On OFF LABEL Sovaldi and Olysio!

[GrammyA]

In my 3rd week now and feeling really strong.  Without the nasty Interferon and Ribavarin this time - I have had minimal side effects and I am so very grateful!  My 2 week labs came in today and ALL of them are in normal range... including AST and ALT.  Second month of the meds have been ordered and are now on their way so stay tuned for more updates as we knock out these 12 weeks of treatment.  I truly believe this 3rd attempt to SVR will be the final one as it will be the cure I have needed using these 2 drugs!
I will keep you all posted.
Hugs and God Bless!

[mike716]

Hi, ZapFan.

Thanks for clearing things up about how it works with the specialty pharmacies and the insurance issue.

Did Olysio make you apply for coverage and get denied by Medicare? What was the point to that, if your plan A doesn't cover drugs?

Isn't it a little scary to start Tx when you only have one or two bottles of each med, since they could stop sending them and cut you off in the middle of treatment? This has always worried me, because I have seen it happen in Buenos Aires with an HIV/HCV co-infectee I know there. There was some kind of screw-up and the meds became unavailable for a while. But maybe this doesn't happen in the U.S.

I don't even have social security because I worked free-lance all my life and didn't pay in. And my income is very low, some years none at all, as I am living off savings that are invested where I get hardly any interest. I have to sell pieces of my invested savings to live. So it wouldn't be fair of the drug companies or the insurers to force me to pay for insurance. But maybe they don't care about fairness.

I have a hospital health plan in Buenos Aires, where I live part of the year, but it's cheap compared to U.S. medical insurance and covers all test procedures, which are done in-house (ultrasound, MRI, CT, bloods, Fibroscan, viral load PCR, biopsy, etc.). Medical is much more "popular" down there, and there are even lots of public hospitals where you can get excellent attention for free.

The lady at the specialty pharmacy that's handling my scrips said she would keep me updated every few days. She called me on Friday to say that all necessary paperwork was now in the hands of the pharmas. She's very nice. Of course, I am becoming a nervous wreck from all this uncertainty, despite having lived with the knowledge that  have HCV for six years. I have never gotten used to the anxiety and have to take pills for it.

Good luck with your Tx. With S+O you should be okay.

Mike

[mike716]

Hi, cackywalker.

That is a strange story indeed. So many ups and downs, you must be emotionally exhausted.

I guess the pharmas can make you try to get insurance. I didn't realize that until recently. I have a feeling something similar is going to happen to me, although one of the pharma assistance programs said I wasn't eligible for Medicare and Medicaid (something about the time of year).

On the other hand, it's good of Gilead to help you by getting your MD to write the letter of necessity. It shows that the pharma assistance programs are pro-active, which is a very good thing.

Why did it take so long for the scrips to get tranferred to an in-network specialty pharmacy?

Making a cirrhotic person wait 1-1/2 years for Tx is inhuman and shows clearly how screwed up this so-called health system is. It's shameful.

But good luck to your hubby!

Mike

[ZapFan]

Hi Mike

A letter of denial is a letter of denial you get if you apply for extra help with Drug coverage... if you have to many resources you will be denied for the extra help, also known as a low income subsidy. The makers of Olysio require you to apply and get denied if you claim you have no drug coverage, as I do not, because I refuse to sign up for medicare part D. I am on SSD and cannot afford to pay for Part B or D..I only have part A. Which is no charge and covers major medical like hospital stays, etc.

Yes, I did receive 1 bottle a Month, so ,by the time I started I had to bottls each of Sovaldi and Olysio, and 2 mo. supply of Ribavirin...I now am on week #6 and I have all the meds for the 12 wk treatment.

Yes, My doc at SB contacted the specialty Pharm, and gave them all 3 scripts, refills included, and they did the work.....but like I said, you need to keep them on their toes...the more you call the faster it will happen.

At first I was applying on my own to all 3 drug co., and faxing them info ....but I should not have done this, because the special pharm was doing it for me, so, it was a little counter productive...but you do need to supply the drug co...with anything they ask for.

