› Forums › General Melanoma Community › Paradigm shift
- This topic has 10 replies, 4 voices, and was last updated 13 years, 7 months ago by LynnLuc.
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- March 31, 2011 at 3:33 pm
It’s interesting to consider the paradigm shift occurring in therapy for MM. The FDA approval of ipi raises many questions in my mind (as stage IV m1a), so perhaps others will offer their thoughts on them:
It’s interesting to consider the paradigm shift occurring in therapy for MM. The FDA approval of ipi raises many questions in my mind (as stage IV m1a), so perhaps others will offer their thoughts on them:
- Is ipi likely to replace IL-2 as first-line therapy for most patients? It seems to be less toxic and offers a higher rate of durable remission. Is that correct? It’s my understanding that IL-2 never reached phase III trials and thus its impact on OS has never been quantified. True? So is it only anecdotal evidence that suggests durable remissions for a small percentage of IL-2 patients? Anything published on that?
- Reimbursement for ipi is the next big hurdle. It seems BMS set an extremely high price point knowing it would have to negotiate the price down with the formularies. Any reason to think this process won’t take many months given what’s been happening with Provenge? In the meanwhile, are compassionate use trials with ipi permanently closed? What happens to those who need/want ipi but can’t get into a trial and clearly can’t afford self-pay? Will BMS pony up until Medicare and the insurance companies make a judgment?
- Is there drug trial data that shows higher effectiveness for ipi at 10 mg/kg vs. 3 mg/kg? Does higher dose affect the rate of durable responses? Do FDA guidelines allow higher dosages?
- The assumption seems to be that BMS will now sit on its trials of anti-PD1 agents, which I’ve heard showed promise in phase I—higher response rate, lower toxicity. Are there other companies developing similar agents that might therefore accelerate their trials for melanoma patients?
- What other agents are there in trials that might ultimately replace current first-line treatment options? What about the tyrosine kinase inhibitors? Any way of judging their prospects?
- Any hope for OncoVex being a reasonable treatment options for m1a’s? Where is it in the development pipeline? What would it take for it to become competitive with ipi for those with sub-qs only?
- Sorry, I can't resist: Does anyone know how much BMS execs are paid?
Lots of questions. Anyone with informed answers? Thanks.
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- March 31, 2011 at 5:49 pm
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- March 31, 2011 at 5:49 pm
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- March 31, 2011 at 6:02 pm
ITEM 7—STOCKHOLDER PROPOSAL ON PHARMACEUTICAL PRICE RESTRAINT
The proponents of this resolution are Trinity Health, 27870 Cabot Drive, Novi, Michigan 48377 as
lead-filer and 13 other religious investors who are members of The Interfaith Center for Corporate
Responsibility.
WHEREAS:
The cost of brand name drugs, some of them our Company’s, have skyrocketed in this country in
recent years;
The Government’s General Accountability Office (GAO) found that between 2000-2008, 416
brand-name drugs had “extraordinary price increases”; most of these increases ranged from 100% to
499%;
Medco’s 2010 Drug Trend Report found that, while generic drug prices increased 0.3%, “inflation
in branded drugs accelerated to an all-time high of 9.2%” and that the prices of specialty drugs
increased 14.7%;
The Office of Actuary, Centers for Medicare and Medicaid Services projects that prescription drug
expenditures will increase in 2018 92.7% from 2008 expenditures, exceeding all major categories of
national health expenditures. It states: “Prescription drug spending is expected to be the fast growing
component of Medicare over the projection period”;
AARP’s Public Policy Institute reported that the price of brand name prescriptions most widely
used by Medicare beneficiaries increased by 9.7% in the 12 months ending with March 2010 and was
much higher than the rate of increase observed during any of the prior eight years (2002-2009). While
inflation rose 0.3% during his period, price increases for such drugs ranged from 5.3-9.3%;
AARP has also stated that the positive goals of the new health care reform law “could be eroded
over the years if escalating drug prices are not addressed”;
While passage of health reform legislation was a major achievement, there are ongoing concerns
as to its long-term affordability and accountability for controlling costs. Failure to control costs could
undermine the goals of health care reform, i.e. accessible and affordable health care for all;
This resolution’s sponsors are not satisfied that the Company has made a clear case offering fiscal
and moral justification for such exorbitant price increases. Neither has it given sufficient assurances
that the present pattern of increases that far exceed the Consumer Price Index will not continue.
