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Post by agedhippie on Oct 24, 2017 18:49:49 GMT -5
"It is MNKD's fault for not conducting trials that show superiority." "The FDA views Afrezza as similar to RAAs" These are oxymoron. We almost did not even get approved by FDA because of this. That is WHY our latest label change was so important. It is true RAAs, if timed and dosed perfectly, can knock down A1C very effectively, but in reality, one cannot time and dose perfectly. We always know this and can show "superiority" in this aspect and FDA had just accepted that. It was never MNKD's fault to start with, and now FDA was convinced of Afrezza's superiority. The problem is that when RAA and Afrezza were compared in the 171 trial the A1c result was just not there. That's the evidence and that's what the FDA have to accept. Until that trial is repeated and there are different result the data stands. What Mannkind did is perfectly reasonable. They needed to pass that trial so they adopted a conservative protocol to make sure they got through, it's standard procedure for drug companies - don't blow the trial or you don't get approval. Once they had passed though they could alter the protocol to what they really want and go for superiority with no risk of losing approval.
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Post by sophie on Oct 24, 2017 19:29:23 GMT -5
You didn't know that? There are all levels of health insurance policies and coverage's. Some depend on employers, some depend on wallets.
Additionally, do not believe everything you read about these life saving treatments.
Because I am a caring person, do you get flu shots?
My job requires that I get a flu shot, yes. And you are correct, but I suppose the reason I didn't understand what you were saying is because that claim supports my argument. You get what you pay for. I'm sure the higher levels of policies have a broader formulary which likely would include Afrezza, or at the very least, have it available by prior authorization. The original argument was that every plan should cover all variants of insulin because insulin is required for life. Sure, if you're willing to pay more, you should get more. However, while I give money to those less fortunate than me, I do not think the government should have the power to force people into charity. I do my part the best I can and encourage as many others to do theirs as well. The government only has as much utility as we the people give it. If everyone did what they were supposed to, government would be unnecessary. I'm not calloused, insensitive, or a cold-hearted bitch. In truth, I've probably seen too much that has broken my heart and still does. There is an entire world of people outside of diabetes who need to be remembered as well. I only bring this up because often times the board seems to think these issues are isolated only to diabetes and Afrezza, when in reality, the entire system is broken. We need more advocates and doers for several other disease processes as well. In a perfect world, everyone would have what they wanted. Unfortunately there are still some that cannot afford even what they need.
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Post by mnholdem on Oct 24, 2017 19:33:56 GMT -5
Posters seem to be arguing all around the main point of Sophie's initial statement, which was that insurers/payers use only the a1C measurement to compare insulin, because a1C is the measurement by which the diabetes treatment community has used to gauge effectiveness for decades.
The FDA has initiated dialogue on the use of better measurements, but virtually none of the pharmaceuticals have had their brands tested against anything BUT how effective their insulin is at lowering a1C.
Until a1C is replaced by better measurements (e.g. Time-in-Range, severity of hyper- or hypo-glycemic excursions, frequency of out-of-range excursions, etc.) Afrezza will continue being evaluated by payers using this antiquated measurement.
Fortunately, advances in CGM / near real-time monitoring is accelerating the speed at which science is changing the landscape, but it will likely be several years until a1C is replaced. When that happens, all the pharmaceutical companies currently marketing RAA insulin in this multi-$billion industry will need to conduct additional trials to demonstrate the effectiveness of their brands using the new measurements demanded by the diabetes community - trials which MannKind has already been conducting for Afrezza.
Disruptive medicine often ushers in new ways of looking at a disease. Take a good look at Afrezza. It's leading the way in showing the medical community how significant the speed of an insulin is for controlling this disease.
Change will be resisted until the medical community becomes fully convinced that change is needed. The insurance companies will maintain the status quo until then, unless there's an uprising like the one that JDRF Diabetes Foundation is currently leading.
