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Post by uvula on Mar 2, 2023 9:16:25 GMT -5
[Disclaimer: pure speculation and guesses]
The $35 cap is per month not per quantity. This could be a good loophole for mnkd.
We don't know for certain but if a person used afrezza for all of their mealtime insulin, the cost to mnkd for that quantity is probably more than $35/month.
However, if a person used afrezza as a supplemental insulin for stubborn highs, then it is possible that this quantity of insulin costs mnkd less than $35/month.
Does this make any sense or is this just nonsense?
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Post by agedhippie on Mar 2, 2023 9:47:18 GMT -5
[Disclaimer: pure speculation and guesses] The $35 cap is per month not per quantity. This could be a good loophole for mnkd. We don't know for certain but if a person used afrezza for all of their mealtime insulin, the cost to mnkd for that quantity is probably more than $35/month. However, if a person used afrezza as a supplemental insulin for stubborn highs, then it is possible that this quantity of insulin costs mnkd less than $35/month. Does this make any sense or is this just nonsense? That makes sense. Didn't Mannkind offer a capped insulin cost at one point? They could just use that with a new price point. |
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Post by MnkdWASmyRtrmntPlan on Mar 2, 2023 10:20:25 GMT -5
Effective January 1, 2023, out-of-pocket costs for insulin are capped at $35 per monthly prescription among Medicare Part D enrollees under the Inflation Reduction Act (IRA).
A similar cap takes effect in Medicare Part B on July 1, 2023.Jan 24, 2023
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Post by agedhippie on Mar 2, 2023 10:23:30 GMT -5
Effective January 1, 2023, out-of-pocket costs for insulin are capped at $35 per monthly prescription among Medicare Part D enrollees under the Inflation Reduction Act (IRA). A similar cap takes effect in Medicare Part B on July 1, 2023.Jan 24, 2023 Lilly is separately capping it's insulin (maybe not their new RAA though) prices at $35, not just with Medicare. |
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Post by MnkdWASmyRtrmntPlan on Mar 2, 2023 10:25:09 GMT -5
How does $35 insulin cap work?
Starting Jan. 1, Medicare members, who include people 65 years and older and people with disabilities, should pay no more than $35 a month in copays or other out-of-pocket costs for an insulin prescription.
Medicare benefit plans and in some cases drug manufacturers will pick up the rest of the drug's cost. Jan 11, 2023
So, who will pick up the other $1,000 or so per Rx for Afrezza? I kept wondering if the government will pick up some of the more expensive insulins. Anyone?
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Post by Thundersnow on Mar 2, 2023 10:30:16 GMT -5
Lily's decision to lower their insulin to $35 will put pressure on Novo and Sanofi to follow. This will bring more negativity to MNKD in the short term.
This will force Mike to find a solution to lower production expenses like AUTOMATION. Hope he has an answer. This will speed up the transition.
This will also force MNKD to show the advantages of using Afrezza. It's like buying a Ferrari vs a Ford. There's no comparison. MNKD will have to prove to the doctors and patients that paying a premium worth it. Which is why the ABC Study will be important and the LARGER study will be very important.
