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FDA Sued by Health Advocates Over High Cost of Harvoni

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Hartford, CTIt is difficult to know what is really motivating two public health groups bent on finding out why Harvoni, the blockbuster Hep C drug, is so darned expensive. But one can assume, given a rise in denied claims and corresponding Harvoni Denied Insurance Claim Lawsuits, that Treatment Action Group (TAG) and the Global Health Justice Partnership (GHJP) can envision on the horizon a pattern of denied claims as insurance providers balk at the expense inherent to Harvoni.

The efficacy and effectiveness of Harvoni in the treatment of hepatitis C is not at issue. But its cost is: a single treatment regimen, which involves taking one Harvoni pill per day, costs $94,000. While insurance companies generally are not allowed to deny a claimant due medication as prescribed, they can seek less expensive alternatives. The problem is there is no real alternative to Harvoni other than its close cousin, Sovaldi, which is almost as expensive. That said, it leaves insurance companies with little choice but to fund the expensive medication or find creative ways to deny a legitimate claim.

Hence, the uptick in Harvoni Lawsuits. The Gilead Hep C Denied Insurance Claim Lawsuit filed by the two health advocacy groups is not tied to any specific denied claim but rather tackles the very issue as to why many such claims are denied: the exorbitant cost of Harvoni, which the plaintiffs in the lawsuit describe as “unprecedented.”

TAG and GHJP - the latter backed by the Yale School of Law - initially attempted to get to the bottom of the exorbitant price charged for Harvoni through a request for data from Gilead in November. Other pharmaceutical companies have apparently stepped to the plate, but there was no data forthcoming from Gilead.

Undaunted, the two advocacy groups next filed a request under the Freedom of Information Act with the US Food and Drug Administration (FDA) in December. TAG and GHJP would like the FDA to comment on why the costs for Harvoni and Gilead’s Sovaldi are so prohibitively high.

However, it has been reported that the FDA has yet to respond to the request, leaving TAG and GHJP little recourse but to sue. Which they have done, launching a lawsuit against the federal regulator.

“This delay will leave doctors and patients in the dark for too long,” Amy Kapczynski, a Yale Law School professor and director of GHJP, said in a statement. “Prompt disclosure of this information, which the FDA already collects, will allow doctors and policymakers to make more-informed treatment choices with real and immediate consequences for public health and spending.”

The plaintiffs claim that communication from the FDA suggested it could take up to two years to process and respond to their Freedom of Information application, without any guarantee of approval. In the meantime, patients in need of the benefits afforded by Harvoni remain at risk of having their insurance claims denied, due to the prohibitive cost.

There is also concern over the clinical data the FDA used to approve both Sovaldi and Harvoni, given the two drugs were fast-tracked to market. “Public access to the raw clinical trial data is necessary so that doctors and patients can make informed treatment decisions and cost-benefit determinations,” the complaint says. “As it stands now, doctors and patients lack the benefit of any independent assessment of the data that led to the approval of Sovaldi and Harvoni.”

The Gilead Hep C Denied Insurance Claim Lawsuit brought by the two health groups over the high cost associated with Harvoni is Treatment Action Group et al. v. Food and Drug Administration et al., Case No. 3:15-cv-00976, in the US District Court for the District of Connecticut.

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READER COMMENTS

Posted by

on
After close to three years of rigorous tests denials, two specialists and three insurance plans I was finally approved for Harvoni. Actually on my 6th day of treatment. Viral load went up at my last blood test and my specialist attempted for three months but claim was denied and I was only approved for two months. Funny thing is I was on Medicaid for two and half years and was denied for close to two years. I got a raise at work and got kicked off Medicaid and was forced to buy works second most expansive medical plan and when I told my specialist my new insurance info Harvoni got approved that day. It's sick. From Medicaid to private insurance it got accepted in 12 hours. I work at Home Depot and my prescription coverage is through CVS Caremark. After researching some things I found a news article that cvs Caremark reached a deal with Gilead on Harvoni so my assumption is CVS gets it at a nice discounted price because my copay was 75 dollars per bottle. I pray all of you get this. It's a sick sad world where there is a cure to eradicate the virus and people are worried about filling their pockets. Greed is sick.

Posted by

on
I'm an RN who happened to practice in very high risk areas for HCV. But in the 70s and 80s no one KNEW about it. I was a dialysis nurse for 10 years and a trauma nurse for 6. Plenty of opportunities to have contact with infected blood. I'm now 67 and was told my antigen was positive. Went to see the specialist who told me not to worry, all my preliminary labs look good (liver and renal profiles and CBC) . He did the viral test to confirm and yes, I have a rather.low viral load of 1.2 million. My liver scan was perfect,,,not a scar to be seen. So I I was placed on Harvoni. I was very worried about my co pay: I have Medicare part D.co pay 3700 per bottle.and I need 2 bottles. Since I'm on the cusp of retirement, there are a zillion other things I could use 7K for...oh well. BUT my doctors office hooked me up with the Patient Access Network for Co pay help. I called, they asked a few questions and in less than] 5 minutes told me I qualified for a 15k grant! I was so relieved I started to cry. They work in conjunction with the Liver Foundation. They're very kind and will offer you all sorts of help from group therapy to talk groups.
My problem was I was very angry. I have had this at a minimum of 38 years and possibly 60! I had a lifesaving transfusion at 7. I have no symptoms, no damage and the Harvoni is like taking an aspirin.
I'm fairly confident my blood work will be negative after the first four, I can Feely self feeling less tired, more awake.
I know I'm very lucky and very blessed to have virtually nothing but a few viri floating around, and not even a lot of them. So for anyone who is still a red. Worried about the cost, the Patient Access Network helped me.

