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Harvoni not approved
Hi all
Just called express scripts automated line. My request for Harvoni was not approved. Stayed on the line to speak with a representative. The woman reading me the denial could not pronounce any of the med names even had to sound out how to say peg interferon.
Waiting on my denial letter and appeal from my doctors office.
Dang
Lynn
Just called express scripts automated line. My request for Harvoni was not approved. Stayed on the line to speak with a representative. The woman reading me the denial could not pronounce any of the med names even had to sound out how to say peg interferon.
Waiting on my denial letter and appeal from my doctors office.
Dang
Lynn
Lynn, excuse my ignorance but is your Express Scripts Insurance a Medicare Plan? If it is, have you talked to Gilead (mysupportpath.com) about the denial? You probably have, but if not, it might be worth a try.
Re-treatment of Chronic Hepatitis C Virus Genotype 1 Infection After Relapse: An Open-Label Pilot Study Re-treatment of Chronic HCV Genotype 1 Infection After Relapse
4 November 2014
Anu Osinusi, MD; Anita Kohli, MD; Miriam M. Marti, BS; Amy Nelson, RN; Xiaozhen Zhang, MS; Eric G. Meissner, MD, PhD; Rachel Silk, RN; Kerry Townsend, BA; Phillip S. Pang, MD, PhD; G. Mani Subramanian, MD, PhD; John G. McHutchison, MD; Anthony S. Fauci, MD; Henry Masur, MD; and Shyam Kottilil, MD, PhD
[+-] Article and Author Information
Ann Intern Med. 2014;161(9):634-638. doi:10.7326/M14-1211
Background: The interferon (IFN)–free regimen of sofosbuvir and ribavirin for 24 weeks was recently approved to treat chronic hepatitis C virus (HCV) genotype 1 (GT-1) infection for patients ineligible for IFN. However, sofosbuvir plus ribavirin therapy is associated with relapse in 15% to 30% of patients with HCV GT-1. Neither the mechanism of relapse nor the optimal re-treatment strategy for these patients is defined.
Objective: To assess the safety and efficacy of sofosbuvir plus ledipasvir in patients with chronic HCV GT-1 that relapsed after sofosbuvir plus ribavirin therapy.
Design: Phase 2a, open-label study. (ClinicalTrials.gov: NCT01805882)
Setting: Single U.S site.
Patients: 14 patients with HCV GT-1 that relapsed after treatment with sofosbuvir plus ribavirin for 24 weeks were re-treated with sofosbuvir plus ledipasvir for 12 weeks.
Measurements: HCV RNA concentration and population sequencing to detect NS5B S282T mutations.
Results: All 14 patients treated with sofosbuvir plus ledipasvir for 12 weeks achieved a sustained virologic response, including 7 with advanced liver disease (Knodell Histology Activity Index score of 3 or 4) and 1 with a detectable NS5B S282T mutation after sofosbuvir plus ribavirin therapy. Sofosbuvir plus ledipasvir was well-tolerated with few adverse events. Four grade 3 events (elevated serum creatinine in a patient with baseline renal insufficiency, hypercholesterolemia, and hypophosphatemia) occurred. There were no grade 4 events or treatment discontinuations.
Limitation: Small sample size.
Conclusion: The fixed-dose combination of sofosbuvir plus ledipasvir was efficacious in a small cohort of patients with HCV GT-1 that relapsed after sofosbuvir plus ribavirin therapy, even in the setting of advanced liver disease. Larger studies are needed to confirm these preliminary efficacy results.
4 November 2014
Anu Osinusi, MD; Anita Kohli, MD; Miriam M. Marti, BS; Amy Nelson, RN; Xiaozhen Zhang, MS; Eric G. Meissner, MD, PhD; Rachel Silk, RN; Kerry Townsend, BA; Phillip S. Pang, MD, PhD; G. Mani Subramanian, MD, PhD; John G. McHutchison, MD; Anthony S. Fauci, MD; Henry Masur, MD; and Shyam Kottilil, MD, PhD
[+-] Article and Author Information
Ann Intern Med. 2014;161(9):634-638. doi:10.7326/M14-1211
Background: The interferon (IFN)–free regimen of sofosbuvir and ribavirin for 24 weeks was recently approved to treat chronic hepatitis C virus (HCV) genotype 1 (GT-1) infection for patients ineligible for IFN. However, sofosbuvir plus ribavirin therapy is associated with relapse in 15% to 30% of patients with HCV GT-1. Neither the mechanism of relapse nor the optimal re-treatment strategy for these patients is defined.
Objective: To assess the safety and efficacy of sofosbuvir plus ledipasvir in patients with chronic HCV GT-1 that relapsed after sofosbuvir plus ribavirin therapy.
Design: Phase 2a, open-label study. (ClinicalTrials.gov: NCT01805882)
Setting: Single U.S site.
Patients: 14 patients with HCV GT-1 that relapsed after treatment with sofosbuvir plus ribavirin for 24 weeks were re-treated with sofosbuvir plus ledipasvir for 12 weeks.
Measurements: HCV RNA concentration and population sequencing to detect NS5B S282T mutations.
Results: All 14 patients treated with sofosbuvir plus ledipasvir for 12 weeks achieved a sustained virologic response, including 7 with advanced liver disease (Knodell Histology Activity Index score of 3 or 4) and 1 with a detectable NS5B S282T mutation after sofosbuvir plus ribavirin therapy. Sofosbuvir plus ledipasvir was well-tolerated with few adverse events. Four grade 3 events (elevated serum creatinine in a patient with baseline renal insufficiency, hypercholesterolemia, and hypophosphatemia) occurred. There were no grade 4 events or treatment discontinuations.
