The true cost of TIL and problems for phase 3 trials

Thank you for posting this!

Thank you for posting this!

Thank you for posting this!

I think many researchers in the pharma industry are also in it to help improve the lives of patients

Some are patients themselves

I think many researchers in the pharma industry are also in it to help improve the lives of patients

Some are patients themselves

I think many researchers in the pharma industry are also in it to help improve the lives of patients

Some are patients themselves

Most new medicines come from pharma companies, not from universities or governments.  The problem is how much it costs to develop new drugs.

http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/

Most new medicines come from pharma companies, not from universities or governments.  The problem is how much it costs to develop new drugs.

http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/

Most new medicines come from pharma companies, not from universities or governments.  The problem is how much it costs to develop new drugs.

http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/

As one who works in the industry, I can tell you unequivicably that if a drug does not have profit potential, it will never see the light of day no matter the value to the patient.  It is the harsh truth that comes from having a health care system that is for-profit.  It is rather remarkable that the Dendreon technology made to market with a treatment cost of $80,000. Provenge is a autologous cell therapy for prostate cancer but as a model for other cell therapies, it can be instructive.  It is a company and an immunotherapy that is struggling to get a toehold in the market.  I am sure the marketing teams at other pharma companies are following this with great interest.  Their current lack of success is going to make a getting a second product more challenging…and they do have IP.

The dominant role of pharma in drug development – and its perils – was discussed in an indepth article in the Washington Post earlier this year titled, "As drug industry;s influence over research grows, so does the potential for bias."  (see http://www.washingtonpost.com/business/economy/as-drug-industrys-influence-over-research-grows-so-does-the-potential-for-bias/2012/11/24/bb64d596-1264-11e2-be82-c3411b7680a9_story_1.html).  

As for the primary source of drugs, it is a well-established fact that the industry has turned increasingly to outside drug development to augment depleted in-house pipelines.  The main pathway for drug development today is for an academic researcher at a major institution works with the tech transfer office to either find a pharma R&D champion or create a spin out biotech company to manage the drug / technology until it can be sold.   We have to be infinitely grateful to researchers pushing the boundaries of knowledge and technology to give new ideas and treatments a chance to develop to the point that some pharma company will take a shot at moving it into the clinic.

It is also fair to say that clinical studies are obscenely expensive.  It is not unusual for a cancer clinical study to cost $50,000 – $100,000 per patient.  When you consider Phase I is 10 – 20 patients, Phase II is 60 – 100 and Phase III 200+ patients, it is not hard to see how the cost of drug development runs into the hundreds of millions of dollars very easily.  This is the very reason that public support is essential for new drug development to get over the hurdle of early clinical studies – which pharma will not pay for.  It is the early studies that provide some basis for making a decision to invest in Phase III development.

I don't understand why so many of us seem to feel that it is somehow slimy and unethical for pharmaceutical companies to make a profit. Auto repair shops make a profit. Airlines make a profit. God knows oil compamies, lawyers and hedge fund managers make a profit. What's with bashing the pharma companies?

Name me one major drug that has been developed in a country where there was no capitalist incentive– and by developed I mean discovered in the lab, tested in animals, gone through extensive clinical trials and was proven safe and effective according to US standards. I can't think of a single one.

As for the expense of the whole drug discovery process, do you realize that only 1 out of 3 drugs that enter Phase 1 trials actually make through Phase III? From that perspective, companies "waste" 2/3 of their clinical trial budget each year. Or, looked at another way, each successful clinical trial costs 3 times more than the advertised price.

The government already pays for all those nobel academic researchers who "push the boundaries of knowledge"– that's called research grants and contracts. If you want our government to pay for all the clinical trials and regulatory approvals,  too,I sure hope you're not one of those "smaller government" or "no more taxes" people. You can't have it both ways– insist that tons of time and public money be put into drugs that will help very, very few people while having absolutely no profit potential AND you pay less in taxes and get "big government" out of your lives. Make up your minds.

As Winston Churchill said: "Democracy is the worst form of government– except for all the others." I think that the same could be said about our drug discovery and approval process. Show me something better. 

I don't think it is unethical to develop drugs and make money – that's my job, too.  What I find troubling is that the public interest is not always best served by the marketing team of PharmaCo.  As an example, why isn't Rituxan in a clinical study for adjuvant therapy for melanoma?  Two independent academic studies indicated that it radically reduced recurrance.  Genentech doesn't see the value although you or I just might like to know if our lives could be improved by using a safe drug that eliminates recurrance.  It is in cases like these that an alternate pathway is needed.  

