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Post by compound26 on Apr 20, 2018 12:02:19 GMT -5
Here is how the current ADA standard of care (2018) describes/deals with inhaled insulin: prnt.sc/j7x3c9Cost comparison (of different insulin treatment): prnt.sc/j7x6kuComplete version of the standard of care (2018) care.diabetesjournals.org/content/diacare/suppl/2017/12/08/41.Supplement_1.DC1/DC_41_S1_Combined.pdfMy impression of reading the standard of care (2018): If I am a doctor who is not already well informed about inhaled insulin, based on the information presented in the ADA standard of care, I will have little or no incentives to prescribe inhaled insulin. The standard of care is giving out the [IMHO: somewhat misleading and incomplete ] impression that: (a) inhaled insulin is non-inferior to RAA, but less effective in reducing A1C; (b) inhaled insulin has more limited dosage range; (c) inhaled insulin is contradicted with chronic lung disease and not recommended for someone who smokes; (d) inhaled insulin requires spirometry testing; and (e) is more expensive than RAA. Will ADA update the living standards of care after the ADA and in particular in relation to inhaled insulin with respect to the STAT study? Let's see how this living standards of care work out! |
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Post by peppy on Apr 20, 2018 16:54:26 GMT -5
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Post by compound26 on Apr 20, 2018 16:57:02 GMT -5
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Post by traderdennis on Apr 20, 2018 17:19:35 GMT -5
Here is how the current ADA standard of care (2018) describes/deals with inhaled insulin: prnt.sc/j7x3c9Cost comparison (of different insulin treatment): prnt.sc/j7x6kuComplete version of the standard of care (2018) care.diabetesjournals.org/content/diacare/suppl/2017/12/08/41.Supplement_1.DC1/DC_41_S1_Combined.pdfMy impression of reading the standard of care (2018): If I am a doctor who is not already well informed about inhaled insulin, based on the information presented in the ADA standard of care, I will have little or no incentives to prescribe inhaled insulin. The standard of care is giving out the [IMHO: somewhat misleading and incomplete ] impression that: (a) inhaled insulin is non-inferior to RAA, but less effective in reducing A1C; (b) inhaled insulin has more limited dosage range; (c) inhaled insulin is contradicted with chronic lung disease and not recommended for someone who smokes; (d) inhaled insulin requires spirometry testing; and (e) is more expensive than RAA. Will ADA update the living standards of care after the ADA and in particular in relation to inhaled insulin with respect to the STAT study? Let's see how this living standards of care work out! How do you expect the ADA change the following? They have no control over cost
They have no control over the smoking rate
Insulin resistant T2 who take large amounts of insulin when Afrezza largest dose is 12 units.
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Post by goyocafe on Apr 20, 2018 17:24:50 GMT -5
Here is how the current ADA standard of care (2018) describes/deals with inhaled insulin: prnt.sc/j7x3c9Cost comparison (of different insulin treatment): prnt.sc/j7x6kuComplete version of the standard of care (2018) care.diabetesjournals.org/content/diacare/suppl/2017/12/08/41.Supplement_1.DC1/DC_41_S1_Combined.pdfMy impression of reading the standard of care (2018): If I am a doctor who is not already well informed about inhaled insulin, based on the information presented in the ADA standard of care, I will have little or no incentives to prescribe inhaled insulin. The standard of care is giving out the [IMHO: somewhat misleading and incomplete ] impression that: (a) inhaled insulin is non-inferior to RAA, but less effective in reducing A1C; (b) inhaled insulin has more limited dosage range; (c) inhaled insulin is contradicted with chronic lung disease and not recommended for someone who smokes; (d) inhaled insulin requires spirometry testing; and (e) is more expensive than RAA. Will ADA update the living standards of care after the ADA and in particular in relation to inhaled insulin with respect to the STAT study? Let's see how this living standards of care work out! How do you expect the ADA change the following? They have no control over cost
They have no control over the smoking rate
Insulin resistant T2 who take large amounts of insulin when Afrezza largest dose is 12 units.
12 units is the largest single cartridge. They’ve tested dose linearity up to 48 units. |
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Post by traderdennis on Apr 20, 2018 17:26:58 GMT -5
How do you expect the ADA change the following? They have no control over cost
They have no control over the smoking rate
Insulin resistant T2 who take large amounts of insulin when Afrezza largest dose is 12 units.
