Very important article from Lucinda K. Porter on blogs.hepmag.com
Harvoni: Tips for Navigating Insurance Prior Authorizations for Hepatitis C Treatment
Here is the Link
http://blogs.hepmag.com/lucindakporter
Cinnamon Girl said
Oct 18, 2014
Thanks for that Maddie, I was just coming back to correct what I said. I`ve read about the phases of clinical trials many times before but my memory isn`t so good these days!
maddie said
Oct 18, 2014
Phase 4 refers to studies done just after approval and the med is in use by general public. This link explains all four in brief summary.
Thanks for the update, Isiscat, it all sounds very promising and how reassuring that your doctor is so well-informed and helpful.
I find her comments about the Abbvie combo very interesting, and I must say I wasn`t aware of the existence of phase 4 trials either.
Very pleased for you that your Harvoni tx is finally getting to be a reality, Do keep us posted!
pl1952 said
Oct 17, 2014
Thanks Isis...I was looking for your post -- I remembered you saying you had your appt. on the 16th. This was very informative. That's great -- you'll start treatment before year end!!! Awesome!
Isiscat2011 said
Oct 17, 2014
Greetings fellow passengers on the Harvoni Train. Just wanted to give you an update on my doctor's appointment yesterday. My hepatologist is submitting the request for 24 weeks of Harvoni (no riba). She told me that she submitted the preauthorization requests for 6 patients on the day Harvoni was approved and has been submitting even more requests daily since the the FDA approval; no one has started tx yet. She expects it will take 3-4 weeks for me.
It appears that the length of time it will take to actually get on tx depends on a number of factors such as the length of tx duration requested, the quality and quantity of the supporting medical records, the number of requests that are being processed as well as the system in place in the medical provider's office, the specialty pharmacy, and the insurance company, and perhaps even the urgency for tx (with patients who are severely ill being prioritized). In short, I would expect the length of time will vary among patients. As I said before, as long as I know they are working on it, I don't mind waiting a while longer.
Interestingly, my doc felt quite certain that 12 weeks should be sufficient in my case, although she did agree to request 24. She indicated that within the tx experienced cirrhotic population there are variables that suggest a shorter or longer protocol such as degree of fibrosis, whether the patient was a prior rapid responder, a non-responder or a relapser, etc. She said that insurance companies will be looking at these variables in the patient's supporting medical records. Paradoxically, they will not be performing pre tx genetic testing.
She said the VL testing schedule planned is at 4 weeks and 12 weeks, and then EOT+4 and EOT+12. She also said that she expects the price of the Abbvie combo to be in the same ballpark as Harvoni--perhaps 5K less.
She said that for she has been involved in the clinical trials of both the Harvoni and the Abbvie combos and is currently working on Abbvie's Phase 4. (I didn't even know there was a Phase 4 in clinical trials). She has also treated a substantial number of patients with the Sovaldi/Olysio combo (all cirrhotics). When I asked her which combo she preferred her answer surprised me: Abbvie. She said that while the relapse rates have been very low with the Sovaldi combos they have been even lower with the Abbvie combo. She did say that the results varied, to some extent, among the facilities performing the clinical trials.
She also noted that the Abbvie combo is expected to have potentially greater side effects particularly for those receiving Riba (which I believe will include all genotype 1as).
So, that's it for now. My doc is extremely well informed about HCV tx, and she is also very personable and open minded, so I'm feeling pretty fortunate with that. She also told me she encourages patients to become their own advocates in their medical care. Lastly, she told me that she advises all of her patients that there will be a small number of relapsers, but not to be discouraged by this reality. In the unlikely event that happens we will be prepared for it.
-- Edited by Isiscat2011 on Friday 17th of October 2014 07:50:19 PM
Groupergetter said
Oct 17, 2014
Matt, I specifically asked my doc about taking the riba with the S/L. I told her I would be glad to take it, if it would improve my chances. She didn't think it would help and didn't prescribe it. I pray God she's right. With the relatively small clinical study samples, and this all being so new I guess to some extent we have to rely upon our physicians recommendations.
I got a call from Express Scripts yesterday. They confirmed the meds had been ordered and still awaiting final PA approval. If all goes well it appears I will have the meds before long. Odd the doc's didn't schedule viral load labs as they did the last go round?
Extremely Thankful to have another opportunity. Hope all on this train reach their journey's end. Can I get a window seat? Looking forward to the view.
Matt Chris said
Oct 17, 2014
Hey All
The question of whether or not to include Ribavirin with Harvoni needs to be discussed.
Most the trial studies (Ion 1,2,3,) had some arms of trials include Ribavirin, the final SVR 12 percentage did not show any real advantage including Ribavirin with L&S (Harvoni). Reading the New England Journal of Medicine article on L&S on a Phase 3 trial study on 440 patients the article shows very little case made for including Ribavirin in either 12 or 24 weeks.
