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Post by dreamboatcruise on Mar 21, 2018 13:29:10 GMT -5
agedhippie Your point may be incorrect since for every person that leaves, someone else arrives--in a thriving business. You're only correct if more PWDs leave using Afrezza (if they cover and someone prescribes) than arrive using Afrezza (from a situation where they were on Afrezza). If the ins and outs balance, then reducing complications does pay off now. I was asked by a self-insured company to help put on an internal employee only diabetes fair. In discussion with them they told me their number one health expense is diabetes. That was not including some diabetes related complicates including heart disease which they had not related to diabetes. It seems employees over 45 tend to hang around awhile and some are not leaving until 70. Thats a pretty long time. When they have health issues and good insurance its tough getting these people out the door. The government says over 8 years for those 45-55 www.bls.gov/news.release/pdf/tenure.pdf But diabetics stay longer. Its the 45 year olds you want to identify early and treat early with afrezza. They aren't going anywhere in five years. I asked them how would they feel if in some cases we could stop the progression and potentially reverse some beta cell damage. The self insured market has the biggest incentive to use afrezza if it can actually stop progression and they can get it for less than $400 a box. 40% of the insurance market is self insured. I assume this company does not cover Afrezza? Will certainly be good news if you can convince them to. |
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Post by agedhippie on Mar 21, 2018 13:48:15 GMT -5
A bigger problem is that the majority of large employers self-insure and they know you are going to be out of the door in under 5 years so what do they care about complications compared with keeping costs low now? Your point may be incorrect since for every person that leaves, someone else arrives--in a thriving business. You're only correct if more PWDs leave using Afrezza (if they cover and someone prescribes) than arrive using Afrezza (from a situation where they were on Afrezza). If the ins and outs balance, then reducing complications does pay off now. It's the tragedy of the commons. An insurer acts in their own best interest so if everyone else is covering Afrezza and they are not then that's a win for them because they are getting the benefit without the cost. Single payer health systems are better at this because the patient is their responsibility from cradle to grave so they absolutely have an incentive to control the risk of complications. |
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Post by mnholdem on Mar 21, 2018 14:48:24 GMT -5
The word "Improved" in the titles of the upcoming ADA presentations won't, by itself, generate much interest. However, CEO Castagna threw out a number: 35% reduction of hypoglycemic excursions compared to aspart. I think that number WILL generate a lot of interest.
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Post by akemp3000 on Mar 21, 2018 14:58:13 GMT -5
The word "Improved" in the titles of the upcoming ADA presentations won't, by itself, generate much interest. However, CEO Castagna threw out a number: 35% reduction of hypoglycemic excursions compared to aspart. I think that number WILL generate a lot of interest. Agreed. Once the 35% reduction becomes public data, it seems doctors having patients with severe hypoglycemic events, who have ignored this data, will own a serious liability risk. IMO, some day, an aggressive attorney will file a class action lawsuit against some of the current standard treatments...because of the known superior efficacy of Afrezza. |
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Post by peppy on Mar 21, 2018 15:01:31 GMT -5
The word "Improved" in the titles of the upcoming ADA presentations won't, by itself, generate much interest. However, CEO Castagna threw out a number: 35% reduction of hypoglycemic excursions compared to aspart. I think that number WILL generate a lot of interest. Agreed. Once the 35% reduction becomes public data, it seems doctors having patients with severe hypoglycemic events, who have ignored this data, will own a serious liability risk. IMO, some day, an aggressive attorney will file a class action lawsuit against some of the current standard treatments...because of the known superior efficacy of Afrezza. it will be interesting to see how that data is presented. How it can be used. Rapid acting analogs and hypoglycemia.  |
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Post by dreamboatcruise on Mar 21, 2018 15:43:23 GMT -5
The word "Improved" in the titles of the upcoming ADA presentations won't, by itself, generate much interest. However, CEO Castagna threw out a number: 35% reduction of hypoglycemic excursions compared to aspart. I think that number WILL generate a lot of interest. I think that was in reference to the old Affinity trials, the data for which was presented on a slide right after that 35% reduction comment. That was a published study, so to the limited extent studies can be talked about that didn't make it into the label, that data has been out there. |
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Post by sayhey24 on Mar 21, 2018 16:09:31 GMT -5
