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Post by sayhey24 on Nov 18, 2022 11:39:51 GMT -5
Maybe Sports can verify for VDex and post on the Afrezza Facebook group. I would think this is huge news for VDex.
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Post by peppy on Nov 18, 2022 11:41:28 GMT -5
Maybe Sports can verify for VDex and post on the Afrezza Facebook group. I would think this is huge news for VDex. sportsrancho
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limo
Researcher
Posts: 82
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Post by limo on Nov 18, 2022 11:52:28 GMT -5
Guys I’m throughly confused. Haven’t we have part d since 2021? That’s when mannkind did the press release. Why is this different now.
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Post by peppy on Nov 18, 2022 12:07:41 GMT -5
Guys I’m throughly confused. Haven’t we have part d since 2021? That’s when mannkind did the press release. Why is this different now. I do not know exactly when the legislation passed, however, recall the talk of a $35 insulin cap over the years now? It seems to have passed with some bill that made it through. This is new. One more thing, recall when Hank Paulson knelt infront of Nancy Pelosi and asked her for legislation for the banks in 2009? Turns out the legislature directs the treasury; the money could not be printed to save the banking system with out the legislation. I'll stop. I do respect Pelosi.
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Post by sayhey24 on Nov 18, 2022 12:17:37 GMT -5
Guys I’m throughly confused. Haven’t we have part d since 2021? That’s when mannkind did the press release. Why is this different now. Not for $35 a month. It was covered as a "form" being "inhaled" insulin and was included in the Part D plans BUT it would cost between $10k - $20k per year making it pretty much unaffordable for most. You were better going to insulinsavings.com and buying direct. The article I posted earlier was from 2020 talking about its inclusion. Few doctors would even prescribe because while it was on the formularies no one could afford it. Additionally, it was cheaper for the doctors to prescribe Ozempic and Invokana. Now its cheaper to prescribe afrezza and with afrezza the PWD gets a free CGM.
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Post by cedafuntennis on Nov 18, 2022 12:34:41 GMT -5
I'll stop. I do respect Pelosi. I do respect you but certainly not that person. I'll stop too
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Post by hopingandwilling on Nov 18, 2022 12:53:48 GMT -5
I have avoided posting here for well over two months, with that said I find the current debate/discussion about Afrezza not being covered under the coming set $35.00 charge for insulin a very interesting situation. I can understand why those who support Afrezza might be concerned. However, those administering the Medicare program have good lawyers. And you can bet that the insurance companies have EXCELLENT lawyers to protect their profit margins.
It appears that here on this board the debate is over the use of the word—form—and that all forms of insulin must be covered. To find an answer to this issue, I sought information from the parties involved.
The following information and chart is taken directly from Cigna’s website:
Insulin is a naturally occurring hormone secreted by the pancreas. Individuals with diabetes may require insulin therapy because the pancreas does not produce insulin (type 1 diabetes) or the body does not use insulin properly (type 2 diabetes). Insulin is the mainstay of therapy for individuals with type 1 diabetes. Basal insulin refers to insulin that is long acting and used to keep blood sugar stable in between meals and during the night. “Bolus” refers to insulin that is fast acting and is given following a meal or to treat abnormally high blood glucose levels. There are different types of insulin depending on how quickly they work, when they peak, and how long they last. The types of insulin include rapid-acting, short-acting, intermediate-acting, long-acting, and pre-mixed.
Type of Insulins Onset Peak Duration Compounds/Brands Rapid-acting insulin (Bolus) 10–30 minutes 30 minutes to 3 hours 3–5 hours Glulisine (Apidra®), Lispro (Humalog®) Aspart (NovoLog®, Fiasp®; Ademelog®) Inhaled (Afrezza®)
Short-acting 30 minutes to 1 hour 1–5 hours Up to 12 hours Humulin Regular® Novolin Regular®
Intermediate-acting 1–4 hours 4–12 hours 12–24 hours Humulin NPH Novolin NPH
Long-acting insulin (basal analogs) 1–2 hours Minimal peak Up to 42 hours Detemir (Levemir®) Degludec (Tresiba®) Glargine (Lantus®, Toujeo®) Glargine biosimilar (Basaglar®)
1) Notice that Cigna uses the word—Type vs. the use of the word form.