Most Hepatologist reason that Ribavirin can help in controlling polymorphisms (Ravs) so if you happen to know that you have baseline NS5A Ravs it might be wise, or if you happen to know what Ravs if any caused your relapse you could consider it. Most of us don't unless you were on a trial or paid for a deep gene sequencing lab test. In my case I did final receive the information upon my many requests to Abbvie to reveal if I relapsed because of or with Ravs, well final they said that I had no detectable Ravs at time of relapse. So both my Hepatologists agreed that including Ribavirin was not worth the extra side effects.
Obviously Gilead and the FDA have concluded the same thing, but if you happen to know you have a problem with Ravs from your previous HCV treatments then you may want to read up and then talk to your Doctor about it. The side effects are quite detailed and long on Ribavirin but they are mostly tolerable.
matt
-- Edited by Matt Chris on Friday 17th of October 2014 05:24:02 AM
Groupergetter said
Oct 15, 2014
Miss B wrote:
Thank you for all the welcome messages. It's great to see that some of you are cured and are still on here helping others!
Welcome Miss B, that is part of what makes this such a great forum. Really tremendous folks here, helping each other to get through difficult times. Hoping you get on the Harvoni train.
Looks like I'm gonna have a ticket for the ride. My doc prescribed the Harvoni today. The PA hasn't been approved as yet, but they have sent in the packet with all the necessary documentation. Trying for the whole enchilada, 24 weeks. Apparently there will be some delay but she thought if all goes well it may be under 10 days. Will call the pharmacy tomorrow and try to get their estimates on the time frame. Trying to stay realistic with this...until the Harvoni is in my hands won't get the hopes too high.
hrsetrdr said
Oct 15, 2014
Hey Matt,
Very happy news for sure! Your face is going to cramp up from all that smiling!
Matt Chris said
Oct 15, 2014
Hey BJ
I understand how you feel about the hassle of waiting for Harvoni to be delivered to your home. I am waiting as well
Its really a three part process than can not be avoided with an additional problem of it being just released and not on many of the current specialty drug list yet.
1st process = Your Doctor agrees to prescribe the 12 or 24 week duration of Harvoni.
2nd process = Your medical team (Doctor, nurses, etc) work up a prior authorization consisting of all the substantiating lab reports, liver biopsies, Fibroscans, etc. anything that proves you should qualify for the drugs. (most qualified will be cirrhotics and previous relapse patients) These are used to submit to the Specialty drugs request review broad.
3rd process = Most health insurance companies have a designated paid third party company like "Prime Therapeutics" or "Express Scripts" to review and sift through the insurance customers requests and make recommended approvals or rejections. Which can be appealed and should be appealed.
The advantage we have now is that the FDA and Gilead have agreed on many of the things that would have cause problems in getting the drugs and are taken off the table.
So now the insurance companies will try to find other minor loopholes to reject claims, don't give up because many of our Hep-C friends got approved on other off label combos (Simeprevir & Sofosbuvir) so this should be easy than that.
matt
-- Edited by Matt Chris on Thursday 16th of October 2014 05:49:25 AM
mallani said
Oct 15, 2014
Hi Matt,
Good news. Hope you have an easy trip to SVR. Cheers.
Miss B said
Oct 15, 2014
Shadow10cats, I also wish that they would just give us the prescription we deserve. However, the drug is expensive so I guess we need to jump through some hoops. I am also waiting to hear what criteria I have to meet to get treated. I only have stage 1 fibrosis but I want to get rid of this before it progresses.
If you have to persuade them to treat you, this might help. I read an interesting article that says,
Most patients with HCV-associated lymphoma present with mild liver disease at cancer diagnosis
Here is the link: http://natap.org/2014/AASLDEASL/AASLDEASL_05.htm
This article really makes the case for treatment BEFORE the liver is seriously damaged. 33% of the lymphoma patients had stage 1 fibrosis and 36% had stage 2 fibrosis. Only 10% had stage 3 fibrosis.
Also, the cost of Harvoni is $94,000 vs. $400,000 for a transplant.
Let's hope we don't have to try to convince them.
Miss B said
Oct 15, 2014
Thank you for all the welcome messages. It's great to see that some of you are cured and are still on here helping others!
shadow10cats said
Oct 15, 2014
I have CDPHP in NYS and our scripts are via Caremark. I contacted them about Harvoni & their response to me was: "For your medication, Harvoni, a prior authorization is required. Please have your physician's office contact our prior authorization department directly at 1-800-294-5979. Certain medications require additional clinical information from your physician in order to be considered for coverage through your prescription benefit plan. If approved, this medication needs to be ordered from our Specialty pharmacy at 1-800-237-2767."
So nice way to dodge my question: is it available? And reading between the lines, who knows exactly what the "additional clinical info" is.
I have pretty good bloodwork results so I have to base my case upon how HepC has diminished the quality of my life. How I have cut back on all social activities, gave up outside work I did for additional income, how I no longer have the energy to do the outdoor activities I love, how I have had to reduce my hours at work & even then I can barely make it in or stay thru an entire day, how the disease has affected my mental well being with this awful "brain fog" - it takes me forever to get any task done requiring concentration or thought, the depressio, etc. I don't want to be denied just bec my labs look good.
