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Post by prcgorman2 on Sept 17, 2024 12:31:07 GMT -5
FYI - @sla55 posted in the SENS thread for non-MNKD stocks that SENS just got approval for a 1 year under-the-skin CGM implant. I don't remember the thread that talked about the tennis player pricking his finger to check blood sugar during a tennis match, but I wonder what is the opinion of agedhippie about whether the SENS 1 year CGM would meet the needs better than a finger stick for an athlete? |
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Post by agedhippie on Sept 18, 2024 3:06:29 GMT -5
...I wonder what is the opinion of agedhippie about whether the SENS 1 year CGM would meet the needs better than a finger stick for an athlete? I think it still uses interstitial fluid, but using light rather than reagents, in which case it would have the same problem. I would need to check. |
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Post by prcgorman2 on Sept 24, 2024 6:28:21 GMT -5
agedhippie - I need your help. I cannot stop thinking about Afrezza as the biggest question mark in the MannKind story. We’re told Afrezza has been approved for sale in India, and that Cipla will begin selling Afrezza next year. We know the sale of Afrezza in Brazil was largely a failure and it had too many factors stacked against it to be successful, although that can always change. The factors included cost, and a launch nearly coincident with the arrival of the COVID pandemic. The cost of Afrezza, both to manufacture and to purchase is continuously on my mind. As sayhey24 likes to remind us, cost and insurance coverage are two of the largest inhibiting factors with general unwillingness in the prescriber community to prescribe being a third. The INHALE trials for pump &/vs Afrezza and pediatrics and the added gestational trial should continue to break down prescriber reluctance from a purely knowledge base perspective. More can be done there (and I hope there are more studies such as long-term health), but costs and coverage remain writ large. Lets assume Afrezza could be sold profitably at $35 a prescription for those with insurance coverage in the US and India. (Note: I don’t actually know what a $35 prescription buys.) What are the traditional steps MannKind could (or should) take to place Afrezza on even cost and coverage footing (relatively) with non-ultra rapid acting analog insulins such as are available from the Big 3 BPs? i.e., from Sanofi, Novo Nordisk, and Eli Lilly?
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Post by agedhippie on Sept 24, 2024 9:05:35 GMT -5
... Lets assume Afrezza could be sold profitably at $35 a prescription for those with insurance coverage in the US and India. (Note: I don’t actually know what a $35 prescription buys.) What are the traditional steps MannKind could (or should) take to place Afrezza on even cost and coverage footing (relatively) with non-ultra rapid acting analog insulins such as are available from the Big 3 BPs? i.e., from Sanofi, Novo Nordisk, and Eli Lilly? There are a few $35 dollar offers out there, but I suspect the one you are thinking of is where it is either covered by the insurer or Medicare. In those cases your prescription is covered for $35 per month (3 x $35 for 90 days) regardless of quantity. So typically a type 1 would have two prescriptions, one for basal and one for Afrezza. To get cover the table stakes are matching the price of the incumbent. You see this in Fiasp which was priced the same as their current generation, Novolog, or with Sanofi where Toujeo was priced equivalent to the previous generation, Lantus. The issue I see with Afrezza is that when the label is corrected the therapeutic dose per cartridge will be halved - the conversion that said take one 12u cartridge will now say take two. If you look at the fallout Afrezza will be effectively available in 2u - 4u - 6u cartridge (although labelled 4u - 8u - 12u). It means that while people were talking a 12u unit and wondering why it wasn't behaving as expected, now they will take twice as many cartridges but getting a good result - but at twice the cost. It's not all bleak. In Type 1 (and I suspect Type 2 but I don't know for sure) they don't like you even trying to get pregnant until your TIR is extremely tight, the advice I have heard people given is not to go over 125. That can be done with RAA by heavily modifying your lifestyle but it is hard. My suspicion is that this is why Carol Levy came in because she handles those patient in the Mount Sinai hospital system. There is precedent for insurers treating that group separately from others - back when pumps and CGMs were generally hard to get those patient were covered and got them. If I was Mike I would see pregnancy as an area where I could get traction with insurers without having to compete as hard on price. In theory it is a timeboxed condition so from a risk standpoint the cost can be quantified. With TIR trials for people planning pregnancy against the alternative treatments I think you could get excellent results because everyone is very highly motivated to get a good outcome. The outcomes from pregnancy with poorly controlled levels are known and bad for both the mother and baby with knock-on costs for the insurer. |
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Post by sayhey24 on Sept 24, 2024 11:15:32 GMT -5
