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Post by cjm18 on Jan 6, 2019 1:30:53 GMT -5
I wanted to jump in with some real world feedback on the issue of script writing. Don't mean to be a downer, just giving info that board members might find helpful. We at Vdex interface with a lot of providers and a basic principle we operate under is the more experienced a provider is in the field of diabetes, the LESS likely he/she is to recommend Afrezza. It's obviously not 100%, but the phenomenon is common enough to make the point. In other words, those most "in the know" have soured on the product. I won't get into why that is; most here probably already know. The most common feedback we get from such providers is: "Afrezza's a niche product." "It's too expensive." "Patients aren't that interested." Translation for all of these: the provider doesn't really understand the product. I don't think reps calling on busy docs or TV advertising will turn the ship around quickly, if at all. The product is so different. The conditions of the industry are so unfavorable. The incentives work against providers. This product requires a different sales model. Of course, that's self-serving to say. But, that has been our experience. I hope I'm wrong and scripts take off in the new year. But regardless, we'll be fighting the fight either way. Would love to hear update on this.
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Post by vdexdiabetes on Jan 6, 2019 1:59:06 GMT -5
Cjm, nothing has changed from what I wrote a year ago. If anything the situation may be more extreme now. Afrezza faces a lot of systemic resistance in the medical community. We've battled that this entire year. We've made progress, but still battling.
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Post by cjm18 on Jan 6, 2019 8:52:52 GMT -5
Cjm, nothing has changed from what I wrote a year ago. If anything the situation may be more extreme now. Afrezza faces a lot of systemic resistance in the medical community. We've battled that this entire year. We've made progress, but still battling. So sad. Thanks for sharing. What can Mannkind do besides superiority trials. The cmo mentioned a study to get ultra rapid designation. Guess that was shelved. Peds approval is so far away.
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Post by peppy on Jan 6, 2019 9:05:14 GMT -5
I recognize this as an old thread. predictions for 2018 numbers. here is the gig the way I see it. the rx numbers hit 700. the refills highs. MNKD needs 2500 scripts a week. Scripts had better heat up and fast. MNKD needs three times the number of weekly scripts.
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Post by lifebreath on Jan 6, 2019 10:48:40 GMT -5
I wanted to jump in with some real world feedback on the issue of script writing. Don't mean to be a downer, just giving info that board members might find helpful. We at Vdex interface with a lot of providers and a basic principle we operate under is the more experienced a provider is in the field of diabetes, the LESS likely he/she is to recommend Afrezza. It's obviously not 100%, but the phenomenon is common enough to make the point. In other words, those most "in the know" have soured on the product. I won't get into why that is; most here probably already know. The most common feedback we get from such providers is: "Afrezza's a niche product." "It's too expensive." "Patients aren't that interested." Translation for all of these: the provider doesn't really understand the product. I don't think reps calling on busy docs or TV advertising will turn the ship around quickly, if at all. The product is so different. The conditions of the industry are so unfavorable. The incentives work against providers. This product requires a different sales model. Of course, that's self-serving to say. But, that has been our experience. I hope I'm wrong and scripts take off in the new year. But regardless, we'll be fighting the fight either way. Would love to hear update on this.
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Post by lifebreath on Jan 6, 2019 10:58:58 GMT -5
“This product requires a different sales model” That is what I find the most frustrating about Castagna and his expensive status quo tv commercial campaign. Mnkd really needs to become inovative immediately with their promotion of Afrezza.
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Post by lakon on Jan 6, 2019 11:09:28 GMT -5
“This product requires a different sales model” That is what I find the most frustrating about Castagna and his expensive status quo tv commercial campaign. Mnkd really needs to become inovative immediately with their promotion of Afrezza. The problem is regulation. MNKD has to play nice in a highly regulated market. Yet, they noted interesting plans, including not only direct to consumer advertising, but also direct to consumer sales, but it will take time to get there. I like that they are thinking ahead to the future where one can go to the MNKD web site, Amazon, or any drug store to purchase Technosphere products. I think RLS will get their first, and they can pave the way to an OTC Afrezza along with all the rest of the human hormones that can fit on a Technosphere.
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Post by agedhippie on Jan 6, 2019 11:53:17 GMT -5
“This product requires a different sales model” That is what I find the most frustrating about Castagna and his expensive status quo tv commercial campaign. Mnkd really needs to become inovative immediately with their promotion of Afrezza. The problem is regulation. MNKD has to play nice in a highly regulated market. Yet, they noted interesting plans, including not only direct to consumer advertising, but also direct to consumer sales, but it will take time to get there. I like that they are thinking ahead to the future where one can go to the MNKD web site, Amazon, or any drug store to purchase Technosphere products. I think RLS will get their first, and they can pave the way to an OTC Afrezza along with all the rest of the human hormones that can fit on a Technosphere. The chance of Afrezza ever becoming OTC is vanishingly small for the reasons given previously. That Novolin and Humalin are OTC is a historic aberration and barring a time machine there is no way to get on that particular bandwagon.
