Denied Sovaldi/Daklinza by Medicaid

[Onefluover]

So I was just denied Geno 3 treatment by Molina/Medicaid due to my F 0-1 score. As told to my doctor Medicaid will never pre auth with less than an F 3 fibroscore.

 I've done 150,000 tattoos and piercings in Denver alone, but left the industry two years ago in part due to complications of my Hep C. I may now have no choice but to rebuild a new tattoo empire with this disease active and worsening in order to pay cash for the treatment.

I don't care what anybody says who thinks they know what they're talking about. I was infected with Hep C via the Hep B vaccine in 1990 from the blood bank Nabi Biologicals and their vaccine so that I could be an immunized doner of which I then gave 10 gallons of immunized/tainted plasma. I could not have gotten it any other way.

http://hcvets.com/data/bloodmanagement/isg/toc.htm

 I've paid a million dollars in income taxes and other taxes. I understand these meds are beyond astronomically priced and it's a tough decision for insurers. And the innovators need to recoup costs and make some kind of profit. But somewhere, somehow, someone is going to have to give in.

[KimInTheForest]

Hi Onefluover, and welcome to the forums. Really sorry to hear your insurance refused to cover you due to low fibrosis score. That is an all-too-common story these days, and of course totally unacceptable.

That was an interesting link you shared. Thanks. I have always wondered about those immunoglobulin shots as a source of transmission of HCV. Have had those immunoglobulin shots myself many years ago for trips abroad.

Many/most people are appealing their initial denials from insurance companies, and they often do get covered after a long battle.

Buying generic Sovaldi from India is also an option that an increasing number of people are pursuing. $1,000 for a 3-month supply from India vs. $84,000 for same thing in US. Greg Jefferys is the information hub for how that works, having gone through it himself and now helping others to do likewise. He blogs about it here:

http://blogs.hepmag.com/gregjefferys/

Good luck, and do keep us posted!

kim

[Onefluover]

And I am truly sorry for anyone out there, potentially even on this forum, who may have received a Hep B vaccine of my blood. All of my donated immunized plasma hit the market. It only ended in July of 1992 when they called me in. Prior to this early 90's period of donating I was squeaky clean and had no way of knowing I was selling bad blood.

[Onefluover]

Hi Kim and thank you!

I'm not sure at this moment how to approach my appeal. I just received the paper copy of denial and it said that aside from not being at least F3 that the request did not contain the request form (which clearly says on the form it must), did not include a Child-Pugh score, no urine drug screen or substance abuse screen using a validated tool, no document on counseling of importance of treatment adherence and no lab reports, including INR, bil, al, eGFR, CBC and LFTs.

Most or all of these tests have been performed, including many more. It would appear to me that my doctor submitted my request for Hep C GT 3 treatment on a post-it. So how can I appeal this decision by Molina with completely incomplete documentation? I mean, I have copies of all test results performed except for the drug test (which I twice requested my doctor test me for as I already knew it was mandatory no matter what I may say about any drug history) and Childs. To me it means I have to go back to my doctor and basically tell him he railroaded this request in and must fix it and be trusted to do it again. That may be a tough one for me to have to face him down with. And I know if I do go and redo all these tests and submit the request correctly this time, I'm aware I will be denied again because of the Fibrosis score. My doctors assistant told me this over the phone, that even if we jump "through the hoops", Medicaid said they would never approve for less than F3. But if I am to try to sue Medicaid and possibly the Pharma Co's down the road then this appeal process must be finalized. I'm just not sure whether I should go back to my doctor or submit the appeal myself with my own docs that are still incomplete and now outdated.

I may in the future look into foreign meds but I'm aware of all the pitfalls in that.

My other gripe about being non-F3 denied is that GT 3 causes NASH etc and that it in turn causes non hereditary hemochromatosis which causes high blood pressure and all kinds of other issues that can kill you well before cirrhosis. Or something to that effect. And also decreases effectiveness of treatment.

[Onefluover]

Also I might add that my treatment was denied because "Daklinza is not approved". Which I take to mean that though the FDA has approved it, Medicaid has not yet.(?)

[KimInTheForest]

That's a very difficult situation you are in, Onefluover. And I am not the expert on the maze of insurance denials and appeals since I am in Canada, and our system is different. I know many people on these forums have somehow threaded their way through the insurance company maze in US and finally gotten their drugs after repeated denials and appeals.

I think all doctors who are trying to get their patients' Hep C drugs covered are these days faced with a great deal of extra work to make that happen. Some doctors (or their office staff) rise to that occasion and do whatever it takes with paperwork. But others, maybe less so.

