Excellent predictions. That's if we are lucky. Government and insurance providers are busy writing their Sovaldi criteria now and rationing may be in store. Illinois and Oregon just enacted it new Sovaldi policies. In Illinois, the patient must meet 25 criteria including advanced liver disease, Interferon eligible (not Interferon ineligible), no drug or alcohol abuse in the past 12 months, no prior Sovaldi tx, etc. Here is the list:http://freepdfhosting.com/c6f3495850.pdf
It is going to be a lottery depending on who the payer is and/or which state you live in. Docs will be overwhelmed with prior authorization requests and appeals.
The good news is things will lighten up over time and it could be sooner rather than later.
It reached this stage because profits and greed took over. Doctors were busy practicing medicine while CEOs were busy forming alliances with politicians. It is very sad.
mallani said
Aug 3, 2014
Isiscat2011 wrote:
Nezam Afdhal, MD, director of hepatology at Beth Israel Deaconess Medical Center, recently stated that "there is no advantage to treating with sofosbuvir/ledipasvir for more than 12-weeks."
"Responding to a question about whether there was any benefit for extended treatment in HCV-G1 treatment-experienced patients with cirrhosis, Afdhal said there was none. "You would have to overtreat 9 out every 10 patients to get a benefit from a 24-week ledipasvir/sofosbuvir regimen with or without ribavirin. The benefit simply does not make fiscal or clinical sense, because there is the risk of more side-effects with this treatment approach. So I think that overall, treating for 12 weeks, with a less than 4% relapse rate is the most reasonable approach."
So, I'm confused. Isn't this the same hepatologist who reported at the 2014 EASL Conference that in the 12-week arms cure rates were lower for treatment experienced people with cirrhosis: 86% with sofosbuvir/ledipasvir alone, 82% with sofosbuvir/ledipasvir plus ribavirin, and 100% SVR for all patients treated for 24 weeks based on the ION 2 clinical trial results?
-- Edited by Isiscat2011 on Friday 1st of August 2014 05:42:25 PM
We're being softened up. Time for some predictions.
#1: Ledipasvir will be approved in October, and Gilead will price the combination Sovaldi/ Ledipasvir pill at $1,500. This will be cheaper than Sovaldi/ Olysio.
#2: The last prescription for Olysio will be written in October.
#3: The ASLD will release Guidelines shortly after. These will recommend 12 weeks of treatment for all Geno 1's. There may be an option to add Ribavirin for 1a's, previous Rx-failures and cirrhotics.
#4: Shortly after, there will be the option of 8 weeks of Rx for the Rx-naives, and for those who are less than F2. This will be seized on by Insurance.
#5: There MAY be the option to consider 24 weeks of treatment for those who failed a Sovaldi treatment.
#6: The Geno 3's will be neglected again. They will be left with 24 weeks of Sovaldi/ Riba.
How did the US Health system reach this stage? Treatments are decided by those who pay, be it Insurance Companies or Government. The individual Hepatologist has his hands tied. Sad.
Huey said
Aug 2, 2014
The Doc's are just trying to get caught up ,, They are trying to help but they are slaves to the conglomerate that they get the student loan payment from. The US Doc.s Will follow The Guidance from London in most cases, That is my belief anyway.
Isiscat2011 said
Aug 1, 2014
Matt Chris wrote:
The money part is probably why he has change his thought, I can tell you that all three of my Doctors (two Hepatologists and one ID doctors) recommended 24 weeks. One of them is Dr. Eric Lawitz he runs one of the most well respected HCV Research and trials center in the world.
I'm sure you are right that it is about cost but why should he be so concerned with cost? He's not paying for it. His professional responsibilities are to his patients not the insurance industry. He also cited the potential for increased side effects but I'm not sure that rings true. It seems like side effects, which may or may not be a significant problem, could be dealt with if/when they arise rather than shortening tx time in advance.
This concerns me because I think it could become the "official" policy for US docs. Not only does the reasoning for it appear disingenuous, but the plan also is destined to cause many tx failures. Didn't your doc recently suggest that 12 weeks would be your tx duration? I thought I read that.