I've tried the other crap & I've been waiting a long time for this. I want my life back and I am ready to fight for it.
Has anyone else obtained any info from ins companies?
wmlj1960 said
Oct 15, 2014
Miss B wrote:
Hi,
I'm new here, this is my first post! I'm hoping to jump on the train! I have picked up some good info here on how to prepare for treatment. I'm seeing the dr. tomorrow to ask for Harvoni. I have Kaiser Permanente HMO. I would be interested to hear if anyone here has received Harvoni from KP. I will let you all know how it goes. I did interferon 20 years ago (@#$%&). My numbers normalized while I was on it but relapsed as soon as I finished. I am interested to hear your stories about which insurers cover Harvoni.
Thanks, -B
There is plenty more info here free for the sharing. I know your real happy knowing you have an option this time that's much better than interferon. And I hope you get set up with a Harvoni Tx plan quickly! I'm already on Sovaldi / ribavirin so I won't be joining the train ride but I'll help keep the tracks clear for you all and hope to see a big SVR included in everyones signature after the ride is done. Welcome to the forum Bridget and keep us updated on your progress.
Miss B said
Oct 15, 2014
Congrats Matt! Can't wait to hear how long it takes for you to get your prescription filled.
-b
Tig said
Oct 15, 2014
That's great news Matt! I didnt have anything but good luck when dealing with Prime Therapeutics and I hope the same ease of service applies to you! This is your time to shine buddy! Good luck.... "I can hear that train a comin"....
Tig
Matt Chris said
Oct 15, 2014
Hey All
Had my appointment with my Hepatologist yesterday. All the labs looked normal except AST, ALT and platelets which is normal for me. The happy news is my first abdominal MRI with and without contrast reported "no focal liver lesion" but findings suggest mild portal hypertension.
As far as "Harvoni" the Doctor prescribed 24 weeks to be immediately processed with my insurance. YAHOO!
Now I wait, and follow up with both my doctors insurance processing dept. and Prime Therapeutics which handles these speciaity drugs for BCBS.
matt
-- Edited by Matt Chris on Thursday 16th of October 2014 05:42:53 AM
Tig said
Oct 15, 2014
Hi Bridget,
Welcome to the forum! Glad to make your acquaintance! We are all anxiously waiting on the word regarding the first distribution of Harvoni. Funny,, every time I write that name down, I think about that hockey rink ice machine, the Zamboni! Anyway, I appreciate your report and will be watching to see what your doctor's response will be. When you have some lab info and things like viral load, genotype, anything you care to share, etc., please add it to your signature (if you want that is). It helps understanding your case and when replying. Please keep in touch! Good luck...
Tig
Miss B said
Oct 15, 2014
Hi there,
Back from the doctor at Kaiser Permanente. He said I am a perfect candidate for treatment based on my treatment history, labs & biopsy but they don't have it yet & he doesn't know when they will get it.
I asked what the Kaiser policy is for treatment. He said there was a conference call on it yesterday but he's not on the committee so he will find out what was said. He asked me to email him weekly for updates.
So, I left there without any clear idea if or when I will get Harvoni. Or, even, how is the decision made on who gets it?
I am very interested to hear if anyone has had a prescription for Harvoni filled? I am wondering when Harvoni is going to be available in pharmacies?
Good luck to everyone who is going to the doctor soon, keep us posted.
-b
Huey said
Oct 15, 2014
Welcome glad your on board!
Matt Chris said
Oct 15, 2014
Hey Robert
Glad you are going to join us in Jan. hopefully you will be on the train for 24 weeks.
matt
Matt Chris said
Oct 15, 2014
Hello Bridget
Welcome aboard Bridget, find a great cabin and settle in, Hope your HMO moves quickly on your doctors orders.
matt
robertsamx said
Oct 14, 2014
I"m looking to jump on this train after the first of the year. Its a insurance thing for me, I renew Dec 31, and thanks to the new health care laws my out of pocket is out of this world.. RC
Dzdayscomin said
Oct 14, 2014
Ok the lynchster too!
JLynch30 said
Oct 14, 2014
What about my determination? Solvaldi and interferon/riba (for the 5th time) AND AN APPOINMENT ON October 12TH!!!!! :)
Dzdayscomin said
Oct 14, 2014
I don't think anyone has it yet....but it won't be long before the posts start rolling in on who got their meds.....we should have a pool on who gets it first...just for fun of course! I'm gonna bet Grouper or Isiscat are gonna be first....just because of their determination!
Good luck to all who want it and I hope you get it and it's all it's trumped up to be.
I want all to be cured of this devil of a virus that has hurt so many good people.
Duane
JLynch30 said
Oct 14, 2014
Had appointment at Keiser yesterday - they told me it could be the first of the year - anyone else told differently?