Posted by

on
There is a service that will take you to another country and you can buy a generic for $20k for 84 day supply.

Posted by

on
I feel very lucky and angry. I have genotype 1 and started the Harvoni regime two weeks ago, prescribed to me out of the VA in Houston with no problems to access.

When I researched the costs, I was dumbfounded. How many people are going to die from a lack of access to this drug?

Big Pharma is a big racket.

Posted by

on
The price of this drug is ridiculous and to deny anyone their given right to health is absolutely monstrous. I have a close friend with Hep c and she's started a go fund me page if anyone could please either share it or contribute it would be greatly appreciated. I wish you all the best and I hope something is done soon, to wait for people to get sicker before offering them assistance is barbaric.

Posted by

on
If you live in Canada and can afford the cost, I think the only way is to come to US to see a Dr. to get the prescription and purchase the medication, hope this would help.

I also heard that in India, it costs only $4.00/ pill for Harvony??? I haven't traveled so don't really know if it's true or not.

Posted by

on
I live in Canada and can't get Harvoni. I would even pay the money if I could get help. Any suggestions?

Posted by

on
Making money on the weak and sick of this nation is so sad, you people are going to hell

Posted by

on
In 2004 I became indigent got medicaid and they paid a year of Pegasys Interferon/Ribavirin and Procrit.
Almost $150,000

Posted by

on
The article says they dont know why the groups filed suit? How about big pharma and government dont care about curing people, they care about making $$$. Almost 100k for a fast tracked drug? Who has a 100K sitting around for this? The insurance companies are even worse, just deny deny deny any claim. This sh*t is disgusting and these people should be ashamed of making $$$ off of sick people.

Posted by

on
These prices are ridiculous. The Va paid for my BF treatments and he has cirrhosis of the liver. The dr who treated him against the VA,s wishes was fired bc of the cost and the fact he was so sick. The virus is gone now which will give him more time. For those who just have the virus its crazy that the insurance companies wouldn't want to get a grip on this to stop the spreading of it. How can people afford the treatments??? Shame on them!!!!

Posted by

on
I don't get the high costs and denials. It not only helps the people with hep c bit it also protects numerous healthy people from getting it.

Posted by

on
95,000. to cure hep c which is defined as no virus dected after 12 weeks of ending treatment. No promise of undetectable traces of virus not being able to replicate at some later point. No information about successful treatment for patients with super high viral loads like me 31million plus. How about 95k for cure of liver dusease left behind due to the virus that has disappeared. Can liver disease progress simply due to the damage already done. Cirrhosis to no cirrhosis and backwards through all the stages or even some? I read about insurance companies and medicare are trying to figure a formula for covering claims "the sickest patients" possibly wirhout more mire info on the result of ridding the body of the virus sounds to me like healthier patients with lower state fibrosis would benefit more than a person sick with cirrhosis at a point of no return.

Posted by

on
My lil. Bro. Has hep c, and the price of this treatment is just wrong! But if he was in another country there would be Dr.'s w/out something do all they could to help, but not our own country men!! For sure this world is goin to hell in a hand Baskett, and the pharmaceutical companies will be at the head of the line, may they all rott and their money's with them! In Jesus name, amem

Posted by

on
I am on medicaid and they paid for 56 weeks of the old interferon (didn't work) & will deny nutritional supplements because I'm over 18. I am waiting to see if this will be covered. The price is ridiculous. I'm sure medicaid has thousands with hep c.

Posted by

on
I can't believe the cost of these drugs. I was recently diagnosed with Hepatitis C, and was relieved to find it wasn't a death sentence because there are drugs that can actually cure the disease. When I did the reseaech on the drugs I almost threw up. How does the government body that regulates the cost drugs allow this to go on. I know the cost to make drug is probably less than $5.00, and that's on the high end. I might as well just throw in the towel. This is not the country I at one time was proud to say " This is MY country ",no longer do I hold those feelings. To deny hard working people the access to a drug that might save a life is unthinkable. I hope all involved in this pricing of medications sleep well. Icpray that they never have to suffer what us little people are going through because of their greed.

Posted by

on
Drug companies are making millions on the backs of sick American people. There is no earthly reason for them to charge the 94K for medication that is lifesaving and tissue sparing. How dare they? How dare the FDA approve such a cost? It's a known fact that drug companies charge US citizens astronomical costs when the same medications are available in other countries for a minuscule of what they cost here. And why is that? Because US insurance companies have historically paid out the money for the medications. I don't believe insurance companies are to blame, I completely place the responsibility at the feet of the drug companies and the lawmakers who allow them to literally rob people in need of medication or else die a tragic and/or early death.

Posted by

on
Why aren't people just as mad at the Drug Companies that are more like pimps, than concerned partners of your health, and the FDA who pushed these through without fully vetting them for safety, and effectiveness. I was denied two drugs when they first came out for blood, but as it turned out, they were very dangerous, and now involved in lawsuits now for the number of deaths caused by them.

Posted by

on
I am currently awaiting word from nurses that handle the insurance companies. I am 67 years old have Medicare and a part B supplement and my Humana part D. After reading all the blogs and what is going on I am getting really discouraged. It's all about the money. The big fish eat the little fish.

Posted by

on
I was thinking or finding a doctor to treat my hep c with all the advances of harvoni but after this article it seems hopeless to try im on disibilty medicare and medicaid qmb oand it sounds like it will be to no avail.please contac me back thanks

Posted by

on
I am one of the unfortunate people that has went through the insurance maze of denial for the treatment i need and deserve i am so upset about these unethical companies and the government that i don't know what to do next. HELP

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