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Post by sayhey24 on Mar 6, 2023 18:43:41 GMT -5
... Afrezza is different as it is the only insulin of form "inhaled" so in theory every insurance company has to include it in 2024 but we will see when the 2024 formularities are finalized. Emphasizing the "in theory". I don't think they have to supply all forms, I think those are just the acceptable forms. It comes down to how you read the requirements and those can be pretty opaque. If they stick with the two choice pattern you could meet the bid requirements with novolog and faiasp for example. We need to see the 2024 bid package. We will see. Its on the 2024 spreadsheet which requires the insurance companies to at least provide cost for 2024. I also know CMS got some pressure to include it. I know the CGM vendors would like it included. In the legislation it has "inhaled" The term`selected insulin products' means any dosage form (such as vial, pump, or inhaler dosage forms) of any different type (such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed) of insulin I don't think novolog and faiasp meet the requirement of dosage form "inhaler" but you have been right before. I also think CMS went out of their way this year in handling all the pre auths for it when they would rather have it bid on and in the contract. I am going to think positive. I am still in shock CMS went from a single dose of basal to "insulin treated" for the CGMs but I can guess how it happened. Now, having afrezza would make the CGM vendors reps lives so much easy. |
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Post by agedhippie on Mar 6, 2023 20:36:25 GMT -5
Has anyone formally asked MNKD investor relations what they are expecting? (I know that's cheating  ) |
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Post by agedhippie on Mar 6, 2023 21:19:56 GMT -5
I guess it also bears repeating; inhaled insulin is not mentioned in the Inflation Reduction Act of 2022 except in the context of the modification to the Safe Harbor provision of the Internal Revenue Code (taxes) in order to protect high deductible health plans. In other words the Act does no impose a requirement to supply all forms. This means the requirement to offer inhaled insulin is dependent on the CMS modifying their policy to require it. So far I have found nothing to suggest that they have moved off the two drug per drug category rule to requiring (as opposed to allowing) different formats. The two drug rule from the medicare.gov site: What Medicare Part D drug plans coverAn in-depth review of Part D with links to the underlying legislation: medicareadvocacy.org/medicare-info/medicare-part-d/ |
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Post by prcgorman2 on Mar 7, 2023 7:14:40 GMT -5
Yup. I’m pretty sure I copied-and-pasted the safe harbor provision in a post within the last few months. I did a word search for “inhaled” in the IRA and that (safe harbor) was the only mention I found.
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Post by sayhey24 on Mar 7, 2023 7:43:24 GMT -5
I guess it also bears repeating; inhaled insulin is not mentioned in the Inflation Reduction Act of 2022 except in the context of the modification to the Safe Harbor provision of the Internal Revenue Code (taxes) in order to protect high deductible health plans. In other words the Act does no impose a requirement to supply all forms. This means the requirement to offer inhaled insulin is dependent on the CMS modifying their policy to require it. So far I have found nothing to suggest that they have moved off the two drug per drug category rule to requiring (as opposed to allowing) different formats. The two drug rule from the medicare.gov site: What Medicare Part D drug plans coverAn in-depth review of Part D with links to the underlying legislation: medicareadvocacy.org/medicare-info/medicare-part-d/What you are saying is not wrong but it is where the term "selected insulin products" are defined as any dosage form such as vial, pump or inhaler and any different type such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed of insulin. If you noticed it is also the only place where dosage form "vial" is mentioned. You should see "Dosage Form" is sprinkled through out the legislation and from the above we know "inhaler" is its own dosage form. I think you are trying to say the formulary includes at least 2 drugs in the most commonly prescribed categories and classes and you are trying to argue a fiasp is the same as afrezza. Since they are different categories (dosage forms) I don't think that is correct. It really goes back to the bid requirement as the section you provided is a description not a contractual requirement - we will have to see in June. What we do know is it is currently on the formularity spreadsheet and is required to be costed. I get the feeling you are really hoping it does not get included. I also have the feeling Robert Ford and Kevin Sayer really want it included. Lets see who wins. If it does its pretty clear MNKD has a brand new sales force who also happens to sell Libres and G7s. They also have a brand new game plan for going after the T2 market. All I know is Mike needs to keep a close eye on this and he needs to get the GLP1/afrezza study kicked off ASAP. Did you read the article I posted in the news thread? Not good for the GLP1s. |
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Post by agedhippie on Mar 7, 2023 10:32:17 GMT -5
What you are saying is not wrong but it is where the term "selected insulin products" are defined as any dosage form such as vial, pump or inhaler and any different type such as rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting, and premixed of insulin. If you noticed it is also the only place where dosage form "vial" is mentioned. You should see "Dosage Form" is sprinkled through out the legislation and from the above we know "inhaler" is its own dosage form. I think you are trying to say the formulary includes at least 2 drugs in the most commonly prescribed categories and classes and you are trying to argue a fiasp is the same as afrezza. Since they are different categories (dosage forms) I don't think that is correct. It really goes back to the bid requirement as the section you provided is a description not a contractual requirement - we will have to see in June. What we do know is it is currently on the formularity spreadsheet and is required to be costed. I get the feeling you are really hoping it does not get included. I also have the feeling Robert Ford and Kevin Sayer really want it included. Lets see who wins. If it does its pretty clear MNKD has a brand new sales force who also happens to sell Libres and G7s. They also have a brand new game plan for going after the T2 market. All I know is Mike needs to keep a close eye on this and he needs to get the GLP1/afrezza study kicked off ASAP. Did you read the article I posted in the news thread? Not good for the GLP1s. Contrary to your feelings I really do hope Afrezza is mandated because I want diabetics to have as many options as possible. My other hope is world peace, but I don't think that's likely either.  