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Post by cjc04 on Mar 2, 2023 15:33:28 GMT -5
Lily's decision to lower their insulin to $35 will put pressure on Novo and Sanofi to follow. This will bring more negativity to MNKD in the short term. This will force Mike to find a solution to lower production expenses like AUTOMATION. Hope he has an answer. This will speed up the transition. This will also force MNKD to show the advantages of using Afrezza. It's like buying a Ferrari vs a Ford. There's no comparison. MNKD will have to prove to the doctors and patients that paying a premium worth it. Which is why the ABC Study will be important and the LARGER study will be very important. so you’re saying that the challenge of showing how superior Afrezza is, which has been our only real challenge since 2014 that we’ve made very little to no progress on, is about to become even more of a challenge?? Awesome! |
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Post by sayhey24 on Mar 2, 2023 21:02:03 GMT -5
How does $35 insulin cap work? Starting Jan. 1, Medicare members, who include people 65 years and older and people with disabilities, should pay no more than $35 a month in copays or other out-of-pocket costs for an insulin prescription. Medicare benefit plans and in some cases drug manufacturers will pick up the rest of the drug's cost. Jan 11, 2023 So, who will pick up the other $1,000 or so per Rx for Afrezza? I kept wondering if the government will pick up some of the more expensive insulins. Anyone? Uncle Sam indirectly through what the insurance company bids to supply Plan D for CMS. The insurance companies get a price from the insulin vendor and then calculate their cost and risk and put a bid in to CMS for the contract. If awarded the insurance company manages the coverage and assumes the risk from CMS. Since the 2023 bids were in prior to the Inflation Reduction Act being passed CMS is collecting the costs and providing a rebate to the insurance companies. For 2023 only forms "vial and pen" where included in the bid package. For 2024 the bid packages which go out this month are suppose to include "vial, pen and inhaled". Hopefully Mike has kept a close eye on this so no one "accidently" removed the word "inhaled". |
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Post by agedhippie on Mar 2, 2023 22:28:04 GMT -5
Uncle Sam indirectly through what the insurance company bids to supply Plan D for CMS. The insurance companies get a price from the insulin vendor and then calculate their cost and risk and put a bid in to CMS for the contract. If awarded the insurance company manages the coverage and assumes the risk from CMS. Since the 2023 bids were in prior to the Inflation Reduction Act being passed CMS is collecting the costs and providing a rebate to the insurance companies. For 2023 only forms "vial and pen" where included in the bid package. For 2024 the bid packages which go out this month are suppose to include "vial, pen and inhaled". Hopefully Mike has kept a close eye on this so no one "accidently" removed the word "inhaled". Nobody is going to remove the word inhaled. Insulin may be provided in those formats, not must. The trick is that the cap applies to covered insulin products, and a covered product is defined as one that is in the insurers formulary. It's still up to the insurer to define their formulary and submit it to CMS for approval. All the CMS requires is that in the formulary there are two insulins in each class (RAA, basal, Human R, Human N) covered and those can be provided by the same manufacturer (Fiasp and Novolog) to meet the RAA category, or Novolin R and Humulin R to meet the human insulin category. |
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Post by peppy on Mar 3, 2023 4:50:55 GMT -5
[Disclaimer: pure speculation and guesses] The $35 cap is per month not per quantity. This could be a good loophole for mnkd. We don't know for certain but if a person used afrezza for all of their mealtime insulin, the cost to mnkd for that quantity is probably more than $35/month. However, if a person used afrezza as a supplemental insulin for stubborn highs, then it is possible that this quantity of insulin costs mnkd less than $35/month. Does this make any sense or is this just nonsense? That makes sense. Didn't Mannkind offer a capped insulin cost at one point? They could just use that with a new price point.Good idea Aged. It was Mannkind Direct Purchase program. "Are you paying full price for your mealtime insulin? Sign up for the MannKind direct purchase program during the month of January to lock in your mealtime insulin costs for as little as $4 a day for the next 12 months.* Find out how you can try inhaled insulin at a reduced cost. If you are paying retail prices or high out of pocket copay for your mealtime insulin, register now to start saving. Register at the above website." the website was www.insulinsavings.comIt was 99 dollars a month. The person was lined up with Afrezza help and insurance coverage was worked on. mnkd.proboards.com/post/169905 |
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Post by sayhey24 on Mar 3, 2023 8:15:25 GMT -5
