Hepatitis Forums
Hepatitis C Main Forums => Considering Hepatitis C Treatment => Topic started by: FutureThinker on December 22, 2015, 10:16:20 am
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Is anyone taking this combo for Genotype 1? It's typically for GT 3 but is recently being recommended for GT1. Insurance denied Harvoni, so this one might get approved. Thanks for any info.
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not taking it here but I know it works very well
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It's one of the recommended treatments, per the treatment guidelines: http://www.hcvguidelines.org/node/72. Makes sense, since Daklinza is supposed to work on any genotype, so Sovaldi + Daklinza should work as well as Sovaldi + Ledipasvir (otherwise known as Harvoni). If insurance denies this (I hope they don't!!!), then you could try for Viekira Pak (plus ribavirin for 1a, no ribavirin for 1b)...if insurance denies a Prior Authorization and an Appeal for THAT, the drug company has a Patient Assistance program called 'proCeed' that can get you the medications for free...unlike the makers of Sovaldi and Daklinza. https://www.viekira.com/.
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Thanks, Joe NM --- I saw that this combo is now on the recommended treatments, just wondering if anyone is having insurance issues as with the Harvoni. I went through 2 appeals and Harvoni was still denied. Trying not to have to take the RIBA (required with the Viekira for GT1a), so this one may be possible for me to start treatment, finally! This is a relatively new addition for GT1, so also wondering re: side effects, etc.
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Did you take your appeal to the independent external review you are guaranteed under the Affordable Care Act. That is how I got my Harvoni approved. It works.
Also, Dr. Freeman at fixhepc.com is conducting a huge e trial for 3000+ people.
It's called REDEMPTION.
Coach Mike
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Coach Mike --- Thanks for the info. I have the IMR forms, but my doctor is now recommending the Daklinza hoping my insurance may cover. We also considered resubmitting for Harvoni, and if denied, then doing the IMR. I see there is some info in this forum from people taking the Daklinza w/ other GTs, but it seems this drug combo is relatively new. I'll also look at the info on the trial. Thanks! FT
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What insurance company do you have and/or who is it through?
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BCBS, which is requiring fibrosis of F3 or higher to approve treatment. I prefer not to wait till I get to that point, obviously!
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May want to try to get approved at the beginning of the year as a lot of BCBS plans are removing fibrosis requirement or reducing it to F2 for approval.
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WOW, that's fantastic news, if it's true!!! How do you know about this, as it affects a lot of people! I was reading last night about new drugs in the pipeline and see that Gilead has put in for approval of Velpatasvir as of Oct. 28th, and the Astral studies were very promising. So, next year may be "the year" for many of us, as new drugs get on the market and if you are correct, the F3+ requirement is removed.
Please expand on this info re: fibrosis stage requirements! Thanks, FT
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I'm a Pharmacist that works with doctors office's to help patients get approved for these types of therapies. I know for our state, BCBS has recently lowered their Fibrosis requirement to include F2 patients. Some of the surrounding states are also rumored to be decreasing their Fibrosis staging requirement at the beginning of the year as well, or to remove it completely. January 1st is a huge time for insurance plans as a lot of insurances reevaluate their policy on the drugs and/or therapies they are going to cover. Hopefully your BCBS plan is lowering their requirement, keep in mind not all states are doing this. There is a possibility that some states could even tighten their criteria for treatment and move up to F3/F4 only. But most of the states surrounding me are loosening their criteria.
A majority of plans basically use Fibrosis staging as their sole criteria for treatment. This is due to the AASLD placing patients at different "categories" for urgency of treatment. http://www.hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy-box-summary-recommendations-when-and-whom-initiate. Obviously patients with the most severe complications of HepC such as F3/F4 fibrosis are highest priority for treatment due to the higher likelihood of severe complications such as liver failure, transplant or HCC. Unfortunately, a lot of insurances use this list to say "well, patients that aren't meeting Highest priority criteria per AASLD don't need to be treated yet" and have inappropriately used the guidelines to limit treatment to save money. When in reality all the AASLD was doing is telling clinicians, "hey, these are the type of patients that could die soon if left untreated or the virus complications will progress at a faster rate than other patients.