... Lets assume Afrezza could be sold profitably at $35 a prescription for those with insurance coverage in the US and India. (Note: I don’t actually know what a $35 prescription buys.) What are the traditional steps MannKind could (or should) take to place Afrezza on even cost and coverage footing (relatively) with non-ultra rapid acting analog insulins such as are available from the Big 3 BPs? i.e., from Sanofi, Novo Nordisk, and Eli Lilly? There are a few $35 dollar offers out there, but I suspect the one you are thinking of is where it is either covered by the insurer or Medicare. In those cases your prescription is covered for $35 per month (3 x $35 for 90 days) regardless of quantity. So typically a type 1 would have two prescriptions, one for basal and one for Afrezza. To get cover the table stakes are matching the price of the incumbent. You see this in Fiasp which was priced the same as their current generation, Novolog, or with Sanofi where Toujeo was priced equivalent to the previous generation, Lantus. The issue I see with Afrezza is that when the label is corrected the therapeutic dose per cartridge will be halved - the conversion that said take one 12u cartridge will now say take two. If you look at the fallout Afrezza will be effectively available in 2u - 4u - 6u cartridge (although labelled 4u - 8u - 12u). It means that while people were talking a 12u unit and wondering why it wasn't behaving as expected, now they will take twice as many cartridges but getting a good result - but at twice the cost. It's not all bleak. In Type 1 (and I suspect Type 2 but I don't know for sure) they don't like you even trying to get pregnant until your TIR is extremely tight, the advice I have heard people given is not to go over 125. That can be done with RAA by heavily modifying your lifestyle but it is hard. My suspicion is that this is why Carol Levy came in because she handles those patient in the Mount Sinai hospital system. There is precedent for insurers treating that group separately from others - back when pumps and CGMs were generally hard to get those patient were covered and got them. If I was Mike I would see pregnancy as an area where I could get traction with insurers without having to compete as hard on price. In theory it is a timeboxed condition so from a risk standpoint the cost can be quantified. With TIR trials for people planning pregnancy against the alternative treatments I think you could get excellent results because everyone is very highly motivated to get a good outcome. The outcomes from pregnancy with poorly controlled levels are known and bad for both the mother and baby with knock-on costs for the insurer. So most of the issue was T1s starting with a 4 and not an 8. For the T2s many are already taking multiple 12s especially if they don't stop the spike before the pancreas releases its insulin. If I were Mike I would have gone after gestational years ago. That was really low hanging fruit. Not going over 125 without afrezza has to be a challenge. Even with afrezza its a challenge but staying under 140 in 2 hours post meal not much of one. I guess my question is why did it take Carol Levy so long to get on the afrezza train? Ten years after approval seems like she was snoozing or something changed. |
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Post by agedhippie on Sept 24, 2024 11:49:20 GMT -5
... Not going over 125 without afrezza has to be a challenge. Even with afrezza its a challenge but staying under 140 in 2 hours post meal not much of one. I guess my question is why did it take Carol Levy so long to get on the afrezza train? Ten years after approval seems like she was snoozing or something changed. Not going over 125 is definitely a challenge, but can be done and I know people who did it. Most of them swapped to a low carb high fat (LCHF) diet which gives slow and low peaks RAA can handle. The problem, as always, isn't the food it's your body which can decide for no apparent reason that now is a good time to mess with your levels. It is also the reasons why pregnant type 1s got CGMs far ahead of most other people. I am going to ignore your comment about Carol Levy because you know nothing about her, have little idea what she has been doing, and are obviously just trolling. |
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Post by sayhey24 on Sept 24, 2024 13:23:44 GMT -5
... Not going over 125 without afrezza has to be a challenge. Even with afrezza its a challenge but staying under 140 in 2 hours post meal not much of one. I guess my question is why did it take Carol Levy so long to get on the afrezza train? Ten years after approval seems like she was snoozing or something changed. Not going over 125 is definitely a challenge, but can be done and I know people who did it. Most of them swapped to a low carb high fat (LCHF) diet which gives slow and low peaks RAA can handle. The problem, as always, isn't the food it's your body which can decide for no apparent reason that now is a good time to mess with your levels. It is also the reasons why pregnant type 1s got CGMs far ahead of most other people. I am going to ignore your comment about Carol Levy because you know nothing about her, have little idea what she has been doing, and are obviously just trolling. I have no idea what Carol Levy has been doing but now after 10 years she is interested in afrezza. Thats why I asked the question so I could learn a little more about her. If she is an expert in diabetes she must have been following Al Mann when he was developing afrezza. Since the Gen-2 inhaler nothing has changed and that was 2010? Why the interest now? What has changed? Why wait 10 years after approval? Did she read some of the posts here on Proboards or something else? Here is what we know - if you want to control your PPG in near real-time RAA's can not compete with afrezza. What we saw in Inhale-3 is even the AID can't compete with afrezza for PPG control. We have been saying this for years right here on Proboards. Where has Carol been? |