2) Notice that Afrezza is listed under the Rapid Acting type.
3) Notice that under this Rapid Acting type that there are 5 options for this type insulin. Afrezza and four others.
It is my opinion that the word type and form are interchangeable words. If the lawyers involved in the wording being used for the insulin being covered—if they had said insulin and any related delivery method for getting the insulin into the user’s body—this situation would be resolved. Should this become a court case—the insurance companies will state and defend their position by saying they are providing insulin for all types of users. Since users will have choices for each type of insulin, it doesn’t mean that insurance companies have to cover all of them.
Just my opinion! Since Afrezza is the most expensive insulin on the market they have solved their problem with the $35 locked in reimbursement for insulin. The solution for MannKind is to lower their prices!
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Post by peppy on Nov 18, 2022 13:33:46 GMT -5
I have avoided posting here for well over two months, with that said I find the current debate/discussion about Afrezza not being covered under the coming set $35.00 charge for insulin a very interesting situation. I can understand why those who support Afrezza might be concerned. However, those administering the Medicare program have good lawyers. And you can bet that the insurance companies have EXCELLENT lawyers to protect their profit margins. It appears that here on this board the debate is over the use of the word—form—and that all forms of insulin must be covered. To find an answer to this issue, I sought information from the parties involved. The following information and chart is taken directly from Cigna’s website: Insulin is a naturally occurring hormone secreted by the pancreas. Individuals with diabetes may require insulin therapy because the pancreas does not produce insulin (type 1 diabetes) or the body does not use insulin properly (type 2 diabetes). Insulin is the mainstay of therapy for individuals with type 1 diabetes. Basal insulin refers to insulin that is long acting and used to keep blood sugar stable in between meals and during the night. “Bolus” refers to insulin that is fast acting and is given following a meal or to treat abnormally high blood glucose levels. There are different types of insulin depending on how quickly they work, when they peak, and how long they last. The types of insulin include rapid-acting, short-acting, intermediate-acting, long-acting, and pre-mixed. Type of Insulins Onset Peak Duration Compounds/Brands Rapid-acting insulin (Bolus) 10–30 minutes 30 minutes to 3 hours 3–5 hours Glulisine (Apidra®), Lispro (Humalog®) Aspart (NovoLog®, Fiasp®; Ademelog®) Inhaled (Afrezza®) Short-acting 30 minutes to 1 hour 1–5 hours Up to 12 hours Humulin Regular® Novolin Regular® Intermediate-acting 1–4 hours 4–12 hours 12–24 hours Humulin NPH Novolin NPH Long-acting insulin (basal analogs) 1–2 hours Minimal peak Up to 42 hours Detemir (Levemir®) Degludec (Tresiba®) Glargine (Lantus®, Toujeo®) Glargine biosimilar (Basaglar®) 1) Notice that Cigna uses the word—Type vs. the use of the word form. 2) Notice that Afrezza is listed under the Rapid Acting type. 3) Notice that under this Rapid Acting type that there are 5 options for this type insulin. Afrezza and four others. It is my opinion that the word type and form are interchangeable words. If the lawyers involved in the wording being used for the insulin being covered—if they had said insulin and any related delivery method for getting the insulin into the user’s body—this situation would be resolved. Should this become a court case—the insurance companies will state and defend their position by saying they are providing insulin for all types of users. Since users will have choices for each type of insulin, it doesn’t mean that insurance companies have to cover all of them. Just my opinion! Since Afrezza is the most expensive insulin on the market they have solved their problem with the $35 locked in reimbursement for insulin. The solution for MannKind is to lower their prices! Hoping and willing, I see what you are saying, the catch 22. However, look at this publication. Things have changed? boomerbenefits.com/whats-going-on-with-medicare-and-insulin-coverage/#:~:text=When%20it%20comes%20to%20injectable
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Post by sayhey24 on Nov 18, 2022 13:44:42 GMT -5