As an extreme example, let's say I invented a cure for moles on the left cheek.  Clinical studies show it is safe & effective but a marketing survey shows that only 5,000 people have moles on their left cheek that would use this drug.  If your one of the 5,000, you want that drug, but you will never get it because there is no value for a micro market like that.  Those people are SOL.  It goes on all the time.  

You are right about the poor conversion from Phase III to drug…I believe the industry metric right now is about $1.3 billion per approved drug.  Clinical research isn't free…pay now or pay later, but the bill has to be paid.  All I am saying is that many ideas never see the light of day – we don't even know if they will work or not – because the Phase I/II studies don't get funded (Pharma rarely pays for those).   

I do not think that the government should pay for all clinical studies, but they need to support promising drugs over the "valley of death" – the zone where so many drugs die for lack of funding.   I do not object to wisely spent tax dollars and putting up $$  to make it so.  (I do object to waste, but that is another story).   

isn't that what The Orphan Drug Act is for?

isn't that what The Orphan Drug Act is for?

isn't that what The Orphan Drug Act is for?

My friend who had TIL was told by a NCI doc that she was lucky she didn't foot the bill.  He said It cost $500K for her treatment, which includes scans, doctors fees, ICU, drugs, and a lot more that's not regulated by outside insurance control.. It is the labor of many staff members too and the facility charge.  Heck it cost me 2K to go the ER for 5 stitches and my insurance covered part of it. 

I don't know how many times I have to say this, but the full cost of the treatment is not $500k. It is around $100k, including IL-2, TIL generation, private hosptial stay, scans etc. I know this to be the case, because I paid for it in full.

Also, from http://clincancerres.aacrjournals.org/content/17/7/1664.full

"It is reasonable to assume, based on various estimates provided by the authors of this article, several of whom have established adoptive immunotherapy programs within their institutions, that treatment of a patient with T-cell adoptive immunotherapy will cost less than a typical course of treatment with targeted small molecule or antibody signaling antagonists."

And from http://biopharmconsortium.com/blog/2012/09/28/is-novartis-building-a-viable-business-model-for-adoptive-immunotherapy-for-cancer/

"Despite the fact that ACT is the only type of therapy that has resulted in high percentages of durable compete responses in metastatic melanoma, it is not widely available. ACT is only available in a small number of cancer canters worldwide, and there has been little commercial interest in developing ACT.

Adoptive immunotherapies are still considered experimental, are not FDA-approved, and are not covered by third party payers. Thus only a handful of locations can bear the financial burden of administering adoptive immunotherapy. If a cancer center has a cell production facility with the required staff, the cost of producing a single dose of T-cells for adoptive transfer is approximately $20,000. ACT treatment also entails factoring in the cost of hospitalization. However, most patients only require a single dose.

The cost of ACT is, however, much lower than a full course of other immunotherapies…"

I found these two articles searching google for 30 seconds. I am sure there are plenty more if you care to look. 

Ben.

Ben,

 How could you have paid for it when they don't charge patients for it?  That doesn't make sense.  Our tax dollars pay for it!  No one is charged at NCI for treatment.  Not even patients from other countries, they're free too.  Why and how did you pay at NCI?

Anonymous, 

I paid for it in Europe. I am an Australian. They agreed to give the treatment if I paid for it.

Where in Europe.  I am from Germany and the NCI in US will do it free. I only found the Netherlands for over 70K.  Why did you decide not to go to US?   How long ago did you have ACT?

I did it in Manchester. Not US due to history of brain mets. Started 1 year ago.

So the cost there would be different than the US?  The Netherlands was 70K.

As one who works in the industry, I can tell you unequivicably that if a drug does not have profit potential, it will never see the light of day no matter the value to the patient.  It is the harsh truth that comes from having a health care system that is for-profit.  It is rather remarkable that the Dendreon technology made to market with a treatment cost of $80,000. Provenge is a autologous cell therapy for prostate cancer but as a model for other cell therapies, it can be instructive.  It is a company and an immunotherapy that is struggling to get a toehold in the market.  I am sure the marketing teams at other pharma companies are following this with great interest.  Their current lack of success is going to make a getting a second product more challenging…and they do have IP.

The dominant role of pharma in drug development – and its perils – was discussed in an indepth article in the Washington Post earlier this year titled, "As drug industry;s influence over research grows, so does the potential for bias."  (see http://www.washingtonpost.com/business/economy/as-drug-industrys-influence-over-research-grows-so-does-the-potential-for-bias/2012/11/24/bb64d596-1264-11e2-be82-c3411b7680a9_story_1.html).  