I always think the patient is his/her own best advocate. If it were me, I would probably want to be submitting that appeal myself, and gathering all of the documents and lab results necessary for that. And if my current doctor wasn't forthcoming in giving me the tests or the results that I needed, I would probably find another doctor. Even though no one should have to go through all that BS, of course.

I believe there are some agencies that can help. You would almost be better with no health insurance because then you could apply directly to Gilead's Support path and get covered for Sovaldi+ribavirin. (Or sovaldi/daklinza if it is available.)

I am hoping some of the more knowledgeable forum members with experience dealing with the insurance companies in US and the advocacy agencies that can help you will chime in here.

Best of luck!
kim

[gnatcatcher]

Onefluover, I wish I had more than this one link to offer you. Bristol-Myers Squibb supplies certain support services related to its drug Daklinza and doesn't seem to rule out Medicaid patients for financial and other help the way Gilead rules them out:
https://bmsdm.secure.force.com/patientsupportconnect/servlet/servlet.FileDownload?file=00Pi000000PGTP1EAP

Courage, and good luck!

Gnatty

[Onefluover]

Thank you Gnatty. I will call BMS and go see my doctor to inquire about his part in filling out this form. It's an odd situation that two competing companies offer a medicine that only works when combined. That I am sure will be consolidated in the near future. But if I can get BMS to cover Daklinza then maybe it will be easier to get Medicaid or even Gilead to cover Sovaldi. And another benefit of applying to the link you posted for me is BMS will have my case in their system and may reach out to me down the road for test/study of something new. Thanks!

[Maxlaw]

I have two thoughts on your situation.  One, it is my understanding that any FDA-approved drug must be provided by Medicaid.  Daklinza is now FDA approved.

Two, have you thought about a clinical trial? I was GT3a and was cured by AbbVie's next generation protease inhibitors, ABT-493 and ABT-530 in this trial:

https://clinicaltrials.gov/ct2/show/NCT02243293?term=abt-493+abt-530+genotype+3&rank=1

This trial is still recruiting and, in fact, has recently added new cohorts due to the success of the 12-week cohorts for non-cirrhotics.

I was also denied treatment by my insurance company because of low fibrosis score, but since I had GT3a and was infected 40 years ago, I didn't want to wait through a protracted fight with the insurance company or wait to get "sick enough" to meet their criteria for treatment.  I sought out the clinical trial and was lucky enough to get accepted.

Good luck to you...you WILL get cured!!

--Max

[Joe NM]

REGARDING YOUR APPEAL/MISSING ITEMS ON PRIOR AUTHORIZATION REQUEST:
You can submit all of those labs, etc., with the appeal (always submit everything required with the appeal, just like you would with a Prior Authorization). You can give written consent for your doctor's office to file the appeal as well and then you won't have to do a whole Medical Records Request to get those labs. If it's a Medicaid program, they may say that the labs all have to be within 6 weeks of when the Prior Authorization was submitted, so if that looks like it could be the case, you can have the required labs re-done before submitting the appeal and include those with it. Part of the Appeals process is giving you a chance to submit new documentation not included with the Prior Authorization.

[Onefluover]

Joe NM, thanks. I have copies of all the labs. Made sure I went and picked them up each step of the way. What had not been tested and therefore not submitted in addition to what was tested and not submitted that was required was a drug screan, biopsy, and fibroscan. (I had a Fibrospect 2 done). Anyways, I have most of the labs but yes, most are now well over the 30 day lifespan mentioned in the denial. Going back to this GI (who is actually hundreds of miles away) and asking him to fix this mess and submit a proper appeal to me is like hiring a security guard to watch over your property and while you're away he cleans you out. I'm not one to go back for more punishment. And so.... I have an appointment with a new GI who is local and I suppose I'm going to start this process all over again but this time I'll know what to watch out for.

[Onefluover]

I have two thoughts on your situation.  One, it is my understanding that any FDA-approved drug must be provided by Medicaid.  Daklinza is now FDA approved.

Two, have you thought about a clinical trial? I was GT3a and was cured by AbbVie's next generation protease inhibitors, ABT-493 and ABT-530 in this trial:

https://clinicaltrials.gov/ct2/show/NCT02243293?term=abt-493+abt-530+genotype+3&rank=1

This trial is still recruiting and, in fact, has recently added new cohorts due to the success of the 12-week cohorts for non-cirrhotics.

I was also denied treatment by my insurance company because of low fibrosis score, but since I had GT3a and was infected 40 years ago, I didn't want to wait through a protracted fight with the insurance company or wait to get "sick enough" to meet their criteria for treatment.  I sought out the clinical trial and was lucky enough to get accepted.

