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Post by sophie on Nov 10, 2016 17:13:58 GMT -5
Agree with most everything. However, looking at the headwinds Afrezza has faced so far, I'd be skeptical that a label of ultra-fast would really make that much difference. If it isn't about lower A1c or lower incidence of hypos, I'd question whether it would really impact prescribing behavior. It's not as if the pk/pd profile isn't out there. If doctors are inclined to see benefit in quick action, they already have the data to understand Afrezza delivers. As for patients, unless MNKD is free to connect the dots and explain in ads that faster can mean better control and less hypos, merely being able to call it ultra-rapid may do little to ignite interest. If they get better labeling regarding the dosing, that could help set the stage for more consistently good patient experiences. Does anyone know if this would do anything for better tier placement since we'd no longer be competing with other RAA's? Or are they simply still grouped as prandial/basal insulins?
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Post by goyocafe on Nov 10, 2016 17:20:30 GMT -5
"I think the designation of ultra rapid would be significant because not only would the drug be 'only in class'"
Read more: mnkd.proboards.com/thread/6664/yesterdays-all-good-big-takeaway?page=2#ixzz4PeAYF3UuCuriously, I saw on one formulary last week that Afrezza was listed under "Miscellaneous" since it wasn't an Oral Anti-Diabetic or Injectable Insulin or Pen. So hard for them to list it as "Inhalable Insulin". Maybe the label will encourage them to at least give it a category under insulin somehow somewhere.
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Post by rockstarrick on Nov 10, 2016 18:33:46 GMT -5
Agree with most everything. However, looking at the headwinds Afrezza has faced so far, I'd be skeptical that a label of ultra-fast would really make that much difference. If it isn't about lower A1c or lower incidence of hypos, I'd question whether it would really impact prescribing behavior. It's not as if the pk/pd profile isn't out there. If doctors are inclined to see benefit in quick action, they already have the data to understand Afrezza delivers. As for patients, unless MNKD is free to connect the dots and explain in ads that faster can mean better control and less hypos, merely being able to call it ultra-rapid may do little to ignite interest. If they get better labeling regarding the dosing, that could help set the stage for more consistently good patient experiences. Does anyone know if this would do anything for better tier placement since we'd no longer be competing with other RAA's? Or are they simply still grouped as prandial/basal insulins? Insulin products seemed to be classified by time stamps, (how long they take to peak, and how long they remain in the system). If Afrezza was given a label of Ultra Rapid Acting it would be in a class all its own, (first in class, only in class). Mannkind could then focus their attention on educating Healthcare Providers and PWD on the benefits of an Ultra Rapid Insulin vs a Rapid Acting Insulin product, (there are too many to count in my opinion). After this is accomplished, I could see Afrezza covered with no restrictions at the highest tier, (whatever that is). I believe the time stamp of Afrezza is beneficial on both the time it takes to peak, and also how quickly it is out of the system. The Ultra Rapid onset allows a PWD to dose closer to the start of the meal without having their blood sugar get too high for too long, and the Ultra Rapid exit of Afrezza protects a PWD from hypoglycemia because Afrezza is out of their system in about the same time it takes to digest the meal. Al Mann talked about this in a Conference at John Hopkins Medical Center, he said that the fact that current RAA's, (Rapid Acting Analog Insulin products) remain in the system after digestion is complete, is the main cause of hypoglycemia, and as Al claimed, the biggest challenge with Insulin Therapy. If a faster time stamp is a prerequisite to a superior Insulin product, when we get that label, everything else should follow, Insurance coverage, Dr's prescribing, and PWD requesting Afrezza. Remember, I'm just the Bass Player so this is just an attempt to voice my opinion of the answer you seek. can anybody else chime in and correct any false comments I may have made. Thanks in advance.
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Post by sportsrancho on Nov 10, 2016 19:51:06 GMT -5
Rock, I think that's the easiest to understand expansion I have heard:-) Great post.