Don't confuse desire and reality (although I think the Afrezza mandate is far more likely to become reality) Inhaler is definitely it's own dosage form. However, there is no requirement to offer every dosage form possible. The references to dosage form scattered throughout the Act are around data aggregation and not formularies. Afrezza is a good example of dosage forms. Afrezza's class is human insulin (with Humulin R and Novolin R) and the dosage form is inhaled (Fiasp's class is RAA and dosage form is subq and vial.) I see no evidence that Robert Ford and Kevin Sayer care one way or the other. In the SoC basal insulin comes ahead of mealtime insulin. Their focus now is on getting CGMs extended to non-insulin users because that's the growth area. I agree that a GLP-1 + Afrezza trial would be good, but I am not sure what the other arm should be, GLP-1 + RAA or basal? That news isn't going to have any impact on GLP-1. It's the old problem of 4x increase is a great headline, but 4x a tiny number remains a tiny number. Look at the actual numbers vs. the risk of not taking the drug. |
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Post by sayhey24 on Mar 7, 2023 12:00:01 GMT -5
Aged - the other arm is just like Affinty 2 - placebo. GLP1s did not make the Affinity 2 trial where afrezza showed superiority. It will again on the GLP1/afrezza arm show superiority but more important it will show CGM recorded post prandial numbers.
Some things take on faith and I am not going to give you evidence. What I can say is the CGM vendors were trying to get once daily basal approved but then something happened and CMS approved "insulin treated". I am pretty sure that was not a coincidence but you will need to take that on faith.
You are correct the current SoC has basal before mealtime but again - don't thing of afrezza as another insulin. Think of it as an easy way to get Medicare to pay for CGMs. Maybe not so much Dexcom but Abbott has a lot of money and Robert Ford said he wants $10B in Libre sales by 2025 and he said this Medicare approval is key to opening up the T2s. Remember the CGM with a basal he said is like having a "rearview mirror" and we know a CGM with afrezza is like "Forward Looking Radar".
MNKD on its own as we have learned has little chance of changing the SoC. If afrezza is an easier sell as an add-on to sell CGMs than subq insulin then all of a sudden there is big money wanting to see changes to the SoC. What we do know is subq insulin is a pain for GPs and they don't want hypos. A 4u of afrezza on top of metofrmin, etc. is not causing hypos and already has the Affinity 2 results showing superiority. Add the 8u or a couple of 12us and all of a sudden we have "Forward Looking Radar".
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Post by agedhippie on Mar 7, 2023 19:19:08 GMT -5
Aged - the other arm is just like Affinty 2 - placebo. GLP1s did not make the Affinity 2 trial where afrezza showed superiority. It will again on the GLP1/afrezza arm show superiority but more important it will show CGM recorded post prandial numbers. Some things take on faith and I am not going to give you evidence. What I can say is the CGM vendors were trying to get once daily basal approved but then something happened and CMS approved "insulin treated". I am pretty sure that was not a coincidence but you will need to take that on faith. You are correct the current SoC has basal before mealtime but again - don't thing of afrezza as another insulin. Think of it as an easy way to get Medicare to pay for CGMs. Maybe not so much Dexcom but Abbott has a lot of money and Robert Ford said he wants $10B in Libre sales by 2025 and he said this Medicare approval is key to opening up the T2s. Remember the CGM with a basal he said is like having a "rearview mirror" and we know a CGM with afrezza is like "Forward Looking Radar". MNKD on its own as we have learned has little chance of changing the SoC. If afrezza is an easier sell as an add-on to sell CGMs than subq insulin then all of a sudden there is big money wanting to see changes to the SoC. What we do know is subq insulin is a pain for GPs and they don't want hypos. A 4u of afrezza on top of metofrmin, etc. is not causing hypos and already has the Affinity 2 results showing superiority. Add the 8u or a couple of 12us and all of a sudden we have "Forward Looking Radar". How much of a splash did Affinity-2 make in the market? It's obvious that if you add insulin, any insulin, vs. a placebo the insulin will win. That's not going to persuade anyone medical. What happened with the CGM for insulin use approval is that the manufactures did the work and produced the evidence. CMS has a track record of doing the right thing if you can present them with evidence which means multiple large trials - they were the first to approve pumps for Type 1 diabetics which forced the commercial insurers to keep up. The CGM decision will do the same for Type 2 CGM approvals commercially. I don't think faith had any place in this. Afrezza is insulin, as inconvenient as that may be for your desires. That means that you have to get a doctor to prescribed it contrary to the SoC to get it ahead of basal insulin. That doesn't happen unless there is evidence (large scale trial data) to support the change and I have yet to see any CGM maker even starting down that track. Starting down the track to the use of CGMs by non-insulin users? Definitely. Ultimately; as you say, there is no evidence to support the idea, just that it would be nice if it was true. |
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Post by sayhey24 on Mar 8, 2023 7:51:59 GMT -5
Aged - the facts are the facts and while "to date" Affinity 2 was a marketing disaster it was a medical success as it showed superiority.
