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Post by sayhey24 on Sept 24, 2024 18:38:18 GMT -5
I'm unburdened about where Carol Levy has been. I'm glad she is engaged and hopeful it will make a difference. My original question was regarding steps needed to get cost and insurance coverage at parity with non-ultra rapid acting analogs. I didn't get a direct answer which is OK because I can do more research than just asking questions on ProBoards. I guess I'll just say it is not sufficient for MannKind management to ignore the disparity in insurance coverage and say "patients and doctors who are unable to get Afrezza covered by insurance can contact us for a $99/month coverage". That's a lot of wasted time (is money) and $99/month is an approximate 3x increase as compared to RAA competitors, and if new label says use 2x as much Afrezza, than now it's an ~6x premium as compared to RAA. I do not assume that is sustainable or acceptable. I am not sure I understand what you are asking "at parity with non-ultra rapid acting analogs". The only ultra rapid acting insulin is afrezza. Fiasp isn't ultra. Are you asking what will get the price of afrezza to Novolog being covered by insurance? The answer is afrezza gets insurance coverage. Al Mann intentionally premium priced afrezza. There are probably some old interviews still on the internet where Al talked about being able to low ball the price but he believed afrezza was so good insurance would have to cover it so he premium priced it. Lets see what happens in the next 9 months. Inhale-3 results will be in and so will Inhale-1. I don't know the timeline for gestational but all the results should be great and afrezza should quickly become the standard of care for gestational. They should also make a lot of noise with the kids. If Mike is right this will get afrezza insurance and will solve the price issue. I think I also answered the Carol Levy question for you, no charge.
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Post by agedhippie on Sept 25, 2024 4:12:55 GMT -5
What can I say? It's a really good fit. MNKD needs to change the Stigma around INSULIN. When people hear that word they CRINGE. It will be difficult to change that mindset but the bottom line is that Afrezza is as safe as taking High Blood Pressure medicine (assuming you follow directions). EDUCATION IS KEY!!! The stigma is related to insulin meaning your diabetes is in a bad place. Changing that would require moving up Afrezza so it is used far earlier and becomes expected, but that needs trials to prove medical benefit. Sigma is not helped by doctors using insulin as a compliance threat (if you don't do better you will end up on insulin...) Afrezza is definitely not as safe as blood pressure medicine, it's still insulin. You will absolutely never get that statement approved. Afrezza is safer than RAA, but if you look at the trial data you will still see hypos. People treat insulin and glucose as a mechanistic system, but it isn't, it's a biological system with a load of poorly understood inputs. This is the number one gripe diabetics have about endos.
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Post by sayhey24 on Sept 25, 2024 6:08:20 GMT -5
MNKD needs to change the Stigma around INSULIN. When people hear that word they CRINGE. It will be difficult to change that mindset but the bottom line is that Afrezza is as safe as taking High Blood Pressure medicine (assuming you follow directions). EDUCATION IS KEY!!! The stigma is related to insulin meaning your diabetes is in a bad place. Changing that would require moving up Afrezza so it is used far earlier and becomes expected, but that needs trials to prove medical benefit. Sigma is not helped by doctors using insulin as a compliance threat (if you don't do better you will end up on insulin...) Afrezza is definitely not as safe as blood pressure medicine, it's still insulin. You will absolutely never get that statement approved. Afrezza is safer than RAA, but if you look at the trial data you will still see hypos. People treat insulin and glucose as a mechanistic system, but it isn't, it's a biological system with a load of poorly understood inputs. This is the number one gripe diabetics have about endos. How many studies do we have which show the significant benefits of early insulin intervention with T2s? IDK, maybe a zillion. With CGMs and afrezza the results would only be better. Making some progress here would take some creativity which I am not sure MNKD management has. I hope I am wrong. At this point we are where we are with T2s. BP makes $Bs selling non-insulin products into the T2 market. The ADA fully supports the treat to fail SoC. The first study MNKD needs to start making some progress is adding afrezza to GLP1s. After afrezza wins then of course we have the insurance coverage problem and no T2 is paying $1200 a box. Maybe a "new" T2 specific afrezza product with significant price reductions maybe the only way to get market share.
