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Boceprevir Approved Today

Very exciting!
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223152 tn?1346978371
You can do better than that.  Lone Star?  You are right about what happens in the dark shadows of the insurance companies and the pharmacies.  Hope it is sooner than later.
frijole
Helpful - 0
Avatar universal
frijole: a case of LoneStar if I recall,  but it's not over till it's over - I still have no pills in hand. This part of the process - what happens in insco cubicles - is way more mysterious than any of the biology, trials or FDA review.

Trish:
>GD embellishes just slightly at times,
NO! tell me it  isn't so,,,besides even an un-embellished hemorrhoid is no fun.

Not sure there's much to be done to speed up the time it takes chain pharmacies to update their computer systems regardless of what the manufacturer does. The pharmacist did advise trying other pharmacies, some may be more prompt.
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Avatar universal
I showed my Dr the new drugs coming out on my 2nd visit, he said he didn't know anything about boceprevir but said he knew about telaprevir so I think tela is the one I will be on.
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Avatar universal
yeah....I have to say, that would have been my personal choice too, simply from dealing with a non-tela itching issue.  You do realize that GD embellishes just slightly at times, right?  I'm not convinced those eggplants were emerald-encrusted, I think they were green rhinestones - which I suppose are only slightly less terrifying.  

Up to a month to get into the pharmacy....I wonder if Merck would push it a little faster to your pharmacy if you happen to say...."by that time maybe Telaprevir will be on the market".  :-\  Looks like you'll be one of the first pioneers with this and it will be interesting to see how this all unfolds.  Hope this all happens quickly.

Hope you're managing okay with your side effects and you're getting a break here and there.

Trish
Helpful - 0
223152 tn?1346978371
Dang!.  You have the Rx.  I guess I lost the bet.    (Do you rememember what the stakes were?)

I have a consult in Dallas on 6/10(new heppo at the clinic I consulted with after relapse) and we will see where it goes from there.

frijole
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Avatar universal
thanks for the good words! I ended up settling on boce over tela because of the sides.

The discussion of "anorectal" distress in the vertex submission was the final straw. Isobella had posted on this but I had assumed it was related to one  of those mucous membrane mysteries of female anatomy beyond the comprehension of mere males. Mremeet's comments convinced me otherwise - and I've  been heavily influenced (terrified even) by GD's horror posts regarding passing pineapples and emerald-encrusted eggplants .

So it'll be victrelis. Dr. wrote the rx and submitted it to my insco for approval who will presumably ponder this for weeks. As of today my local Walgreens did not yet have victrelis in their computer system. Pharmacist thought up to a month, I'll check with Merck.
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Avatar universal
"saw my Dr, yesterday ro ask about the roadmap from here. He said after approval, send an email and he would write the rx. Then take that to  a pharmacy to trigger the other two unknowns : availability and insco coverage."

This is exciting, to think you could be on a PI relatively quick.  It will be good to see how the unknowns shake out finally after all this waiting.  I would have to think they want to be really quick out of the gate with Telaprevir approval on their heels and Telaprevir will also want to be quick out of the gate with Boceprevir already out there.  As the doc quoted in the article said, insurance companies will have a hard time denying any coverage for these meds due to the demand and based upon much improved results when they're included. I think however it will be good to finally *know*.  One of other threads on this suggests that Merck is ready with a patient assistance program also, so looking good so far.

Good luck with this....I'm glad this came around in time to fit into your own treatment and I hope things shake out well.

Trish
Helpful - 0
683664 tn?1330966324
Wonderful news!  Here's the part I like best:

The demand will be high, and there's no way insurance companies can avoid paying for these," said Dr. Lee, who participated in clinical testing for both boceprevir and telaprevir.