Miss B said
Oct 14, 2014
Hi,
I'm new here, this is my first post! I'm hoping to jump on the train! I have picked up some good info here on how to prepare for treatment. I'm seeing the dr. tomorrow to ask for Harvoni. I have Kaiser Permanente HMO. I would be interested to hear if anyone here has received Harvoni from KP. I will let you all know how it goes. I did interferon 20 years ago (@#$%&). My numbers normalized while I was on it but relapsed as soon as I finished. I am interested to hear your stories about which insurers cover Harvoni.
Thanks, -B
Groupergetter said
Oct 13, 2014
Thanks Matt, I called Gilead as well to see if they had any information for those who have relapsed after previous Sovaldi tx. Neither of the folks I spoke to had a clue? Maybe it's all still too new? Yes I have my copay coupon printed.
Matt Chris said
Oct 13, 2014
Hey all Harvoni TX Train ticket holders
I called Gilead and got the National Drug Code (NDC) for Harvoni
Code # 61958-1801-1
Your Insurance company needs this number to process the doctor drug prescription order.
In talking to Gliead / Harvoni help desk they said the pipeline is ready to fill prescriptions and only hold up will be your insurance company.
matt
-- Edited by Matt Chris on Tuesday 14th of October 2014 12:38:30 AM
-- Edited by Matt Chris on Tuesday 14th of October 2014 12:44:51 AM
Matt Chris said
Oct 13, 2014
Hey Greg
Welcome aboard find a seat with a view and sign up for a cabin because you are schedule for 24 week long trip on the Harvoni TX Train
Matt
Groupergetter said
Oct 13, 2014
Hoping I'll be boarding this train with everyone else. Should know more after my appointment this week. Good to see all the excitement and enthusiasm.
Gator Man said
Oct 13, 2014
Isiscat2011 wrote:
Hey Gator Man:
We better bump your friend up to the front of the train. She's turned yellow. !!
There are a lot of yellow friends in Emoticon City. Maybe Gilead will give them a deal on Harvoni!
rebeca said
Oct 13, 2014
8 weeks..in which cases?
I´ve read in the prescribing information :
Treatment-Naïve Adults without Cirrhosis ION-3 (Study 0108)
The treatment difference between the 8-week treatment of HARVONI and 12-week treatment of HARVONI was 2.3% (97.5% confidence interval 7.2% to 2.5%). Among subjects with a baseline HCV RNA <6 million IU/mL, the SVR was 97% (119/123) with 8-week treatment of HARVONI and 96% (126/131) with 12-week treatment of HARVONI.
Effect of Baseline HCV Polymorphisms on Treatment Response
In treatment-naïve subjects whose virus had baseline NS5A polymorphisms at resistance-associated positions in Studies ION-1 and ION-3, relapse rates were 6% (3/48) after 8 weeks and 1% (1/113) after 12 weeks of treatment with HARVONI. Relapse rates among subjects without baseline NS5A polymorphisms at resistance-associated positions were 5% (8/167) after 8 weeks and 1% (3/306) after 12 weeks treatment with HARVONI.
-- Edited by rebeca on Monday 13th of October 2014 08:21:02 PM
Isiscat2011 said
Oct 13, 2014
Hey Gator Man:
We better bump your friend up to the front of the train. She's turned yellow. !!
Matt Chris said
Oct 13, 2014
Thanks Jill for the encouragement for all our members that will ride this train.
BTW make sure you have your Gilead / Harvoni coupon follow this link.
Well done, Matt, good to see the Harvoni tx Train getting cranked up and ready to rolll!
Best of luck to all passengers who are along for the ride...I`ll be waving from the sidelines and wishing you all a smooth journey!
All aboard for your destination >>>>> Station SRV!!
Ro said
Oct 13, 2014
Thank you! Sounds like a good cabin...hope it is a serene trip....I will be on the long tour...24 weeks.....
Just spoke with the doctor's office nurse. They have applied for my treatment, just waiting to hear from blue cross....I have everything crossed
Looking forward to this journey.
Matt Chris said
Oct 13, 2014
Hello Ro
Welcome aboard, we have saved you cabin 1a near the observation deck.
You also have got your ducks in a row, great job!
matt
Ro said
Oct 13, 2014
Save me a seat, I hope to be boarding soon.. Got labs etc. done. Repeat CAT on Thursday...hoping to be on the maiden voyage!
Matt Chris said
Oct 13, 2014
Hey PL
Welcome abroad, sounds like you will joining us on a later departure date. No problem there is plenty of cabins available. Perhaps your schedule and insurance situation will work better for you starting out the new year. I would make sure that your insurance is not going to modulate to a unwanted variable.
matt
Matt Chris said
Oct 13, 2014
Hey Mary (ak.Mugsy)
Welcome aboard, find one of those cozy cabins and enjoy the feeling of having no HCV ruling your blood again. Sound like you got your ducks in a row for your appointment. Great job in preparing yourself.
matt
-- Edited by Matt Chris on Monday 13th of October 2014 04:14:39 PM
pl1952 said
Oct 13, 2014
I'm boarding! Save me a seat! Appt. is 12/23! It's been a long wait!
Save me a seat, please. I go to Portland on Tuesday for my labs and ultrasound and then see the hepatologist on Wednesday morning.