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Post by uvula on Sept 25, 2024 7:55:07 GMT -5
We had a short pause and now we are starting the same arguments/discussions all over again.
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Post by casualinvestor on Sept 25, 2024 8:58:49 GMT -5
Here a diabetic user anecdote. My in-laws were talking about diabetes and a brother in law proudly stated that he was just on metformin and didn't need insulin. The word in italics was said with a bit of scorn/derision. This is a guy who has been diabetic for a couple years. Lost weight for about a year after finding out, then got lazy and gained most of it back. I assume still on metformin.
It fits perfectly with what aged has been saying.
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Post by prcgorman2 on Sept 25, 2024 9:47:25 GMT -5
We had a short pause and now we are starting the same arguments/discussions all over again. My fault. I was thinking about Cipla beginning sales of Afrezza next year and wondered what their marketing plan would be. Would they only sell to affluent persons with diabetes, or would they be able to price Afrezza where it was affordable to most? Would they only target persons with Type 1 diabetes, or would there be an effort to penetrate the much larger T2 population? I couldn't help thinking the cost per prescription would need to be steeply discounted as compared to the US, and if that is possible and still able to be profitable, what prevents conventional negotiation with PBMs in the US? Doctors, doctor office staffs, and patients would all prefer to avoid step therapy programs and prior authorizations.
MannKind has been doing a good job of addressing prescriber reluctance based on insufficient clinical data which leaves cost and insurance coverage as the other major barriers inhibiting adoption and sales. Glibly waving a hand at "as low as $99" after everything else fails does not sit well with me. If that is simply the best MannKind can do, so be it, but is that the best MannKind can do? Should we just be resigned to glacial sales growth as a permanent fixture of the MannKind Insulin Business Unit because the days of median average high price of insulin are forever behind us?
I'm just not sure what my frame of reference should be regarding Afrezza as an important contributor to MannKind revenue. When Afrezza was the only product it was critically important. Now that there is Tyvaso DPI revenue and other products moving through pipeline towards approval and launch, Afrezza has much less importance, but I believe Afrezza is bar none the best and safest and fastest acting mealtime insulin on the planet and it ought to be "the best selling drug of all time" if it can compete at parity with RAA insulins. Can it? I want to know.
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Post by ktim on Sept 25, 2024 12:54:02 GMT -5
MannKind has been doing a good job of addressing prescriber reluctance based on insufficient clinical data which leaves cost and insurance coverage as the other major barriers inhibiting adoption and sales. Glibly waving a hand at "as low as $99" after everything else fails does not sit well with me. If that is simply the best MannKind can do, so be it, but is that the best MannKind can do? Should we just be resigned to glacial sales growth as a permanent fixture of the MannKind Insulin Business Unit because the days of median average high price of insulin are forever behind us?
I'm just not sure what my frame of reference should be regarding Afrezza as an important contributor to MannKind revenue. When Afrezza was the only product it was critically important. Now that there is Tyvaso DPI revenue and other products moving through pipeline towards approval and launch, Afrezza has much less importance, but I believe Afrezza is bar none the best and safest and fastest acting mealtime insulin on the planet and it ought to be "the best selling drug of all time" if it can compete at parity with RAA insulins. Can it? I want to know. For what it's worth, the long range revenue projection chart Mannkind presented last year, showed Afrezza growing to about $450 (maybe a bit higher) by 2032. I wouldn't call that glacial (though also not a hockey stick). That is under the assumption peds has a positive impact on the trajectory. I'm a bit skeptical of that, given lack of insurance coverage, but management put that out there.
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Post by sayhey24 on Sept 25, 2024 17:13:55 GMT -5
We had a short pause and now we are starting the same arguments/discussions all over again. My fault. I was thinking about Cipla beginning sales of Afrezza next year and wondered what their marketing plan would be. Would they only sell to affluent persons with diabetes, or would they be able to price Afrezza where it was affordable to most? Would they only target persons with Type 1 diabetes, or would there be an effort to penetrate the much larger T2 population? I couldn't help thinking the cost per prescription would need to be steeply discounted as compared to the US, and if that is possible and still able to be profitable, what prevents conventional negotiation with PBMs in the US? Doctors, doctor office staffs, and patients would all prefer to avoid step therapy programs and prior authorizations.
