limo
Researcher
Posts: 82
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Post by limo on Nov 30, 2023 9:46:47 GMT -5
Does anyone have any color on whether Afrezza is getting dropped or not? Hoping as its the only inhalable it will be kept on "In an informal survey of 22 Medicare plans, 10 plans are dropping at least one insulin from their formulary, according to Diane Omdahl, founder of 65 Inc., which provides Medicare enrollment guidance through fee-for-service, one-on-one consultations. Four plans are dropping four or more different insulins, she said. If you’re banking on the $35 out-of-pocket insulin cap to continue saving money next year, you must check your plan to see if your insulin is still covered. Only if your drug plan covers your insulin will you receive the $35 cap, according to the Centers for Medicare & Medicaid Services (CMS)." eu.usatoday.com/story/money/personalfinance/2023/11/30/medicare-plans-dropping-insulin-may-cost-you/71623776007/ |
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Post by prcgorman2 on Dec 2, 2023 10:32:09 GMT -5
mnholdem used to keep track of formularies and coverage, but that was a long time ago. It was good work illuminating depressing facts. Insurance coverage continues to be one of the biggest remaining hurdles for sales of Afrezza. Because the T2 market is more than 10x the T1 market, MannKind has made some marketing efforts to penetrate it (the lamentable flying hamburger commercial comes to mind), but the strategy MNKD is following for now is focus on pediatric T1s. Because of the demonstratable safety and performance of Afrezza, the idea is to get moms, children, and endocrinologists on board with using Afrezza for mealtime insulin (or as a correction tool) and assuming the pediatric study will help achieve that result.
The thought is Afrezza for T2s will be easier to sell and get coverage if endocrinoligists become Afrezza fans. That’s a pretty poor description of the “strategy” but I think it’s the gist. Basically, MannKind is not trying very hard to penetrate the T2 and Medicare market because they don’t have good mindshare on safety and benefit of Afrezza so they’re tackling that first.
agedhippie, stevil, and matt convinced me long ago that the only way to solve for coverage was to solve for prescriber mindshare and the only way to solve that was with at-scale clinical studies that demonstrated safety (SAFETY, SAFETY) and superiority. The on-going pediatric study is the first time MannKind has been able to do that because of the disastrous Sanofi deal which nearly bankrupt MNKD. This process of get a drug approved, and then do the studies to persuade doctors to prescribe is the common marketing path. Afrezza didn’t follow that path because Sanofi renegged on the worldwide marketing agreement with MannKind and it was Sanofi’s responsibility to perform those studies as part of the agreement. When Sanofi backed out, it left MannKind in dire straits with no money to do the studies and no marketing and sales department to even try to sell Afrezza even if they could do the studies. Poor Mike Castagna bravely (insanely?) accepted the Chief Marketing Officer job to re-launch Afrezza sans money, studies, and insurance coverage.
If the pediatric study achieves its goal (and if Tyvaso DPI continues to underwrite MannKind, and if clofazamine and/or nintedanib add disposable capital to the warchest), additional studies become more appealing to help establish Afrezza on an even footing with other prandial insulin products.
I invested in MannKind because I was convinced Afrezza would be the best mealtime insulin on the market in the world, bar none. I think Afrezza has proven to be that product, but I’m not the one that needs to be convinced. It’s the doctors. So here we are almost 10 years after FDA approval finally doing what should have been done 8 or 9 years ago. And of course there was that little 2 year delay because of a crippling global pandemic, but we appear to finally be making material progress.
We investors will see what the results of the Pediatric study can do for the business in a year or two, but MannKind management are getting the inside information on the study results and will plan next steps accordingly. It is telling that both MNKD and JP Morgan have stated their assumptions about the revenue opportunity of 10% of the T1 market. If we assume the US T1 market is about 3M individuals, we can probably guess pediatrics makes up about 20% or 600K individuals. 10% of the T1 market would be 50% of the pediatric market. I think that implies MNKD and JP Morgan are bullish on the expected results of the Pediatric Study.
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Post by prcgorman2 on Dec 3, 2023 10:08:31 GMT -5
I need to correct myself. I said Mike Castagna “bravely (insanely?) accepted the Chief Marketing Officer job”. I forgot that he did not accept the job. Instead, he lobbied for it while he was still employed as a senior executive specializing in drug re-launch at Amgen. MannKind was clearly in trouble, so it is a testament to his faith in Dr. Mann’s work and Afrezza that he tried to get a job on a sinking ship assuming that he could help right it so that someday it would become a thriving concern. Going on 7 years later, he appears to be on track to do just that.
Matt Pfeffer once said the MannKind story would be “epic”. At the time it was an extremely poor choice of words. Because epic stories tend to have deep low points and soaring high points, MannKind has had the deep low points covered, so all we need are the soaring high points to make Matt’s words come true.