I haven't discussed it with my doc yet but 12 weeks is the vibe I'm getting for cirrhotics and anything beyond that will be a crap shoot. There is little patients can do about it without the full support of docs; the insurance companies will be looking for reasons to limit duration. The question is: Are docs going to give them the reasons? Very disappointing if the answer is yes.
Matt Chris said
Aug 1, 2014
Hey Isiscat
I would like to ask him , if he had personal failed previous treatment and is cirrhotic how would he approach his choice of 12 weeks (82%) or 24 weeks (100%)
I am not saying that everyone should be treated for 24 weeks, but if you have failed other DAA's and are cirrhotic the best course is the longer one, plain and simple.
The money part is probably why he has change his thought, I can tell you that all three of my Doctors (two Hepatologists and one ID doctors) recommended 24 weeks. One of them is Dr. Eric Lawitz he runs one of the most well respected HCV Research and trials center in the world.
Eric Lawitz, MD, is Vice President of Scientific and Research Development at The Texas Liver Institute and Clinical Professor of Medicine at the San Antonio University of Texas Health Science Center
If Nezam Afdhal, MD was one of the 18 % of GT1a that failed treatment what do you think his answer would be?
matt
Isiscat2011 said
Aug 1, 2014
P.S. Assuming real world results echo ION 2 clinical trial results (which is not necessarily a safe assumption) I could agree with the conclusion that treating for 24 weeks would result in over-treating some patients. (It would also result in undertreating some.)
But, why is Dr. Afdahl misstating the facts? Notably, this doctor's recommendations will guide other treating physicians, as he is prominent in the field of HepC tx.
Isiscat2011 said
Aug 1, 2014
Nezam Afdhal, MD, director of hepatology at Beth Israel Deaconess Medical Center, recently stated that "there is no advantage to treating with sofosbuvir/ledipasvir for more than 12-weeks."
"Responding to a question about whether there was any benefit for extended treatment in HCV-G1 treatment-experienced patients with cirrhosis, Afdhal said there was none. "You would have to overtreat 9 out every 10 patients to get a benefit from a 24-week ledipasvir/sofosbuvir regimen with or without ribavirin. The benefit simply does not make fiscal or clinical sense, because there is the risk of more side-effects with this treatment approach. So I think that overall, treating for 12 weeks, with a less than 4% relapse rate is the most reasonable approach."
So, I'm confused. Isn't this the same hepatologist who reported at the 2014 EASL Conference that in the 12-week arms cure rates were lower for treatment experienced people with cirrhosis: 86% with sofosbuvir/ledipasvir alone, 82% with sofosbuvir/ledipasvir plus ribavirin, and 100% SVR for all patients treated for 24 weeks based on the ION 2 clinical trial results?
Excellent predictions. That's if we are lucky. Government and insurance providers are busy writing their Sovaldi criteria now and rationing may be in store. Illinois and Oregon just enacted it new Sovaldi policies. In Illinois, the patient must meet 25 criteria including advanced liver disease, Interferon eligible (not Interferon ineligible), no drug or alcohol abuse in the past 12 months, no prior Sovaldi tx, etc. Here is the list:http://freepdfhosting.com/c6f3495850.pdf
It is going to be a lottery depending on who the payer is and/or which state you live in. Docs will be overwhelmed with prior authorization requests and appeals.
The good news is things will lighten up over time and it could be sooner rather than later.
It reached this stage because profits and greed took over. Doctors were busy practicing medicine while CEOs were busy forming alliances with politicians. It is very sad.
We're being softened up. Time for some predictions.
#1: Ledipasvir will be approved in October, and Gilead will price the combination Sovaldi/ Ledipasvir pill at $1,500. This will be cheaper than Sovaldi/ Olysio.
#2: The last prescription for Olysio will be written in October.
#3: The ASLD will release Guidelines shortly after. These will recommend 12 weeks of treatment for all Geno 1's. There may be an option to add Ribavirin for 1a's, previous Rx-failures and cirrhotics.
#4: Shortly after, there will be the option of 8 weeks of Rx for the Rx-naives, and for those who are less than F2. This will be seized on by Insurance.