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Post by joeypotsandpans on Oct 24, 2017 19:38:14 GMT -5
When it come to insulin, all insulins should be covered by every company that is going to set up shop and claim to be a health insurance company, collect money from people, and regulate coverage on medicines for a human. Something required by the body, such as insulin, shouldn't be up for debate. This goes for all insulins that are FDA approved, IMO. How would you feel if someone preferred brand only drugs and not generics? Would you similarly acquiesce simply based on preference? Or would you tell them to take the generic since it is essentially the same thing and for a much cheaper price? The problem is that with a pandemic disease like diabetes, you cannot give the option to everyone and keep prices low for everyone else. This is the unfortunate part of insurance. Everyone wants the best care but wants to pay the least for it. Good care is expensive. No one is stopping anyone from accessing Afrezza. They simply do not want to pay the premium for it. They want to share the cost of a better drug with other people- people who may not want to pay that added premium for their care. I think what you're failing to see is the other side of the same coin of your argument. Your argument boils down to "I shouldn't have to pay extra money for something that I need" whereas I would rebut, "neither should I" I shouldn't have to pay for the privilege of you getting better care than what is necessary for your health. You would live a long and fruitful life on the other insulins that are available. If you would like to have a better quality of life, that is your prerogative. But you should have to pay for it, not me. At the end of the day, coverage depends on the contracted rate that MNKD agrees to do business with PBMs. More favorable contracts earn lower copays. Insurance companies would much rather spend $10 for a medication than spend $40 for one that will produce fairly similar results. That is not unethical. It is good business. As much as it pains me to say it, insurance companies must think with a business mind, not a compassionate mind. There needs to be far more black and white than gray because there are simply too many exceptions to make with gray and you would waste far more resources creating that gray space than keeping black and white more affordable for everyone else. Let's not conflate arguing points here 1. Afrezza is superior to other RAAs 2. The FDA views Afrezza as similar to RAAs. You and I both believe Afrezza to be a superior product. The FDA has allowed for more separation, but for the metrics that currently matter most (A1c), it still appears to be equal. I'm not going to get into an argument with you that Afrezza and injectables are similar. They are not. However, their effect (A1c) has yet to be distinguished in the FDA's eyes. This is not unique to Afrezza. There are many, many, many drugs that have terrible coverage because there are a number of cheaper alternatives that provide similar results. And, I think if you're honest, you would not want to pay a premium for someone else's medicine just because they wanted it when they would have similar therapeutic effects on a much cheaper medication. I have said this so many times, but for whatever reason the same arguments perpetuate- The onus for superiority is on the drug manufacturer. It is not the FDA's fault, per say, that Afrezza has crappy insurance coverage. It is MNKD's fault for not conducting trials that show superiority. Like it or not, medicine is evidence based and conservative. That much will not change as long as there is a governing body over medications. While I agree in general with your argument about alternative treatments that keep costs reduced in this particular case your argument is flawed, you will be paying more because of lesser compliance when telling the patient to take the alternative insulin....they will lie to their physician that they are jabbing themselves and poking their fingers X amount of times a day to check their BG. Some T2's may be masochistic but most will lie to themselves and their physicians about being compliant and in the end you will be paying more for kidney failures/dialysis, neuropathy treatments, increased cardio complications, among a vast array of other issues from the progression of the disease. While the true benefit of Afrezza is the next best thing to a healthy pancreas, there are a large amount of advanced T2's which will suffer more damage because they will not keep to a regimen of sticking themselves on a regular basis. Truth be told, I could see a much reduced cost to the insurance companies with them supplying a freestyle and afrezza...if you watch the you tube videos on those that shared their experiences (mostly in the UK that I saw) with the freestyle they said because of the ease and features they actually had to keep themselves from checking their BG too frequently....and they weren't even in the freedom zone yet of having the benefit of using Afrezza. I could easily see myself checking my BG at will with a freestyle and challenging myself to maintain in range everyday dosing with Afrezza....that is the type of compliance that would actually reduce the total overall costs to insurers in the end with a much healthier diabetic population Think compliance compliance compliance....you need to see it from the patients standpoint because in this case it is ultimately the biggest effect on the insurers bottom line regarding reducing theirs and in turn your costs.