MannKind has been doing a good job of addressing prescriber reluctance based on insufficient clinical data which leaves cost and insurance coverage as the other major barriers inhibiting adoption and sales. Glibly waving a hand at "as low as $99" after everything else fails does not sit well with me. If that is simply the best MannKind can do, so be it, but is that the best MannKind can do? Should we just be resigned to glacial sales growth as a permanent fixture of the MannKind Insulin Business Unit because the days of median average high price of insulin are forever behind us?
I'm just not sure what my frame of reference should be regarding Afrezza as an important contributor to MannKind revenue. When Afrezza was the only product it was critically important. Now that there is Tyvaso DPI revenue and other products moving through pipeline towards approval and launch, Afrezza has much less importance, but I believe Afrezza is bar none the best and safest and fastest acting mealtime insulin on the planet and it ought to be "the best selling drug of all time" if it can compete at parity with RAA insulins. Can it? I want to know. I thought Cipla was running Inhale-2. This is for the T2s. I do not believe Cipla got approval from the Drug Controller General of India yet for afrezza although their version of our Adcom recommended approval. Mike has gone dark on Cipla. I am not sure why. The last we heard Cipla was showing a 1.5 - 2.0% A1c reduction in their trial. Then we got radio silence. Hope spring external with this one. In terms of Afrezza we are about 10 years behind schedule and RAAs can not compete against afrezza and neither can any of the antiglycemics including the GLP1s once our three issues are fixed. Once Mike fixes the label, SoC and cost afrezza will be one of the greatest selling drugs of all time. Sales are about 2 years away. Right now Tyvaso DPI is paying the bills, nothing more and nothing less. Comparing Tyvaso DPI potential to afrezza is like comparing a state champion HS football team to the Kansas City Chiefs.
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Post by sayhey24 on Sept 25, 2024 17:22:15 GMT -5
We had a short pause and now we are starting the same arguments/discussions all over again. OK, so what is the answer? I bet a few people would like to know. How many studies do we have which show the significant benefits of early insulin intervention with T2s? Just one would be extremely significant for afrezza.
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Post by cretin11 on Sept 25, 2024 22:18:39 GMT -5
My fault. I was thinking about Cipla beginning sales of Afrezza next year and wondered what their marketing plan would be. Once Mike fixes the label, SoC and cost afrezza will be one of the greatest selling drugs of all time. That’s what we were saying in 2017, how time flies!
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Post by prcgorman2 on Sept 26, 2024 6:37:20 GMT -5
Once Mike fixes the label, SoC and cost afrezza will be one of the greatest selling drugs of all time. That’s what we were saying in 2017, how time flies! Whoever said that in 2017? It wasn’t me. Mike might have but I would have been skeptical. I don’t remember ever hearing him say that. What I remember was the interview where he candidly admitted re-launch of drugs historically succeeds less than 40% of the time. I don’t want to list off all of the stuff that was against a quick fix for Afrezza and I don’t remember anybody predicting the government would step in to artificially limit the price of insulin. I think it is somewhat of a miracle that Afrezza and MannKind are still here for us to puzzle over the future and indeed look forward to what’s next.
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Post by cretin11 on Sept 26, 2024 10:25:06 GMT -5
That’s what we were saying in 2017, how time flies! Whoever said that in 2017? It wasn’t me. Mike might have but I would have been skeptical. I don’t remember ever hearing him say that. What I remember was the interview where he candidly admitted re-launch of drugs historically succeeds less than 40% of the time. Yes, we were saying that in 2017. By "we" i mean most loyal MNKD longs at that time. Those items sayhey24 mentioned - label, SoC, cost - were topics we discussed and most of us were optimistic about them. And why not? Afrezza was and still is a miraculous and brilliant product. You were one of the few (along with Spencer Osborne, LFD, et al.) who knew better. I don't recall you correcting us back then, but can't blame you for keeping it to yourself to avoid being called names like fake long, naked short or worse! In fact, we did get a label change in 2017, which Mike called a pivotal moment for the company and said the change had removed the language restricting our promotional activity. In 2017 when he predicted Afrezza would help millions of PWDs, we all were on board with that and none of us said "oops he must mean thousands, not millions of PWDs." When Mike was asked in 2017 about the decision to spend money on TV ads rather than hiring more sales reps, he explained that scaling up the sales force would take four, five or six months to translate into big script increases, while TV ads would only take two months for meaningful impact in script growth. The pessimistic 40% comment you mention must've occurred later, i can't recall. But in 2017 you were way ahead of Mike with your skepticism, so kudos are owed to you (and Spencer, LFD et al., to be fair). That was seven years ago, how time does fly!