What you are suggesting is the doctors follow the SoC. The CGM sales reps are not going to want to wait for Step 2 and 3 of the SoC let alone step 4 to sell their CGMs. Are you kidding me that would takes years. The goal of selling the CGM is to add insulin to the current patient regime which starts with metformin - aka Affinity-2. Is it easier to add afrezza to metformin or basal to metformin? Thats the sweet spot of the Medicare market for the CGMs.
The other facts are doctors don't want hypos, patients don't want needles and most important the CGM vendors want to sell CGMs ASAP. Robert Ford said $10B by 2025.
At this point we will need to wait and see. If afrezza does not make the 2024 formularity list then the answer will be basal at Step 4. If it does I think it comes down to what kind of buffet the Abbott and Dexcom sales reps bring for lunch and what's an easier sell; afrezza or a basal? Prescribing either would "jump" the SoC guidelines.
We know from a no hypo/needle perspective afrezza should be an easier sell to jump the SoC guidelines. We also know taking the basal with the CGM is like looking in the rearview mirror. I also think the CMS CGM guidance just trumped the SoC. If you want the CGM you need to be "insulin treated" sooner than later. If you want to follow the SoC guidance which does not include the CGM wait until step 4 for the basal. I think the argument will be thats fine but prescribe the afrezza now for post meal corrections and get the CGM. I think your argument of following the SoC forces the doctors to wait until step 4 for the basal which our CGM friends are not going to like.
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Post by sportsrancho on Mar 8, 2023 23:43:05 GMT -5
While agedhippie and sayhey are talking I am reading posts on Facebook in the private Afrezza group ..and all they’re complaining about is the green cartridge and the blue cartridge look too similar in color🤣 They’re loving it😊
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Post by mytakeonit on Mar 8, 2023 23:51:11 GMT -5
So color blind and a ton of other problems ... Ha! Maybe MNKD needs to add stripes or dots to the cartridges . Ha!
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Post by prcgorman2 on Mar 9, 2023 0:51:15 GMT -5
While agedhippie and sayhey are talking I am reading posts on Facebook in the private Afrezza group ..and all they’re complaining about is the green cartridge and the blue cartridge look too similar in color🤣 They’re loving it😊 I assume you mean the Afrezza group members are loving Afrezza, and the worst thing said is a complaint of the colors being insufficiently contrasting to ensure whether they’re using a small, medium, or large cartridge? I suppose that could be a real problem for folks who are color blind and have difficulty distinguiishing between blue and yellow (or don’t see color at all). Anyway, if I understood correctly and you meant they generally are very pleased, that is an entertaining contrast to the great discussion between agedhippie and sayhey24, and I’m glad to hear it, and thank you for sharing (sincerely, for cretin11). |
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Post by sayhey24 on Mar 9, 2023 7:38:19 GMT -5
While agedhippie and sayhey are talking I am reading posts on Facebook in the private Afrezza group ..and all they’re complaining about is the green cartridge and the blue cartridge look too similar in color🤣 They’re loving it😊 I assume you mean the Afrezza group members are loving Afrezza, and the worst thing said is a complaint of the colors being insufficiently contrasting to ensure whether they’re using a small, medium, or large cartridge? I suppose that could be a real problem for folks who are color blind and have difficulty distinguiishing between blue and yellow (or don’t see color at all). Anyway, if I understood correctly and you meant they generally are very pleased, that is an entertaining contrast to the great discussion between agedhippie and sayhey24, and I’m glad to hear it, and thank you for sharing (sincerely, for cretin11). We have had the cartridge discussion here for years. It afrezza's biggest marketing mistake. They should be called small, medium and large. If you look at the top of the cartridges they currently have 4u, 8u or 12u which is not noticeable and someone with not perfect eyesight may not even see it. The colors are another thing and the foil on the container doesn't match. It should. How about small, medium and large with one white, one black and the third red with the size clearly marketed on the cartridge. If they are color blind the red will look a bit orange. Facebooks biggest problem is now solved on Proboards. All Mike needs to do is get it done so we can get the GLP1/afrezza study going. |
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Post by lennymnkd on Mar 9, 2023 7:58:31 GMT -5
But with units it give the user some sense of incremental increase understanding.
Color seems generic and undefinable .
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Post by Clement on Mar 9, 2023 8:35:01 GMT -5
There's an app for that (color).
Most people have cell phones and keep them nearby.
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)
Don't confuse desire and reality (although I think the Afrezza mandate is far more likely to become reality)