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Post by centralcoastinvestor on Oct 24, 2017 19:51:09 GMT -5
Posters seem to be arguing all around the main point of Sophie's initial statement, which was that insurers/payers use only the a1C measurement to compare insulin, because a1C is the measurement by which the diabetes treatment community has used to gauge effectiveness for decades. The FDA has initiated dialogue on the use of better measurements, but virtually none of the pharmaceuticals have had their brands tested against anything BUT how effective their insulin is at lowering a1C. Until a1C is replaced by better measurements (e.g. Time-in-Range, severity of hyper- or hypo-glycemic excursions, frequency of out-of-range excursions, etc.) Afrezza will continue being evaluated by payers using this antiquated measurement. Fortunately, advances in CGM / near real-time monitoring is accelerating the speed at which science is changing the landscape, but it will likely be several years until a1C is replaced. When that happens, all the pharmaceutical companies currently marketing RAA insulin in this multi-$billion industry will need to conduct additional trials to demonstrate the effectiveness of their brands using the new measurements demanded by the diabetes community - trials which MannKind has already been conducting for Afrezza. Disruptive medicine often ushers in new ways of looking at a disease. Take a good look at Afrezza. It's leading the way in showing the medical community how significant the speed of an insulin is for controlling this disease. Change will be resisted until the medical community becomes fully convinced that change is needed. The insurance companies will maintain the status quo until then, unless there's an uprising like the one that JDRF Diabetes Foundation is currently leading. Damn holdem that was well stated.
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Post by sophie on Oct 24, 2017 19:58:01 GMT -5
How would you feel if someone preferred brand only drugs and not generics? Would you similarly acquiesce simply based on preference? Or would you tell them to take the generic since it is essentially the same thing and for a much cheaper price? The problem is that with a pandemic disease like diabetes, you cannot give the option to everyone and keep prices low for everyone else. This is the unfortunate part of insurance. Everyone wants the best care but wants to pay the least for it. Good care is expensive. No one is stopping anyone from accessing Afrezza. They simply do not want to pay the premium for it. They want to share the cost of a better drug with other people- people who may not want to pay that added premium for their care. I think what you're failing to see is the other side of the same coin of your argument. Your argument boils down to "I shouldn't have to pay extra money for something that I need" whereas I would rebut, "neither should I" I shouldn't have to pay for the privilege of you getting better care than what is necessary for your health. You would live a long and fruitful life on the other insulins that are available. If you would like to have a better quality of life, that is your prerogative. But you should have to pay for it, not me. At the end of the day, coverage depends on the contracted rate that MNKD agrees to do business with PBMs. More favorable contracts earn lower copays. Insurance companies would much rather spend $10 for a medication than spend $40 for one that will produce fairly similar results. That is not unethical. It is good business. As much as it pains me to say it, insurance companies must think with a business mind, not a compassionate mind. There needs to be far more black and white than gray because there are simply too many exceptions to make with gray and you would waste far more resources creating that gray space than keeping black and white more affordable for everyone else. Let's not conflate arguing points here 1. Afrezza is superior to other RAAs 2. The FDA views Afrezza as similar to RAAs. You and I both believe Afrezza to be a superior product. The FDA has allowed for more separation, but for the metrics that currently matter most (A1c), it still appears to be equal. I'm not going to get into an argument with you that Afrezza and injectables are similar. They are not. However, their effect (A1c) has yet to be distinguished in the FDA's eyes. This is not unique to Afrezza. There are many, many, many drugs that have terrible coverage because there are a number of cheaper alternatives that provide similar results. And, I think if you're honest, you would not want to pay a premium for someone else's medicine just because they wanted it when they would have similar therapeutic effects on a much cheaper medication. I have said this so many times, but for whatever reason the same arguments perpetuate- The onus for superiority is on the drug manufacturer. It is not the FDA's fault, per say, that Afrezza has crappy insurance coverage. It is MNKD's fault for not conducting trials that show superiority. Like it or not, medicine is evidence based and conservative. That much will not change as long as there is a governing body over medications. While I agree in general with your argument about alternative treatments that keep costs reduced in this particular case your argument is flawed, you will be paying more because of lesser compliance when telling the patient to take the alternative insulin....they will lie to their physician that they are jabbing themselves and poking their fingers X amount of times a day to check their BG. Some T2's may be masochistic but most will lie to themselves and their physicians about being compliant and in the end you will be paying more for kidney failures/dialysis, neuropathy treatments, increased cardio complications, among a vast array of other issues