Wishing SVR for all,
Lapis
Helpful - 0
Avatar universal
I just wanted to say how happy I am that these new drugs are finally being approved. Those of you who have waited so long and patiently hopefully your time has come. And frijole, you'll always have a special place in my heart. I've been post tx/svr for 3 years and 2 months now, after my 72 week bid. You were one of the first to come to my aid with valuable info that could only be emailed, which helped convince my insurance company and show my resolve to my hep doc that I wanted and needed to do my 72 weeks of tx...So thank you again and good luck to all!!
Pro
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223152 tn?1346978371
This is such a relief.  I have printed the 31 pages of labeling information -- ah for quiet Saturday afternoon reading.

The clinic in Dallas I consulted with after relapse has made me an appointment for June 10.  That in itself was interesting because I never managed to call them back when they called to schedule one.  So they must have scheduled all relapsers to consult on new treatments.  I do plan to go.

Thank you, FDA and thank you, researchers.

frijole
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Avatar universal
From the Wall Street Journal

By JONATHAN D. ROCKOFF

The Food and Drug Administration approved the first new treatment for the infectious disease hepatitis C in almost a decade, green-lighting a Merck & Co. drug that heralds a wave of stronger medicines.

Hepatitis C patients, particularly those who failed to respond to existing treatments, have been waiting for an approval like Friday's, of the drug boceprevir. More than three million Americans have a chronic form of the disease, which can destroy the liver and kills 10,000 Americans each year.

Existing treatments help just a minority of the infected. During clinical testing, boceprevir cured about two-thirds of patients, compared with less than 40% on current therapies alone.

Boceprevir is a pill that will be taken three times a day and be used with current treatments, an injection of extended-release interferon and an antiviral ribavirin pill. That means patients will continue facing side effects like fatigue and depression that are a risk of existing treatment.

During clinical trials, boceprevir was also linked to a higher incidence of anemia.

Some doctors complain that the regimen for administering the drug will be difficult to master.

The FDA is expected to decide soon on telaprevir, another so-called protease inhibitor from Vertex Pharmaceuticals Inc. and Johnson & Johnson. These drugs work by binding to the hepatitis C virus and preventing it from multiplying.

The two drugs are the first in a wave of new agents attacking hepatitis C that analysts expect to increase a $3 billion world-wide market threefold by 2015.

Merck, of Whitehouse Station, N.J., plans to sell boceprevir under the brand name Victrelis. The company will begin shipping the pills to pharmacies within a week, a spokeswoman said.The company said the drug's wholesale cost would range from $26,400 to $48,400 a patient, depending on the length of treatment.

That means treatment will be expensive. Treatment with the current drugs costs $28,000 a patient, according to William Lee, a hepatitis C doctor at the University of Texas Southwestern Medical Center in Dallas.

But the new drugs "are clearly a step forward. The demand will be high, and there's no way insurance companies can avoid paying for these," said Dr. Lee, who participated in clinical testing for both boceprevir and telaprevir.

He says at least 80 of his 500 patients are waiting to use one of the new agents.

According to the FDA, the last agent it approved to treat chronic hepatitis C was the interferon Pegasys, from Roche Holding AG's Genentech.
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Avatar universal
I just saw this about 5 mins ago online.  Yea!  Now, if any of us can find a way to be able to get it paid for!

Susan400
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Avatar universal
Wonderful news and so long in coming, thank you for posting.
-Dave
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1658980 tn?1330711550
Yikes!  Who can do that?
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29837 tn?1414534648
$1,100 a week OUCH!

Magnum
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1253246 tn?1332073310
Something that I just read on Merck's website:

The wholesale acquisition cost (WAC) of VICTRELIS per week is $1,100.

Wow!!!! cindy
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Avatar universal
Good new and very anxious to see the availability of this med and what the insurance companies/rx plans will cover.  
Helpful - 0
Avatar universal
thanks for posting. The FDA docs, with approval letter and label are here:

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

saw my Dr, yesterday ro ask about the roadmap from here. He said after approval, send an email and he would write the rx. Then take that to  a pharmacy to trigger the other two unknowns : availability and insco coverage.
Helpful - 0
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