Good luck to you...you WILL get cured!!

--Max

Max, thank you!!! I called yesterday, both numbers, but could only leave a message and I emailed as well. All I can do is wait now. I would jump at a chance to enter a study such as this. And hearing your brief story of being cured gives me hope. These modern studies are highly advanced and reletively safe bets. And then I wouldn't be costing the tax payers via Medicaid for life saving treatment -though I paid a million dollars in taxes myself and wouldn't feel too terrible about the Gov footing the bill. One thing though I fear is that I am now living hundreds of miles away from the nearest study site. I have no idea what that may mean. Would I be required to travel to a location multiple times? I could do it but depending on how frequently. I have a young child and a newborn. But I sure hope they reply. Thank you!

[Onefluover]

That's a very difficult situation you are in, Onefluover. And I am not the expert on the maze of insurance denials and appeals since I am in Canada, and our system is different. I know many people on these forums have somehow threaded their way through the insurance company maze in US and finally gotten their drugs after repeated denials and appeals.

I think all doctors who are trying to get their patients' Hep C drugs covered are these days faced with a great deal of extra work to make that happen. Some doctors (or their office staff) rise to that occasion and do whatever it takes with paperwork. But others, maybe less so.

I always think the patient is his/her own best advocate. If it were me, I would probably want to be submitting that appeal myself, and gathering all of the documents and lab results necessary for that. And if my current doctor wasn't forthcoming in giving me the tests or the results that I needed, I would probably find another doctor. Even though no one should have to go through all that BS, of course.

I believe there are some agencies that can help. You would almost be better with no health insurance because then you could apply directly to Gilead's Support path and get covered for Sovaldi+ribavirin. (Or sovaldi/daklinza if it is available.)

I am hoping some of the more knowledgeable forum members with experience dealing with the insurance companies in US and the advocacy agencies that can help you will chime in here.

Best of luck!
kim

Thanks Kim!
And you are right. They told me so! She said that even if we jumped through all the hoops I would still be denied. So I guess that freed my GI up to submit the request for medication without any of the required protocol. In this case, like you, if there is an appeal then I must do it myself. Except again, my appeal done myself would be fatally flawed due to lacking required tests. So, as you suggest, I've made an appt with a new GI and one I will meet with and deal with directly. (The last one was actuall his assistant. The GI was 400 miles away. This is part of the reason why they flopped my treatment prescription.)

Thank you for your concern and help.

[Scoutdoy]

Hi Onefluover, just a little info my doctor told me when submitting paperwork for my medication and probable appeal. I was approved for Harvoni but they were expecting me not to be and started the process to for my appeal. They have an extremely high approval rate there even when insurance initially denied the med. he said it is very very important that every single list of symptoms be included. For instance, if you woke up one day with a headache,,,headaches go on the list....knees were sore one day...joint pain go on the list....don't leave out a single thing. Fatigue....your so tired it's difficult to care for your young children, making your quality of life bad...do you see where I am going? I have young children at home and I am a single parent...they included all that information along with their ages, etc... That is probably why his office has the highest success rate of approvals in the city.

scout

[Else]

So, as you suggest, I've made an appt with a new GI and one I will meet with and deal with directly.

Good call!  Your experience with your first doctor (or the assistant) was ridiculous.  Just because they did not think you could get approval does not give them a pass for not even trying.  Your request was missing so much information I don't think it even qualifies as a legitimate request.

Scout's recommendations also really important.  Best of luck and don't ever give up!  You will get treatment.

[Onefluover]

Scout, thank you for the advice. I will add that to my tool box. Truth is I do have many of the typical signs and symptoms. The most notable is headache, severe and frequant. But many others. I will make sure I stress this to my new GI and that I want him to relay that info to the Pharmacist.

[Onefluover]

Good call!  Your experience with your first doctor (or the assistant) was ridiculous.  Just because they did not think you could get approval does not give them a pass for not even trying.  Your request was missing so much information I don't think it even qualifies as a legitimate request.

Scout's recommendations also really important.  Best of luck and don't ever give up!  You will get treatment.