Huey said
Oct 13, 2014
JLynch30 wrote:
The fixed dose combination ledipasvir-sofosbuvir (90 mg / 400 mg) is FDA-approved for the treatment of chronic hepatitis C genotype 1 in both treatment-naive and treatment-experienced patients. The treatment duration depending on prior treatment experience and the presence or absence of cirrhosis. Treatment experience is defined as patients who have failed treatment with either peginterferon plus ribavirin or peginterferon plus ribavirin plus a HCV protease inhibitor.
Genotype 1 treatment-naïve patients with or without cirrhosis: 12 weeks Genotype 1 treatment-experienced patients without cirrhosis: 12 weeks Genotype 1 treatment-experienced patients with cirrhosis: 24 weeks
Thanks for clearing that up!
JLynch30 said
Oct 13, 2014
The fixed dose combination ledipasvir-sofosbuvir (90 mg / 400 mg) is FDA-approved for the treatment of chronic hepatitis C genotype 1 in both treatment-naive and treatment-experienced patients. The treatment duration depending on prior treatment experience and the presence or absence of cirrhosis. Treatment experience is defined as patients who have failed treatment with either peginterferon plus ribavirin or peginterferon plus ribavirin plus a HCV protease inhibitor.
Genotype 1 treatment-naïve patients with or without cirrhosis: 12 weeks Genotype 1 treatment-experienced patients without cirrhosis: 12 weeks Genotype 1 treatment-experienced patients with cirrhosis: 24 weeks
Thanks for that Maddie, I was just coming back to correct what I said. I`ve read about the phases of clinical trials many times before but my memory isn`t so good these days!
Phase 4 refers to studies done just after approval and the med is in use by general public. This link explains all four in brief summary.
http://academics.wellesley.edu/Chemistry/Chem101/testing/Phases%20of%20Trials.pdf
Thanks for the update, Isiscat, it all sounds very promising and how reassuring that your doctor is so well-informed and helpful.
I find her comments about the Abbvie combo very interesting, and I must say I wasn`t aware of the existence of phase 4 trials either.
Very pleased for you that your Harvoni tx is finally getting to be a reality, Do keep us posted!
Thanks Isis...I was looking for your post -- I remembered you saying you had your appt. on the 16th. This was very informative. That's great -- you'll start treatment before year end!!! Awesome!
Greetings fellow passengers on the Harvoni Train. Just wanted to give you an update on my doctor's appointment yesterday. My hepatologist is submitting the request for 24 weeks of Harvoni (no riba). She told me that she submitted the preauthorization requests for 6 patients on the day Harvoni was approved and has been submitting even more requests daily since the the FDA approval; no one has started tx yet. She expects it will take 3-4 weeks for me.
It appears that the length of time it will take to actually get on tx depends on a number of factors such as the length of tx duration requested, the quality and quantity of the supporting medical records, the number of requests that are being processed as well as the system in place in the medical provider's office, the specialty pharmacy, and the insurance company, and perhaps even the urgency for tx (with patients who are severely ill being prioritized). In short, I would expect the length of time will vary among patients. As I said before, as long as I know they are working on it, I don't mind waiting a while longer.
Interestingly, my doc felt quite certain that 12 weeks should be sufficient in my case, although she did agree to request 24. She indicated that within the tx experienced cirrhotic population there are variables that suggest a shorter or longer protocol such as degree of fibrosis, whether the patient was a prior rapid responder, a non-responder or a relapser, etc. She said that insurance companies will be looking at these variables in the patient's supporting medical records. Paradoxically, they will not be performing pre tx genetic testing.
She said the VL testing schedule planned is at 4 weeks and 12 weeks, and then EOT+4 and EOT+12. She also said that she expects the price of the Abbvie combo to be in the same ballpark as Harvoni--perhaps 5K less.
She said that for she has been involved in the clinical trials of both the Harvoni and the Abbvie combos and is currently working on Abbvie's Phase 4. (I didn't even know there was a Phase 4 in clinical trials). She has also treated a substantial number of patients with the Sovaldi/Olysio combo (all cirrhotics). When I asked her which combo she preferred her answer surprised me: Abbvie. She said that while the relapse rates have been very low with the Sovaldi combos they have been even lower with the Abbvie combo. She did say that the results varied, to some extent, among the facilities performing the clinical trials.
She also noted that the Abbvie combo is expected to have potentially greater side effects particularly for those receiving Riba (which I believe will include all genotype 1as).
So, that's it for now. My doc is extremely well informed about HCV tx, and she is also very personable and open minded, so I'm feeling pretty fortunate with that. She also told me she encourages patients to become their own advocates in their medical care. Lastly, she told me that she advises all of her patients that there will be a small number of relapsers, but not to be discouraged by this reality. In the unlikely event that happens we will be prepared for it.