Hoping - I am not sure if its more of a debate or just SHOCK. Mike said it would get the $35 coverage during the call but provided no details. The details are on the Medicare.gov website. For years on this board we talked about the need for 10 year trials to make such an impact. With legislation as Mike said it changes the game. What you provided from Cigna is consistent. There are two words meaning different things; form; and type Afrezza is a "form". The type of "form" is "inhaled". Cigna is including it in the "type" Rapid Acting. This document talks about forms and types. It does not include new information from the Inflation Reduction Act. boomerbenefits.com/whats-going-on-with-medicare-and-insulin-coverage/#:~:text=When%20it%20comes%20to%20injectable
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Post by agedhippie on Nov 18, 2022 14:01:27 GMT -5
Aetna seems to have done a deal with Novo Nordisk since their formulary only lists Novo insulins with the exception of the U-500 insulin which I think only Lilly makes. OK - but Novo Nordisk does not have an inhaled insulin. Each part D plan by law has to include one form of each; pen, vial and inhaled for each insulin type - rapid acting, intermediate, etc Lilly is no longer making Exubera. If they were then Exubera would be competing with afrezza for inclusion as long as they are both in the rapid insulin type. I think that verbiage about having to cover each form is from the Affordable Insulin Now Act which is dead. My feeling is that the devil is in the detail and I would wait to see how it gets handled next year. I have tried reading the relevant sections (Sec. 11406, 11408) a couple of times and am not sure I really understand this. They refer to covered insulin products (in-formulary), but it's not clear to me that insurers can be compelled to add inhaled insulin. There is a reference in Sec. 11408, which is a safe harbor clause to protect people from getting their health plan reclassified by the IRS if the insurer doesn't offer all formats I believe (I am NOT a lawyer to be clear!)
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Post by sayhey24 on Nov 18, 2022 16:05:06 GMT -5
OK - but Novo Nordisk does not have an inhaled insulin. Each part D plan by law has to include one form of each; pen, vial and inhaled for each insulin type - rapid acting, intermediate, etc Lilly is no longer making Exubera. If they were then Exubera would be competing with afrezza for inclusion as long as they are both in the rapid insulin type. I think that verbiage about having to cover each form is from the Affordable Insulin Now Act which is dead. My feeling is that the devil is in the detail and I would wait to see how it gets handled next year. I have tried reading the relevant sections (Sec. 11406, 11408) a couple of times and am not sure I really understand this. They refer to covered insulin products (in-formulary), but it's not clear to me that insurers can be compelled to add inhaled insulin. There is a reference in Sec. 11408, which is a safe harbor clause to protect people from getting their health plan reclassified by the IRS if the insurer doesn't offer all formats I believe (I am NOT a lawyer to be clear!) Aged - have you gone to Medicare.gov and checked? Afrezza is available in every plan I checked. I even checked Peppy's and 100% its there. The banner is pretty clear $35 per month on 60 and 90 day prescriptions. Lets give Mike credit, what he said was correct. I don't know how they did it but they got the language into the legislation. I guess because Kindle wanted it for ALL Americans and Medicare was the compromise. Dan Kindle introduced the Affordable Insulin Now Act. Kildee introduced and passed it through the House in March 2022 with support from Republicans and Democrats. As a part of the passage of the Inflation Reduction Act, Senate Republicans blocked Kildee’s legislation to cap insulin prices for all Americans from becoming law. While Kildee was still able to successfully cap the price of insulin at $35 for seniors on Medicare in the Inflation Reduction Act, his bill, the Affordable Insulin Now Act, would cap insulin prices for all Americans at $35 a month. Here is what the ADA says "To make sure seniors are getting these savings right away, people who are charged more than $35 per month for their insulin in the first few months after the new Medicare copay cap is enacted will be reimbursed." diabetes.org/sites/default/files/2022-08/What-People-with-Diabetes-Need-to-Know-about-the-Inflation-Reduction-Act.pdfHere is how it got born in the Inflation Reduction Act www.kff.org/medicare/issue-brief/explaining-the-prescription-drug-provisions-in-the-inflation-reduction-act/#:~:text=The%20Inflation%20Reduction%20Act%20limits,and%20no%20deductible%20will%20apply.