My thoughts exactly, Else! Below I will quote the pertinent part of the denial. It reads to me as if Sovaldi wasn't even mentioned by my GI. Daklinza is never prescribed by itself and with GT3 is prescribed along with Sovaldi at this time. The denial also reads as if Daklinza is not approved by Medicaid. Or it was just worded wrong. If I were the doctor subject to this denial I would be quite embarrassed:

   "... Molina Healthcare of Utah has reviewed a request by your healthcare provider,****** *******. Your healthcare provider requested DAKLINZA TABLETS to be authorized. MHU denied the request for DAKLINZA TABLETS at this time because:

The asked for drug Daklinza is not approved. Using standard and accepted rules a Molina Healthcare Doctor of Pharmacy has looked at this request. You do have hepatitis C. To have this covered you must meet the rules in the guideline. There are no chart notes that show one or more of the following: No Hepatitis C Drug Prior Authorization request form, no stage 3 or greater fibrosis confirmed by liver biopsy or Fibroscan, no compensated liver disease confirmed by Child-Pugh score less than or equal to 6, no urin drug screen, no screen for substance abuse using a validated tool, no documentation that member has been counseled on importance of adherence to therapy, and no laboratory reports including INR, total bilirubin, albumin, eGFR, CBC, and LFTs within last 30 days. You would have to meet all of the rules before this could be approved. Please talk to your provider about your healthcare options..." 

It's so dumb because all these labs were done. The Childs-Pugh is calculated based off these labs. It is a 5. I mean he litterally applied to save my life on a post-it when he had it all right in front if him. 

[badbradley]

Onefluover,   
                    Sorry to see someone else going through this BS. I am battling similar issues with my treatment team. It sucks that this medicine is priced so high, you have to battle insurance co. denial after denial, then have to deal with an incompetent treatment team that doesn't have your back on top of everything else. It's very stressful and frustrating.  I will get treated one way or another.
     I don't blame insurance cos. These drugs are priced too high. At the end of the day, that is the problem period. THESE DRUG PRICES NEED TO COME DOWN!!!
     Good luck on getting your medicine. Keep doing what you can do. I will keep updating periodically. Best wishes.
                                               Brad


                                                                   

[Scoutdoy]

Wow, that denial reads as if your medical team didn't do crap! I mean come on, many of the things they said your doctor didn't provide are routine. I would be absolutely livid with your medical team. Get a copy of all your records and see which ones you actually had and then have a consult with the Drs. Office and demand to know why the request wasn't done properly. I would be very pissed if I were you

Scout

[Onefluover]

Brad said, "I don't blame insurance cos".

I agree, Brad. I generally don't like insurance companies. But they are to some degree off the hook in this. They owe at least a certain degree of payouts and I see them doing that. They shouldn't be made to bankrupt themselves.

And that's not even considering the fact that if they were bankrupted, where's the fairness to all those who paid into their system that now loose their investments?

The pharmaceutical co's now, on the one hand they're truly saving lives. On the other their greed is killing people. I look at it like this: now that a cure has been discovered, the federal gov has a moral obligation to see to it that all hep C cases are treated.

Since the cost, if the gov picked up the tab, would bankrupt the gov, then hep C is a threat to national security. That can only leave one option. The pharmaceutical companies either lower their prices dramatically or their patents get yanked.

I know that's contrary to a free market capitalistic system but national security should trump that.

[Onefluover]

Wow, that denial reads as if your medical team didn't do crap! I mean come on, many of the things they said your doctor didn't provide are routine. I would be absolutely livid with your medical team. Get a copy of all your records and see which ones you actually had and then have a consult with the Drs. Office and demand to know why the request wasn't done properly. I would be very pissed if I were you

Scout

Yeah... Primum non nocere.

I am disturbed about it the more I think about it. But what can I do? Start over with a new Doc only to still be denied. It's all I can do. Go from there. I will not ask this former GI to fix this. Hell no. 

[Else]

Brad said, "I don't blame insurance cos".

I agree, Brad. I generally don't like insurance companies. But they are to some degree off the hook in this. They owe at least a certain degree of payouts and I see them doing that. They shouldn't be made to bankrupt themselves.

It wouldn't bankrupt the insurance companies.  Most don't pay anywhere near the retail, much publicized, price of the infamous $1000 pill.  Or the $1125 pill in Harvoni's case.  They get massive discounts from the manufacturer.  They are not required to disclose what they actually pay - and they don't.  The average discount is 46% (I got this percentage from the HCV Guidelines update.)

The HCV Guidelines were amended on August 20th to address this.  http://www.hcvguidelines.org/full-report/overview-cost-reimbursement-and-cost-effectiveness-considerations-hepatitis-c-treatment.

To put it another way, a 12 week course of treatment could actually cost the insurance company $51,000, NOT $100,000.  That's the cost of a hip replacement to site just one example.  Many other treatments for chronic diseases well-exceed the cost of a CURE for HCV infection.

The whole "the cost of treating this silent epidemic will crash the healthcare system" is bulls**t.

But an election year is coming up so we'll all hear lots of said b.s.  Alas, politics is in fact a part of this whole fiasco.  The HCV Guidelines say as much. 