[cackywalker]

To make a long story short, my husband got hep c, g 1A, from a blood transfusion in 1985 when he had leukemia.  In Jan 2013, a CT scan for another reason showed cirrhosis, and a liver biopsy as well. He tried to get on clinical trials at Emory in Atlanta for over a year, and he thought he was going to be on one in in April, and made an appt with his hepatologist for clearance.  Then the trial was canned.  BUT our hepatologist  saidhe could get my husband on Sovaldi/Olysio.  The speciality drug company  he used was TLC Pharmacy in Louisana.  They were great. Olysio was approved almost immediately.  But Gilead required that my husband apply for Obamacare ( were uninsured, but had Christian Healthcare Ministries which is a sharing program).  He was approved for Alliant Solocare here in Georgia, gold plan.  At first, they denied coverage for Sovaldi, but Gilead had our doctor do  a letter of necessity and Alliant approved payment.  They Gilead covered the $16,000 copay.  We pay $5.00/month (plus the monthly premium).  The sad part was that TLC pharmacy was not in network with Alliant, but they transferred the prescrips to Diplomat Pnarmacy.  So after a 1-1/2 year wait, my husband started the treatment on June 4th!

[mike716]

Hi, ZapFan.

Thanks for all the helpful info.

I'm having a similar experience. The specialty pharmacy told me they will take care of contacts with the pharma companies. I just had to write a brief letter and send it with my 1040s from last year to the specialty pharmacy, who called me and said they will let me know what's happening.

Coupla questions:
- What is a letter of denial from social security? How do you get it?
- Did you receive one bottle a month and stockpile them instead of taking them? That's what it sounds like from your post.
- Did Stonybrook get the specialty pharmacy for you?

The Stonybrook patient assistance program sounds great. I wish I could do it all there, but it's so far away, and I'm already signed up with this private MD in Manhattan.

I guess I'll just wait and see what happens. Even if I'm approved by Gilead and Janssen, I may get hung up on the co-pay.

Cheers.

Mike

[ZapFan]

Mike,
I went to Stonybrook gastroenterologist in East Setauket, Long Island on Feb 5.
They prescribed Solvaldi/Olysio/Ribavirin for 12 weeks as per the cosmos study.
I'm genotype 1a for 28 years.
I applied to Gilead for Solvaldi, J&J for Olysio, and Ribavirin with Karman Pharmacy..I filled out apps, faxed income info, applications, all kinds of things.. kept calling the companies , kept bugging my Doctor...I thought I was doing the right thing...After 3 weeks of this faxing , calling, etc.,
the Doc called me and said a specialty pharmacy was going to secure all the meds and send to my home. Apparently she gave them all the rx's.... I kept calling them to see whats up.
Well, finally after 2 months I got approved for all 3 meds. So I did not really need to do anything except fax over my SSD income.
J&J  and Gilead both needed a letter of neccessity because Olysio and Solvaldi together is off label use. once I got that letter things began to move. J&J also wanted a letter of denial from social security for the low income subsidy, they still sent me meds while I applied for that, and the letter was due in 3 months, I already would be finished with the treatment by then, I faxed that letter as soon as I got my last bottle of Olysio.
Finally in April I had all 3 meds in my hands..It was like gold.
But, I was not allowed to start yet, i had to get more bloodwork, and I had to change or stop some other meds for another condition because they would interfere with the Hep C meds, and I had to get an ultrasound.
Then I  went for orientation, and finally started on May 1.
After 2 weeks my liver enzymes were normal for the first time in 28 years.
After 4 weeks my viral load that started at 1.5 million, was now undetectable!
I still have 7 weeks to go.
Only bad side effects were anemia from the Ribavirin,
Otherwise I feel great.
So good luck...let the specialty pharmacy do the work, but keep calling them to check on the progress.
I am on SSD, only have medicare part A....no Part B, or Part D.....
And it is over $150,000 for 12 weeks....
Part D is no good, they want like a $13,000 deductable.
And I get 90% off my bills thru the Stonybrook Hosp. patient assistance program....any other questions, lemme know.