Hep C Discussion Forum

shadow10cats wrote:

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If you do need to appeal I can send you or post some links I found useful as guidelines such as how to address some of the reasons they use for denial & what you should include & how to write the appeal. Mine turned out being 6 pages long & although I may have included some things, that in my naivete or exuberance to do a good job, may not have been completely accurate; overall I think I did OK for a novice.

Also the insurance companies have been quoting sections of the AASLD guildelines to deny treatment. If they do that to you, then you will want to watch for the updated guidelines to see if anything can help you.

I just rec'd this email today in regards to their guidelines and when new updates are expected:

Dear BJ:

The update to the guidance recommendations for treating HCV are currently under review for approval by AASLD and IDSA leadership. We expect them to be finalized soon for the website, possibly during the week of December 21^st.

Sincerely,

Audrey

Audrey Davis-Owino

Director of Governance and Practice Guidelines
American Association for the Study of Liver Diseases

-- Edited by shadow10cats on Tuesday 9th of December 2014 07:25:44 PM

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Thank you BJ! Luckily it turned out that my approval went through without a hitch.  Your information will be a huge help for anyone who gets the runaround from their insurer.  And it will be interesting to see what the AASLD guidelines say this month!

- Tess 

Thanks matt and Tig.  We'll see what happens.  My doc should have the results of my blood work this week and hopefully will send in the approval form right away.  I'm ready to appeal if we get a denial.

Fingers crossed!!!

Tess

Then there is this....

-- Results Demonstrate Efficacy of Sovaldi-Based Regimen in GT1 Infected Patients Who Failed Prior Therapy with Other Direct Acting Antivirals--

-- Data Support Retreatment with Sovaldi-Based Regimen in GT2 or GT3 Infected Patients Who Failed Prior Treatment with Sovaldi --

LONDON--(BUSINESS WIRE)--Apr. 10, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from an open-label clinical trial (Study GS-US-334-0109) evaluating once-daily Sovaldi® (sofosbuvir) 400 mg tablets for the retreatment of chronic hepatitis C virus (HCV) infection among patients who failed prior therapy. These data will be presented in two oral sessions at the 49th Annual Meeting of the European Association for the Study of the Liver (The International Liver Congress 2014) in London.

In Study GS-US-334-0109 (Oral #55), patients with genotype 1 HCV infection (n=80) received 12 weeks of treatment with once-daily Sovaldi plus weight-based ribavirin (RBV) twice-daily (1,000 or 1,200 mg/day) and pegylated interferon (peg-IFN; 180 g/week). Patients in the study had failed prior regimens containing peg-IFN, RBV and an investigational NS3 protease inhibitor, with or without investigational direct-acting antivirals (DAAs) (NS5A and/or non-nucleoside NS5B inhibitors). Forty-five percent of patients (n=36) had received more than one course of prior therapy, and 90 percent (n=72) had at least one viral mutation associated with HCV NS3, NS5A or NS5B drug resistance.

Among the 50 patients for whom sustained virologic response data was available 12 weeks after the end of treatment (SVR12), 74 percent (n=37/50) achieved SVR12. Additionally, 80 percent (n=28/35) of patients with baseline resistance against two or more DAAs achieved SVR12.

This study demonstrates that Sovaldi-based regimens can achieve high cure rates even among hepatitis C patients who previously failed therapy with baseline resistance to at least two DAAs, said Stanislas Pol, MD, PhD, Professor of Hepatology and Gastroenterology, Paris Descartes University, Paris, France, and a principal investigator. Importantly, Sovaldi has now demonstrated efficacy among genotype 1 HCV infected patients who failed prior treatment with three or four drug regimens and have developed viral resistance to some of the components of those regimens.

In a separate presentation (Oral #8), retreatment with Sovaldi in genotype 2 (n=11) or genotype 3 (n=96) HCV infected patients who previously failed treatment with 12 or 16 weeks of Sovaldi plus RBV in the Phase 3 studies FISSION, FUSION and POSITRON was evaluated. Thirty-six percent of these patients (39/107) had cirrhosis. Patients were retreated either with a 12-week regimen of Sovaldi, RBV and peg-IFN, or a 24-week, interferon-free regimen of Sovaldi plus RBV. The choice of regimen was determined by study investigators.

Among patients with available SVR12 data, 63 percent (n=25/40) of those who received the 24-week all-oral regimen and 92 percent (n=24/26) of those who received the 12-week regimen of Sovaldi, RBV, and peg-IFN achieved SVR12.

These data support initial findings from the Phase 3 trials, which demonstrate that Sovaldi is an effective treatment option and one that may also be particularly important for genotype 2 and 3 patients who failed a previous sofosbuvir-based regimen, said Rafael Esteban, MD, Head of the Internal Medicine and Liver Unit, Hospital Universitari Vall dHebron and Professor of Medicine, Universitat Autónoma de Barcelona, Barcelona, Spain and a principal investigator for the study.

Sovaldi was well tolerated in Study GS-US-334-0109. The most common adverse events were consistent with the safety profiles of peg-IFN and/or RBV. Additional information about the study can be found at www.clinicaltrials.gov.

- See more at: http://www.gilead.com/news/press-releases/2014/4/gilead-announces-results-from-study-of-sovaldi-for-retreatment-of-chronic-hepatitis-c-in-patients-not-cured-with-prior-antiviral-therapy#sthash.GbRq6Zkv.dpuf

Isn't there the concern that patients that failed Tx on Sovaldi in general may have the possibility of transient (maybe) RAV's? Again it probably comes down to money. I recall you and Malcolm discussing this possibility.

Tig

Why would they exclude people that relapsed on Sovaldi and Olysio? There is a study that shows that people that relapsed on Sovaldi and Ribiviran  can be successfully treated with Harvoni:

http://www.familypracticenews.com/news/journals/single-article/sofosbuvirledipasvir-effective-for-relapsed-hep-c-patients/61f3e868769ed6ee913673ba6638dc3e.html

In case the PDF doesn't open, here is the criteria:

Prior-Approval Requirements
Age 18 years of age or older
Diagnosis
Patient must have the following:

Chronic Hepatitis C - Genotype 1 AND ONE of the following:
1. Treatment-naïve, without cirrhosis
2. Treatment-naïve, with cirrhosis
3. Previously treated with Hepatitis C therapy not including Sovaldi and Olysio, and was determined to be a treatment failure or has relapsed 
         a. Patient must have moderate to severe cirrhosis confirmed by a Metavir score 3-4, Knodell score 9-18, or Fibro test score 0.58-0.72.

AND ALL of the following:
1. Presence of viral load (HCV RNA) in the serum prior to treatment
2. NO concurrent or prior therapy with any regimens containing sofosbuvir
3. Must be prescribed by a board-certified gastroenterologist, hepatologist,
oncologist, or infectious disease specialist
4. NO history of alcohol and/or substance abuse in the past 6 months

Prior - Approval Limits
Duration
Treatment-Naïve, without cirrhosis, pre-treatment HCV RNA < 6 million IU/ml:
8 weeks (56 tablets per 56 days)

Treatment-Naïve, without cirrhosis, pre-treatment HCV RNA > 6 million IU/ml:
12 weeks (84 tablets per 84 days)HARVONI
(ledipasvir & sofosbuvir)

Treatment-Naïve with cirrhosis:
12 weeks (84 tablets per 84 days)

Non-responders to prior HCV therapy with cirrhosis:
24 weeks (168 tablets per 168 days)