from the progression of the disease. While the true benefit of Afrezza is the next best thing to a healthy pancreas, there are a large amount of advanced T2's which will suffer more damage because they will not keep to a regimen of sticking themselves on a regular basis. Truth be told, I could see a much reduced cost to the insurance companies with them supplying a freestyle and afrezza...if you watch the you tube videos on those that shared their experiences (mostly in the UK that I saw) with the freestyle they said because of the ease and features they actually had to keep themselves from checking their BG too frequently....and they weren't even in the freedom zone yet of having the benefit of using Afrezza. I could easily see myself checking my BG at will with a freestyle and challenging myself to maintain in range everyday dosing with Afrezza....that is the type of compliance that would actually reduce the total overall costs to insurers in the end with a much healthier diabetic population Think compliance compliance compliance....you need to see it from the patients standpoint because in this case it is ultimately the biggest effect on the insurers bottom line regarding reducing theirs and in turn your costs. I don't disagree with you, but I kid you not, until you have evidence to back up these claims, not a whole lot of change will occur. It's not enough to make common sense claims. They then have to be proven in the real world before being adopted. I think we're starting to see the beginning of the shift, but it's still a ways away, meaning, I'm on the same page as you, but the medical community and insurance companies are lagging behind the brave pioneers that started the movement.
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Post by mango on Oct 24, 2017 20:19:27 GMT -5
How would you feel if someone preferred brand only drugs and not generics? Would you similarly acquiesce simply based on preference? Or would you tell them to take the generic since it is essentially the same thing and for a much cheaper price? There is not a generic version of Afrezza and there will not be one any time in the foreseeable future. Afrezza does something that no other mealtime insulin can achieve, and that is physiologically mimicking the first phase insulin response. T2D have loss the early phase insulin response and Afrezza brings this back into the picture. This is how postprandial glucose homeostasis is restored with Afrezza. There is no other option to consider here. The problem is that with a pandemic disease like diabetes, you cannot give the option to everyone and keep prices low for everyone else. Says who? Maybe things need to change. This is the unfortunate part of insurance. Everyone wants the best care but wants to pay the least for it. Good care is expensive. No one is stopping anyone from accessing Afrezza. They simply do not want to pay the premium for it Health insurance companies, PBM, the specialists aka Endos, and the ADA's current Standards of Care certainly hinder people from accessing Afrezza. They want to share the cost of a better drug with other people- people who may not want to pay that added premium for their care. I think what you're failing to see is the other side of the same coin of your argument. Your argument boils down to "I shouldn't have to pay extra money for something that I need" whereas I would rebut, "neither should I" I shouldn't have to pay for the privilege of you getting better care than what is necessary for your health. How, specifically, are you and only you paying for someone's "privilege" of receiving better medical care than yourself if said person is also paying for their own health insurance? Access to insulin is not a privilege, it is a right. Any person with diabetes that wishes to use Afrezza instead of the insulin he/she is told to take should be able to receive it and have coverage for it when they are giving a portion of their paycheck to a health insurance company. You would live a long and fruitful life on the other insulins that are available. If you would like to have a better quality of life, that is your prerogative. But you should have to pay for it, not me. If someone is already paying for health insurance then he/she should be able to receive coverage for Afrezza. A better quality of life is a right, not a privilege. We are born into this world, we do not walk into it. At the end of the day, coverage depends on the contracted rate that MNKD agrees to do business with PBMs. More favorable contracts earn lower copays. Insurance companies would much rather spend $10 for a medication than spend $40 for one that will produce fairly similar results That very well may be the case in several instances, but that is not the case with Afrezza. No other insulin physiologically mimics the first phase insulin response and restores postprandial glucose homeostasis, and no other insulin exists on Earth that is inhaled. Inhaling insulin versus injecting insulin does not produce similar results in this case. That is not unethical. It is good business. When you play a significant role in governing other people's health, it is showing respect, compassion, and establishing trust with people with diabetes that makes for good business in health insurance and diabetics lives. No one should be having any authority over another person's health if they do not have the best interests of the patient first and last. Health is not a privilege, it is a natural process of life and we are here today because the process of health in evolution is the foundation to what has enabled some species to adapt, survive, and evolve into an ever increasing complexity. As much as it pains me to say it, insurance companies must think with a business mind, not a compassionate mind. There needs to be far more black and white than gray because