I was asked by a self-insured company to help put on an internal employee only diabetes fair. In discussion with them they told me their number one health expense is diabetes. That was not including some diabetes related complicates including heart disease which they had not related to diabetes. It seems employees over 45 tend to hang around awhile and some are not leaving until 70. Thats a pretty long time. When they have health issues and good insurance its tough getting these people out the door. The government says over 8 years for those 45-55 www.bls.gov/news.release/pdf/tenure.pdf But diabetics stay longer. Its the 45 year olds you want to identify early and treat early with afrezza. They aren't going anywhere in five years. I asked them how would they feel if in some cases we could stop the progression and potentially reverse some beta cell damage. The self insured market has the biggest incentive to use afrezza if it can actually stop progression and they can get it for less than $400 a box. 40% of the insurance market is self insured. I assume this company does not cover Afrezza? Will certainly be good news if you can convince them to. Actually they do cover afrezza if its prescribed. The problem is most PCPs know little about diabetes except for prescribing metformin. Their problem is they are incurring huge costs because metformin just hides for a few years bigger issues which turn into huge costs. The suggestion that these 45ish who are working for big companies are leaving in 5 years is completely wrong. By that age many have been institutionalized and they are figuring out strategies to make it to retirement and keep their health benefits. At 55 they are hoping not to get kicked out the door and they are hoping to make it to 60 and then 66. The root cause is the PCP. Their knowledge of diabetes is very limited and what they have been doing is wrong. The VDex model is the right model but it needs to be done with serious funding in some type of partnership with the Onduo's. Existing insurance companies have some exploratory projects with CGMs. The next step will be adding afrezza if they really want to achieve TIR. I did find out the other day a 500 PWD study is being done outside Philly with the IWatch CGM, so interesting things are happening. It is just taking so long. |
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Post by peppy on Mar 21, 2018 16:29:43 GMT -5
The word "Improved" in the titles of the upcoming ADA presentations won't, by itself, generate much interest. However, CEO Castagna threw out a number: 35% reduction of hypoglycemic excursions compared to aspart. I think that number WILL generate a lot of interest. I think that was in reference to the old Affinity trials, the data for which was presented on a slide right after that 35% reduction comment. That was a published study, so to the limited extent studies can be talked about that didn't make it into the label, that data has been out there. Hypoglycemia As with other insulin products, the most common adverse event associated with Afrezza is hypoglycemia.12 A 12-week, double-blind, placebo-controlled, randomized, parallel-group study compared the efficacy, safety, and tolerability of TI with that of TP in insulin-naïve patients with T2DM whose disease was suboptimally controlled with oral antidiabetic agents. There was no significant difference in the rates of hypoglycemic events between the TI (n = 26) and TP (n = 22) groups at the end of the study (43% versus 36%, respectively; P = 0.321).26 In the 52-week trial by Rosenstock and colleagues, the rate of mild-to-moderate hypoglycemia was lower in patients treated with TI plus SC glargine (n = 155) compared with those receiving SC premixed insulin analog (n = 228) (48% versus 69%, respectively). The rate of severe hypoglycemia was also lower with TI plus SC glargine (n = 14) than with SC premixed insulin analog (n = 33) (4% versus 10%, respectively).25 In the Affinity 2 trial, however, the rate of hypoglycemia (of any severity) was significantly higher in the TI group than in the TP group (68% versus 31%, respectively; P < 0.0001).22,24 www.ncbi.nlm.nih.gov/pmc/articles/PMC4634344/ |
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Post by goyocafe on Mar 21, 2018 16:34:36 GMT -5
I think that was in reference to the old Affinity trials, the data for which was presented on a slide right after that 35% reduction comment. That was a published study, so to the limited extent studies can be talked about that didn't make it into the label, that data has been out there. Hypoglycemia As with other insulin products, the most common adverse event associated with Afrezza is hypoglycemia.12 A 12-week, double-blind, placebo-controlled, randomized, parallel-group study compared the efficacy, safety, and tolerability of TI with that of TP in insulin-naïve patients with T2DM whose disease was suboptimally controlled with oral antidiabetic agents. There was no significant difference in the rates of hypoglycemic events between the TI (n = 26) and TP (n = 22) groups at the end of the study (43% versus 36%, respectively; P = 0.321).26 In the 52-week trial by Rosenstock and colleagues, the rate of mild-to-moderate hypoglycemia was lower in patients treated with TI plus SC glargine (n = 155) compared with those receiving SC premixed insulin analog (n = 228) (48% versus 69%, respectively). The rate of severe hypoglycemia was also lower with TI plus SC glargine (n = 14) than with SC premixed insulin analog (n = 33) (4% versus 10%, respectively).25 In the Affinity 2 trial, however, the rate of hypoglycemia (of any severity) was significantly higher in the TI group than in the TP group (68% versus 31%, respectively; P < 0.0001).22,24 www.ncbi.nlm.nih.gov/pmc/articles/PMC4634344/If I recall, they were forced to dose 20 minutes before a meal. I'm looking forward to seeing study results that let the participants use the drug in a manner consistent with its PK PD profile and not driven by some misguided assumption that all meal time insulin is the same. F the FDA. |
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Post by dreamboatcruise on Mar 21, 2018 16:36:19 GMT -5