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Post by sayhey24 on Nov 18, 2022 16:42:49 GMT -5
Aged - here is the definition of form and type from the legislation ‘(I) IN GENERAL.—The term ‘selected insulin products’ means any 20 dosage form (such as vial, pump, or 21 inhaler dosage forms) of any different 22 type (such as rapid-acting, short-act23 ing, intermediate-acting, long-acting, 24 ultra long-acting, and premixed) of insulin. thehill.com/wp-content/uploads/sites/2/2022/08/Inflation-Reduction-Act-of-2022.pdf
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Post by peppy on Nov 18, 2022 16:44:01 GMT -5
OK - but Novo Nordisk does not have an inhaled insulin. Each part D plan by law has to include one form of each; pen, vial and inhaled for each insulin type - rapid acting, intermediate, etc Lilly is no longer making Exubera. If they were then Exubera would be competing with afrezza for inclusion as long as they are both in the rapid insulin type. I think that verbiage about having to cover each form is from the Affordable Insulin Now Act which is dead. My feeling is that the devil is in the detail and I would wait to see how it gets handled next year. I have tried reading the relevant sections (Sec. 11406, 11408) a couple of times and am not sure I really understand this. They refer to covered insulin products (in-formulary), but it's not clear to me that insurers can be compelled to add inhaled insulin. There is a reference in Sec. 11408, which is a safe harbor clause to protect people from getting their health plan reclassified by the IRS if the insurer doesn't offer all formats I believe (I am NOT a lawyer to be clear!) Mike C; First, we want to quick start program to get patients started quickly here in Q4 to pilot that as we get ready for next year to house scale our business. In 2023, we fully expect that Afrezza will be covered in Medicare at $35 under the inflation protection act bill that was passed. That changes the game as one of the major objections for Afrezza is around access, I really want you to see that patients can only pay $35 for Afrezza and it's not a short while a low-cost cash program available. We expect to finally launch BluHale [Inaudible], which is our patient addition integrated with CGM in Q1 as a pilot with a full-scale launch in Q2 next year soon if that goes well. www.fool.com/earnings/call-transcripts/2022/11/08/mannkind-corporation-mnkd-q3-2022-earnings-call-tr/?source=eptyholnk0000202&campaign=891997&pc_source=TheMotleyFool_Awin&awc=12195_1668804877_a988797f190c12e2899082af9ffe38ba&utm_source=aw&utm_campaign=891997alethea ======================================================================================================== Passed under the inflation protection act. Heh. It is November. MNKD price work, MNKD is set to pop. Another catalyst here. sayhey24 weehaw, and nice work. sportsrancho
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Post by alethea on Nov 18, 2022 16:50:52 GMT -5
Thank you Peppy. Although I can't prove it, I am almost positive the $35 will not apply for Medicare supplemental plans like mine until MAYBE the next selection period next October. Nonetheless I will point it out to my health insurance rep but I don't expect this to work right now. I have never found Afrezza covered under any Plan available to me so far.
Thank again.
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Post by peppy on Nov 18, 2022 16:52:26 GMT -5
Thank you Peppy. Although I can't prove it, I am almost positive the $35 will not apply for Medicare supplemental plans like mine until MAYBE the next selection period next October. Nonetheless I will point it out to my health insurance rep but I don't expect this to work right now. I have never found Afrezza covered under any Plan available to me so far. Thank again. I wonder on advantage plans. I took the A,B,C and D. Let us know.
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