[Onefluover]

It wouldn't bankrupt the insurance companies.  Most don't pay anywhere near the retail, much publicized, price of the infamous $1000 pill.  Or the $1125 pill in Harvoni's case.  They get massive discounts from the manufacturer.  They are not required to disclose what they actually pay - and they don't.  The average discount is 46% (I got this percentage from the HCV Guidelines update.)

The HCV Guidelines were amended on August 20th to address this.  http://www.hcvguidelines.org/full-report/overview-cost-reimbursement-and-cost-effectiveness-considerations-hepatitis-c-treatment.

To put it another way, a 12 week course of treatment could actually cost the insurance company $51,000, NOT $100,000.  That's the cost of a hip replacement to site just one example.  Many other treatments for chronic diseases well-exceed the cost of a CURE for HCV infection.

The whole "the cost of treating this silent epidemic will crash the healthcare system" is bulls**t.

But an election year is coming up so we'll all hear lots of said b.s.  Alas, politics is in fact a part of this whole fiasco.  The HCV Guidelines say as much.

No, I agree with that as well, Else. Everyone who paid for insurance is entitled prompt treatment, whatever the costs. But even at the discounted prices it is sure to wreak havoc. They say the true number of infectee's is probebly three times higher. I am admin advisor on the worlds oldest and largest pandemic flu and everything virus forum so I know a little about how and why the true numbers are even much higher thàn that but assuming ten million is the number (in US), even at the roughly 50% discount, that's a half a trillion dollars. Though spread out over probebly many years, I see your point. It would wreck some insurers but is not undoable. But a more realalistic approach would be for the gov to step in and squeeze the cost of treatment down to something more reasonable like about 10k or even less but mandate that all Americans get tested and treated if infected. The savings would pay for that "wall" which is just considering that 80 years ago hepatitis did not exist in the United States and most of all forms came from south of the border.

So my opinion is that the government should force the pharmaceutical companies to reduce their prices substantially lower. The insurers should then cover all insured cases of which Pharma will still make a mighty fortune, and the government should cover the remainder if for no other reason than national security because I'll tell you what. I once single-handedly put 1,200 people on food strike and 3,000 on work strike over some stupid donuts and I have the potential to become quite p****d off over this and there is a very large army of us out there.

[badbradley]

Government is not making any headway in their attempts at drug price negotiating.http://www.reuters.com/article/2015/02/02/us-usa-budget-medicare-idUSKBN0L61OW20150202

Also , this is just an example of one drug company pressuring insurance companies.

"If a patient's insurer balks at paying the $1,000 per pill cost of Sovaldi or the $94,500 cost of Harvoni, Gilead may now deny the patient medication access via it's own patient assistance program," said Michael Weinstein, president of Aids Healthcare Foundation."In essence, Gilead is holding Hepatitis C patients hostage as a negotiating strategy with health insurers for drugs that they ridiculously overpriced in the first place, so whatever discounts Gilead has offered are most likely rendered moot. Gilead has always been at the forefront in overpricing it's medications as well as price gouging government programs, but this is entirely new territory--it so plainly shows what little regard and compassion Gilead actually holds for patients. Blacklisting these patients is nothing more than a means for Gilead to pressure - shake down really - the patient's insurers."

http://www.businesswire.com/news/home/20150722005839/en/AHF-Criticizes-Gilead-Blacklisting-Hepatitis-Patients-Patient#.VfWnTzNRHIU

[Else]

So my opinion is that the government should force the pharmaceutical companies to reduce their prices substantially lower. The insurers should then cover all insured cases of which Pharma will still make a mighty fortune, and the government should cover the remainder if for no other reason than national security.

I couldn't agree with you more.  And good for you for not being passive in effecting change in the past.  It's citizens like you that make a difference.

Great but unhappy links, Brad.  It kills me to see the supposed "leader of the free world" go to Big Phrma - hat in hand - asking for sustainable pricing.  Our government has a very strange way of deciding when to throw its weight around.  And when not to.

"Free market forces"?  Bah.  Let's see someone throw their hat in the ring, maybe funded by a Kickstarter, to give Gilead some good old-fashioned capitalistic competition.  No?  But we're all free to try. 

[Mike]

I'm not a fan of big Pharma; but I do understand cause and effect and basic economics/business.

If the government forces a company to reduce prices, that company will 1.) quit providing the product, 2.) be less inclined to invest the billions in capital to develop new 'miracle' products  and 3.) take the government to court, thus tying the issue up for many years due to the protracted legal fight.