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Post by prcgorman2 on Sept 26, 2024 11:05:13 GMT -5
Whoever said that in 2017? It wasn’t me. Mike might have but I would have been skeptical. I don’t remember ever hearing him say that. What I remember was the interview where he candidly admitted re-launch of drugs historically succeeds less than 40% of the time. Yes, we were saying that in 2017. By "we" i mean most loyal MNKD longs at that time. Those items sayhey24 mentioned (label, SoC, cost) were topics we discussed and most of us were optimistic about them. And why not? Afrezza was and still is a miraculous and brilliant product. You were one of the few (along with Spencer Osborne, LFD, et al.) who knew better. I don't recall you correcting us back then, but can't blame you for keeping it to yourself to avoid being called names like fake long, naked short or worse! In fact, we did get a label change in 2017, at which time Mike called that a pivotal moment for the company and said the change had removed the language restricting our promotional activity. When he predicted in 2017 that Afrezza would help millions of PWDs, we all were on board with that and none of us said "oops he must mean thousands, not millions of PWDs." When Mike was asked in 2017 about the decision to spend money on TV ads rather than hiring more sales reps, he explained that scaling up the sales force would take four, five or six months to translate into big script increases, while TV ads would only take two months for meaningful impact in script growth. The pessimistic 40% comment you mention must've been later than that, i can't recall. But in 2017 you were way ahead of Mike with your skepticism, so kudos are owed to you (and Spencer, LFD et al., to be fair). That was seven years ago, how time does fly! Oh good grief. Must've hit a nerve. Piling me in with Spencer Osborne, LFD, et al. Not very amusing attempt to spin.
I remembered the "likelihood of success for re-launch less than 40%" because his expertise at Amgen was re-launch and the number was sobering but very believable. I like believable versus agenda spin.
You've said multiple times Mike said this and Mike said that, and I'm not doing much better because I'm not sure I could find a working reference to the interview which was all audio, but let's leave our divergent "he said" memories of 7 years ago in the past. Regardless of what Mike might have said 7 years ago, I'm interested in what the next 7 years is going to bring.
I'm very pleased we're here to fuss and discuss and it's due to a tremendous amount of laudable work by MannKind management that has us positioned to have fewer and fewer reasons to be overly concerned about Afrezza, and I do expect label change (but not SoC) to include pediatric use, and at some point gestational use. It's progress.
Given the reminder from ktim on MannKind revenue projections for Afrezza which did indicate about a 9x increase in sales (well past 2030?), COGS may be the bottom-line inhibiting factor and if so, so be it. It's good that Afrezza is available for persons with diabetes, and if I eventually cross over into T2 land, it will be top of mind for getting treatment.
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Post by cretin11 on Sept 26, 2024 11:11:12 GMT -5
To be fair, all i said was how time flies and that we were all saying the same things sayhey24 is saying now, back in 2017. Which was accurate. You pointed out how you knew better, even back then. I'm not calling you a clone of Spencer or LFD, but they were also pessimistic about Afrezza. They (and you) were right, while Mike and the rest of us were overly optimistic as it turned out.
It's all good, we may politely discuss those events without gnashing of teeth, as now we have the UTHR partnership keeping us safely afloat and allowing us to focus on other pipeline projects. Meanwhile, trust me that Bill and the team at VDEX are not giving up on Afrezza (nor is MNKD), it is still as miraculous as it was in 2017, hopefully one day the "millions of PWDs" prediction will not be so off target!
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Post by sr71 on Sept 26, 2024 12:10:36 GMT -5
Meanwhile, I've been adding this week on the way down.
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