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Post by lennymnkd on Jan 6, 2019 12:07:32 GMT -5
One drop Amazon And Uber ! Mike has mention this before / it not like he’s not thinking 🤔
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Post by mnholdem on Jan 6, 2019 15:51:18 GMT -5
The problem is regulation. MNKD has to play nice in a highly regulated market. Yet, they noted interesting plans, including not only direct to consumer advertising, but also direct to consumer sales, but it will take time to get there. I like that they are thinking ahead to the future where one can go to the MNKD web site, Amazon, or any drug store to purchase Technosphere products. I think RLS will get their first, and they can pave the way to an OTC Afrezza along with all the rest of the human hormones that can fit on a Technosphere. The chance of Afrezza ever becoming OTC is vanishingly small for the reasons given previously. That Novolin and Humalin are OTC is a historic aberration and barring a time machine there is no way to get on that particular bandwagon. An OTC channel has to be maintained for those who are unemployed and/or lack insurance to get the life-saving insulin they need to live. It's often the case that the poorest often get the worst care and it's certainly true when it comes to OTC insulin brands, which are not rapid-acting human/analog insulin. Frankly, I think MannKind could choose to submit a sNDA in the future to make Afrezza an Over-The-Counter insulin, but that would not be feasible until after the FDA post-market 5-year lung safety trial shows positive outcomes and the company has a different CEO.
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Post by lennymnkd on Jan 6, 2019 16:12:42 GMT -5
“And the company has a different CEO” ? Because Mikes is not up to it or we will be bought out by then !
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Post by agedhippie on Jan 6, 2019 18:41:34 GMT -5
The chance of Afrezza ever becoming OTC is vanishingly small for the reasons given previously. That Novolin and Humalin are OTC is a historic aberration and barring a time machine there is no way to get on that particular bandwagon. An OTC channel has to be maintained for those who are unemployed and/or lack insurance to get the life-saving insulin they need to live. It's often the case that the poorest often get the worst care and it's certainly true when it comes to OTC insulin brands, which are not rapid-acting human/analog insulin. Frankly, I think MannKind could choose to submit a sNDA in the future to make Afrezza an Over-The-Counter insulin, but that would not be feasible until after the FDA post-market 5-year lung safety trial shows positive outcomes and the company has a different CEO. I think I misread what you were saying. I was taking about OTC as not requiring a prescription. I think you meant could be purchase at a pharmacy without involving insurance.
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Post by mango on Jan 6, 2019 20:15:26 GMT -5
The problem is regulation. MNKD has to play nice in a highly regulated market. Yet, they noted interesting plans, including not only direct to consumer advertising, but also direct to consumer sales, but it will take time to get there. I like that they are thinking ahead to the future where one can go to the MNKD web site, Amazon, or any drug store to purchase Technosphere products. I think RLS will get their first, and they can pave the way to an OTC Afrezza along with all the rest of the human hormones that can fit on a Technosphere. The chance of Afrezza ever becoming OTC is vanishingly small for the reasons given previously. That Novolin and Humalin are OTC is a historic aberration and barring a time machine there is no way to get on that particular bandwagon. What if MannKind went the biosimilar route for human insulin that is currently OTC?
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Post by mnholdem on Jan 6, 2019 20:45:46 GMT -5
An OTC channel has to be maintained for those who are unemployed and/or lack insurance to get the life-saving insulin they need to live. It's often the case that the poorest often get the worst care and it's certainly true when it comes to OTC insulin brands, which are not rapid-acting human/analog insulin. Frankly, I think MannKind could choose to submit a sNDA in the future to make Afrezza an Over-The-Counter insulin, but that would not be feasible until after the FDA post-market 5-year lung safety trial shows positive outcomes and the company has a different CEO. I think I misread what you were saying. I was taking about OTC as not requiring a prescription. I think you meant could be purchase at a pharmacy without involving insurance. No, you read it right. I was referring to Afrezza one day becoming available without a prescription, such as is referred to in this article by APhA" Few patients with diabetes are aware that some forms of insulin can be purchased without a prescription. Many doctors are also not aware of this. The two types of OTC human insulin are made by Eli Lilly and Novo Nordisk. They are older versions and take longer to metabolize than prescription versions. FDA says the availability lets patients gain access to the drug "quickly in urgent situations, without delays." IMS Health reports that about 15% of people with diabetes who buy insulin make OTC purchases. The availability of OTC insulin presents a difficult issue, however. It could save the lives of patients who lack insurance or regular access to a doctor, or who otherwise do not have insulin when they need it. But use of insulin can carry major risks if patients do not get the dose or timing right. Taking the wrong dose consistently can lead to high blood pressure, kidney disease, nerve damage, loss of eyesight, or stroke.
Source: www.pharmacist.com/article/you-can-buy-otc-insulin-should-youAfrezzas API is simple Insulin (Human) delivered via an inert powder stored in unit-measure cartridges loaded into an inhaler device. Is there a safer insulin sold OTC? One key to answering that question will be completion of the lung safety study. I propose that the answer is NO. Afrezza would be a much safer alternative to the OTC insulin brands sold today without a prescription.
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Post by agedhippie on Jan 6, 2019 20:48:59 GMT -5
The chance of Afrezza ever becoming OTC is vanishingly small for the reasons given previously. That Novolin and Humalin are OTC is a historic aberration and barring a time machine there is no way to get on that particular bandwagon. What if MannKind went the biosimilar route for human insulin that is currently OTC? It wouldn't matter. The exemption is specific to injectable human insulin. I think it may even be specific to Humalin/Novolin. This is a good summary - Why is Some Insulin Available Over the Counter?
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