Aa
Vertex Telaprevir Starting FDA Approval This Summer
Interesting reading....
http://hepatitiscnewdrugs.blogspot.com/2010/04/vertex-telaprevir-starting-fda-approval.html
Magnum
http://hepatitiscnewdrugs.blogspot.com/2010/04/vertex-telaprevir-starting-fda-approval.html
Magnum
Good lord, too many newcastle browns, 3 Scottish bouncers and you lived to tell the tale! Many have not. A fitting testament indeed to the efficiency of the UK national health service.
not sure about the 'educated friend' bit though,
dointime
not sure about the 'educated friend' bit though,
dointime
You make an excellent point about us here not getting procrit. In fact some people do get epo (=procrit) and neupogen but it depends on where you live and who your doc is. In general the docs here are more with the one-size-fits-all tx and not as up to date with individualising tx. As you point out, this is going to become more of an issue than it already is when the PI's arrive.
dointime
dointime
"Then the UK national health service body NICE has to decide whether to pay for them or not"
-------------------------
Considering that consultants have been telling some people to wait for PI's, they better approve them or people will riot.
What concerns me is that PIs cause more anemia and you guys are not allowed Procrit. Docs reduce the dose of Ribavirin instead. Same thing with Australia.
Since PIs cause anemia....what if they reduce the dose of the PI instead of reducing the Ribavirin? That would increase breakthroughs and resistance.
"Now correct me if I'm wrong but don't people in US go to Canada or Mexico for drugs because they are cheaper there? But the drugs that they get are FDA-approved, right?"
------------------------
Yes. They are cheaper because the drug companies have to price drugs according to the cost of living for that country.
In Mexico, you can get many meds without a prescription (unless they're narcotics, tranquilizers, etc)
Co
-------------------------
Considering that consultants have been telling some people to wait for PI's, they better approve them or people will riot.
What concerns me is that PIs cause more anemia and you guys are not allowed Procrit. Docs reduce the dose of Ribavirin instead. Same thing with Australia.
Since PIs cause anemia....what if they reduce the dose of the PI instead of reducing the Ribavirin? That would increase breakthroughs and resistance.
"Now correct me if I'm wrong but don't people in US go to Canada or Mexico for drugs because they are cheaper there? But the drugs that they get are FDA-approved, right?"
------------------------
Yes. They are cheaper because the drug companies have to price drugs according to the cost of living for that country.
In Mexico, you can get many meds without a prescription (unless they're narcotics, tranquilizers, etc)
Co
"Why can't you get the meds from another source instead of England? People here in the US often either go to Canada or Mexico to get their meds. "
-------------
Price would be a huge impediment.
Cost Effectiveness of STAT-C Agents in Treating Genotype 1 Chronic Hepatitis C.
P. G. Northup; A. M. Al-Osaimi; S. H. Caldwell; C. K. Argo.
Background:
The treatment of genotype 1 chronic hepatitis C (HCV) is evolving with the advent of a new class of drugs specifically targeted at the HCV molecule. Early clinical trial data show promise that the STAT-C agents will improve sustained virologic response (SVR) rates. This study was designed to explore the potential cost effectiveness of two of these agents: Boceprevir (BOC) and Telaprevir (TEL).
Methods:
A simple cost effectiveness model was developed to simulate a cohort of non-cirrhotic patients with genotype 1 HCV undergoing therapy with combination pegylated interferon (PEG-IFN) and ribavirin (RBV) along with Boceprevir or Telaprevir.
Three competing treatment strategies were simulated:
1) Standard of care 48 week, weight based PEG-IFN and RBV (SOC),
2) Twelve week course of TEL combined with PEG-IFN+RBV followed by 12 additional weeks of PEG-IFN+RBV and
3) Four week lead-in with PEG-IFN+RBV followed by 44 weeks of triple therapy BOC combined with PEG-IFN+RBV.
