for the studies and new drug they have developed to get olysio/ Janssen, out of the picture.  That's what ledipasvir and dasabuvir essentially do.

Then there's the Turquoise study that had a 92% effective rate for the 12 week treatment and a 96% effective rate for the 24 week treatment--same exact drugs.  The facts have been known! This doh-doh didn't do a good job, and there were errors too!  The other study I have not mentioned is called the Ion-2 Study and is geared for experienced patients who did not do well on the current drugs.  One other study is called the Abbvi study.  I haven't even had time to look that one up.  Due to federal funding and public institutions, abstracts are easy to get if you use keywords request for proposal (RFP) in your search.

So tomorrow I find out what's up with my doc and then I will ask his opinion about me doing an appeal just to help make sure educated people are handling OUR lives! Not lazy uneducated people like the one who wrote my report.

Also, re money, vaccines are big business! There are several companies on that...it is in everyone's best interest to develop vaccines and stop this health crisis.  I do not think insurance companies want to continue to subsidize what I consider to be a "silent" pandemic....not just a silent disease.  Problem, the crazy virus does mutate and with so many genotypes, is a problem.  However, look at our side effects and the other areas of the healthcare system that are affected...eg kidney disease.  

In 1969, the govt passed a law that guarantees all kidney patients receive help due to the cost and at that time not enough research. So, transplants are cheaper than drugs and the treatments that are debilitating...kidney transplants are paid for by the govt.  

  I think we might be headed in that direction because right now it is cheaper to transplant a liver then to deal with these drugs....problem..the virus is in the RNA.  Typically the virus resurfaces within ten years of a transplant, and typically with a quick harsh response--sicker faster.  So, there are a lot of issues outside of hep c that make eradicating the disease more equitable than making money for temporary fixes. My bet, the drugs cost a lot now because the long-term picture for making pharmaceutical companies money is just not there.  So big money now, before it's fighting over the varying degrees of vaccines.... OMG,sorry,that was my rant on politics, healthcare and appeals reports written with inadequate information, and money motivated businesses. (I guess I left out sex and religion!)  

Please look up the studies and please find out as much as you can.  One thing I have noticed is I have you all to thank for filling in some of the blanks and then the personal side too!  Can you believe the media has been reporting for almost a year about the drugs most of us have been on as safe drugs that work and have NO side effects.... I mean, really?  We need to get the public educated too. That in turn is our family and friends, then on to legislators and hopefully a healthcare fix.  I am seriously tired of the dog and pony show I feel I've been on since my first clinical Interferon trial in 1994.  This is a great forum to get everyone educated, treated, and get our lives back.  If anything, take note of the appeals process, it most certainly can be fought and won--especially if they keep up the kind of "rejection letter" I just got.  This is why we all need to stay on top of this stuff.

Thanks, sorry I went off, I am very passionate about this stuff--beyond my life and onto the bigger picture too-because the personal sharing helps so much too!

Best wishes, dbz

[mhudnall]

Insurance companies deny treatment to increase profits, sadly that is just a fact of life when dealing with them.

The Solvadi stroy is well-known regarding Billy Tauzin, former LA representative who got bipartisan support for a bill that made it illegal for medicare and medicaid to negotiate with Pharma over prescription drug prices. The bill passed, was signed and a  week late Billy Tauzin was no longer a rep but had quit to become the head lobbyist of Big Pharma. That's why Solvadi costs $90,000 and why it will always cost $90,000. They paid good bribe money and already got their payback, so its done deal.

So if you think their goal is to eradicate HCV, that just isn't in their plans. And you always have to push for the right thing, especially if they balk.

[WmoMitch]

This 24 wk sim/sof issue could be important for many patients who are in high-priority classes for treatment.  It is critical to point out that the AASLD/IDSA guidelines do not reflect final COSMOS Cohort 2 data.  These guidelines include the statement:

"No SVR data are yet available from cohort 2, which received 24 weeks of treatment."

Of course that SVR data has been available since April 2014 and it showed that the small group of 24 wk patients all achieved SVR 12.  If an insurance company is denying 24 wks based upon the AASLD/IDSA guidelines, you have the right to point out that the guidelines were formulated without the most recent info.  AASLD/IDSA did a wonderful job of compiling data and recommending treatment, but the rapid pace of studies has not allowed them to keep everything up to date.  Some would argue that even this newest SVR data is not a powerful argument for 24 wks since the numbers were so small.  Read, learn, be your own best advocate.