12 units is the largest single cartridge. They’ve tested dose linearity up to 48 units. So you would take 3-4 massive hits of a 12 unit cartridge? That sounds brutal versus a single needle prick, not to mention the monthly cost of 270+ 12 unit cartridges. |
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Post by goyocafe on Apr 20, 2018 17:29:59 GMT -5
12 units is the largest single cartridge. They’ve tested dose linearity up to 48 units. So you would take 3-4 massive hits of a 12 unit cartridge? That sounds brutal versus a single needle prick. I think the “massive hits” would be about the same as 3-4 normal breaths, but go ahead and prick yourself. |
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Post by matt on Apr 21, 2018 9:42:38 GMT -5
The standard of care is giving out the [IMHO: somewhat misleading and incomplete ] impression that: (a) inhaled insulin is non-inferior to RAA, but less effective in reducing A1C; (b) inhaled insulin has more limited dosage range; (c) inhaled insulin is contradicted with chronic lung disease and not recommended for someone who smokes; (d) inhaled insulin requires spirometry testing; and (e) is more expensive than RAA. Each of those impressions comes directly from the Afrezza label with the exception of average wholesale price. ADA is not going to issue a recommendation that contradicts a company-authored and FDA approved medication label. Until, and unless, Mannkind does the 8,000-10,000 patient long-term safety study FDA has mandated, the black box warning is going to remain. You can dislike the recommendation, but you cannot complain that it is not fact-based. Average wholesale price is what it is, and it is likewise a fact that Afrezza is not the cheapest RAA insulin on the market. The company could reduce the price, but given the cash bleed I am not sure that the trade-off between sales volume gained and profit margin lost would be worth it from a financial standpoint. There is only one way to test what dropping the price below $400 would do to the company's financial results. |
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Post by goyocafe on Apr 21, 2018 9:52:16 GMT -5
The standard of care is giving out the [IMHO: somewhat misleading and incomplete ] impression that: (a) inhaled insulin is non-inferior to RAA, but less effective in reducing A1C; (b) inhaled insulin has more limited dosage range; (c) inhaled insulin is contradicted with chronic lung disease and not recommended for someone who smokes; (d) inhaled insulin requires spirometry testing; and (e) is more expensive than RAA. Each of those impressions comes directly from the Afrezza label with the exception of average wholesale price. ADA is not going to issue a recommendation that contradicts a company-authored and FDA approved medication label. Until, and unless, Mannkind does the 8,000-10,000 patient long-term safety study FDA has mandated, the black box warning is going to remain. You can dislike the recommendation, but you cannot complain that it is not fact-based. Average wholesale price is what it is, and it is likewise a fact that Afrezza is not the cheapest RAA insulin on the market. The company could reduce the price, but given the cash bleed I am not sure that the trade-off between sales volume gained and profit margin lost would be worth it from a financial standpoint. There is only one way to test what dropping the price below $400 would do to the company's financial results. What do you suppose Dr. Kendall is going to be able to accomplish with the deck stacked so much against MNKD? Reading your post leaves me with the impression that this is a lost cause. |
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Post by mnholdem on Apr 21, 2018 10:28:28 GMT -5
In the case of Afrezza, the science will prevail. No matter how much the medical industry may be stacked against newcomers, it will not be able to hide what near-/real-time monitors will reveal about how well mainstream treatments perform in controlling the disease. Without new (and industry-accepted) BG monitors, achieving broad acceptance of Afrezza may have been hopeless, but that is no longer the case. The science of understanding diabetes and how to best treat it has advanced more in the past few years than it has in nearly a century, when insulin was first discovered.  |
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Post by agedhippie on Apr 21, 2018 18:19:48 GMT -5
Each of those impressions comes directly from the Afrezza label with the exception of average wholesale price. ADA is not going to issue a recommendation that contradicts a company-authored and FDA approved medication label. Until, and unless, Mannkind does the 8,000-10,000 patient long-term safety study FDA has mandated, the black box warning is going to remain. You can dislike the recommendation, but you cannot complain that it is not fact-based. Average wholesale price is what it is, and it is likewise a fact that Afrezza is not the cheapest RAA insulin on the market. The company could reduce the price, but given the cash bleed I am not sure that the trade-off between sales volume gained and profit margin lost would be worth it from a financial standpoint. There is only one way to test what dropping the price below $400 would do to the company's financial results. What do you suppose Dr. Kendall is going to be able to accomplish with the deck stacked so much against MNKD? Reading your post leaves me with the impression that this is a lost cause. I think people have unrealistic expectations about what Dr Kendell can achieve. He is not on any of the committees, he has spent the last seven years working to push non-insulin diabetes drugs, and now he is working for an insulin manufacturer. His value to Mannkind is knowing how to frame trial submissions for maximum impact, and PR. Those two tasks alone will make a significant difference if delivered competently. |
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