there are simply too many exceptions to make with gray and you would waste far more resources creating that gray space than keeping black and white more affordable for everyone else. Someone that does not truly care about the health and well being of others should never have the privilege of having authority over someone else's health. I have said this so many times, but for whatever reason the same arguments perpetuate- The onus for superiority is on the drug manufacturer. It is not the FDA's fault, per say, that Afrezza has crappy insurance coverage. It is MNKD's fault for not conducting trials that show superiority. Like it or not, medicine is evidence based and conservative. That much will not change as long as there is a governing body over medications. Whose fault is it that the people that make the Standards of Care and the Endo Consensus statements do not understand that Metformin does not and cannot mimic the early phase insulin response and restore postprandial glucose homeostasis, and is not the hormone needed by the body to do these things? Whose fault is it that those of authority are corrupt and see to the vested interests of themselves and the BP that funds them? I look at the Endo Consensus and I see nothing but pure corruption and bias. The Financial Disclosure is literally saddening, especially after reading their official stance on how T2D should be managed.
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Post by peppy on Oct 24, 2017 20:24:22 GMT -5
I hope you get to try all the life saving medications your heart desires. I for one will try to be frugal with my medical dollar, so there is more for you.
One more thing sophie, I hope all this life saving medication does not screw up your charge. ions and all.
hmmmm
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Post by mango on Oct 24, 2017 21:07:42 GMT -5
There is an entire world of people outside of diabetes who need to be remembered as well I agree that there are countless people needlessly suffering without any support or advocacy. One of the things that I admire about the diabetes community is compassion for others. The people with diabetes that I have had the privilege of getting to know are some of the kindest, most thoughtful people on this planet, and many everywhere advocate for others suffering all the time. We discuss many other forms of suffering on this forum besides diabetes, but because this is a website dedicated to MannKind, diabetes is the main topic. That is ok with me, because people with diabetes also need more support and more advocates. We can all help one another and support one another regardless of the type of medical condition. I only bring this up because often times the board seems to think these issues are isolated only to diabetes and Afrezza, when in reality, the entire system is broken. Absolutely the entire system is broken. But taking up for those that are a part of the system is not a good way to fix, grow, and change the system. We all have the ability to change, including those involved in the system that is corrupt and has failed to make a positive impact for humans, animals, and Earth. We need more advocates and doers for several other disease processes as well. In a perfect world, everyone would have what they wanted. Unfortunately there are still some that cannot afford even what they need. I sincerely agree with you that everyone that is suffering from any disease needs love and support. I like to think that in a perfect world, we would never have the opportunity to learn and grow. Love is the only thing we can give someone that is free, heals and can last a lifetime. And I'm sorry for arguing with you Sophie, I understand what you mean. All we can do is try and not give up. Maybe, just maybe, things will get better, we just have to believe and trust the hope that inspires us in this direction. Al Mann summed this up much better and simpler— For life repays what you put in
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Post by straightly on Oct 24, 2017 21:14:59 GMT -5
Posters seem to be arguing all around the main point of Sophie's initial statement, which was that insurers/payers use only the a1C measurement to compare insulin, because a1C is the measurement by which the diabetes treatment community has used to gauge effectiveness for decades. The FDA has initiated dialogue on the use of better measurements, but virtually none of the pharmaceuticals have had their brands tested against anything BUT how effective their insulin is at lowering a1C. Until a1C is replaced by better measurements (e.g. Time-in-Range, severity of hyper- or hypo-glycemic excursions, frequency of out-of-range excursions, etc.) Afrezza will continue being evaluated by payers using this antiquated measurement. Fortunately, advances in CGM / near real-time monitoring is accelerating the speed at which science is changing the landscape, but it will likely be several years until a1C is replaced. When that happens, all the pharmaceutical companies currently marketing RAA insulin in this multi-$billion industry will need to conduct additional trials to demonstrate the effectiveness of their brands using the new measurements demanded by the diabetes community - trials which MannKind has already been conducting for Afrezza. Disruptive medicine often ushers in new ways of looking at a disease. Take a good look at Afrezza. It's leading the way in showing the medical community how significant the speed of an insulin is for controlling this disease. Change will be resisted until the medical community becomes fully convinced that change is needed. The insurance companies will maintain the status quo until then, unless there's an uprising like the one that JDRF Diabetes Foundation is currently leading. Well said. It made me fell much better for not sold any shares on the run up.