I assume this company does not cover Afrezza? Will certainly be good news if you can convince them to. Actually they do cover afrezza if its prescribed. The problem is most PCPs know little about diabetes except for prescribing metformin. Their problem is they are incurring huge costs because metformin just hides for a few years bigger issues which turn into huge costs. The suggestion that these 45ish who are working for big companies are leaving in 5 years is completely wrong. By that age many have been institutionalized and they are figuring out strategies to make it to retirement and keep their health benefits. At 55 they are hoping not to get kicked out the door and they are hoping to make it to 60 and then 66. The root cause is the PCP. Their knowledge of diabetes is very limited and what they have been doing is wrong. The VDex model is the right model but it needs to be done with serious funding in some type of partnership with the Onduo's. Existing insurance companies have some exploratory projects with CGMs. The next step will be adding afrezza if they really want to achieve TIR. I did find out the other day a 500 PWD study is being done outside Philly with the IWatch CGM, so interesting things are happening. It is just taking so long. Can you provide a link to the study using the Apple Watch CGM technology. I'm very curious to see how it's structured and what endpoints they have. |
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Post by agedhippie on Mar 21, 2018 17:21:34 GMT -5
The word "Improved" in the titles of the upcoming ADA presentations won't, by itself, generate much interest. However, CEO Castagna threw out a number: 35% reduction of hypoglycemic excursions compared to aspart. I think that number WILL generate a lot of interest. Agreed. Once the 35% reduction becomes public data, it seems doctors having patients with severe hypoglycemic events, who have ignored this data, will own a serious liability risk. IMO, some day, an aggressive attorney will file a class action lawsuit against some of the current standard treatments...because of the known superior efficacy of Afrezza. Not going to happen. The doctors are prescribing drugs according to their labels so they are on rock solid ground. Just because a drug is old doesn't mean it is negligent to prescribe it as long as the FDA has not withdrawn it. |
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Post by mnholdem on Mar 21, 2018 17:44:31 GMT -5
The physicians are also protected from liability when they follow the industry's Diabetes Standard of Care. If the SOC changes, then you may have something to hang your hat on.
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Post by falconquest on Mar 21, 2018 18:33:32 GMT -5
The skeptic in me thinks the lost data none of us have seen is similar to the agreement with RLS that was worth up to $100M. Standard mnkd playbook. Sales are down because underperforming sales reps were fired but don't worry because this issue was solved. Everything is wonderful now. Really? History would suggest a short time price spike followed by dilution followed by a price crash. I hope I'm wrong. As a Sales Rep. I have to defend my peers. In order to be successful in sales you have to have something to sell. While we know Afrezza is truly a miracle drug, consider the barriers to entry. That is something that Reps. can't control. If you were brow beaten everyday because you didn't have adequate insurance coverage and it required a physician to hire an educator for a patient that should really have a CGM also, then the barriers to entry are very high. Reps. like to make money. If your product is considered a dud when it comes to barriers and demand is low, how motivated do you think you would be? We all know the Afrezza story but getting a physician to make a "paradigm shift" is likely very challenging. They will take the easy route. Dr. Kendall has his work cut out for him because Reps. can't change the current climate. It has to come from higher up. Holding Reps. feet to the fire is disingenuous. It boils down to marketing and that is a skill that Castagna is supposed to be good at. |
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Post by nylefty on Mar 21, 2018 19:25:35 GMT -5
The skeptic in me thinks the lost data none of us have seen is similar to the agreement with RLS that was worth up to $100M. Standard mnkd playbook. Sales are down because underperforming sales reps were fired but don't worry because this issue was solved. Everything is wonderful now. Really? History would suggest a short time price spike followed by dilution followed by a price crash. I hope I'm wrong. As a Sales Rep. I have to defend my peers. In order to be successful in sales you have to have something to sell. While we know Afrezza is truly a miracle drug, consider the barriers to entry. That is something that Reps. can't control. If you were brow beaten everyday because you didn't have adequate insurance coverage and it required a physician to hire an educator for a patient that should really have a CGM also, then the barriers to entry are very high. Reps. like to make money. If your product is considered a dud when it comes to barriers and demand is low, how motivated do you think you would be? We all know the Afrezza story but getting a physician to make a "paradigm shift" is likely very challenging. They will take the easy route. Dr. Kendall has his work cut out for him because Reps. can't change the current climate. It has to come from higher up. Holding Reps. feet to the fire is disingenuous. It boils down to marketing and that is a skill that Castagna is supposed to be good at. How do you explain Mike's statement that some MannKind reps have been doing well, while the fired reps were not producing? |
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Post by nadathing on Mar 21, 2018 19:35:12 GMT -5
My endo practices at The International Diabetes Center in St. Louis Park, MN (suburb of Minneapolis). This was a site for a P3 trial of Bydureon that I participated in for 3 years. My doctor was not involved in the study. When Bydureon was approved she was reluctant to prescribe it because of the black box warning. I insisted and she wrote the script. I asked if she had heard of or seen a presentation on Afrezza and she said no. She said that pharma reps are not allowed to see the doctors. What a mess.
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