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Post by markado on Aug 7, 2020 8:45:48 GMT -5
It seems the hang-up here has been avid prescribers, because DR's, Endos, GP's don't like "unproven" change - I use that word very specifically but sarcastically - that could potentially put them or their practice at greater risk. But, what if, quantifiably, as in the directionally projectable decrease of hypoglycemic events for the average patient base, and hence reduction in more grave and costly complications/hospitalizations, etc., can be clearly modeled out and presented? Not just to DR's but to their Medical Malpractice Insurance providers? Obviously, and I've touched on this, before, but the same holds true for a simple assumptions B2B comparison of Afrezza vs other needle or pen based solutions. If you can't follow the money, get ahead of it. Reducing mutimillion/multi-billion loss drivers gets executives' attention. This could be completely outsourced as an objective assessment (both models), and since it would be prorietary, MNKD can learn from it and choose to share it, if advantageous, at their discretion.
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Post by agedhippie on Aug 7, 2020 9:19:08 GMT -5
It seems the hang-up here has been avid prescribers, because DR's, Endos, GP's don't like "unproven" change - I use that word very specifically but sarcastically - that could potentially put them or their practice at greater risk. But, what if, quantifiably, as in the directionally projectable decrease of hypoglycemic events for the average patient base, and hence reduction in more grave and costly complications/hospitalizations, etc., can be clearly modeled out and presented? Not just to DR's but to their Medical Malpractice Insurance providers? Obviously, and I've touched on this, before, but the same holds true for a simple assumptions B2B comparison of Afrezza vs other needle or pen based solutions. If you can't follow the money, get ahead of it. Reducing mutimillion/multi-billion loss drivers gets executives' attention. This could be completely outsourced as an objective assessment (both models), and since it would be prorietary, MNKD can learn from it and choose to share it, if advantageous, at their discretion. No. Insulin is approved by the FDA for the treatment of diabetes, and it is part of the standard of care. As such it would be extremely hard to make a malpractice suit stick. Now if Mannkind did what you suggested in your last line (a trial to prove superiority) then, while the malpractice aspect would still be out, the medical world would be a whole lot happier about prescribing it - look how RAA displace Regular insulin as an example. |
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Post by matt on Aug 7, 2020 11:58:12 GMT -5
Now if Mannkind did what you suggested in your last line (a trial to prove superiority) then, while the malpractice aspect would still be out, the medical world would be a whole lot happier about prescribing it - look how RAA displace Regular insulin as an example. ^^^ What he said. The only data that exists allows MNKD to make a claim that it is non-inferior to injectable insulins, which is a little bit like saying that a Honda Accord is not inferior to a Toyota Camry but is 10 times the price. If that were the case you would see very few Hondas on the street. So it is with drugs; there are attributes of Afrezza that potentially justify the higher cost but the data does not exist to demonstrate the cost-benefit relationship. When MNKD chooses to make such data available, they will be able to get changes on the FDA approved label and if the data is truly credible then insurance companies will be glad to move Afrezza to Tier 1. Everybody is in favor of more efficacious drugs that are more cost effective than existing therapies. It does no good to whine that Lilly and Novo Nordisk own the market when their drugs are far cheaper and even MNKD's own clinical trials show that efficacy is not statistically different than Afrezza. Whose job is it to run the necessary studies? Mannkind. Why haven't they? Partly because the company does not have the money (this would not be a cheap trial) and perhaps because they lack conviction that the results would be what they need to move the needle (no pun intended). |
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Post by sayhey24 on Aug 7, 2020 13:04:29 GMT -5
Now if Mannkind did what you suggested in your last line (a trial to prove superiority) then, while the malpractice aspect would still be out, the medical world would be a whole lot happier about prescribing it - look how RAA displace Regular insulin as an example. ^^^ What he said. The only data that exists allows MNKD to make a claim that it is non-inferior to injectable insulins, which is a little bit like saying that a Honda Accord is not inferior to a Toyota Camry but is 10 times the price. If that were the case you would see very few Hondas on the street. So it is with drugs; there are attributes of Afrezza that potentially justify the higher cost but the data does not exist to demonstrate the cost-benefit relationship. When MNKD chooses to make such data available, they will be able to get changes on the FDA approved label and if the data is truly credible then insurance companies will be glad to move Afrezza to Tier 1. Everybody is in favor of more efficacious drugs that are more cost effective than existing therapies. It does no good to whine that Lilly and Novo Nordisk own the market when their drugs are far cheaper and even MNKD's own clinical trials show that efficacy is not statistically different than Afrezza. Whose job is it to run the necessary studies? Mannkind. Why haven't they? Partly because the company does not have the money (this would not