As for the primary source of drugs, it is a well-established fact that the industry has turned increasingly to outside drug development to augment depleted in-house pipelines.  The main pathway for drug development today is for an academic researcher at a major institution works with the tech transfer office to either find a pharma R&D champion or create a spin out biotech company to manage the drug / technology until it can be sold.   We have to be infinitely grateful to researchers pushing the boundaries of knowledge and technology to give new ideas and treatments a chance to develop to the point that some pharma company will take a shot at moving it into the clinic.

It is also fair to say that clinical studies are obscenely expensive.  It is not unusual for a cancer clinical study to cost $50,000 – $100,000 per patient.  When you consider Phase I is 10 – 20 patients, Phase II is 60 – 100 and Phase III 200+ patients, it is not hard to see how the cost of drug development runs into the hundreds of millions of dollars very easily.  This is the very reason that public support is essential for new drug development to get over the hurdle of early clinical studies – which pharma will not pay for.  It is the early studies that provide some basis for making a decision to invest in Phase III development.

As one who works in the industry, I can tell you unequivicably that if a drug does not have profit potential, it will never see the light of day no matter the value to the patient.  It is the harsh truth that comes from having a health care system that is for-profit.  It is rather remarkable that the Dendreon technology made to market with a treatment cost of $80,000. Provenge is a autologous cell therapy for prostate cancer but as a model for other cell therapies, it can be instructive.  It is a company and an immunotherapy that is struggling to get a toehold in the market.  I am sure the marketing teams at other pharma companies are following this with great interest.  Their current lack of success is going to make a getting a second product more challenging…and they do have IP.

The dominant role of pharma in drug development – and its perils – was discussed in an indepth article in the Washington Post earlier this year titled, "As drug industry;s influence over research grows, so does the potential for bias."  (see http://www.washingtonpost.com/business/economy/as-drug-industrys-influence-over-research-grows-so-does-the-potential-for-bias/2012/11/24/bb64d596-1264-11e2-be82-c3411b7680a9_story_1.html).  

As for the primary source of drugs, it is a well-established fact that the industry has turned increasingly to outside drug development to augment depleted in-house pipelines.  The main pathway for drug development today is for an academic researcher at a major institution works with the tech transfer office to either find a pharma R&D champion or create a spin out biotech company to manage the drug / technology until it can be sold.   We have to be infinitely grateful to researchers pushing the boundaries of knowledge and technology to give new ideas and treatments a chance to develop to the point that some pharma company will take a shot at moving it into the clinic.

It is also fair to say that clinical studies are obscenely expensive.  It is not unusual for a cancer clinical study to cost $50,000 – $100,000 per patient.  When you consider Phase I is 10 – 20 patients, Phase II is 60 – 100 and Phase III 200+ patients, it is not hard to see how the cost of drug development runs into the hundreds of millions of dollars very easily.  This is the very reason that public support is essential for new drug development to get over the hurdle of early clinical studies – which pharma will not pay for.  It is the early studies that provide some basis for making a decision to invest in Phase III development.

I don't understand why so many of us seem to feel that it is somehow slimy and unethical for pharmaceutical companies to make a profit. Auto repair shops make a profit. Airlines make a profit. God knows oil compamies, lawyers and hedge fund managers make a profit. What's with bashing the pharma companies?

Name me one major drug that has been developed in a country where there was no capitalist incentive– and by developed I mean discovered in the lab, tested in animals, gone through extensive clinical trials and was proven safe and effective according to US standards. I can't think of a single one.

As for the expense of the whole drug discovery process, do you realize that only 1 out of 3 drugs that enter Phase 1 trials actually make through Phase III? From that perspective, companies "waste" 2/3 of their clinical trial budget each year. Or, looked at another way, each successful clinical trial costs 3 times more than the advertised price.

The government already pays for all those nobel academic researchers who "push the boundaries of knowledge"– that's called research grants and contracts. If you want our government to pay for all the clinical trials and regulatory approvals,  too,I sure hope you're not one of those "smaller government" or "no more taxes" people. You can't have it both ways– insist that tons of time and public money be put into drugs that will help very, very few people while having absolutely no profit potential AND you pay less in taxes and get "big government" out of your lives. Make up your minds.

As Winston Churchill said: "Democracy is the worst form of government– except for all the others." I think that the same could be said about our drug discovery and approval process. Show me something better. 

I don't understand why so many of us seem to feel that it is somehow slimy and unethical for pharmaceutical companies to make a profit. Auto repair shops make a profit. Airlines make a profit. God knows oil compamies, lawyers and hedge fund managers make a profit. What's with bashing the pharma companies?