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Post by peppy on Sept 24, 2024 13:36:26 GMT -5
... Not going over 125 without afrezza has to be a challenge. Even with afrezza its a challenge but staying under 140 in 2 hours post meal not much of one. I guess my question is why did it take Carol Levy so long to get on the afrezza train? Ten years after approval seems like she was snoozing or something changed. Not going over 125 is definitely a challenge, but can be done and I know people who did it. Most of them swapped to a low carb high fat (LCHF) diet which gives slow and low peaks RAA can handle. The problem, as always, isn't the food it's your body which can decide for no apparent reason that now is a good time to mess with your levels. It is also the reasons why pregnant type 1s got CGMs far ahead of most other people. I am going to ignore your comment about Carol Levy because you know nothing about her, have little idea what she has been doing, and are obviously just trolling. quote, Most of them swapped to a low carb high fat (LCHF) diet which gives slow and low peaks RAA can handle. reply, switching the way people eat, what they eat, seems like more work than breathing some Afrezza, twice at meal time. Starting dose and add on dose. |
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Post by prcgorman2 on Sept 24, 2024 13:40:47 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.
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Post by agedhippie on Sept 24, 2024 14:44:36 GMT -5
quote, Most of them swapped to a low carb high fat (LCHF) diet which gives slow and low peaks RAA can handle. reply, switching the way people eat, what they eat, seems like more work than breathing some Afrezza, twice at meal time. Starting dose and add on dose. What I am saying is this how people actually cope today - mostly a combination of LCHF diets and pumps. The main thing is that these people are highly motivated and will make changes. This is why I think Afrezza is a fit, and because it is theoretically time limited I think insurers may play ball. |
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Post by peppy on Sept 24, 2024 15:09:14 GMT -5
quote, Most of them swapped to a low carb high fat (LCHF) diet which gives slow and low peaks RAA can handle. reply, switching the way people eat, what they eat, seems like more work than breathing some Afrezza, twice at meal time. Starting dose and add on dose. What I am saying is this how people actually cope today - mostly a combination of LCHF diets and pumps. The main thing is that these people are highly motivated and will make changes. This is why I think Afrezza is a fit, and because it is theoretically time limited I think insurers may play ball. aged, This is the most positive thing I can remember you saying about Afrezza use. |
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Post by celo on Sept 24, 2024 15:24:10 GMT -5
What I am saying is this how people actually cope today - mostly a combination of LCHF diets and pumps. The main thing is that these people are highly motivated and will make changes. This is why I think Afrezza is a fit, and because it is theoretically time limited I think insurers may play ball. aged, This is the most positive thing I can remember you saying about Afrezza use. Right? A good study and look who's coming aboard. |
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Post by agedhippie on Sept 24, 2024 15:55:11 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. The problem remains as it always has; this either has to be done by pricing which will be hard with the new label because insurers will want to reduce the price below RAA to account for Afrezza being half the strength, or by large trials showing outcomes. The standard for outcomes is HbA1c, like it or not, because that is what complication probabilities are calibrated against based on the huge multi-year data-sets like UKDPS. What is needed for Type 1 is a rerun of the ABC trial, this time with proper numbers and for a year. That would be horribly expensive and I don't think it would be conclusive enough to win over the insurers. It is going to be interesting when the Inhale-3 results come out. The impact will largely depend on how many AID pumps were involved in the trial and how the outcomes for those compare. I cannot remember when the final results are due to be released. There used to be a sliding scale on that $99 offer before Sterling which I suspect is why it says "for as little as $99/month". Is the $99 is an all-you-can-eat price like the $35 cover? |
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Post by agedhippie on Sept 24, 2024 16:11:54 GMT -5
What I am saying is this how people actually cope today - mostly a combination of LCHF diets and pumps. The main thing is that these people are highly motivated and will make changes. This is why I think Afrezza is a fit, and because it is theoretically time limited I think insurers may play ball. aged, This is the most positive thing I can remember you saying about Afrezza use. What can I say? It's a really good fit.  |
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Post by Thundersnow on Sept 24, 2024 17:02:01 GMT -5
aged, This is the most positive thing I can remember you saying about Afrezza use. 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!!! |
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