If Gilead says the new tx will be effective in treating those who relapse, and wants to show that true, one would hope that Gilead would have some type of program to reduce costs on retreatment.
Perhaps this should have been posted in the Daily Funny thread.
Would be nice if someone asked this question at the FDA hearing.
-- Edited by Groupergetter on Tuesday 7th of October 2014 11:49:31 AM
I thought Gilead Guaranteed it so re-treatment of more Sovaldi should be free.
Gator Man said
Oct 7, 2014
Isiscat2011 wrote:
I was looking forward to reading the transcripts and perhaps seeing some questions answered directly by Gilead. Not that the committee members ask many difficult questions at the hearings but one can hope.
... One thing I have learned through my HCV saga is this: The FDA is a dysfunctional mess.
My experience representing and dealing with governmental agencies has at times made sausage making resemble afternoon tea. Having been in executive sessions and off mike discussions, difficult questions are only asked when someone is trying to make a show. Most questions and resultant decisions have already been discussed and made prior to the public forum. I've never dealt with the FDA and rue the day when I handle a federal matter, but "softball" questions at a public hearing comes as no surprise.
Tig said
Oct 7, 2014
Isiscat2011 wrote:
One thing I have learned through my HCV saga is this: The FDA is a dysfunctional mess.
Ding, ding, ding, ding!!!!! Dysfunctional is quite accurate... Unfortunately, we seem to be stuck with the mess as well. As citizens we will never truly know how deep the roots extend into their ineffectiveness. Maybe effectiveness (or not) is a hard thing to put a finger on. Perhaps determining their actual benefit to BS ratio would be a more accurate indicator of their benefit... IDK?
Tig
Isiscat2011 said
Oct 7, 2014
No advisory committee hearing for the S/L combo? I was wondering how they intended to have the hearing and do the approval on the same date but they do take the approval vote at the end of the hearings. This is probably typical for the expedited review process. So hard to get complete information from the FDA web site.
I was looking forward to reading the transcripts and perhaps seeing some questions answered directly by Gilead. Not that the committee members ask many difficult questions at the hearings but one can hope.
I am officially disgusted with the lack of transparency in the FDA drug approval system. Not to mention the FDA's convoluted data system that has even physicians, who are trying to make responsible prescribing decisions, scratching their heads. Most of what occurs between the FDA and Pharma is behind closed doors.
One thing I have learned through my HCV saga is this: The FDA is a dysfunctional mess.
Matt Chris said
Oct 7, 2014
Hey Greg
Just a side note, the FDA did not have an official advisory committee for S&L as they did for Sovaldi 30 day before the release date. I called the FDA and asked for the transcript and they told me there was no meeting.
During the time from Gliead's filing for a NDA in Feb, 2014 and until Oct 10, 2014 they will communicate back and forth on questions and concerns. It seems to me that because Sovaldi/Sofosburvir is the major element in the combo most of the questions had been answered.
The big concern for us cirrhotics is the duration issue, namely will they have an 24 month recommendation criteria for certain conditional patients.
Also Jlynch I would guess you would fall under a re-treatment protocol that might include a longer duration with Ledipasvir.
matt
-- Edited by Matt Chris on Tuesday 7th of October 2014 06:51:16 PM
Groupergetter said
Oct 7, 2014
If Gilead says the new tx will be effective in treating those who relapse, and wants to show that true, one would hope that Gilead would have some type of program to reduce costs on retreatment.
Perhaps this should have been posted in the Daily Funny thread.
Would be nice if someone asked this question at the FDA hearing.
-- Edited by Groupergetter on Tuesday 7th of October 2014 11:49:31 AM
Isiscat2011 said
Oct 7, 2014
Hi John:
Since you are cirrhotic you should be able to get tx without much hassle from your insurance company when the new DAAs are FDA approved. The question will be what drugs to put you on.