Uncle Sam indirectly through what the insurance company bids to supply Plan D for CMS. The insurance companies get a price from the insulin vendor and then calculate their cost and risk and put a bid in to CMS for the contract. If awarded the insurance company manages the coverage and assumes the risk from CMS. Since the 2023 bids were in prior to the Inflation Reduction Act being passed CMS is collecting the costs and providing a rebate to the insurance companies. For 2023 only forms "vial and pen" where included in the bid package. For 2024 the bid packages which go out this month are suppose to include "vial, pen and inhaled". Hopefully Mike has kept a close eye on this so no one "accidently" removed the word "inhaled". Nobody is going to remove the word inhaled. Insulin may be provided in those formats, not must. The trick is that the cap applies to covered insulin products, and a covered product is defined as one that is in the insurers formulary. It's still up to the insurer to define their formulary and submit it to CMS for approval. All the CMS requires is that in the formulary there are two insulins in each class (RAA, basal, Human R, Human N) covered and those can be provided by the same manufacturer (Fiasp and Novolog) to meet the RAA category, or Novolin R and Humulin R to meet the human insulin category. Aged - you could be right but based on my discussions with CMS back in December I don't think what you are saying is correct. Do you have the wording from the 2024 bid package you are referencing? If you look at the FRF it contains numerous afrezza cartridge types. In the FAQ it says the below and I don't have time right now to go through the entire bid package. I was hoping MNKD was going to keep a very close eye on this. Hopefully they are. Q1. What is the Formulary Reference File (FRF)? A1. The FRF is a listing of drugs that Part D plan sponsors must utilize in the submission of Part D formularies to the Centers for Medicare & Medicaid Services (CMS) for review. Each row of the file represents a single drug as identified by an RxNorm concept unique identifier (RXCUI) and related fields outlined in question two below I have responded to many Federal RFPs in my day. The word "must" or "shall" is a requirement. The use of the word "may" makes it a non-requirement and the CMS would not be able to properly score the response. You can see A1. above says "Part D plan sponsors must". This link points to the FRF but we need to find where it talks about "forms" and "types" and I don't have time right now. www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/rxcontracting_formularyguidance |
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Post by agedhippie on Mar 3, 2023 9:57:59 GMT -5
I don't have the 2024 bid package. As you said rightly said earlier it's not out yet, and I haven't found a bootleg copy  The two drug rule is covered in the Medicare part D manual under 30.2.1 - Formulary Categories and Classes: Each category or class must include at least two drugs (unless only one drug is available for a particular category or class, or only two drugs are available but one drug is clinically superior to the other for a particular category or class), regardless of the classification system that is utilized. The two drug minimum requirement must be met through the provision of two chemically distinct drugs.There is a carve out for protected class drugs, but diabetes is not a protected class. That's why if you look at Medicare formularies you will find two of everything! The example I gave earlier of RAA, basal, etc. is from one of the formularies which seems to have done a deal with Novo Nordisk as they had two of their products for each category... |
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Post by sayhey24 on Mar 3, 2023 10:56:10 GMT -5
I don't have the 2024 bid package. As you said rightly said earlier it's not out yet, and I haven't found a bootleg copy The two drug rule is covered in the Medicare part D manual under 30.2.1 - Formulary Categories and Classes: Each category or class must include at least two drugs (unless only one drug is available for a particular category or class, or only two drugs are available but one drug is clinically superior to the other for a particular category or class), regardless of the classification system that is utilized. The two drug minimum requirement must be met through the provision of two chemically distinct drugs.There is a carve out for protected class drugs, but diabetes is not a protected class. That's why if you look at Medicare formularies you will find two of everything! The example I gave earlier of RAA, basal, etc. is from one of the formularies which seems to have done a deal with Novo Nordisk as they had two of their products for each category... What is a "Category or Class" defined as; "long acting"; "rapid acting" etc? Somewhere there should also be "form" and "type". start here - I am hoping MNKD has someone working this near fulltime. Going through this stuff takes some experience and TIME and while I have done many RFP responses mine have been DoD and "Agency". I have never done CMS but it should be similar. www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/rxcontracting_applicationguidance |
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Post by uvula on Mar 3, 2023 15:05:35 GMT -5
One would hope that a PhD in Pharmacy Science would be exactly the right background to navigate through this quagmire.
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Post by prcgorman2 on Mar 5, 2023 19:33:54 GMT -5
One would hope that a PhD in Pharmacy Science would be exactly the right background to navigate through this quagmire. Are you suggesting the CEO should be checking government language in regulations? Or, that MannKind needs to hire or assign a PharmaD to the job? |
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