Limitation: Small sample size.
Conclusion: The fixed-dose combination of sofosbuvir plus ledipasvir was efficacious in a small cohort of patients with HCV GT-1 that relapsed after sofosbuvir plus ribavirin therapy, even in the setting of advanced liver disease. Larger studies are needed to confirm these preliminary efficacy results.
Hi Dee
When Incivek was first released I asked about getting it from my Gastro I was seeinghe said no because of the cirrhosis. I don't believe I was having any platelet problems at the time at least no one had mentioned it to me. The reason was based on my treatment history as a null responder with cirrhosis they said the likelyhood of successfully treatment was about 14% and because of the cirrhosis they were concerned I could decompensate on treatment. So too much risk and too little likelyhood of success. I went for a second opinion at the University of WA liver transplant department they agreed I should not treat.
Yes the reason for denial from express scripts is because I failed Sovaldi. I guess the one day turn around is them trying to "improve" customer service. They said on the recording they answer in 24 hours. Fill out check sheet, check boxes, oops prior treatment with Sovaldi, denied.
I filled out their survey it was check a box with boxes for comments. Rate the service you have received kinda thing. Needless to say I did not give them very good grades. Pretty sure it is anonymous so doubt I will hear anything.
Still not done yet and what do I have to lose they already said no.
Best to all
Lynn
When Incivek was first released I asked about getting it from my Gastro I was seeinghe said no because of the cirrhosis. I don't believe I was having any platelet problems at the time at least no one had mentioned it to me. The reason was based on my treatment history as a null responder with cirrhosis they said the likelyhood of successfully treatment was about 14% and because of the cirrhosis they were concerned I could decompensate on treatment. So too much risk and too little likelyhood of success. I went for a second opinion at the University of WA liver transplant department they agreed I should not treat.
Yes the reason for denial from express scripts is because I failed Sovaldi. I guess the one day turn around is them trying to "improve" customer service. They said on the recording they answer in 24 hours. Fill out check sheet, check boxes, oops prior treatment with Sovaldi, denied.
I filled out their survey it was check a box with boxes for comments. Rate the service you have received kinda thing. Needless to say I did not give them very good grades. Pretty sure it is anonymous so doubt I will hear anything.
Still not done yet and what do I have to lose they already said no.
Best to all
Lynn
I stated that in a weird way. Sorry. The part that was small was tghe harvoni study on relapsers. I will look for the article and post it.
An article came out today about a very small study that showed that between 15 and 30% of people relapse on sovaldi. So, a small number of these patients were given harvoni and all of them made it to SVR. Larger studies need to be done to see if these results can be replicated. But remember that trials are not the "real world". Hopefully the larger trials will get the same results.
It seems to me that Express Scripts is really fighting paying for harvoni. They have been quoted as saying that the Abbvie drugs will be drugs that they will pay for. Of course, no one knows the cost of the Abbvie drugs yet, so I wouldn't count on anything as gospel.
Dacalatavir is another drug with a fabulous profile as far as SVR. Hopefully they will be filing with FDA soon. I know how frustrating it is to wait for things to happen when you want to treat NOW. I am truly confident that most of us will get one of these fabulous new combos real soon. So hang in there. It will happen.
It seems to me that Express Scripts is really fighting paying for harvoni. They have been quoted as saying that the Abbvie drugs will be drugs that they will pay for. Of course, no one knows the cost of the Abbvie drugs yet, so I wouldn't count on anything as gospel.
Dacalatavir is another drug with a fabulous profile as far as SVR. Hopefully they will be filing with FDA soon. I know how frustrating it is to wait for things to happen when you want to treat NOW. I am truly confident that most of us will get one of these fabulous new combos real soon. So hang in there. It will happen.
About the Express Scripts Survey, I would tell them the problems you are having, I don't think it can hurt to try. Sometimes going around different ways can lead one to the end result they need. Perhaps a kind soul will read your story and be moved to go to a supervisor.
I have found, working for the Feds that is the only way to do it sometimes.
Someone once accused me of finagling my way around the system, all I was trying to do was get the job done. Sometimes one has to think outside of the box. Like when I was not approved, I kept calling the insurance company til I finally got to the approving official and found out that they did not have all required info. I don't know why they did not call me or the doctor but maybe that is how the game is played. People not serious about tx give up.
Not saying that is happening to you, just thinking your doctor sent in request and you were denied on same day, or at least it looks that way on here.
Can-do thanks for your nice response. It suddenly occurred to me that others reading this post might get the wrong impression, that people with cirrhosis can't treat with Riba. That is not true. Many people with cirrhosis have treated with it. At times I forget about all the people reading but not writing. I have seen this on other sites where 5 people respond and 100's read. I wish we had that. It would help people to understand how important this information is.
I have found, working for the Feds that is the only way to do it sometimes.
Someone once accused me of finagling my way around the system, all I was trying to do was get the job done. Sometimes one has to think outside of the box. Like when I was not approved, I kept calling the insurance company til I finally got to the approving official and found out that they did not have all required info. I don't know why they did not call me or the doctor but maybe that is how the game is played. People not serious about tx give up.
Not saying that is happening to you, just thinking your doctor sent in request and you were denied on same day, or at least it looks that way on here.
Can-do thanks for your nice response. It suddenly occurred to me that others reading this post might get the wrong impression, that people with cirrhosis can't treat with Riba. That is not true. Many people with cirrhosis have treated with it. At times I forget about all the people reading but not writing. I have seen this on other sites where 5 people respond and 100's read. I wish we had that. It would help people to understand how important this information is.
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