Like I said though, this may not be indicative of your plan. With an F3/F4 plan such as yours, their policy and procedures for HepC can only get better, not worse. If you were my patient, I would retry getting you approved for Harvoni or Viekira (whatever their preferred product is) at the beginning of the year. My guess is that your plan wont pay for Sovaldi + Daklinza regardless of your Fibrosis staging, as its almost double the cost of Harvoni or Viekira and < the same efficacy.
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Thanks for the info. I agree, now that I've looked more into the Daklinza info, it is more expensive than Harvoni so it is doubtful that BCBS will cover. Not sure why my MD thinks they may. I also agree in how the insurance cos have been using the AASLD guidelines, and I noticed the newer guidelines since the 11/15 meeting have changed their wording somewhat re: F1-2 patients. I need to go look at my insurance's Specialty drug list to see if Daklinza is even on it at this point. And, as I mentioned in my last post, the new Gilead drug application adds more to think about.
Lots to think about in this new year! Thanks again, FT
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Just saw on another topic on this forum that one person's insurance approved the Daklinza but not the Solvaldi.......... perhaps that is what my doctor was referring to when it was said that my insurance might pay for this. Doesn't help much, though, when the Solvaldi is $80,000. FT
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Here is my 2 cents:
13 months back on a flight from Asia had terrible chills, fever and bad liver pain with bloating. Anyway got home and somehow knew it was the Hepc causing this. It was high time to get treated. We dont have insurances in my country similar to the US but the law states that Hepc MUST be treated with state money and EVRYONE MUST BE TREATED.
Cutting the story short the doctor refused sovaldi or harvoni. They advised peginterferon + ribavirin without any fibroscan done or anything like that.
I refused.
Travelled again to Asia fibro done it was in the range 10-15 kpa. The doc there said F3 fibrosis wait for Harvoni its coming or take sovaldi, peg interf. and ribavirin.
I needed time.
Back home it took 6 months to get a new fibroscan BUT I HAD DECIDED I was going to Bangladesh or India to get that Harvoni if they Doc still had problems to give me Gilead Harvoni at home. My country does not allow import of medicines by post or courier.
The cost of generic Harvoni which works as good as the original costs JUST $ 1200 for 12 weeks by DHL from India. Thats 84 orange tabs :D. The US does allow import for 3 months for personal use.
In my case the EU put out the law that all F3/F4 MUST BE TREATED ON PRIORITY.
My fibroscan showed 26 kpa V/Load 900000, the doctor could not refuse. I got the 3 months of Harvoni, I was surprised. Its been 22 days I am on it.
So I hope you got my drift if the US insurers are acting bitchy just go elsewhere. Its really possible. The Indian companies are licenced by Gilead and you need just 12 weeks with the low fibro you have.
There is also a Pharmas market at fixhepc site, check it out if you decide to import it.
So HAPPY NEW YEAR and God bless. Wishing you well and hoping to see you get well soon :)
I am not a native English speaker so please excuse my language :P
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Thanks for all the info and thank goodness you are in treatment!! I just saw last night that the FDA intends to make an approval decision on the new Gilead drug (SOF and VEL) by/on June 28th........ I think I'm going to call Gilead and discuss my situation with them and get a bit more info on this new combo. Since Solvaldi is in it, I'm guessing it's going to be $$$$$$, but I'm going to find out.
Happy new year to you, too, and let's hope with possibly 4 drugs on the market for GT1 that this will be a good year for many of us. FT
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Hi,
One can get Twinvir shipped to the U.S. from a trusted source for $1000 for 12 weeks.
CM
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Hey Coach Mike, Came across some of your other postings under "Just going to Buy Harvoni" last spring when you were fighting SO hard to get treatment -- very inspiring!!! At any rate, I am going the IMR route for Harvoni, so I'll post again in the near future when that battle is decided. It just shouldn't be this hard to get treatment for a confirmed medical condition in the USA....... FT
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Wow,
This has been a journey!!
My experience pales, however, to those pioneers like Lucinda and others who went through the "interferon" era.
I was very fortunate. Many people have not been.
We have an effective cure now.
No one should have to fight to get it.
Period.
But, if you DO have to fight, or just prefer to, fight like hell.
CM
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So the answer to my original question came yesterday from the FDA: Daklinza + Solvadi is now approved for GT 1, along with 3. Very good news!! This is gonna be the year......... FT