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Post by mango on Oct 24, 2017 22:22:23 GMT -5
Posters seem to be arguing all around the main point of Sophie's initial statement, which was that insurers/payers use only the a1C measurement to compare insulin, because a1C is the measurement by which the diabetes treatment community has used to gauge effectiveness for decades. The FDA has initiated dialogue on the use of better measurements, but virtually none of the pharmaceuticals have had their brands tested against anything BUT how effective their insulin is at lowering a1C. Until a1C is replaced by better measurements (e.g. Time-in-Range, severity of hyper- or hypo-glycemic excursions, frequency of out-of-range excursions, etc.) Afrezza will continue being evaluated by payers using this antiquated measurement. Fortunately, advances in CGM / near real-time monitoring is accelerating the speed at which science is changing the landscape, but it will likely be several years until a1C is replaced. When that happens, all the pharmaceutical companies currently marketing RAA insulin in this multi-$billion industry will need to conduct additional trials to demonstrate the effectiveness of their brands using the new measurements demanded by the diabetes community - trials which MannKind has already been conducting for Afrezza. Disruptive medicine often ushers in new ways of looking at a disease. Take a good look at Afrezza. It's leading the way in showing the medical community how significant the speed of an insulin is for controlling this disease. Change will be resisted until the medical community becomes fully convinced that change is needed. The insurance companies will maintain the status quo until then, unless there's an uprising like the one that JDRF Diabetes Foundation is currently leading. What's not making sense to me is how such focus and implied importance can be put onto solely the A1c level, while ignoring entirely the significance of the two components that regulate its direction based off what it is doing independently of the other, and are what make up the value point. This will not be able to go ignored for long, after the results from clinical trial data are published. Perhaps then, and only then, will they too see the irony in all this. A CGM cant distinguish between an FDA "real life" clinical trial versus the "real life" not associated with an FDA approved clinical trial. The data gathered in both settings have an equal amount of real and life in those data points. A CGM doesn't change its behavior in a controlled setting versus real life, every day living—it is the person that is ultimately responsible for ensuring the way he/she lived every moment during the FDA clinical trial mimicked their real life living while not involved in an FDA clinical trial. At some point you have to ask yourself why majority of people do not produce those wonderful data from the FDA clinical trial in "real life". For once, perhaps a standard in the way data is gathered and the value of that data will be only reliable when using a CGM, because lets be honest, we can't see what is happening, "in real time" without one being used, so to counter their argument and ignorance I propose we oust to hold the value of data gathered during "real time" as the highest level of reliable data one can currently have. At what point does the difference of "real life" to the data gathered in actual real life becomes superior to that of an FDA trial which influences behavior and outcomes is the real ticket to me. It would be value equal to that of the same real lif simulation that occurs when the patient is seen at the clinic and sent home with their insulin therapy. Apparently that is the current practice and doesn't mimic the data outcomes of a controlled experiment. Put a CGM on a patient and I bet the CGM will show the data the same way regardless the simulation it is used. Makes too much sense to me. It's ridiculous. 😱
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Post by rockstarrick on Oct 24, 2017 22:28:59 GMT -5
