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Post by stevil on Nov 21, 2024 11:59:08 GMT -5
Didn’t feel comfortable with it. One was a new type 1 LADA so I thought he’d like to not have to inject so much- it didn’t last long enough for him, even at the higher doses. Part of it was probably my fault too- I tried to educate him on carb counting / food complexity/ glycemic index, etc and the light didn’t seem to go on. He had better results on Afrezza but it ultimately frustrated him and he wanted to go back on RAAs because they were “more forgiving “ in the sense they didn’t require so much work to get perfect results. He wanted to not feel like he needed to pay so much attention to his diabetes and eventually wanted to go on the pump. So I bridged him back into RAAs and handed him off to the endo.
The other 2 were stuck in their ways. Had been type 1s for several decades and didn’t feel like learning a new trick.
The last one was afraid of the lung issue and wants to wait for safety data when more people are on it. He wasn’t happy about only a few thousand people a year being on it.
I’ve had as many as 30 patients on Afrezza over the past year and a half. Either insurance denied the new PA (despite very favorable results) or they got “better” on GLP-1s and didn’t need insulin anymore (prediabetic numbers) or cough or treatment fatigue and wanted basal instead of prandial insulin. These are my type 2s.
It’s important to let people here know about my experience. I only have a couple thousand people on my panel but have worked in 2 different states now and it seems to be a common theme- people and insurance don’t care about better results. It comes down to convenience and price. Patients would rather inject a GLP-1 once a week than inhale 3-5 times a day to control their blood sugar. And MNKD doesn’t have the might of the other BPs to get preferred insurance status.
From my own experience, Afrezza seems dead in the water and has for a long time. I held out hope for the inhale results but it doesn’t seem to have done anything for insurance. I can’t get my patients to use the medication if I try. It’s not covered for the ones that would do the work to optimize their health and the ones that don’t care don’t want to stay on it even if I move mountains to get it for them.
Im sure I’ll get scolded on here because I don’t care or don’t try hard enough for my patients, but I only see my family 3 days a week as it is. I work from 6:30-22:00 T-Fri as it is. I’ve got more important priorities than to let my patients suck all the available life out of me. I have to try to save some for my family.
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Post by peppy on Nov 21, 2024 13:26:52 GMT -5
Type 1 is the target population. I am sad to hear Stevil that they do not like Afrezza.
The Continuous glucose monitors of the initial group, I remember them. The Glycemic control.
Thank you Stevil for report.
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Post by sayhey24 on Nov 21, 2024 14:16:44 GMT -5
I am with Aged on this. The lowest hanging fruit is gestational. However as Stevil says - "It’s not covered for the ones that would do the work to optimize their health". I would think expecting moms would want to optimize their health but who is paying $2k a month? Its the same for the kids. While their moms may want to optimize their health can they afford $2k per month? Its pretty simple - afrezza needs insurance coverage to fix the price issue. I just checked my insurance and its still listed as "NF" - Non-Formulary. Assuming Mike can fix the cost issue, I am not sold on GLP-1s for glucose control if afrezza is available. Long term use can be pretty risky diabetesjournals.org/care/article/33/2/453/27096/GLP-1-Based-Therapy-for-Diabetes-What-You-Do-Not |
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Post by cretin11 on Nov 21, 2024 14:55:07 GMT -5
stevil your perspecive and experiences are appreciated and valued here. We need to hear it even if we don't like the implications. For me, one implication is clear: PEDS will have limited effect and much less impact than we want or expect, unless we partner wisely. Since the almost decade from when Sanofi handed back Afrezza, MannKind has failed to solve the issues we've discussed repeatedly: insurance coverage, pricing, educating the public (including doctors and patients). Whether we don't have the right personnel for the job, or perhaps it's "just too darned difficult" because of any number of excuses, that doesn't matter now. We lost the decade that had such promise of Afrezza traction. What matters now is PEDS gives us another (maybe our last?) chance. We have enough evidence to conclude MannKind (without major changes) isn't capable of maximizing the commercialization of Afrezza even if PEDS results are stellar. Nobody should know this better than castagna so I fully expect us to partner accordingly. Then hopefully we finally achieve the Afrezza traction that PWDs deserve, not to mention us long suffering loyal MNKD longs.
