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Paradigm shift

Forums General Melanoma Community Paradigm shift

  • Post
    PeterO
    Participant

      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:

      1. 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?
      2. 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?
      3. 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?
      4. 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?
      5. 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?
      6. 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?
      7. 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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        jim Breitfeller
        Participant

          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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          jim Breitfeller
          Participant

            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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            Janis B.
            Participant

              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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              Janis B.
              Participant

                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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                  lhaley
                  Participant

                    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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                    lhaley
                    Participant

                      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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                    LynnLuc
                    Participant

                      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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                      LynnLuc
                      Participant

                        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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