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limo
Researcher
Posts: 82
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Post by limo on Dec 12, 2023 2:36:18 GMT -5
cant workout how to paste a screen shot. But this is copied from the Afrezza group on Facebook "Hi who here has had to appeal to your insurance to stay on Afrezza? We received a letter today that starting 1/24 it is not a covered med. We see Endo on Thursday and will have her start the process. Any advice would be appreciated 🤞🏻🤞🏻"looks like some firms are dropping Afrezza from formulary. Anyone herd  anything else? |
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Post by agedhippie on Dec 12, 2023 6:05:28 GMT -5
I think this was discussed earlier in the Medicare Part D thread. It is a knock-on from the $35 insulin cap with Medicare. The issue is that Afrezza is an order of magnitude more expensive than RAA and the insurer can no-longer recover that cost via rebates and co-pays for Medicare plans. If the insurer drops Afrezza from their Medicare formulary but leaves it in their commercial plan formulary then there are going to be questions about why it is one plan and not the other. It's far simpler all around to drop it from all plans which they can do since it is classed with meal time insulins and there are alternatives.
You can file for a formulary exception, but if you do that you are paying the full price as the cap only covers the formulary. TBH, if I was in this position I would jump to the $99 offer and bite the bullet on cost which while expensive is less expensive than the alternative via insurance.
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Post by sayhey24 on Dec 12, 2023 7:20:50 GMT -5
Does anyone have any color on whether Afrezza is getting dropped or not? Hoping as its the only inhalable it will be kept on "In an informal survey of 22 Medicare plans, 10 plans are dropping at least one insulin from their formulary, according to Diane Omdahl, founder of 65 Inc., which provides Medicare enrollment guidance through fee-for-service, one-on-one consultations. Four plans are dropping four or more different insulins, she said. If you’re banking on the $35 out-of-pocket insulin cap to continue saving money next year, you must check your plan to see if your insulin is still covered. Only if your drug plan covers your insulin will you receive the $35 cap, according to the Centers for Medicare & Medicaid Services (CMS)." eu.usatoday.com/story/money/personalfinance/2023/11/30/medicare-plans-dropping-insulin-may-cost-you/71623776007/ limo - go to medicare.gov and search on part c or d plans. Add Afrezza and search for your zipcode. What you will see is afrezza listed for all plans but the insurance company is not covering the cost. To get the $35 you need to go through the pre auth process. About 90% were getting approved but I have not kept current if thats still the case. Mike said a few months back he is hoping to get afrezza covered in 2025. We will see. |
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limo
Researcher
Posts: 82
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Post by limo on Dec 12, 2023 7:38:21 GMT -5
Does anyone have any color on whether Afrezza is getting dropped or not? Hoping as its the only inhalable it will be kept on "In an informal survey of 22 Medicare plans, 10 plans are dropping at least one insulin from their formulary, according to Diane Omdahl, founder of 65 Inc., which provides Medicare enrollment guidance through fee-for-service, one-on-one consultations. Four plans are dropping four or more different insulins, she said. If you’re banking on the $35 out-of-pocket insulin cap to continue saving money next year, you must check your plan to see if your insulin is still covered. Only if your drug plan covers your insulin will you receive the $35 cap, according to the Centers for Medicare & Medicaid Services (CMS)." eu.usatoday.com/story/money/personalfinance/2023/11/30/medicare-plans-dropping-insulin-may-cost-you/71623776007/ limo - go to medicare.gov and search on part c or d plans. Add Afrezza and search for your zipcode. What you will see is afrezza listed for all plans but the insurance company is not covering the cost. To get the $35 you need to go through the pre auth process. About 90% were getting approved but I have not kept current if thats still the case. Mike said a few months back he is hoping to get afrezza covered in 2025. We will see. thanks i have done just that (with someone elses postcode as i live in the UK). I was worried it was going to be dropped altogether, so happy to see its still there albeit tier 3. Good to see afrezza mentioned a few times in the ADA SOC 24 , although somewhat frustrating it doesn't get referred to as an "URA" where the likes of fiasp gets referred to as URAA. Makes no sense at all. |
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Post by agedhippie on Dec 12, 2023 7:41:57 GMT -5
thanks i have done just that (with someone elses postcode as i live in the UK). I was worried it was going to be dropped altogether, so happy to see its still there albeit tier 3. ... Who was covering it at tier 3? |
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limo
Researcher
Posts: 82
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Post by limo on Dec 12, 2023 7:51:46 GMT -5
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Post by agedhippie on Dec 12, 2023 11:14:49 GMT -5
Ah. An insurer will allow the employer to select whatever drugs they want if they are self insuring. For example EmblemHealth is administering HIP and GHI for the NYC government. If you look at the Medicare plans available in New York to the public you will see that Afrezza is not an option for them (neither is CIGNA who owns Express Scripts). The Express Scripts formulary is not a final version because it's dated August. This site shows the definitive version for public plans because it is the government site all insurers have to go to for approval. They cannot change their plans without approval so the site is always accurate. Put in 10001 as the post code if you want NYC. www.medicare.gov/plan-compare/#/?year=2024&lang=en |
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Post by daisyz on Jan 8, 2024 10:09:39 GMT -5
Afrezza, 2023 - Blue Shield, CA, Silver copay was $250.
2024 it's $538.57.