Consider, for example, that there was a $11 billion dollar investment to bring Sovaldi to market, which was the precursor of Harvoni. If a company can't recoup the R&D costs, and make a profit, these drugs (and many more in the R&D phase) will not come to market.

Then what? It's a catch 22.

There is also the fact that 80% of those with chronic HCV infection have no symptoms, have no liver damage and won't develop liver disease. This is one of the reasons, along with cost, making insurers are balk on the 'treatment-for-everyone' protocol.

I'm not saying I support the wait and treat approach. I don't. I am saying, however, that I understand the underlying reasons and there are no simple solution.


Best wishes, Mike

[Scoutdoy]

Although I don't like it, I believe you are absolutely correct Mike. Why would a company spend years and money to research and produce a drug if they gain nothing for their efforts. If you for one minute think research for cancer drugs or HIV drugs are getting done just for the moral issue of curing people then I have a bridge to sell you. If there is no incentive there really is no production and technology ceases to move forward. Do I like it? No. Do I think one persons life is more valuable than another's ? No. Life isn't fair, and in a few years when the patents expire and this drug is a generic,,,many lives will be saved. The number of people who will die waiting or fighting for this drug will honestly be insignificant compared to the number of lives saved over the next 50 years. Unfortunately,  we are in this group of people and some of us will die. I hope not, but realistically....it will happen.


Scout

[Mike]

The good news is that people with advanced disease are getting approved for treatment with the new direct-acting antivirals (e.g., Sovaldi et. al.). Moreover, there are more drugs (DAA's) coming to market and future treatment costs will drop.

In addition, HCV progresses slowly and most those infected can forego immediate treatment without consequence.

The bad news is that some with no, or minimal disease progression, aren't getting  treated due to insurance denials and an inability to pay the out-of-pocket costs  (note: insurers don't deny treatment, they deny payment for treatment).

The simple truth, however, is that there is not an infinite number of public health dollars available to cover the entire disease spectrum (cancer, diabetes, heart disease, MS, MD, ALS, HIV, HCV, orthopedic injuries and so forth). Scarce treatment dollars mean manged care and treatment denials.   

Consider this: for every health dollar spent on diabetes or cancer treatment, management and care, one less dollar is available for (insert your favorite disease/disability). 

The sad fact is public health dollars are limited and finite.

Lastly, nobody supports a wait-and-treat model, and sound public health policy would include a treat-all protocol with the latest and greatest medicine available.

Perhaps we will arrive at this medical nirvana in the future- but we're not there yet. And I can't see it on the near horizon.

Best wishes, Mike

[Onefluover]

I'm no socialist so I have to agree, Mike and Scout. I made my own millions without interference until the state gov came in and interfered and I sold and walked away. Now I don't make squat.

I do think the meds are ruthlessly overpriced. What, they, Gilead, made 18 billion in the first 90 days of Harvoni? Much more since then and much more to come. Not bad. But who am I or is anyone else to define what is a fair or just profit?

I feel tugged in both directions on this one, believe me. Did you'all know that the US Government holds the patent on the Ebola virus? Including any vaccine or cure of any type? You know why? So that no group or country can discover a cure and then horde that cure for their own interests while others die. They hold many, many such patents for the same reasons. Not so that they can make a profit or horde it for them(our)selves.

http://www.google.com/patents/US20120251502

Hepatitis C is a world wide pandemic. There are 3 million infected in the US. Believed to be three times that many and I think even more than that. I never did drugs prior to being diagnosed let alone shot them. No tattoos. No gay sex. No transfusions. None of the well-established known routs. So how did I get it? And the rarest genotype to boot.

I've twice been through the series of vaccinations for Hep B. Either the vaccine infected me or Hep C is easier to aquire than is realized or admitted to.

My point is that all those quiet and symptomless people out there who are not in dire need of a ludicrously expensive bottle of pills are probably quietly spreading this bug around potentially with exponential growth.

What do we do when one in 3 Americans are infected with no symptoms? In the name of national security the government has the authority to yank the patent(s) and make the medicine themselves if they wanted to.

Not a good thing for a freedom loving country but look at all the other s**t they do and get away with.

But rather than go to that extreme, I'd prefer to see a gentle negotiation in which the companies who invented these drugs reduce their prices in exchange for a mandate by the gov that everyone get tested and treated.

Pharma will make more money that way and all will be happy.

[Onefluover]

Going back to Maxlaws tip on clinical trials with link, does anyone know more about this? I called them and left messages on both numbers provided plus emailed them but have heard nothing back.