Posters seem to be arguing all around the main point of Sophie's initial statement, which was that insurers/payers use only the a1C measurement to compare insulin, because a1C is the measurement by which the diabetes treatment community has used to gauge effectiveness for decades. The FDA has initiated dialogue on the use of better measurements, but virtually none of the pharmaceuticals have had their brands tested against anything BUT how effective their insulin is at lowering a1C. Until a1C is replaced by better measurements (e.g. Time-in-Range, severity of hyper- or hypo-glycemic excursions, frequency of out-of-range excursions, etc.) Afrezza will continue being evaluated by payers using this antiquated measurement. Fortunately, advances in CGM / near real-time monitoring is accelerating the speed at which science is changing the landscape, but it will likely be several years until a1C is replaced. When that happens, all the pharmaceutical companies currently marketing RAA insulin in this multi-$billion industry will need to conduct additional trials to demonstrate the effectiveness of their brands using the new measurements demanded by the diabetes community - trials which MannKind has already been conducting for Afrezza. Disruptive medicine often ushers in new ways of looking at a disease. Take a good look at Afrezza. It's leading the way in showing the medical community how significant the speed of an insulin is for controlling this disease. Change will be resisted until the medical community becomes fully convinced that change is needed. The insurance companies will maintain the status quo until then, unless there's an uprising like the one that JDRF Diabetes Foundation is currently leading. What's not making sense to me is how such focus and implied importance can be put onto solely the A1c level, while ignoring entirely the significance of the two components that regulate its direction based off what it is doing independently of the other, and are what make up the value point. This will not be able to go ignored for long, after the results from clinical trial data are published. Perhaps then, and only then, will they too see the irony in all this. A CGM cant distinguish between an FDA "real life" clinical trial versus the "real life" not associated with an FDA approved clinical trial. The data gathered in both settings have an equal amount of real and life in those data points. A CGM doesn't change its behavior in a controlled setting versus real life, every day living—it is the person that is ultimately responsible for ensuring the way he/she lived every moment during the FDA clinical trial mimicked their real life living while not involved in an FDA clinical trial. It's ridiculous. 😱 Exactly, A1c is just The average of two shitty numbers,,,, WTH 😎
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Post by mango on Oct 24, 2017 22:40:02 GMT -5
What's not making sense to me is how such focus and implied importance can be put onto solely the A1c level, while ignoring entirely the significance of the two components that regulate its direction based off what it is doing independently of the other, and are what make up the value point. This will not be able to go ignored for long, after the results from clinical trial data are published. Perhaps then, and only then, will they too see the irony in all this. A CGM cant distinguish between an FDA "real life" clinical trial versus the "real life" not associated with an FDA approved clinical trial. The data gathered in both settings have an equal amount of real and life in those data points. A CGM doesn't change its behavior in a controlled setting versus real life, every day living—it is the person that is ultimately responsible for ensuring the way he/she lived every moment during the FDA clinical trial mimicked their real life living while not involved in an FDA clinical trial. It's ridiculous. 😱 Exactly, A1c is just The average of two shitty numbers,,,, WTH 😎
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Post by peppy on Oct 24, 2017 22:54:18 GMT -5
Posters seem to be arguing all around the main point of Sophie's initial statement, which was that insurers/payers use only the a1C measurement to compare insulin, because a1C is the measurement by which the diabetes treatment community has used to gauge effectiveness for decades. The FDA has initiated dialogue on the use of better measurements, but virtually none of the pharmaceuticals have had their brands tested against anything BUT how effective their insulin is at lowering a1C. Until a1C is replaced by better measurements (e.g. Time-in-Range, severity of hyper- or hypo-glycemic excursions, frequency of out-of-range excursions, etc.) Afrezza will continue being evaluated by payers using this antiquated measurement. Fortunately, advances in CGM / near real-time monitoring is accelerating the speed at which science is changing the landscape, but it will likely be several years until a1C is replaced. When that happens, all the pharmaceutical companies currently marketing RAA insulin in this multi-$billion industry will need to conduct additional trials to demonstrate the effectiveness of their brands using the new measurements demanded by the diabetes community - trials which MannKind has already been conducting for Afrezza. Disruptive medicine often ushers in new ways