-- Edited by Isiscat2011 on Friday 17th of October 2014 07:50:19 PM
Matt, I specifically asked my doc about taking the riba with the S/L. I told her I would be glad to take it, if it would improve my chances. She didn't think it would help and didn't prescribe it. I pray God she's right. With the relatively small clinical study samples, and this all being so new I guess to some extent we have to rely upon our physicians recommendations.
I got a call from Express Scripts yesterday. They confirmed the meds had been ordered and still awaiting final PA approval. If all goes well it appears I will have the meds before long. Odd the doc's didn't schedule viral load labs as they did the last go round?
Extremely Thankful to have another opportunity. Hope all on this train reach their journey's end. Can I get a window seat? Looking forward to the view.
Hey All
The question of whether or not to include Ribavirin with Harvoni needs to be discussed.
Most the trial studies (Ion 1,2,3,) had some arms of trials include Ribavirin, the final SVR 12 percentage did not show any real advantage including Ribavirin with L&S (Harvoni). Reading the New England Journal of Medicine article on L&S on a Phase 3 trial study on 440 patients the article shows very little case made for including Ribavirin in either 12 or 24 weeks.
Most Hepatologist reason that Ribavirin can help in controlling polymorphisms (Ravs) so if you happen to know that you have baseline NS5A Ravs it might be wise, or if you happen to know what Ravs if any caused your relapse you could consider it. Most of us don't unless you were on a trial or paid for a deep gene sequencing lab test. In my case I did final receive the information upon my many requests to Abbvie to reveal if I relapsed because of or with Ravs, well final they said that I had no detectable Ravs at time of relapse. So both my Hepatologists agreed that including Ribavirin was not worth the extra side effects.
Obviously Gilead and the FDA have concluded the same thing, but if you happen to know you have a problem with Ravs from your previous HCV treatments then you may want to read up and then talk to your Doctor about it. The side effects are quite detailed and long on Ribavirin but they are mostly tolerable.
matt
-- Edited by Matt Chris on Friday 17th of October 2014 05:24:02 AM
Welcome Miss B, that is part of what makes this such a great forum. Really tremendous folks here, helping each other to get through difficult times. Hoping you get on the Harvoni train.
Looks like I'm gonna have a ticket for the ride. My doc prescribed the Harvoni today. The PA hasn't been approved as yet, but they have sent in the packet with all the necessary documentation. Trying for the whole enchilada, 24 weeks. Apparently there will be some delay but she thought if all goes well it may be under 10 days. Will call the pharmacy tomorrow and try to get their estimates on the time frame. Trying to stay realistic with this...until the Harvoni is in my hands won't get the hopes too high.
Hey Matt,
Very happy news for sure! Your face is going to cramp up from all that smiling!
Hey BJ
I understand how you feel about the hassle of waiting for Harvoni to be delivered to your home. I am waiting as well
Its really a three part process than can not be avoided with an additional problem of it being just released and not on many of the current specialty drug list yet.
1st process = Your Doctor agrees to prescribe the 12 or 24 week duration of Harvoni.
2nd process = Your medical team (Doctor, nurses, etc) work up a prior authorization consisting of all the substantiating lab reports, liver biopsies, Fibroscans, etc. anything that proves you should qualify for the drugs. (most qualified will be cirrhotics and previous relapse patients) These are used to submit to the Specialty drugs request review broad.
3rd process = Most health insurance companies have a designated paid third party company like "Prime Therapeutics" or "Express Scripts" to review and sift through the insurance customers requests and make recommended approvals or rejections. Which can be appealed and should be appealed.
The advantage we have now is that the FDA and Gilead have agreed on many of the things that would have cause problems in getting the drugs and are taken off the table.
So now the insurance companies will try to find other minor loopholes to reject claims, don't give up because many of our Hep-C friends got approved on other off label combos (Simeprevir & Sofosbuvir) so this should be easy than that.
matt
-- Edited by Matt Chris on Thursday 16th of October 2014 05:49:25 AM
Hi Matt,
Good news. Hope you have an easy trip to SVR. Cheers.
Shadow10cats, I also wish that they would just give us the prescription we deserve. However, the drug is expensive so I guess we need to jump through some hoops. I am also waiting to hear what criteria I have to meet to get treated. I only have stage 1 fibrosis but I want to get rid of this before it progresses.
If you have to persuade them to treat you, this might help. I read an interesting article that says,
Most patients with HCV-associated lymphoma present with mild liver disease at cancer diagnosis
Here is the link: http://natap.org/2014/AASLDEASL/AASLDEASL_05.htm
This article really makes the case for treatment BEFORE the liver is seriously damaged. 33% of the lymphoma patients had stage 1 fibrosis and 36% had stage 2 fibrosis. Only 10% had stage 3 fibrosis.
Also, the cost of Harvoni is $94,000 vs. $400,000 for a transplant.
Let's hope we don't have to try to convince them.
Thank you for all the welcome messages. It's great to see that some of you are cured and are still on here helping others!
I have CDPHP in NYS and our scripts are via Caremark. I contacted them about Harvoni & their response to me was: "For your medication, Harvoni, a prior authorization is required. Please have your physician's office contact our prior authorization department directly at 1-800-294-5979. Certain medications require additional clinical information from your physician in order to be considered for coverage through your prescription benefit plan. If approved, this medication needs to be ordered from our Specialty pharmacy at 1-800-237-2767."