RESOLVED: Shareholders request the Board of Directors create and implement a policy of price
restraint on branded pharmaceuticals, utilizing a combination of approaches to keep drug prices at
reasonable levels, such as an increase that would not exceed the previous year’s Consumer Price
Index, and report to shareholders by September 2011 on changes in policies and pricing procedures
for pharmaceutical products (withholding any competitive information, and at reasonable cost).
Board of Directors’ Position
The Board of Directors recommends a vote “AGAINST” this proposal for the following
reasons:
Our Board of Directors firmly believes that prescription drugs are so important that everyone
should have access to them. We believe the best approach to ensure broad access to affordable
medicines for the uninsured and underinsured is through expanded coverage, not price restraints.
Accordingly, we recommend a vote AGAINST the proposal.
Source:http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9ODYyMjJ8Q2hpbGRJRD0tMXxUeXBlPTM=&t=1
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- March 31, 2011 at 6:02 pm
ITEM 7—STOCKHOLDER PROPOSAL ON PHARMACEUTICAL PRICE RESTRAINT
The proponents of this resolution are Trinity Health, 27870 Cabot Drive, Novi, Michigan 48377 as
lead-filer and 13 other religious investors who are members of The Interfaith Center for Corporate
Responsibility.
WHEREAS:
The cost of brand name drugs, some of them our Company’s, have skyrocketed in this country in
recent years;
The Government’s General Accountability Office (GAO) found that between 2000-2008, 416
brand-name drugs had “extraordinary price increases”; most of these increases ranged from 100% to
499%;
Medco’s 2010 Drug Trend Report found that, while generic drug prices increased 0.3%, “inflation
in branded drugs accelerated to an all-time high of 9.2%” and that the prices of specialty drugs
increased 14.7%;
The Office of Actuary, Centers for Medicare and Medicaid Services projects that prescription drug
expenditures will increase in 2018 92.7% from 2008 expenditures, exceeding all major categories of
national health expenditures. It states: “Prescription drug spending is expected to be the fast growing
component of Medicare over the projection period”;
AARP’s Public Policy Institute reported that the price of brand name prescriptions most widely
used by Medicare beneficiaries increased by 9.7% in the 12 months ending with March 2010 and was
much higher than the rate of increase observed during any of the prior eight years (2002-2009). While
inflation rose 0.3% during his period, price increases for such drugs ranged from 5.3-9.3%;
AARP has also stated that the positive goals of the new health care reform law “could be eroded
over the years if escalating drug prices are not addressed”;
While passage of health reform legislation was a major achievement, there are ongoing concerns
as to its long-term affordability and accountability for controlling costs. Failure to control costs could
undermine the goals of health care reform, i.e. accessible and affordable health care for all;
This resolution’s sponsors are not satisfied that the Company has made a clear case offering fiscal
and moral justification for such exorbitant price increases. Neither has it given sufficient assurances
that the present pattern of increases that far exceed the Consumer Price Index will not continue.
RESOLVED: Shareholders request the Board of Directors create and implement a policy of price
restraint on branded pharmaceuticals, utilizing a combination of approaches to keep drug prices at
reasonable levels, such as an increase that would not exceed the previous year’s Consumer Price
Index, and report to shareholders by September 2011 on changes in policies and pricing procedures
for pharmaceutical products (withholding any competitive information, and at reasonable cost).
Board of Directors’ Position
The Board of Directors recommends a vote “AGAINST” this proposal for the following
reasons:
Our Board of Directors firmly believes that prescription drugs are so important that everyone
should have access to them. We believe the best approach to ensure broad access to affordable
medicines for the uninsured and underinsured is through expanded coverage, not price restraints.
Accordingly, we recommend a vote AGAINST the proposal.
Source:http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9ODYyMjJ8Q2hpbGRJRD0tMXxUeXBlPTM=&t=1
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- March 31, 2011 at 6:17 pm
Hi ogler,
I had about 99 of the 100 questions you asked; so glad you did the work 🙂 I'm Stage IIIC, on wait and watch status for about a year. My question centers around the treatment guidelines for this drug. I've seen, for example, that with patients with breast cancer (of course), there exists a standing protocol depending on stage and type. These guidelines seem to be followed on patients w/ or w/o active disease. I guess they are, what, meant to assist the body in targeting the growth of future cancer cells? Or strengthening the immune system?