be a cheap trial) and perhaps because they lack conviction that the results would be what they need to move the needle (no pun intended). Matt - this is incorrect. The data does exist to show fewer cases of hypoglycemia and superior post prandial control for T1s. It also showed superiority in the Affinity 2 trial for T2s. Dr. Kendall realized this data was readily available which is why he thought making the argument would be easy. Do fewer cases of hypoglycemia save money? I would think so but that is the case which needs to be sold to the insurance carriers. Does better postprandial control reduce health costs by improved vascular health resulting in things like fewer heart attacks? I would think so and other trials point to this but the story has to be made. Heck - they made that argument with SGLT2s and even Aged got dupped by that claim when the issue being addressed is postprandial excursions. I would like to see that "Heart" symbol on the afrezza box - heart healthy. I am not sure what issues Dr. Kendall ran into making this argument. I would like to know as its not that the trial data is not there. It is. Afrezza will never be better than non-inferior to other insulin on a one dose to one dose basis over 24hrs. We also know the FDA called double dosing afrezza during Afffinty 1 cheating but we also know by doing this afrezza will always win as was shown in Affinity 1 and STAT. The reality is double dosing scares old school insulin users and doctors. |
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Post by agedhippie on Aug 7, 2020 14:46:19 GMT -5
^^^ What he said. The only data that exists allows MNKD to make a claim that it is non-inferior to injectable insulins, which is a little bit like saying that a Honda Accord is not inferior to a Toyota Camry but is 10 times the price. If that were the case you would see very few Hondas on the street. So it is with drugs; there are attributes of Afrezza that potentially justify the higher cost but the data does not exist to demonstrate the cost-benefit relationship. When MNKD chooses to make such data available, they will be able to get changes on the FDA approved label and if the data is truly credible then insurance companies will be glad to move Afrezza to Tier 1. Everybody is in favor of more efficacious drugs that are more cost effective than existing therapies. It does no good to whine that Lilly and Novo Nordisk own the market when their drugs are far cheaper and even MNKD's own clinical trials show that efficacy is not statistically different than Afrezza. Whose job is it to run the necessary studies? Mannkind. Why haven't they? Partly because the company does not have the money (this would not be a cheap trial) and perhaps because they lack conviction that the results would be what they need to move the needle (no pun intended). Matt - this is incorrect. The data does exist to show fewer cases of hypoglycemia and superior post prandial control for T1s. It also showed superiority in the Affinity 2 trial for T2s. Dr. Kendall realized this data was readily available which is why he thought making the argument would be easy. Do fewer cases of hypoglycemia save money? I would think so but that is the case which needs to be sold to the insurance carriers. Does better postprandial control reduce health costs by improved vascular health resulting in things like fewer heart attacks? I would think so and other trials point to this but the story has to be made. Heck - they made that argument with SGLT2s and even Aged got dupped by that claim when the issue being addressed is postprandial excursions. I would like to see that "Heart" symbol on the afrezza box - heart healthy. I am not sure what issues Dr. Kendall ran into making this argument. I would like to know as its not that the trial data is not there. It is. Afrezza will never be better than non-inferior to other insulin on a one dose to one dose basis over 24hrs. We also know the FDA called double dosing afrezza during Afffinty 1 cheating but we also know by doing this afrezza will always win as was shown in Affinity 1 and STAT. The reality is double dosing scares old school insulin users and doctors. The question was whether not prescribing Afrezza could constitute medical malpractice. The answer is no, the label says it can be used for diabetes and that is the end of the story. That then raised the idea that if Mannkind can run suitable trials to prove superiority then the medical world would naturally migrate in the same way that they did from Regular insulin to RAA (to the original MMP point it is worth noting that Regular insulin is still prescribed despite RAA being superior). To achieve superiority is going to take a large scale superiority trial, not a patchwork of single arm studies, pilots, and short term trials. On SGLT2 - they have large scale trial data proving the heart benefit in diabetics which is good enough for me. As I have pointed out before blood glucose levels are only one part of diabetes. In the case of Type 1 there is also the lack of c-peptides which they now think help repair the cardiovascular system. If Afrezza wants to be considered heart healthy then do the trial to prove it, otherwise it's just an unsupported claim and will be treated as such. |
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Post by itellthefuture777 on Aug 7, 2020 17:15:59 GMT -5
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Post by agedhippie on Aug 7, 2020 19:15:22 GMT -5
It's interesting, but it needs a trial structured that way to be taken seriously. Basically STAT-2. |
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Post by sportsrancho on Aug 7, 2020 21:20:30 GMT -5
