I am genotype 1a, 3 time null responder. Last tx was pegintron with Ribavirin in 04. I was dx cirrhosis Jan 08. I had some esophageal varicies banded 2 years ago and have small amount of ascities. I am Child A MELD 7.
I will be seeing my hepatologist tomorrow and plan on asking about getting an off label usage prescribed through Express Scripts. I am working full time and have pretty good insurance through my employer.
Has anyone been prescribed the off label combo and not from a drug trial just by Doctor prescription?
What needs to happen to get Express scripts to allow this? I have seen Express Scripts has both Sovaldi and Olysio in their drug formulary so I know they have both medicines available.
I'm following a lot of people that are taking this 'off label' combo. Insurance requires the criteria of being intolerant to peg/RIBA and with your prior failure of treatment, IMO and what I've seen, that puts you at the top of the list with a very good chance of approval.
I'm in the process of having this same combo approved...1a with cirhossis. So my advise is to go for it!
FYI to ALL
As other member have mention and provided links. Hopefully your provider and insurance company are aware of the following. If you are having problems getting treatment don't be afraid to ask if they are aware of these recommendations.
The FDA hasn't approved off label use yet but the Infectious Diseases Society of America (IDSA) and American Association for the Study of Liver Diseases (AASLD) has recommended it
The link is for retreatment of prior failed tx On the left side of the page is a tab for treatment naive
I have only listed the first recommendation on the list for HCV genotype 1 others including other genotypes are on that page.
Recommended regimen for HCV genotype 1 PEG/RBV (without an HCV protease inhibitor) nonresponder patients:
Daily sofosbuvir (400 mg) plus simeprevir (150 mg), with or without weight-based RBV (1000 mg [75 kg]) for 12 weeks is recommended for retreatment of HCV genotype 1 infection, regardless of subtype or IFN eligibility
Rating: Class IIa Weight of evidence and/or opinion is in favor of usefulness and efficacy Level B Data derived from a single randomized trial, or nonrandomized studies
Left tab - Methods -> Table 2. Grading System Used (explains the ratings)
(Post-treatment results may be limited for some treatments and recommendations. (Be sure to read the text about the treatment and not just the charts. Your age, fibrous status, hepatic impairment (class A, B or C), cirrhosis class,other specifics like mutations, current medical condition and test results may a factor)
Left tab INTRODUCTION
...To provide healthcare professionals with timely guidance as new therapies are available and integrated into HCV regimens, the Infectious Diseases Society of America (IDSA) and American Association for the Study of Liver Diseases (AASLD) have developed a web-based process for the rapid formulation and dissemination of evidence-based, expert-developed recommendations for hepatitis C management.
The AASLD/IDSA hepatitis C guidance addresses management issues ranging from testing and linkage to care, the crucial first steps toward improving health outcomes for HCV-infected persons, to the optimal treatment regimen in particular patient situations. Recommendations are based on evidence and are rapidly updated as new data from peer-reviewed evidence become available. For each treatment option, recommendations reflect the best possible management for a given patient and a given point of disease progression. Recommendations are graded with regard to the level of the evidence and strength of the recommendation. The AASLD/IDSA hepatitis C Guidance is supported by the membership-based societies and not by pharmaceutical companies or other commercial interests.
My opinion - since this site indicates it will be update when recommendations are changed or added, you should revisit the site just before you make a treatment decision or talk to your provider.
How to Disagree With Your Doctor
Thanks Jimmy for the info
I had seen that also and brought a copy of the recommended protocol for prior failures you listed above to my Dr appointment for ammo. But my Dr was already up to speed so I didn't have a problem persuading her. I hope she is successful persuading my drug coverage insurer.
Good luck everyone!
Finally getting a chance to slay the dragon!
This is my first time posting. I would like to say thank you to all who have shared such great information!
I'm HCV positive, diagnosed in 1996. My doctor is pushing treatment and it's time. My blood work is crazy abnormal. AST 404, ALT 275 and many other abnormals.
I have never been treated. Now I find myself needing treatment with no insurance. I don't qualify for Market Place healthcare. I'm looking at Cigna or other insurance companies that will cover me and cover Sovaldi combination drugs. With the tier system, I am afraid that they will try to put me on a cheaper drug; interferon/ribavirin, which does not show as promising results. Also looking into drug trials. I have heard that Gilead will pay for meds, however, when I went on their site, I noticed that they will pay a little over $7000, and that's it. The treatment is around $84,000. Any advice from someone who has been through this would be most appreciated.
Has anyone been treated with Sovaldi combo drugs without insurance, and if so, how did you wrangle that?
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