So, does ipi fall under this classification of drugs? Basically used as a POSSIBLE deterrent? Or will it be just like existing clinical trials for melanoma, where you must qualify or beg for it?
I remain, of course, profoundly grateful, for stalling out at Stage III for one whole year, but never stop looking for something that could possible actively battle the beast for me.
And finally, re CEO compensation – maybe the CEO, at 11 mill a year could chip in for your drugs!
Thanks for your questions. I look for answers from many on this board who are so much more knowledgeable than me.
Thanks!!
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- March 31, 2011 at 7:19 pm
There are reasons that they don't give these drugs as a preventative measure. Look at the odds. They only work with a small percentage of patients, yet are extremly toxic, sometimes causing death. If the odds were 85% that the drug would work then maybe it would be suggested. Melanoma is extremely individual and they don't know if it actually works on someone until they see measurable results. Breast cancer on the other hand has standard protocals that are not quite as toxic and they have better odds of working.
What is needed is more research in melanoma drugs so that one day there will be preventative drugs.
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- March 31, 2011 at 7:19 pm
There are reasons that they don't give these drugs as a preventative measure. Look at the odds. They only work with a small percentage of patients, yet are extremly toxic, sometimes causing death. If the odds were 85% that the drug would work then maybe it would be suggested. Melanoma is extremely individual and they don't know if it actually works on someone until they see measurable results. Breast cancer on the other hand has standard protocals that are not quite as toxic and they have better odds of working.
What is needed is more research in melanoma drugs so that one day there will be preventative drugs.
-
- March 31, 2011 at 6:17 pm
Hi ogler,
I had about 99 of the 100 questions you asked; so glad you did the work 🙂 I'm Stage IIIC, on wait and watch status for about a year. My question centers around the treatment guidelines for this drug. I've seen, for example, that with patients with breast cancer (of course), there exists a standing protocol depending on stage and type. These guidelines seem to be followed on patients w/ or w/o active disease. I guess they are, what, meant to assist the body in targeting the growth of future cancer cells? Or strengthening the immune system?
So, does ipi fall under this classification of drugs? Basically used as a POSSIBLE deterrent? Or will it be just like existing clinical trials for melanoma, where you must qualify or beg for it?
I remain, of course, profoundly grateful, for stalling out at Stage III for one whole year, but never stop looking for something that could possible actively battle the beast for me.
And finally, re CEO compensation – maybe the CEO, at 11 mill a year could chip in for your drugs!
Thanks for your questions. I look for answers from many on this board who are so much more knowledgeable than me.
Thanks!!
-
- March 31, 2011 at 10:36 pm
All I know about all those statements is that I am currently in a trial that uses MDX 1106—newly purchased by BMS and is now known as BMS 936558 – the Anti PD-1. I have taken it every other week as part of my vaccine trial that also included 72 peptide injections . I will continue to takethe Anti PD-1(BMS 936558 ) every 3 months for 2 years as a booster…after which time my onc ( Dr Jeff Weber) says I may want to consider taking it the rest of my life as long as I remain NED…he also stated eventually it will also be approved for melanoma. I worry that the cost will also be prohibitive and it too will be considered experimental and or unproven to benefit me and insurances won't touch me…scary how big drug companies prey on the people who are least likely to afford it.
BMS bought the drug from Medderex and did not develop it.
Patients who have participated in the study trialss only to end up with the less effective and placbo drugs paid for this drug…with their lives….
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- March 31, 2011 at 10:36 pm
All I know about all those statements is that I am currently in a trial that uses MDX 1106—newly purchased by BMS and is now known as BMS 936558 – the Anti PD-1. I have taken it every other week as part of my vaccine trial that also included 72 peptide injections . I will continue to takethe Anti PD-1(BMS 936558 ) every 3 months for 2 years as a booster…after which time my onc ( Dr Jeff Weber) says I may want to consider taking it the rest of my life as long as I remain NED…he also stated eventually it will also be approved for melanoma. I worry that the cost will also be prohibitive and it too will be considered experimental and or unproven to benefit me and insurances won't touch me…scary how big drug companies prey on the people who are least likely to afford it.
BMS bought the drug from Medderex and did not develop it.
Patients who have participated in the study trialss only to end up with the less effective and placbo drugs paid for this drug…with their lives….
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