Rapid and early virologic response rates, treatment failure and breakthrough rates, growth factor requirements, and SVR rates were extracted from publically available phase 2 clinical trial results (PROVE 1 and SPRINT-1). PEG-IFN, RBV, and erythropoetic growth factor costs were extrapolated from commercially available pharmacy pricing guides. Progression to decompensated cirrhosis and the possibility of liver transplantation was simulated in treatment failures. Wide ranges of costs for the STAT-C agents were explored.
Results:
The treatment strategies using the STAT-C agents were more effective than the standard of care therapy. A 1,000 patient Monte Carlo simulation of the SOC treatment yielded 440 SVRs, 130 deaths from progression of liver disease, and 30 liver transplants. The TEL strategy yielded 640 SVRs, 100 deaths from disease progression, and 10 liver transplants. Finally, the BOC arm yielded 740 SVRs, 50 deaths from liver disease, and 10 liver transplants. The number needed to treat to prevent a death from liver disease or liver transplantation was 4 for the TEL arm and 2 for the BOC arm. Both TEL and BOC were highly cost-effective throughout a wide range of potential direct drug costs from $12,000 to $120,000. Assuming a base case cost of $50,000 for BOC or TEL for a complete course of therapy, the marginal cost effectiveness of TEL (over SOC) was $7,876 while the marginal cost effectiveness of BOC (over TEL) was $7,678.
Conclusions:
Despite the high up-front costs of TEL or BOC, both agents are likely to be highly cost effective in the treatment of genotype 1 HCV based on phase 2 clinical trial viral response data.
http://www.hcvadvocate.org/news/reports/AASLD%202009/Abstracts/AASLD%202009%20Abstracts.htm#Th1571
-------------
Price would be a huge impediment.
Cost Effectiveness of STAT-C Agents in Treating Genotype 1 Chronic Hepatitis C.
P. G. Northup; A. M. Al-Osaimi; S. H. Caldwell; C. K. Argo.
Background:
The treatment of genotype 1 chronic hepatitis C (HCV) is evolving with the advent of a new class of drugs specifically targeted at the HCV molecule. Early clinical trial data show promise that the STAT-C agents will improve sustained virologic response (SVR) rates. This study was designed to explore the potential cost effectiveness of two of these agents: Boceprevir (BOC) and Telaprevir (TEL).
Methods:
A simple cost effectiveness model was developed to simulate a cohort of non-cirrhotic patients with genotype 1 HCV undergoing therapy with combination pegylated interferon (PEG-IFN) and ribavirin (RBV) along with Boceprevir or Telaprevir.
Three competing treatment strategies were simulated:
1) Standard of care 48 week, weight based PEG-IFN and RBV (SOC),
2) Twelve week course of TEL combined with PEG-IFN+RBV followed by 12 additional weeks of PEG-IFN+RBV and
3) Four week lead-in with PEG-IFN+RBV followed by 44 weeks of triple therapy BOC combined with PEG-IFN+RBV.
Rapid and early virologic response rates, treatment failure and breakthrough rates, growth factor requirements, and SVR rates were extracted from publically available phase 2 clinical trial results (PROVE 1 and SPRINT-1). PEG-IFN, RBV, and erythropoetic growth factor costs were extrapolated from commercially available pharmacy pricing guides. Progression to decompensated cirrhosis and the possibility of liver transplantation was simulated in treatment failures. Wide ranges of costs for the STAT-C agents were explored.
Results:
The treatment strategies using the STAT-C agents were more effective than the standard of care therapy. A 1,000 patient Monte Carlo simulation of the SOC treatment yielded 440 SVRs, 130 deaths from progression of liver disease, and 30 liver transplants. The TEL strategy yielded 640 SVRs, 100 deaths from disease progression, and 10 liver transplants. Finally, the BOC arm yielded 740 SVRs, 50 deaths from liver disease, and 10 liver transplants. The number needed to treat to prevent a death from liver disease or liver transplantation was 4 for the TEL arm and 2 for the BOC arm. Both TEL and BOC were highly cost-effective throughout a wide range of potential direct drug costs from $12,000 to $120,000. Assuming a base case cost of $50,000 for BOC or TEL for a complete course of therapy, the marginal cost effectiveness of TEL (over SOC) was $7,876 while the marginal cost effectiveness of BOC (over TEL) was $7,678.