Name me one major drug that has been developed in a country where there was no capitalist incentive– and by developed I mean discovered in the lab, tested in animals, gone through extensive clinical trials and was proven safe and effective according to US standards. I can't think of a single one.

As for the expense of the whole drug discovery process, do you realize that only 1 out of 3 drugs that enter Phase 1 trials actually make through Phase III? From that perspective, companies "waste" 2/3 of their clinical trial budget each year. Or, looked at another way, each successful clinical trial costs 3 times more than the advertised price.

The government already pays for all those nobel academic researchers who "push the boundaries of knowledge"– that's called research grants and contracts. If you want our government to pay for all the clinical trials and regulatory approvals,  too,I sure hope you're not one of those "smaller government" or "no more taxes" people. You can't have it both ways– insist that tons of time and public money be put into drugs that will help very, very few people while having absolutely no profit potential AND you pay less in taxes and get "big government" out of your lives. Make up your minds.

As Winston Churchill said: "Democracy is the worst form of government– except for all the others." I think that the same could be said about our drug discovery and approval process. Show me something better. 

I don't think it is unethical to develop drugs and make money – that's my job, too.  What I find troubling is that the public interest is not always best served by the marketing team of PharmaCo.  As an example, why isn't Rituxan in a clinical study for adjuvant therapy for melanoma?  Two independent academic studies indicated that it radically reduced recurrance.  Genentech doesn't see the value although you or I just might like to know if our lives could be improved by using a safe drug that eliminates recurrance.  It is in cases like these that an alternate pathway is needed.  

As an extreme example, let's say I invented a cure for moles on the left cheek.  Clinical studies show it is safe & effective but a marketing survey shows that only 5,000 people have moles on their left cheek that would use this drug.  If your one of the 5,000, you want that drug, but you will never get it because there is no value for a micro market like that.  Those people are SOL.  It goes on all the time.  

You are right about the poor conversion from Phase III to drug…I believe the industry metric right now is about $1.3 billion per approved drug.  Clinical research isn't free…pay now or pay later, but the bill has to be paid.  All I am saying is that many ideas never see the light of day – we don't even know if they will work or not – because the Phase I/II studies don't get funded (Pharma rarely pays for those).   

I do not think that the government should pay for all clinical studies, but they need to support promising drugs over the "valley of death" – the zone where so many drugs die for lack of funding.   I do not object to wisely spent tax dollars and putting up $$  to make it so.  (I do object to waste, but that is another story).   

I don't think it is unethical to develop drugs and make money – that's my job, too.  What I find troubling is that the public interest is not always best served by the marketing team of PharmaCo.  As an example, why isn't Rituxan in a clinical study for adjuvant therapy for melanoma?  Two independent academic studies indicated that it radically reduced recurrance.  Genentech doesn't see the value although you or I just might like to know if our lives could be improved by using a safe drug that eliminates recurrance.  It is in cases like these that an alternate pathway is needed.  

As an extreme example, let's say I invented a cure for moles on the left cheek.  Clinical studies show it is safe & effective but a marketing survey shows that only 5,000 people have moles on their left cheek that would use this drug.  If your one of the 5,000, you want that drug, but you will never get it because there is no value for a micro market like that.  Those people are SOL.  It goes on all the time.  

You are right about the poor conversion from Phase III to drug…I believe the industry metric right now is about $1.3 billion per approved drug.  Clinical research isn't free…pay now or pay later, but the bill has to be paid.  All I am saying is that many ideas never see the light of day – we don't even know if they will work or not – because the Phase I/II studies don't get funded (Pharma rarely pays for those).   

I do not think that the government should pay for all clinical studies, but they need to support promising drugs over the "valley of death" – the zone where so many drugs die for lack of funding.   I do not object to wisely spent tax dollars and putting up $$  to make it so.  (I do object to waste, but that is another story).   

Have y'all forgotten that there are three chemos and high does IL2 is used. That makes the drug companies rich who sell this to the govt. in US.  There are plenty of outside contractors making money on TIL.  It costs $500k per patient in the US by taxpayer money and 70K out of pocket at the Netherlands.  Not sure what it costs at the others.

Have y'all forgotten that there are three chemos and high does IL2 is used. That makes the drug companies rich who sell this to the govt. in US.  There are plenty of outside contractors making money on TIL.  It costs $500k per patient in the US by taxpayer money and 70K out of pocket at the Netherlands.  Not sure what it costs at the others.