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Post by sophie on Nov 10, 2016 19:55:14 GMT -5
Does anyone know if this would do anything for better tier placement since we'd no longer be competing with other RAA's? Or are they simply still grouped as prandial/basal insulins? Insulin products seemed to be classified by time stamps, (how long they take to peak, and how long they remain in the system). If Afrezza was given a label of Ultra Rapid Acting it would be in a class all its own, (first in class, only in class). Mannkind could then focus their attention on educating Healthcare Providers and PWD on the benefits of an Ultra Rapid Insulin vs a Rapid Acting Insulin product, (there are too many to count in my opinion). After this is accomplished, I could see Afrezza covered with no restrictions at the highest tier, (whatever that is). I believe the time stamp of Afrezza is beneficial on both the time it takes to peak, and also how quickly it is out of the system. The Ultra Rapid onset allows a PWD to dose closer to the start of the meal without having their blood sugar get too high for too long, and the Ultra Rapid exit of Afrezza protects a PWD from hypoglycemia because Afrezza is out of their system in about the same time it takes to digest the meal. Al Mann talked about this in a Conference at John Hopkins Medical Center, he said that the fact that current RAA's, (Rapid Acting Analog Insulin products) remain in the system after digestion is complete, is the main cause of hypoglycemia, and as Al claimed, the biggest challenge with Insulin Therapy. If a faster time stamp is a prerequisite to a superior Insulin product, when we get that label, everything else should follow, Insurance coverage, Dr's prescribing, and PWD requesting Afrezza. Remember, I'm just the Bass Player so this is just an attempt to voice my opinion of the answer you seek. can anybody else chime in and correct any false comments I may have made. Thanks in advance. I appreciate your reply. I was asking more for pharmacy insurance coverage reasons. That way the Novo's and Lilly's can block all other RAA's they want, but if we're in our own category, we could still make a non exclusive contract for best tier placement since it wouldn't technically be in the same class.
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Post by dreamboatcruise on Nov 10, 2016 20:15:54 GMT -5
I appreciate your reply. I was asking more for pharmacy insurance coverage reasons. That way the Novo's and Lilly's can block all other RAA's they want, but if we're in our own category, we could still make a non exclusive contract for best tier placement since it wouldn't technically be in the same class. That would seem to depend on how the exclusive deals were negotiated (assuming those type of things are in place). It could exclude other pens, all prandial, all insulin or just RAA. It's been brought up multiple times, and I don't think anyone claimed to have insight into what was likely.
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Post by rockstarrick on Nov 10, 2016 20:24:09 GMT -5
Insulin products seemed to be classified by time stamps, (how long they take to peak, and how long they remain in the system). If Afrezza was given a label of Ultra Rapid Acting it would be in a class all its own, (first in class, only in class). Mannkind could then focus their attention on educating Healthcare Providers and PWD on the benefits of an Ultra Rapid Insulin vs a Rapid Acting Insulin product, (there are too many to count in my opinion). After this is accomplished, I could see Afrezza covered with no restrictions at the highest tier, (whatever that is). I believe the time stamp of Afrezza is beneficial on both the time it takes to peak, and also how quickly it is out of the system. The Ultra Rapid onset allows a PWD to dose closer to the start of the meal without having their blood sugar get too high for too long, and the Ultra Rapid exit of Afrezza protects a PWD from hypoglycemia because Afrezza is out of their system in about the same time it takes to digest the meal. Al Mann talked about this in a Conference at John Hopkins Medical Center, he said that the fact that current RAA's, (Rapid Acting Analog Insulin products) remain in the system after digestion is complete, is the main cause of hypoglycemia, and as Al claimed, the biggest challenge with Insulin Therapy. If a faster time stamp is a prerequisite to a superior Insulin product, when we get that label, everything else should follow, Insurance coverage, Dr's prescribing, and PWD requesting Afrezza. Remember, I'm just the Bass Player so this is just an attempt to voice my opinion of the answer you seek. can anybody else chime in and correct any false comments I may have made. Thanks in advance. I appreciate your reply. I was asking more for pharmacy insurance coverage reasons. That way the Novo's and Lilly's can block all other RAA's they want, but if we're in our own category, we could still make a non exclusive contract for best tier placement since it wouldn't technically be in the same class. I agree
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