I'm anxious in part because this trial window is rapidly closing. Is it common to not get a return call or email for days or weeks? Do they only respond if they're interested in you? And what if I live outside of any of the trial sites? For me the nearest locations would be in LA where I'm from or Denver where I just moved from. If that wouldn't disqualify me would I be expected to travel to a site frequently? I will if I must. I meet all of their criteria except maybe my location.

I would be so happy to be a test subject if it meant a shot at being cured and I could bypass the whole government insurance (Medicaid) mess I, as an F0/1, face.

[Maxlaw]

Hi One,

I asked to be referred by my gastro doctor to the doctors in another city (about 75 miles away) who conduct many different trials. I got an appointment with one of the doctors there and told them I was interested in being considered for a trial...he told me the first thing we needed to do was a liver biopsy, both to have a definitive answer as to where I was with my liver condition and because the trials would require it as some trials are for non-cirrhotics only and some are for cirrhotics only. I scheduled the biopsy, and a few days prior the study coordinator contacted me about the trial I ended up being in. I had to make a quick decision because they were only taking 10 people for this particular trial at this site. I did have to travel there for 14 visits (but got paid $50 for each visit upon conclusion of my participation). I went once for a screening visit and then once a week for the first month, and then once a month after that until 12 weeks post-treatment, and then the final visit 3 months after that.

--Max

[Onefluover]

Thanks Maxi! This tells me much and is a great help. I won't hesitate to travel if I must. I'm 400 miles to LA where I'm from or 650 to Denver where I just moved from. I've got 2 motorhomes, 2 trucks, 2 cars and a Harley so I can do this while my family stays here. If they would just call me back... I have my first visit with the new GI on the 29th. Maybe he can get ahold of them. I would so rather enter this particular study than push for Medicaid coverage that I probably won't get. In fact this study is the only one open for G3. It's really my only hope.

Thanks! Oneflu

[Else]

I'm glad you're keeping up with trials opportunities.  But don't give up on getting treatment through Medicaid either.  From the way you described it, you never really got a legitimate "prior approval" submitted at all, so I would utterly disregard that denial.

Having said that, your new doctor's first request for a prior authorization probably will get denied.  That's just the first step, not a defeat!  Make sure all of your extrahepatic manifestations are duly recorded in your medical record, and repeated by your doctor in a "letter of medical support".  And repeated by yourself in any cover letters you write in the appeals process.

Have your own copies of all information sent to Medicaid by your doctor on your behalf.  (You really want to be 100% sure on what was actually sent.  Trust but verify.)

So you're in California?  Check this site out for current info.  https://www.cms.gov/Medicare/Appeals-and-Grievances/MMCAG/

Exhaust every level of the appeals process.  In each denial letter you will be told in (fairly  ) clear language what your legal right is in further appeal options.  Don't quit.

According to your sig line, your fibrosis score may be low (F0-F1, right?)  But you have compelling additional medical complications.

My fibrosis score was "too low" ( ) at F1-F2.  My viral load same as yours.  I take my second Harvoni today at noon.  Don't let anyone tell you it can't be done.  It can! 

[Onefluover]

Oh yeah you bet, Else! New GI and as far as I know all tests will be redone and resubmitted promptly. I have all copies of labs, everything except whatever they submitted that was denied because nothing was submitted...

This time I'm sure it will be done properly because the new GI knows why he is the new GI. If he were to do the same thing I would definitely sue.

No, I'm in Utah. St George. I'm from Burbank CA where there is a test site nearby and I moved here from Aurora CO where there is a test site. LA is closer but I havnt lived there for a long time. Aurora is further but my two businesses are still open there and one of my business landlords lives on site of my business on acres and would alow me to park my motorhome there during this test cycle so that I'd have a place and shower, etc, and would only need to pay gas. This landlord is my best friend. ironicly, my other business landlord ownes two of only five businesses alowed inside of the worlds largest medical research facility where this test is being conducted. he is alsi my other best friend. My landlords really liked me.

 Except that I just got off the phone with the folks doing this test and was told it closed two weeks ago but a new GT3 test will open in two months and they will work to get me into this test. This is great news!!! Infant stages but gives me a lot of hope. They are going to email me the info today so I will know more later.

[Rosie13]

Hey onefluover, I just read this whole exchange before responding because it was so excellent from all the contributors.I was in your position just a few weeks back.one thing I did was travel to experts because my local GI's were so pathetic.That was Mayo clinic in Florida. They did all my appeals but I was being told that there was nothing they could do because my insurance did not cover name brand drugs...hello there is no generic.I had to fight the nurse!Then I stated calling foundations for help.wide eyed I had about $60,000 in one afternoon.
Patient Advocate Foundation 800-532-5274 gave me 10k goes to specialty parm.
Patient Access Network 866-316-7263 gave me $15k & once used get 15k more
Genetech (Gilead program) 877-505-6986 tops out $23,625
After all my dialing for dollars Florida blue decided to cover me under the major medical portion of my policy.The nurse apologized. Please know we are pulling for you to get CURED! Push hard...I am on day lucky 13!