#5: There MAY be the option to consider 24 weeks of treatment for those who failed a Sovaldi treatment.
#6: The Geno 3's will be neglected again. They will be left with 24 weeks of Sovaldi/ Riba.
How did the US Health system reach this stage? Treatments are decided by those who pay, be it Insurance Companies or Government. The individual Hepatologist has his hands tied. Sad.
The Doc's are just trying to get caught up ,, They are trying to help but they are slaves to the conglomerate that they get the student loan payment from. The US Doc.s Will follow The Guidance from London in most cases, That is my belief anyway.
I'm sure you are right that it is about cost but why should he be so concerned with cost? He's not paying for it. His professional responsibilities are to his patients not the insurance industry. He also cited the potential for increased side effects but I'm not sure that rings true. It seems like side effects, which may or may not be a significant problem, could be dealt with if/when they arise rather than shortening tx time in advance.
This concerns me because I think it could become the "official" policy for US docs. Not only does the reasoning for it appear disingenuous, but the plan also is destined to cause many tx failures. Didn't your doc recently suggest that 12 weeks would be your tx duration? I thought I read that.
I haven't discussed it with my doc yet but 12 weeks is the vibe I'm getting for cirrhotics and anything beyond that will be a crap shoot. There is little patients can do about it without the full support of docs; the insurance companies will be looking for reasons to limit duration. The question is: Are docs going to give them the reasons? Very disappointing if the answer is yes.
Hey Isiscat
I would like to ask him , if he had personal failed previous treatment and is cirrhotic how would he approach his choice of 12 weeks (82%) or 24 weeks (100%)
I am not saying that everyone should be treated for 24 weeks, but if you have failed other DAA's and are cirrhotic the best course is the longer one, plain and simple.
The money part is probably why he has change his thought, I can tell you that all three of my Doctors (two Hepatologists and one ID doctors) recommended 24 weeks. One of them is Dr. Eric Lawitz he runs one of the most well respected HCV Research and trials center in the world.
Eric Lawitz, MD, is Vice President of Scientific and Research Development at The Texas Liver Institute and Clinical Professor of Medicine at the San Antonio University of Texas Health Science Center
If Nezam Afdhal, MD was one of the 18 % of GT1a that failed treatment what do you think his answer would be?
matt
P.S. Assuming real world results echo ION 2 clinical trial results (which is not necessarily a safe assumption) I could agree with the conclusion that treating for 24 weeks would result in over-treating some patients. (It would also result in undertreating some.)
But, why is Dr. Afdahl misstating the facts? Notably, this doctor's recommendations will guide other treating physicians, as he is prominent in the field of HepC tx.
Nezam Afdhal, MD, director of hepatology at Beth Israel Deaconess Medical Center, recently stated that "there is no advantage to treating with sofosbuvir/ledipasvir for more than 12-weeks."
"Responding to a question about whether there was any benefit for extended treatment in HCV-G1 treatment-experienced patients with cirrhosis, Afdhal said there was none. "You would have to overtreat 9 out every 10 patients to get a benefit from a 24-week ledipasvir/sofosbuvir regimen with or without ribavirin. The benefit simply does not make fiscal or clinical sense, because there is the risk of more side-effects with this treatment approach. So I think that overall, treating for 12 weeks, with a less than 4% relapse rate is the most reasonable approach."
http://www.hcplive.com/conferences/2014-easl/Is-There-Any-Advantage-to-Treating-Patients-with-Hepatitis-C-for-Longer-than-12-Weeks-with-Combination-SofosbuvirLedipasvir
So, I'm confused. Isn't this the same hepatologist who reported at the 2014 EASL Conference that in the 12-week arms cure rates were lower for treatment experienced people with cirrhosis: 86% with sofosbuvir/ledipasvir alone, 82% with sofosbuvir/ledipasvir plus ribavirin, and 100% SVR for all patients treated for 24 weeks based on the ION 2 clinical trial results?
http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4627-easl-2014-sofosbuvirledipasvir-cures-more-than-90-of-first-time-and-retreated-genotype-1-patients
Comments?
-- Edited by Isiscat2011 on Friday 1st of August 2014 05:42:25 PM