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Post by prcgorman2 on Nov 21, 2024 15:28:56 GMT -5
stevil your perspecive and experiences are appreciated and valued here. We need to hear it even if we don't like the implications. For me, one implication is clear: PEDS will have limited effect and much less impact than we want or expect, unless we partner wisely. Since the almost decade from when Sanofi handed back Afrezza, MannKind has failed to solve the issues we've discussed repeatedly: insurance coverage, pricing, educating the public (including doctors and patients). Whether we don't have the right personnel for the job, or perhaps it's "just too darned difficult" because of any number of excuses, that doesn't matter now. We lost the decade that had such promise of Afrezza traction. What matters now is PEDS gives us another (maybe our last?) chance. We have enough evidence to conclude MannKind (without major changes) isn't capable of maximizing the commercialization of Afrezza even if PEDS results are stellar. Nobody should know this better than castagna so I fully expect us to partner accordingly. Then hopefully we finally achieve the Afrezza traction that PWDs deserve, not to mention us long suffering loyal MNKD longs. I like your optimism but don’t share it. You say partner. OK. Who? What is in it for the partner? What will the partner do that will make a material difference? Specifics. No handwaving. |
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Post by cretin11 on Nov 21, 2024 15:47:11 GMT -5
What's in it for the partner? Owning a piece of a brilliant technology with the possibility of revolutionizing diabetes care, improving the lives of millions of PWDs, and as a side bonus, getting a cut of massive profits. I remember Al Mann's words regarding those goals. I think he was onto something, but you are not alone in your pessimism as there have been many skeptics regarding Afrezza over the years. So far the skeptics are "winning" but IMO that's more to do with who has been tasked with commercializing Afrezza, not with the brilliance of the technology itself. I'm still holding out hope, perhaps foolishly so, but I'll continue to err on the side of optimism even if to my detriment. Afrezza is that good.
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Post by prcgorman2 on Nov 21, 2024 15:58:05 GMT -5
I can’t tell you how much I appreciate your insights.
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Post by cretin11 on Nov 21, 2024 16:25:13 GMT -5
I can’t tell you how much I appreciate your insights. Well that doesn't mean you can't try! But seriously, that validation means a lot and it encourages me to continue sharing. Keep the faith prc!  |
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Post by celo on Nov 21, 2024 17:11:22 GMT -5
Diabetes is a complicated and difficult market. Let’s use this great technology where it can really be utilized. Mankind should put their energy and time somewhere else.
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Post by mpg54 on Nov 21, 2024 19:09:40 GMT -5
Diabetes is a complicated and difficult market. Let’s use this great technology where it can really be utilized. Mankind should put their energy and time somewhere else. The problem is 3-4 years to get a drug from conception, through trials, and finally approval. There’s plenty of time and energy for what is an approved drug. Unless you prefer sitting on your hands and waiting for another 10 years hoping for a winner somewhere along the line? We finally have Peds trial data and are down to approx 1 year from a Peds approval. Update the label, get rid of the black box warning if possible and make a hard run at seeing how well MNKD can sell Afrezza. I don’t like this focus on everything else thinking, that’s a pipe dream years away. Partner talk is useless, no one is partnering on what is considered a well known dud. Of course we believe in it, why else would we be on this board year after year? No company capable of selling Afrezza cares about the passion of this board. It’s in MNKD hands and has been for a while, Mike has some ammunition loaded for next year and 2026, time to see what is possible or not possible. That said, we are also close with both Cloz & Nine, neither are guaranteed successes either and I believe there’s more than enough time & energy for them… |
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Post by prcgorman2 on Nov 21, 2024 19:53:24 GMT -5
Diabetes is a complicated and difficult market. Let’s use this great technology where it can really be utilized. Mankind should put their energy and time somewhere else. The problem is 3-4 years to get a drug from conception, through trials, and finally approval. There’s plenty of time and energy for what is an approved drug. Unless you prefer sitting on your hands and waiting for another 10 years hoping for a winner somewhere along the line? We finally have Peds trial data and are down to approx 1 year from a Peds approval. Update the label, get rid of the black box warning if possible and make a hard run at seeing how well MNKD can sell Afrezza. I don’t like this focus on everything else thinking, that’s a pipe dream years away. Partner talk is useless, no one is partnering on what is considered a well known dud. Of course we believe in it, why else would we be on this board year after year? No company capable of selling Afrezza cares about the passion of this board. It’s in MNKD hands and has been for a while, Mike has some ammunition loaded for next year and 2026, time to see what is possible or not possible. That said, we are also close with both Cloz & Nine, neither are guaranteed successes either and I believe there’s more than enough time & energy for them… Yup. Agree. EBU is treading water. I'm not forgetting that the share price started it's serious climb right around the INHALE presentation at ADA. Could be a coincidence, or related. I'm not in favor of jettisoning Afrezza, basically ever. It's the best prandial insulin product on the planet, and beyond that, I'm selfish. I may need it at some point. |
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Post by cretin11 on Nov 21, 2024 23:45:44 GMT -5