Have y'all forgotten that there are three chemos and high does IL2 is used. That makes the drug companies rich who sell this to the govt. in US.  There are plenty of outside contractors making money on TIL.  It costs $500k per patient in the US by taxpayer money and 70K out of pocket at the Netherlands.  Not sure what it costs at the others.

My friend who had TIL was told by a NCI doc that she was lucky she didn't foot the bill.  He said It cost $500K for her treatment, which includes scans, doctors fees, ICU, drugs, and a lot more that's not regulated by outside insurance control.. It is the labor of many staff members too and the facility charge.  Heck it cost me 2K to go the ER for 5 stitches and my insurance covered part of it. 

My friend who had TIL was told by a NCI doc that she was lucky she didn't foot the bill.  He said It cost $500K for her treatment, which includes scans, doctors fees, ICU, drugs, and a lot more that's not regulated by outside insurance control.. It is the labor of many staff members too and the facility charge.  Heck it cost me 2K to go the ER for 5 stitches and my insurance covered part of it. 

I don't know how many times I have to say this, but the full cost of the treatment is not $500k. It is around $100k, including IL-2, TIL generation, private hosptial stay, scans etc. I know this to be the case, because I paid for it in full.

Also, from http://clincancerres.aacrjournals.org/content/17/7/1664.full

"It is reasonable to assume, based on various estimates provided by the authors of this article, several of whom have established adoptive immunotherapy programs within their institutions, that treatment of a patient with T-cell adoptive immunotherapy will cost less than a typical course of treatment with targeted small molecule or antibody signaling antagonists."

And from http://biopharmconsortium.com/blog/2012/09/28/is-novartis-building-a-viable-business-model-for-adoptive-immunotherapy-for-cancer/

"Despite the fact that ACT is the only type of therapy that has resulted in high percentages of durable compete responses in metastatic melanoma, it is not widely available. ACT is only available in a small number of cancer canters worldwide, and there has been little commercial interest in developing ACT.

Adoptive immunotherapies are still considered experimental, are not FDA-approved, and are not covered by third party payers. Thus only a handful of locations can bear the financial burden of administering adoptive immunotherapy. If a cancer center has a cell production facility with the required staff, the cost of producing a single dose of T-cells for adoptive transfer is approximately $20,000. ACT treatment also entails factoring in the cost of hospitalization. However, most patients only require a single dose.

The cost of ACT is, however, much lower than a full course of other immunotherapies…"

I found these two articles searching google for 30 seconds. I am sure there are plenty more if you care to look. 

Ben.

I don't know how many times I have to say this, but the full cost of the treatment is not $500k. It is around $100k, including IL-2, TIL generation, private hosptial stay, scans etc. I know this to be the case, because I paid for it in full.

Also, from http://clincancerres.aacrjournals.org/content/17/7/1664.full

"It is reasonable to assume, based on various estimates provided by the authors of this article, several of whom have established adoptive immunotherapy programs within their institutions, that treatment of a patient with T-cell adoptive immunotherapy will cost less than a typical course of treatment with targeted small molecule or antibody signaling antagonists."

And from http://biopharmconsortium.com/blog/2012/09/28/is-novartis-building-a-viable-business-model-for-adoptive-immunotherapy-for-cancer/

"Despite the fact that ACT is the only type of therapy that has resulted in high percentages of durable compete responses in metastatic melanoma, it is not widely available. ACT is only available in a small number of cancer canters worldwide, and there has been little commercial interest in developing ACT.

Adoptive immunotherapies are still considered experimental, are not FDA-approved, and are not covered by third party payers. Thus only a handful of locations can bear the financial burden of administering adoptive immunotherapy. If a cancer center has a cell production facility with the required staff, the cost of producing a single dose of T-cells for adoptive transfer is approximately $20,000. ACT treatment also entails factoring in the cost of hospitalization. However, most patients only require a single dose.

The cost of ACT is, however, much lower than a full course of other immunotherapies…"

I found these two articles searching google for 30 seconds. I am sure there are plenty more if you care to look. 

Ben.

Where in Europe.  I am from Germany and the NCI in US will do it free. I only found the Netherlands for over 70K.  Why did you decide not to go to US?   How long ago did you have ACT?

Where in Europe.  I am from Germany and the NCI in US will do it free. I only found the Netherlands for over 70K.  Why did you decide not to go to US?   How long ago did you have ACT?

I did it in Manchester. Not US due to history of brain mets. Started 1 year ago.

I did it in Manchester. Not US due to history of brain mets. Started 1 year ago.

So the cost there would be different than the US?  The Netherlands was 70K.

So the cost there would be different than the US?  The Netherlands was 70K.