So nice way to dodge my question: is it available? And reading between the lines, who knows exactly what the "additional clinical info" is.
I have pretty good bloodwork results so I have to base my case upon how HepC has diminished the quality of my life. How I have cut back on all social activities, gave up outside work I did for additional income, how I no longer have the energy to do the outdoor activities I love, how I have had to reduce my hours at work & even then I can barely make it in or stay thru an entire day, how the disease has affected my mental well being with this awful "brain fog" - it takes me forever to get any task done requiring concentration or thought, the depressio, etc. I don't want to be denied just bec my labs look good.
I've tried the other crap & I've been waiting a long time for this. I want my life back and I am ready to fight for it.
Has anyone else obtained any info from ins companies?
There is plenty more info here free for the sharing. I know your real happy knowing you have an option this time that's much better than interferon. And I hope you get set up with a Harvoni Tx plan quickly! I'm already on Sovaldi / ribavirin so I won't be joining the train ride but I'll help keep the tracks clear for you all and hope to see a big SVR included in everyones signature after the ride is done. Welcome to the forum Bridget and keep us updated on your progress.
Congrats Matt! Can't wait to hear how long it takes for you to get your prescription filled.
-b
That's great news Matt! I didnt have anything but good luck when dealing with Prime Therapeutics and I hope the same ease of service applies to you! This is your time to shine buddy! Good luck.... "I can hear that train a comin"....
Tig
Hey All
Had my appointment with my Hepatologist yesterday. All the labs looked normal except AST, ALT and platelets which is normal for me. The happy news is my first abdominal MRI with and without contrast reported "no focal liver lesion" but findings suggest mild portal hypertension.
As far as "Harvoni" the Doctor prescribed 24 weeks to be immediately processed with my insurance. YAHOO!
Now I wait, and follow up with both my doctors insurance processing dept. and Prime Therapeutics which handles these speciaity drugs for BCBS.
matt
-- Edited by Matt Chris on Thursday 16th of October 2014 05:42:53 AM
Hi Bridget,
Welcome to the forum! Glad to make your acquaintance! We are all anxiously waiting on the word regarding the first distribution of Harvoni. Funny,, every time I write that name down, I think about that hockey rink ice machine, the Zamboni! Anyway, I appreciate your report and will be watching to see what your doctor's response will be. When you have some lab info and things like viral load, genotype, anything you care to share, etc., please add it to your signature (if you want that is). It helps understanding your case and when replying. Please keep in touch! Good luck...
Tig
Hi there,
Back from the doctor at Kaiser Permanente. He said I am a perfect candidate for treatment based on my treatment history, labs & biopsy but they don't have it yet & he doesn't know when they will get it.
I asked what the Kaiser policy is for treatment. He said there was a conference call on it yesterday but he's not on the committee so he will find out what was said. He asked me to email him weekly for updates.
So, I left there without any clear idea if or when I will get Harvoni. Or, even, how is the decision made on who gets it?
I am very interested to hear if anyone has had a prescription for Harvoni filled? I am wondering when Harvoni is going to be available in pharmacies?
Good luck to everyone who is going to the doctor soon, keep us posted.
-b
Welcome glad your on board!
Hey Robert
Glad you are going to join us in Jan. hopefully you will be on the train for 24 weeks.
matt
Hello Bridget
Welcome aboard Bridget, find a great cabin and settle in, Hope your HMO moves quickly on your doctors orders.
matt
I"m looking to jump on this train after the first of the year. Its a insurance thing for me, I renew Dec 31, and thanks to the new health care laws my out of pocket is out of this world.. RC
Ok the lynchster too!
What about my determination? Solvaldi and interferon/riba (for the 5th time) AND AN APPOINMENT ON October 12TH!!!!! :)
I don't think anyone has it yet....but it won't be long before the posts start rolling in on who got their meds.....we should have a pool on who gets it first...just for fun of course! I'm gonna bet Grouper or Isiscat are gonna be first....just because of their determination!
Good luck to all who want it and I hope you get it and it's all it's trumped up to be.
I want all to be cured of this devil of a virus that has hurt so many good people.
Duane
Had appointment at Keiser yesterday - they told me it could be the first of the year - anyone else told differently?
Hi,
I'm new here, this is my first post! I'm hoping to jump on the train! I have picked up some good info here on how to prepare for treatment. I'm seeing the dr. tomorrow to ask for Harvoni. I have Kaiser Permanente HMO. I would be interested to hear if anyone here has received Harvoni from KP. I will let you all know how it goes. I did interferon 20 years ago (@#$%&). My numbers normalized while I was on it but relapsed as soon as I finished. I am interested to hear your stories about which insurers cover Harvoni.
Thanks,
-B
Thanks Matt, I called Gilead as well to see if they had any information for those who have relapsed after previous Sovaldi tx. Neither of the folks I spoke to had a clue? Maybe it's all still too new? Yes I have my copay coupon printed.