Conclusions:
Despite the high up-front costs of TEL or BOC, both agents are likely to be highly cost effective in the treatment of genotype 1 HCV based on phase 2 clinical trial viral response data.
http://www.hcvadvocate.org/news/reports/AASLD%202009/Abstracts/AASLD%202009%20Abstracts.htm#Th1571
I see your point, my educated friend. I spent a month in Fulham in 1974. got in a fight with three Scottish bouncers at the Greyhound Pub and was rushed to emergency. Didn't have to pay anything, even though I wasn't a British subject. I then had to go to the dentist after being release from the hospital three days later. I had to have a couple of teeth capped that were cracked in the fight. If I'm not mistaken, I had to pay an equivalent of $3 US. I will never forget the courtesy of all the English people who helped me there.
One funny note. I was obviously drunk at the pub, not having eaten anything before drinking too many Newcastle Browns, and when I arrived in the emergency room and was having my cuts sewn up in my face, because I was under a bright light, the nurse said "We have ways to make you talk" with a German accent. I laughed even though it hurt...
Mag
One funny note. I was obviously drunk at the pub, not having eaten anything before drinking too many Newcastle Browns, and when I arrived in the emergency room and was having my cuts sewn up in my face, because I was under a bright light, the nurse said "We have ways to make you talk" with a German accent. I laughed even though it hurt...
Mag
Hi Magnum,
First off it's a question of who pays. The UK system is not like in the US where the insurance pays - if you have insurance. Here the national health service pays for the doc and the drugs. It is not usual for people to pay privately for this because
a) it's a lot of money for the drugs and the doc and
b) private doctors don't have the backup systems of a big hospital in case the treatment goes pear shaped.
Now correct me if I'm wrong but don't people in US go to Canada or Mexico for drugs because they are cheaper there? But the drugs that they get are FDA-approved, right? Therefore US docs are allowed to prescribe them. Well the same goes here. UK docs are only allowed to prescribe and treat with drugs which are licensed for use in Europe. Even if I could get a Mexican doc to prescribe the meds, it would hardly be fair to my UK doc to take them clandestinely off my own bat, possibly end up in ER, and possibly have the shadow of professional misconduct fall on the poor man.
Believe me, when I was on the waiting list for my first tx I thought through all the ins and outs of these things and came to the conclusion that if I were desperate I would have to get the money somehow, get a referral, and take my body over to the US to live for the duration. That's before even thinking about the US visa requirements. Luckily I'm not desperate at this point so my plan A is to wait and treat here.
Wishing you well for your next tx. It is cold comfort when you still have to wait, but you lucky guys over there are going to get the new drugs soonest,
dointime
First off it's a question of who pays. The UK system is not like in the US where the insurance pays - if you have insurance. Here the national health service pays for the doc and the drugs. It is not usual for people to pay privately for this because
a) it's a lot of money for the drugs and the doc and
b) private doctors don't have the backup systems of a big hospital in case the treatment goes pear shaped.
Now correct me if I'm wrong but don't people in US go to Canada or Mexico for drugs because they are cheaper there? But the drugs that they get are FDA-approved, right? Therefore US docs are allowed to prescribe them. Well the same goes here. UK docs are only allowed to prescribe and treat with drugs which are licensed for use in Europe. Even if I could get a Mexican doc to prescribe the meds, it would hardly be fair to my UK doc to take them clandestinely off my own bat, possibly end up in ER, and possibly have the shadow of professional misconduct fall on the poor man.