It's interesting, but it needs a trial structured that way to be taken seriously. Basically STAT-2. They took it way before they ate...what is it that we cannot structure these trials appropriately, who do we pay to do this!! Same thing with the pediatric trial. |
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Post by sayhey24 on Aug 8, 2020 6:41:34 GMT -5
Matt - this is incorrect. The data does exist to show fewer cases of hypoglycemia and superior post prandial control for T1s. It also showed superiority in the Affinity 2 trial for T2s. Dr. Kendall realized this data was readily available which is why he thought making the argument would be easy. Do fewer cases of hypoglycemia save money? I would think so but that is the case which needs to be sold to the insurance carriers. Does better postprandial control reduce health costs by improved vascular health resulting in things like fewer heart attacks? I would think so and other trials point to this but the story has to be made. Heck - they made that argument with SGLT2s and even Aged got dupped by that claim when the issue being addressed is postprandial excursions. I would like to see that "Heart" symbol on the afrezza box - heart healthy. I am not sure what issues Dr. Kendall ran into making this argument. I would like to know as its not that the trial data is not there. It is. Afrezza will never be better than non-inferior to other insulin on a one dose to one dose basis over 24hrs. We also know the FDA called double dosing afrezza during Afffinty 1 cheating but we also know by doing this afrezza will always win as was shown in Affinity 1 and STAT. The reality is double dosing scares old school insulin users and doctors. The question was whether not prescribing Afrezza could constitute medical malpractice. The answer is no, the label says it can be used for diabetes and that is the end of the story. That then raised the idea that if Mannkind can run suitable trials to prove superiority then the medical world would naturally migrate in the same way that they did from Regular insulin to RAA (to the original MMP point it is worth noting that Regular insulin is still prescribed despite RAA being superior). To achieve superiority is going to take a large scale superiority trial, not a patchwork of single arm studies, pilots, and short term trials. On SGLT2 - they have large scale trial data proving the heart benefit in diabetics which is good enough for me. As I have pointed out before blood glucose levels are only one part of diabetes. In the case of Type 1 there is also the lack of c-peptides which they now think help repair the cardiovascular system. If Afrezza wants to be considered heart healthy then do the trial to prove it, otherwise it's just an unsupported claim and will be treated as such. Aged - its pretty clear from the study data, afrezza significantly reduces the chance of severe hypos. If MNKD were to put on an education campaign on this and a week later an endo totally disregards this info and their PWD dies from a severe hypo, I bet there are a few lawyers willing to take that case. If MNKD got the word out wide enough - say some serious TV ads insted of a flying hamburger saying take the afrezza and significantly reduce your chance of severe hypo, I am sure there are some enterprising lawyers who would try and put a class action case together. When you say superiority I am not sure what this means. Are you talking A1c, post prandial BG, chance of hypo, better control than metformin, etc. I think we have all the study data for each. On a dose to dose basis using A1c afrezza will always be non-inferior, just like Affinity 1 says. Two hour post prandial, afrezza will always kick ass over an RAA. If you are looking to stop the post prandial spike which is a major cause of cardivascular issues, afrezza is hands down the way to go. Is an SGLT2 as good as afrezza in stopping the spike - no way, not even close. Will an SGLT2 help if not using afrezza, sure. However, I would never take it but thats a personal decision. I also think no matter how slim the chance Fournier's gangrene looks pretty nasty. |
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Post by agedhippie on Aug 8, 2020 9:16:23 GMT -5
Aged - its pretty clear from the study data, afrezza significantly reduces the chance of severe hypos. If MNKD were to put on an education campaign on this and a week later an endo totally disregards this info and their PWD dies from a severe hypo, I bet there are a few lawyers willing to take that case. If MNKD got the word out wide enough - say some serious TV ads insted of a flying hamburger saying take the afrezza and significantly reduce your chance of severe hypo, I am sure there are some enterprising lawyers who would try and put a class action case together. When you say superiority I am not sure what this means. Are you talking A1c, post prandial BG, chance of hypo, better control than metformin, etc. I think we have all the study data for each. On a dose to dose basis using A1c afrezza will always be non-inferior, just like Affinity 1 says. Two hour post prandial, afrezza will always kick ass over an RAA. If you are looking to stop the post prandial spike which is a major cause of cardivascular issues, afrezza is hands down the way to go. Is an SGLT2 as good as afrezza in stopping the spike - no way, not even close. Will an SGLT2 help if not using afrezza, sure. However, I would never take it but thats a personal decision. I also think no matter how slim the chance Fournier's gangrene looks pretty nasty. The doctor would have prescribed an approved drug in an approved manner. That's a bulletproof case. I have no doubt that you could find a lawyer to take the case, this is the US after all, but they will lose. The second problem is that Afrezza did not make a statistically significant reduction in severe hypos (ones that require assistance) which is why