There may be a question about retreating you with Sovaldi. Gilead has not given adequate guidance about retreating with Sovaldi yet but I expect Gilead's reps will be asked this question at the FDA hearing on Friday. The information about whether or not Sovaldi should be repeated has been conflicting. A second question will be whether your insurance will pay for Sovaldi again. If not the Sovaldi/Ledipasvir combo then you should be able to get on the Abbvie combo in December.
Did you find a new doc? That is really important and what I would be doing right away if you haven't yet.
JLynch30 said
Oct 7, 2014
I relapsed on solvaldi/ribravirin/interferon - any word if I will be eligible for new treatment?
I thought Gilead Guaranteed it so re-treatment of more Sovaldi should be free.
My experience representing and dealing with governmental agencies has at times made sausage making resemble afternoon tea. Having been in executive sessions and off mike discussions, difficult questions are only asked when someone is trying to make a show. Most questions and resultant decisions have already been discussed and made prior to the public forum. I've never dealt with the FDA and rue the day when I handle a federal matter, but "softball" questions at a public hearing comes as no surprise.
Ding, ding, ding, ding!!!!! Dysfunctional is quite accurate... Unfortunately, we seem to be stuck with the mess as well. As citizens we will never truly know how deep the roots extend into their ineffectiveness. Maybe effectiveness (or not) is a hard thing to put a finger on. Perhaps determining their actual benefit to BS ratio would be a more accurate indicator of their benefit... IDK?
Tig
No advisory committee hearing for the S/L combo? I was wondering how they intended to have the hearing and do the approval on the same date but they do take the approval vote at the end of the hearings. This is probably typical for the expedited review process. So hard to get complete information from the FDA web site.
I was looking forward to reading the transcripts and perhaps seeing some questions answered directly by Gilead. Not that the committee members ask many difficult questions at the hearings but one can hope.
I am officially disgusted with the lack of transparency in the FDA drug approval system. Not to mention the FDA's convoluted data system that has even physicians, who are trying to make responsible prescribing decisions, scratching their heads. Most of what occurs between the FDA and Pharma is behind closed doors.
One thing I have learned through my HCV saga is this: The FDA is a dysfunctional mess.
Hey Greg
Just a side note, the FDA did not have an official advisory committee for S&L as they did for Sovaldi 30 day before the release date. I called the FDA and asked for the transcript and they told me there was no meeting.
During the time from Gliead's filing for a NDA in Feb, 2014 and until Oct 10, 2014 they will communicate back and forth on questions and concerns. It seems to me that because Sovaldi/Sofosburvir is the major element in the combo most of the questions had been answered.
The big concern for us cirrhotics is the duration issue, namely will they have an 24 month recommendation criteria for certain conditional patients.
Also Jlynch I would guess you would fall under a re-treatment protocol that might include a longer duration with Ledipasvir.
matt
-- Edited by Matt Chris on Tuesday 7th of October 2014 06:51:16 PM
If Gilead says the new tx will be effective in treating those who relapse, and wants to show that true, one would hope that Gilead would have some type of program to reduce costs on retreatment.
Perhaps this should have been posted in the Daily Funny thread.
Would be nice if someone asked this question at the FDA hearing.
-- Edited by Groupergetter on Tuesday 7th of October 2014 11:49:31 AM
Hi John:
Since you are cirrhotic you should be able to get tx without much hassle from your insurance company when the new DAAs are FDA approved. The question will be what drugs to put you on.
There may be a question about retreating you with Sovaldi. Gilead has not given adequate guidance about retreating with Sovaldi yet but I expect Gilead's reps will be asked this question at the FDA hearing on Friday. The information about whether or not Sovaldi should be repeated has been conflicting. A second question will be whether your insurance will pay for Sovaldi again. If not the Sovaldi/Ledipasvir combo then you should be able to get on the Abbvie combo in December.
Did you find a new doc? That is really important and what I would be doing right away if you haven't yet.
I relapsed on solvaldi/ribravirin/interferon - any word if I will be eligible for new treatment?