Hey all Harvoni TX Train ticket holders
I called Gilead and got the National Drug Code (NDC) for Harvoni
Code # 61958-1801-1
Your Insurance company needs this number to process the doctor drug prescription order.
In talking to Gliead / Harvoni help desk they said the pipeline is ready to fill prescriptions and only hold up will be your insurance company.
matt
-- Edited by Matt Chris on Tuesday 14th of October 2014 12:38:30 AM
-- Edited by Matt Chris on Tuesday 14th of October 2014 12:44:51 AM
Hey Greg
Welcome aboard find a seat with a view and sign up for a cabin because you are schedule for 24 week long trip on the Harvoni TX Train
Matt
Hoping I'll be boarding this train with everyone else.
Should know more after my appointment this week. Good to see all the excitement and enthusiasm.
There are a lot of yellow friends in Emoticon City. Maybe Gilead will give them a deal on Harvoni!
8 weeks..in which cases?
I´ve read in the prescribing information :
Treatment-Naïve Adults without Cirrhosis ION-3 (Study 0108)
The treatment difference between the 8-week treatment of HARVONI and 12-week treatment of HARVONI was 2.3% (97.5% confidence interval 7.2% to 2.5%). Among subjects with a baseline HCV RNA <6 million IU/mL, the SVR was 97% (119/123) with 8-week treatment of HARVONI and 96% (126/131) with 12-week treatment of HARVONI.
Effect of Baseline HCV Polymorphisms on Treatment Response
In treatment-naïve subjects whose virus had baseline NS5A polymorphisms at resistance-associated positions in Studies ION-1 and ION-3, relapse rates were 6% (3/48) after 8 weeks and 1% (1/113) after 12 weeks of treatment with HARVONI. Relapse rates among subjects without baseline NS5A polymorphisms at resistance-associated positions were 5% (8/167) after 8 weeks and 1% (3/306) after 12 weeks treatment with HARVONI.
-- Edited by rebeca on Monday 13th of October 2014 08:21:02 PM
Hey Gator Man:
We better bump your friend up to the front of the train. She's turned yellow. !!
Thanks Jill for the encouragement for all our members that will ride this train.
BTW make sure you have your Gilead / Harvoni coupon follow this link.
http://www.mysupportpath.com/
or checkout this great Thread started by Shadow10cats
http://hepcfriends.activeboard.com/t58754986/discount-coupon-from-gilead-for-harvoni/
Thanks Shadow10Cats this is very important link
matt
Well done, Matt, good to see the Harvoni tx Train getting cranked up and ready to rolll!
Best of luck to all passengers who are along for the ride...I`ll be waving from the sidelines and wishing you all a smooth journey!
All aboard for your destination >>>>> Station SRV!!
Thank you! Sounds like a good cabin...hope it is a serene trip....I will be on the long tour...24 weeks.....
Just spoke with the doctor's office nurse. They have applied for my treatment, just waiting to hear from blue cross....I have everything crossed
Looking forward to this journey.
Hello Ro
Welcome aboard, we have saved you cabin 1a near the observation deck.
You also have got your ducks in a row, great job!
matt
Save me a seat, I hope to be boarding soon.. Got labs etc. done. Repeat CAT on Thursday...hoping to be on the maiden voyage!
Hey PL
Welcome abroad, sounds like you will joining us on a later departure date. No problem there is plenty of cabins available. Perhaps your schedule and insurance situation will work better for you starting out the new year. I would make sure that your insurance is not going to modulate to a unwanted variable.
matt
Hey Mary (ak.Mugsy)
Welcome aboard, find one of those cozy cabins and enjoy the feeling of having no HCV ruling your blood again. Sound like you got your ducks in a row for your appointment. Great job in preparing yourself.
matt
-- Edited by Matt Chris on Monday 13th of October 2014 04:14:39 PM
I'm boarding! Save me a seat! Appt. is 12/23! It's been a long wait!
Maybe 8 weeks? That would be nice...
http://www.nytimes.com/2014/10/11/business/harvoni-a-hepatitis-c-drug-from-gilead-wins-fda-approval.html?_r=0
Tig
Save me a seat, please. I go to Portland on Tuesday for my labs and ultrasound and then see the hepatologist on Wednesday morning.
Thanks for clearing that up!
The fixed dose combination ledipasvir-sofosbuvir (90 mg / 400 mg) is FDA-approved for the treatment of chronic hepatitis C genotype 1 in both treatment-naive and treatment-experienced patients. The treatment duration depending on prior treatment experience and the presence or absence of cirrhosis. Treatment experience is defined as patients who have failed treatment with either peginterferon plus ribavirin or peginterferon plus ribavirin plus a HCV protease inhibitor.
Genotype 1 treatment-naïve patients with or without cirrhosis: 12 weeks
Genotype 1 treatment-experienced patients without cirrhosis: 12 weeks
Genotype 1 treatment-experienced patients with cirrhosis: 24 weeks