Diabetes is a complicated and difficult market. Let’s use this great technology where it can really be utilized. Mankind should put their energy and time somewhere else. Update the label, get rid of the black box warning if possible and make a hard run at seeing how well MNKD can sell Afrezza. We tried that already. If mike can’t convince anyone to partner with us, I doubt he can convince insurers to cover Afrezza, doctors to prescribe it, nor patients to demand it. But if he now has the ammunition as you suggest, then partnering should be possible. Ultimately what matters is success, with or without a partner. I happen to believe we need the partner (or some internal changes) to achieve that success, but would be quite happy to be wrong. |
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Post by mpg54 on Nov 22, 2024 0:41:50 GMT -5
Update the label, get rid of the black box warning if possible and make a hard run at seeing how well MNKD can sell Afrezza. We tried that already. If mike can’t convince anyone to partner with us, I doubt he can convince insurers to cover Afrezza, doctors to prescribe it, nor patients to demand it. But if he now has the ammunition as you suggest, then partnering should be possible. Ultimately what matters is success, with or without a partner. I happen to believe we need the partner (or some internal changes) to achieve that success, but would be quite happy to be wrong. If you recall we also tried the partnership route already and it nearly sunk the company. Yes, I think he’ll have ammunition with the Peds trial data, Peds approval, and a possible label change. Do I think that would be enough for a partner to invest millions into trying to sell a previous failure, HELL NO. I don’t know what kind of deal you think is possible? Nothing that wouldn’t be a near giveaway, no thanks. I don’t believe any partnership is remotely possible at this point. Happy to be wrong, but I’d be in shocked if a deal was made that was anywhere near equitable. This ammunition is nothing more than a chance to chip away at the barriers holding the drug back. It’s not going to wipe away its 10 years of failure. It’s my belief that MNKD is going to have to prove Afrezza can be successful on its own before any potential partner would ever consider touching it. What is success, that’s a TBD, but it’s certainly not 100m a year… |
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Post by Thundersnow on Nov 22, 2024 2:19:38 GMT -5
While pediatric and adult trials may not be interchangeable I think Inhale-3 results are a pretty good indicator of what we will see with the kids. Given the moms are "personal coaches" for the kids I am expecting some damn great results. Now, we know wearing a pump while playing sports is not great. About 40% of 10 year olds play basketball. Wearing a pump while playing basketball is not great. Its not great playing soccer either which is the second largest youth participation sport. Then you have the moms talking and if they are hearing no pump, great control and few worries about "lows" and I think we have a winner. We also only have about 1500 pediatric endos to target and some well organized "mom" social media groups. I would be shocked if Afrezza wasn't approved for kids. That still leaves the issues of cost and inertia. I would expect the insurance formulary coverage to be identical between kids and adults since they are both using the same insurer. I would also expect pre-approval issue to be the same for kids as it is for adults. As for inertia, Omnipod is pretty much standard for newly diagnosed kids and the clinics are very comfortable with that as they understand them and can get good results. As for sport, don't remember that mother complaining about Levemir being discontinued because it meant her daughter went low playing sports? The basal insulin problem remains. You can fix that by eating a load of carbs before you start exercising, but that's going to spike you and having high levels is bad for sport. You might want to revisit the reduced salesforce strategy in light of the changes. They are tightly focused on hospital groups now. Afrezza for PEDS will be approved and MNKD will partner with a large Pharma to market it. A good friend is a PEDS Endo and he has training sessions scheduled. Once the READ OUT is public MNKD will start negotiations. Remember when Sanofi said they want 6 - 9 Months to prepare for a drug launch. Most BP's are similar. Also this could be a reason why MNKD cut their salesforce by 45% and are focused on high volume clients. No need to waste resources in underperforming areas when a larger BP can handle those areas. |
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Post by Thundersnow on Nov 22, 2024 2:29:26 GMT -5
We tried that already. If mike can’t convince anyone to partner with us, I doubt he can convince insurers to cover Afrezza, doctors to prescribe it, nor patients to demand it. But if he now has the ammunition as you suggest, then partnering should be possible. Ultimately what matters is success, with or without a partner. I happen to believe we need the partner (or some internal changes) to achieve that success, but would be quite happy to be wrong. If you recall we also tried the partnership route already and it nearly sunk the company. Yes, I think he’ll have ammunition with the Peds trial data, Peds approval, and a possible label change. Do I think that would be enough for a partner to invest millions into trying to sell a previous failure, HELL NO. I don’t know what kind of deal you think is possible? Nothing that wouldn’t be a near giveaway, no thanks. I don’t believe any partnership is remotely possible at this point. Happy to be wrong, but I’d be in shocked if a deal was made that was anywhere near equitable. This ammunition is nothing more than a chance to chip away at the barriers holding the drug back. It’s not going to wipe away its 10 years of failure. It’s my belief that MNKD is going to have to prove Afrezza can be successful on its own before any potential partner would ever consider touching it. What is success, that’s a TBD, but it’s certainly not 100m a year… Nah I think you're way off base. The DATA will show Afrezza works and works very well. If you remember MNKD did not have the right DOSAGE which caused diabetics and doctors to discontinue it. To them there was no benefit and doctors were not fully trained so they were not smart enough or cared about trying to make it work. There were a few doctors that were excited and figured it out and have been very successful. With Inhale 3 and 1 it will be a paradigm shift and a large pharma (probably with a WW footprint) will partner with MNKD. MNKD is in a much stronger position than 10 years ago with Sanofi. Who knows maybe Sanofi will come back around and give MNKD a sweet deal. Time will tell...... |
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