Box of 4s and 8s.
Complete BS
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Post by celo on Jan 8, 2024 11:03:05 GMT -5
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Post by rickf on Jan 9, 2024 11:27:47 GMT -5
mnholdem used to keep track of formularies and coverage, but that was a long time ago. It was good work illuminating depressing facts. Insurance coverage continues to be one of the biggest remaining hurdles for sales of Afrezza. Because the T2 market is more than 10x the T1 market, MannKind has made some marketing efforts to penetrate it (the lamentable flying hamburger commercial comes to mind), but the strategy MNKD is following for now is focus on pediatric T1s. Because of the demonstratable safety and performance of Afrezza, the idea is to get moms, children, and endocrinologists on board with using Afrezza for mealtime insulin (or as a correction tool) and assuming the pediatric study will help achieve that result. The thought is Afrezza for T2s will be easier to sell and get coverage if endocrinoligists become Afrezza fans. That’s a pretty poor description of the “strategy” but I think it’s the gist. Basically, MannKind is not trying very hard to penetrate the T2 and Medicare market because they don’t have good mindshare on safety and benefit of Afrezza so they’re tackling that first. agedhippie, stevil, and matt convinced me long ago that the only way to solve for coverage was to solve for prescriber mindshare and the only way to solve that was with at-scale clinical studies that demonstrated safety (SAFETY, SAFETY) and superiority. The on-going pediatric study is the first time MannKind has been able to do that because of the disastrous Sanofi deal which nearly bankrupt MNKD. This process of get a drug approved, and then do the studies to persuade doctors to prescribe is the common marketing path. Afrezza didn’t follow that path because Sanofi renegged on the worldwide marketing agreement with MannKind and it was Sanofi’s responsibility to perform those studies as part of the agreement. When Sanofi backed out, it left MannKind in dire straits with no money to do the studies and no marketing and sales department to even try to sell Afrezza even if they could do the studies. Poor Mike Castagna bravely (insanely?) accepted the Chief Marketing Officer job to re-launch Afrezza sans money, studies, and insurance coverage. If the pediatric study achieves its goal (and if Tyvaso DPI continues to underwrite MannKind, and if clofazamine and/or nintedanib add disposable capital to the warchest), additional studies become more appealing to help establish Afrezza on an even footing with other prandial insulin products. I invested in MannKind because I was convinced Afrezza would be the best mealtime insulin on the market in the world, bar none. I think Afrezza has proven to be that product, but I’m not the one that needs to be convinced. It’s the doctors. So here we are almost 10 years after FDA approval finally doing what should have been done 8 or 9 years ago. And of course there was that little 2 year delay because of a crippling global pandemic, but we appear to finally be making material progress. We investors will see what the results of the Pediatric study can do for the business in a year or two, but MannKind management are getting the inside information on the study results and will plan next steps accordingly. It is telling that both MNKD and JP Morgan have stated their assumptions about the revenue opportunity of 10% of the T1 market. If we assume the US T1 market is about 3M individuals, we can probably guess pediatrics makes up about 20% or 600K individuals. 10% of the T1 market would be 50% of the pediatric market. I think that implies MNKD and JP Morgan are bullish on the expected results of the Pediatric Study. Interesting commentary! I think I agree with you but it seems to me that a LOT of hope is going into the pediatric results 0 love to have Agedhippie's thoughts on this! |
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Post by prcgorman2 on Jan 9, 2024 11:46:30 GMT -5
Completely agree. I assume the Pediatric trial will be successful in terms of getting FDA approval, and it is reasonable to hope it will also prove superiority (not non-inferiority) and I hope to goodness SAFETY (SAFETY! SAFETY!). If SAFETY isn't clearly proven that would be a follow-on study IF the results of the Peds trial (etc) "move the needle", at least in terms of increasing prescriptions. If not, well, it will be interesting to see what MannKind chooses to do with an apparently moribund business unit. (I'd be dismayed for all Afrezza users [including and potentially especially if I become one) if Afrezza were to be removed from the market.)
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Post by sayhey24 on Jan 9, 2024 15:15:31 GMT -5
Completely agree. I assume the Pediatric trial will be successful in terms of getting FDA approval, and it is reasonable to hope it will also prove superiority (not non-inferiority) and I hope to goodness SAFETY (SAFETY! SAFETY!). If SAFETY isn't clearly proven that would be a follow-on study IF the results of the Peds trial (etc) "move the needle", at least in terms of increasing prescriptions. If not, well, it will be interesting to see what MannKind chooses to do with an apparently moribund business unit. (I'd be dismayed for all Afrezza users [including and potentially especially if I become one) if Afrezza were to be removed from the market.) From social media the moms are loving it. From a safety perspective they are seeing fewer hypo concerns. I will be shocked if it does not provide great results for the kids. After great results and FDA approval, then what? Based on past experience BP will throw the kitchen sink at MNKD and getting insurance coverage is not changing. Few will pay $1000 month. Over time the Moms may make enough noise but BP will push back at every attempt they try. At this point I don't see a significant improvement in scripts no matter how great the kids results are. |
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