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Hep C Discussion Forum -> On Treatment -> Harvoni 8 wks vs 12 wks for treatment experienced
Post Info TOPIC: Harvoni 8 wks vs 12 wks for treatment experienced
awaw5


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RE: Harvoni 8 wks vs 12 wks for treatment experienced
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Tig,

Thanks!! Your reply was extremely helpful. Lots of useful info that i will put to good use. 



__________________

54yo, geno 1a, DX 1983 HCV

TX #1: 1999 DAILY IFN 3mu & Ribavirin for 9mos. Stopped Tx in 7mos due to HCV RNA of 260,000 increased to 1 Million from tx.  

TX #2: SOT 7/21/16 Harvoni. 

SOT: HCV RNA 3 million. F1-F2, NASH N0. ALT 288, AST 116

Current: HCV undetected, ALT 22, AST 19
Tig


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Hello, 

Your story follows that of many individuals being roadblocked by their insurance companies. Your physician MUST go to bat for you and represent you in your appeal. Your physician should be making the appeal. There are a few things that come to mind and I'll list them. You can use this as ammunition to support your position. You are most definitely in the 12 week category according to the AASLD/EASL Guidelines set forth this year.. Your doctor should know this and trust me, so does the insurance company. They may be using your low fibrosis score and low viral load to justify it, but guidelines are guidelines.

There have been Federal court decisions made this year that overturned the denials based on funding and the necessity for advanced disease being a requirement for treatment in general. You aren't being denied treatment, just the recommended treatment duration. Show them you know better and offer it to them.

There are records somewhere and I'm sure the insurance company can find them in the NSA database (sarcasm noted), if they wanted to. So here are some thoughts and opinions. They may help you develop a plan. I'm also including the current AASLD HCV Guidelines and Gilead's own ION Phase 3 trial summaries. You will note that nowhere do they recommend 8 weeks for treatment experienced. The earlier phase 2 results may speak of treatment results in 8 week TE patients, but if they had been effective, they would've been part of the Phase 3 trials.

So here are some thoughts: 

  • AASLD 2016 Guidelines state 12 weeks of Harvoni for TE Int/Riba patients
  • Doctor should be representing you in your appeal and ask for a peer to peer consult.
  • Insurance carrier is basing decision on cost (jmho) Not ethical.
  • Request the name of the individual that recommended this course of action.
  • Your former Insurance carrier will have your records of treatment, call them.
  • Contact previous lab and see if they maintained records from that treatment.
  • Contact previous pharmacy for medication records.
  • If they subject you to the wrong course of treatment and you relapse, demand a guarantee of the correct treatment on demand and before fibrosis progresses.

AASLD 2016 Treatment Guidelines

Gilead ION Phase 3 Results

 

One last thing, Ellen Guthrie is a Board Certified Internal Medicine Specialist. Records show her in Salt Lake City. She must be the physician making the decisions for your health carrier. Your doctor should be having a little chat with Dr. Guthrie. If your doctor is a Gastroenterologist or Hepatologist, his/her knowledge and treatment recommendations on HCV should trump hers. Maybe... Worth investigating though.

 



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Tig

67yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 9+ years!

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awaw5


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My insurance only approved 8 wks of Harvoni claiming that I had not been on peginterferon plus ribavirin... They site "Ellen Guthrie Internal Medicine" as their source it seems. Anyone know what that is?

1) I had failed daily interferon with ribavirin but since I don't think my first doc that wrote the RX reported that I had IFN+Rib 16 yrs ago (I am now seeing a different doc.) I called the doc that had me on the IFN+Rib in 1999 & they said all records were destroyed from 10 yrs ago! So I'll just have to say what I can about what I was on. 

2) The literature from Gilead says 12 wks for "treatment experienced patients include those who have failed a peginterferone alfa + ribavirin..." So it says "include those" & NOT "only those", therefore altho I wasn't on PegIFN specifically, I did fail a prev IFN+Rib treatment - so that should qualify me.

So I'm going to appeal on those 2 points to start off, to get 12 wks & see what happens. Any ideas or experiences appealing to insurance for 12 wks?

QUESTIONS: 

* Was 8 weeks ever tested on Treatment Experienced so we could know the percentage difference in response for Trtmt Experienced 8 wks vs 12 wks?

* Why do Treatment Experienced supposedly need 12 wks? Is it because the previous treatment likely made the virus "tougher or stronger" and therefore harder to eradicate by current treatments?



__________________

54yo, geno 1a, DX 1983 HCV

TX #1: 1999 DAILY IFN 3mu & Ribavirin for 9mos. Stopped Tx in 7mos due to HCV RNA of 260,000 increased to 1 Million from tx.  

TX #2: SOT 7/21/16 Harvoni. 

SOT: HCV RNA 3 million. F1-F2, NASH N0. ALT 288, AST 116

Current: HCV undetected, ALT 22, AST 19
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