[Else]

Rosie, you're a rock star!  That is some amazing fund raising.  Wow.  What great resources you've passed along!   

[Rosie13]

 :)Hi Else! Noone was more shocked than me! After being dragged thru the mud all week......each call gave me a clue to the puzzle.The my path program was not useful because the insurance refused everything & Gilead will only help if insurance  is paying something.They didn't tell me about the other program.I think the specialty Clinic gave me the last clue...the big get!!!!!!

[Bree]

Insightful thread all the way around.  Lots of resources also.  Every day I'm amazed by the resilience, tenacity, and lengths that we go through to find a way.  Great points across the board on pharma and gov.  I'm so grateful for agencies that help outside of insurance too.  I ended up getting approved through Support Path a minute before they changed their rules by a lady there who championed for me.  So, as much as the cost of treatment is just plain sad, they helped me in the end so I'm very grateful.  I applied even after my doctor kind of said don't bother.  Glad I didn't listen to the naysayers.  Good luck to you onefluover.  I feel like it will work out for you!

[Rosie13]

Bree, I hear you on the way things seem to just workout. We break our spirit with worry & being told no. Your Dr. told you forget it. My nurse told me the insurance can't change their policy for you . I think you prevailed because you had a relationship with your councellor @ Giliad. My nurse called to congratulate me & apologize. If I had not found this forum I may have given up. Let's hope lots of Hepc'ers  find our stories & it keeps them pushing for their lives. I am so grateful for all of the kind people here &  would love to live next door to you all!

[Onefluover]

Rosie, thank you for the numbers. I have saved them and will be going in that direction soon if other avenues fail.

Bree, thank you for your wishes and compliments to this thread. Dito! I wish you all the best too!

Rosie, I don't know if you'd like to live next door to me. My Harley is about the loudest around!!! I live in a quiet secluded neighborhood of almost exclusively Mormon Bishop doctors. I don't think they're too thrilled by me...

Updates:

I got a call from the Special Pharmacy to tell me that activity had been restarted on my prescription. Not knowing what was up I called my GI's office and ended up with his assistant's assistant. A very nice and friendly young lady she was. She told me that after reading the denial from Medicaid she felt bad for me and took it upon herself to resubmit the request for meds and include all the labs and forms etc available and also to personally argue my position to them. Not an appeal as I understand it but a resubmission of an incomplete request. She told me she had a lady who's case was similar to mine and she personally pushed and hounded Medicaid until seven months later, a week ago, they gave in and authorized the meds. Yaaaa, clapping, clapping! But I do wonder if my GI doctors office personel read these posts. 

The other thing is that thanks to Maxlaws post here I am now registered and on a list for any of several AbbVie GT3 trials opening up in about Nov in LA. I chose LA over Denver on account of LA is 400 miles away, Denver is 650. Denver would be a three day round trip. LA I could leave in morn, do my one or two hour visit and be home by bed time. But I made millions of dollars in Denver recently and so have reasons to go visit. Except this isn't about fun visits. The lady from LA said that the drugs they are testing have a higher likelihood of success than Sovaldi/Daklinza for GT3. She also said that they already have a list of subjects compiled so there's no guarentees I'll make it in this round which I understand but also that there's a trial coming out next year that they have high hopes of being 100% effective for GT3.

Thanks everyone for your responses and input.

Ken

[Maxlaw]

That's all really good news, Ken! How nice of that young lady to do that for you! Looks like you may be getting cured sooner rather than later! Glad I could contribute some useful information. I was told off the record that the next gen AbbVie drugs I took were "highly successful." It is my understanding that AbbVie intends to combine these into one drug for a once daily dose for Phase 3 which is to start early next year (the results of the Phase 2 trial for GT3 that I was in will be published in Feb. 2016...originally were to be published this year, but they recently added the 8-week and cirhhotic cohorts because of the high success, so the phase 2 trial was extended a bit).

Good luck to you...and keep forging ahead as your own advocate!

Best,
Max

[Else]

I smile when I read your posts, Ken.  No wonder you were in business for yourself!  Not only are you going to get medication - you're probably going to be able to choose. 

I have quite a few Mormon/bishop/doctors for cousins.  I imagine the sound of a bike over the din of babies and children sounds pretty secretly appealing.