Believe me, when I was on the waiting list for my first tx I thought through all the ins and outs of these things and came to the conclusion that if I were desperate I would have to get the money somehow, get a referral, and take my body over to the US to live for the duration. That's before even thinking about the US visa requirements. Luckily I'm not desperate at this point so my plan A is to wait and treat here.
Wishing you well for your next tx. It is cold comfort when you still have to wait, but you lucky guys over there are going to get the new drugs soonest,
dointime
Why can't you get the meds from another source instead of England? People here in the US often either go to Canada or Mexico to get their meds. I don't know the situation in England but is there a chance of doing that? Can't your doctor look into that?
Mag
Mag
I don't know a lot about this subject but here in UK my doc says that these drugs will need to get a separate European licence after they get FDA approval. He reckons this might take about a year after FDA approval.
Then the UK national health service body NICE has to decide whether to pay for them or not and that's a big can of worms. But they pay for ifn and riba at the moment, so hard to see how they could refuse something more successful which can cut treatment times.
dointime
Then the UK national health service body NICE has to decide whether to pay for them or not and that's a big can of worms. But they pay for ifn and riba at the moment, so hard to see how they could refuse something more successful which can cut treatment times.
dointime
cando - agreed; based on the Phase III completion dates and Merck announcement at EASL10 seems tela should, at most, have a 3-6 month lead. Is this what they mean by 'long after' ? Some of the vertex news, like that 60% non-responder svr claim, kinda makes you wonder..
diamando: sorry, not sure how the approval process in the US correlates with availability in Europe. I believe distribution of telaprevir there is being handled through Johnson and Johnson. Also there may be a different stages of approval in (1) making the drug available and (2) adding it to medicines covered through national health plans.
diamando: sorry, not sure how the approval process in the US correlates with availability in Europe. I believe distribution of telaprevir there is being handled through Johnson and Johnson. Also there may be a different stages of approval in (1) making the drug available and (2) adding it to medicines covered through national health plans.
Thank you all for this valuable informations, since, I personaly am waiting for that approval, and new round of treatment, here in Belgrade, Serbia. I dont know about version of medication here, but I guess it is Boceprevir, anyone is familliar with this information?
Should of added this link
http://janis7hepc.com/2010_internet_hcv_conference_rep.htm
http://janis7hepc.com/2010_internet_hcv_conference_rep.htm
That boceprevir will likely reach the market long after telaprevir is odd as this was posted...
Boceprevir
The drug — developed by Schering-Plough, which merged with Merck in November 2009 — is now in a fully enrolled phase 3 trial. Merck officials expect to file the Food and Drug Administration application later this year, and they hope for approval in 2011.
Boceprevir
The drug — developed by Schering-Plough, which merged with Merck in November 2009 — is now in a fully enrolled phase 3 trial. Merck officials expect to file the Food and Drug Administration application later this year, and they hope for approval in 2011.
magnum: thanks
all: this has gotten posted before and I'm curious about the source of the press release if anyone knows (it doesn't seem to be on the vrtx site, did reuter's get it from an analysts' call?). There's a couple of items on it that are interesting :
1) boceprevir "will likely reach the market long after telaprevir." How so ?
2) "telaprevir sales of $3.9 billion in 2013" kinda implies good estimates for market size and price
Anyone have any ideas about the sources of the above ? Is this just stock-hyping FUD or is there is some (accessible) data?
all: this has gotten posted before and I'm curious about the source of the press release if anyone knows (it doesn't seem to be on the vrtx site, did reuter's get it from an analysts' call?). There's a couple of items on it that are interesting :
1) boceprevir "will likely reach the market long after telaprevir." How so ?
2) "telaprevir sales of $3.9 billion in 2013" kinda implies good estimates for market size and price
Anyone have any ideas about the sources of the above ? Is this just stock-hyping FUD or is there is some (accessible) data?
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