Mannkind had to print that retraction. If you notice the paper issued at the last ADA excluded that class and picked the two lesser types of hypo to make their case. This is not to minimize the nastiness of hypos in general, but the ones that get you hospitalized - that's is not yet proven in a large trial. And it has to be a large trial if you want statistically significant results because of how rare they are. Superiority by the current rules means a better HbA1c. I think we all agree that TIR is a better measure, but the medical world is still at HbA1c although it is moving slowly to TIR. Dosing rules should be dose as appropriate - I like the STAT-1 protocol. You are hung up on glucose levels as a cause of heart disease, which it is, but it is not the only cause if you have diabetes. I am not taking SGLT2 for diabetes, as I said before my endo was quite clear that the impact there would be minimal, but rather for the cardio and kidney benefits. The probability of a bad cardio outcome dwarfs the probability of Fourier's Gangrene making the choice obvious. |
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Post by matt on Aug 8, 2020 10:19:47 GMT -5
Matt - this is incorrect. The data does exist to show fewer cases of hypoglycemia and superior post prandial control for T1s. It also showed superiority in the Affinity 2 trial for T2s. You are comparing apples and oranges. Some drugs do a better job of keeping patients out of the hospital or otherwise improve healthcare outcomes, and those are readily prescribed. If an insurance company is asked to pay a $1,000 premium per year for a cardiovascular drug that substantially reduces the chance of a three-day inpatient stay, they will gladly pay it. If the new drug has a $1,000,000 per year premium, they will not pay for it because the certainty of the drug cost is not outweighed by the cost savings it might provide. While most people don't like to think about the cost-benefit analysis that takes place in insurance providers every day, I assure you that the industry has it down to a fine science and that is precisely how they look at drug prices. Afrezza claims certain benefits over other insulins. MNKD tends to do small and underpowered studies, which is why they fail to demonstrate superiority in a statistical sense, but even if we assume that the benefits are real the economics are not quantified. It we assume that patients consume at least 1 box per month, and that a box of Afrezza is at least $1,000 more expensive than RAI analogs, that tells us that Afrezza adds $12,000 a year to the cost of care. Most people claim that Afrezza users need more units of Afrezza than injectable, so $12,000 is a conservative estimate. Now, how many hypo events are avoided and how many of those events require an emergency room visit and what do all those emergency room visits cost? If 1,000 patients are on Afrezza at a $12,000 premium, do the avoided emergency room visits cost more or less than $12 million? What is the cost impact of "superior post prandial control" for a T1 patient? Is better time-in-range worth $100 a year, $1,000 a year, $10,000 a year, or some other amount? None of those numbers are easy to come up with, but they can be calculated. That is what Mannkind has failed to do. As I said above, there are clinical attributes that potentially justify the higher cost, but simply demonstrating that the attributes exist is not the same thing as economically justifying the price of the product. In a country where healthcare costs absorb 18% of GDP, it is necessary to quantify the economic savings if you want to sell a product at a higher price. |
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Post by cretin11 on Aug 8, 2020 18:10:37 GMT -5
Aged - its pretty clear from the study data, afrezza significantly reduces the chance of severe hypos. If MNKD were to put on an education campaign on this and a week later an endo totally disregards this info and their PWD dies from a severe hypo, I bet there are a few lawyers willing to take that case. If MNKD got the word out wide enough - say some serious TV ads insted of a flying hamburger saying take the afrezza and significantly reduce your chance of severe hypo, I am sure there are some enterprising lawyers who would try and put a class action case together. When you say superiority I am not sure what this means. Are you talking A1c, post prandial BG, chance of hypo, better control than metformin, etc. I think we have all the study data for each. On a dose to dose basis using A1c afrezza will always be non-inferior, just like Affinity 1 says. Two hour post prandial, afrezza will always kick ass over an RAA. If you are looking to stop the post prandial spike which is a major cause of cardivascular issues, afrezza is hands down the way to go. Is an SGLT2 as good as afrezza in stopping the spike - no way, not even close. Will an SGLT2 help if not using afrezza, sure. However, I would never take it but thats a personal decision. I also think no matter how slim the chance Fournier's gangrene looks pretty nasty. The doctor would have prescribed an approved drug in an approved manner. That's a bulletproof case. I have no doubt that you could find a lawyer to take the case, this is the US after all, but they will lose. You’re correct on the first count, that it would be a bulletproof defense. Incorrect that you could find a lawyer to take the case. No lawyer would touch it, it’s too obviously a loser and any lawyer would immediately know that he’d never even recoup his expenses. Doctor prescribing an approved drug in an approved manner: equals no case for medical malpractice, especially with how ridiculously high that burden of proof is these days in most states. End of story. |
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