of looking at a disease. Take a good look at Afrezza. It's leading the way in showing the medical community how significant the speed of an insulin is for controlling this disease. Change will be resisted until the medical community becomes fully convinced that change is needed. The insurance companies will maintain the status quo until then, unless there's an uprising like the one that JDRF Diabetes Foundation is currently leading. What's not making sense to me is how such focus and implied importance can be put onto solely the A1c level, while ignoring entirely the significance of the two components that regulate its direction based off what it is doing independently of the other, and are what make up the value point. This will not be able to go ignored for long, after the results from clinical trial data are published. Perhaps then, and only then, will they too see the irony in all this. A CGM cant distinguish between an FDA "real life" clinical trial versus the "real life" not associated with an FDA approved clinical trial. The data gathered in both settings have an equal amount of real and life in those data points. A CGM doesn't change its behavior in a controlled setting versus real life, every day living—it is the person that is ultimately responsible for ensuring the way he/she lived every moment during the FDA clinical trial mimicked their real life living while not involved in an FDA clinical trial. At some point you have to ask yourself why majority of people do not produce those wonderful data from the FDA clinical trial in "real life". For once, perhaps a standard in the way data is gathered and the value of that data will be only reliable when using a CGM, because lets be honest, we can't see what is happening, "in real time" without one being used, so to counter their argument and ignorance I propose we oust to hold the value of data gathered during "real time" as the highest level of reliable data one can currently have. At what point does the difference of "real life" to the data gathered in actual real life becomes superior to that of an FDA trial which influences behavior and outcomes is the real ticket to me. It would be value equal to that of the same real lif simulation that occurs when the patient is seen at the clinic and sent home with their insulin therapy. Apparently that is the current practice and doesn't mimic the data outcomes of a controlled experiment. Put a CGM on a patient and I bet the CGM will show the data the same way regardless the simulation it is used. Makes too much sense to me. It's ridiculous. 😱 quote: not making sense to me is how such focus and implied importance can be put onto solely the A1c level, while ignoring entirely the significance of the two components that regulate its direction based off what it is doing independently of the other, and are what make up the value point. reply: agreed Mango. When I look at it, a chargeable item that can be done every four months and determine prescription parameters. If I were a sales man, could I have come up with a more efficient all inclusive test for the distribution of ??
sglt2. WARNING: LOWER LIMB AMPUTATION See full prescribing information for complete boxed warning. • In patients with type 2 diabetes who have established cardiovascular disease (CVD) or at risk for CVD, INVOKANA has been associated with lower limb amputations, most frequently of the toe and midfoot; some also involved the leg (5.1) • Before initiating, consider factors that may increase the risk of amputation. Monitor patients receiving INVOKANA for infections or ulcers of the lower limbs, and discontinue if these occur. (5.1)
(sophie, invokana, a life saving medication, I will make sure and save for you if you need it.)
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Post by zuegirdor on Oct 25, 2017 12:06:35 GMT -5
A few years after that, God Willing, the new Treg and Peptide therapies will be refined and we can disagree about the worth of curing diabetics until the price on those therapies comes down. Then you may be right and I will be wrong about the market for Afrezza. For now I am more than happy to disagree. What's funny is that I might be doing more to solve the problem than you are but you're misled into thinking I'm your enemy... Sorry if I came across the wrong way. We both want the same thing. We just have different ways of dealing with the harshness of reality I guess. I wish you sincere good luck on your research if that is what you mean by problem solving. Yeah, my hackles were up. But I think the points I raise are valid. I support them with conviction and common sense argument, if not journal references.
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