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Post by uvula on Mar 5, 2023 21:15:20 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? He should be proactively talking to the government people writing the regulations. Not waiting until the regulations are published. (Disclaimer: I've never run a company.) |
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Post by sayhey24 on Mar 6, 2023 7:31:13 GMT -5
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? He should be proactively talking to the government people writing the regulations. Not waiting until the regulations are published. (Disclaimer: I've never run a company.) I sure hope he and/or his team have been. Back in November he assumed afrezza was just going to be offered for $35. Aged then correctly pointed out it was not on any formularity. For 2024 if they have not been working/lobbying CMS we are going to end up in the same place we are now - pre auths required. With the CMS CGM decision which now only requires the PWD to be "insulin treated" being on the formularity is huge. Abbott had hoped they could convince GPs to prescribe a once daily basal to Medicare T2s so they could sell more CGMs. With this decision all they need to do is have the GP prescribed afrezza for corrections - as an add-on - which is exactly what the Affinity 2 study did. This approach will only work if they do not need pre auths. |
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Post by Thundersnow on Mar 6, 2023 9:50:31 GMT -5
I think the Gov't screwed this up. They should have clarified which insulin gets the $35 price tag. They should have said any insulin that has been on the market for 7+ years will cost $35. I don't see the BIG 3 offering their latest and greatest insulin at $35. This will kill innovation to make better insulin in the future. When Biden said it costs $10 bucks to make a vial he was talking about Humulin N/R which is over 40 years old. I'm sure the new drugs cost more to produce.
No wonder MNKD is down. So much for the days of 90% Profit Margins. That was short lived.
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Post by uvula on Mar 6, 2023 10:00:02 GMT -5
Politicians are lazy and greedy. They didn't screw up. That did exactly what their funders wanted them to do. Lobbyists write the legislation they want and give it the politicians they own. Big Pharma gets what it wants. The politicians get what they want (money).
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Post by peppy on Mar 6, 2023 10:04:24 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? Mike C is a Pharm D, or Mike C has a diploma that makes him a pharm D. |
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Post by peppy on Mar 6, 2023 10:10:32 GMT -5
I think the Gov't screwed this up. They should have clarified which insulin gets the $35 price tag. They should have said any insulin that has been on the market for 7+ years will cost $35. I don't see the BIG 3 offering their latest and greatest insulin at $35. This will kill innovation to make better insulin in the future. When Biden said it costs $10 bucks to make a vial he was talking about Humulin N/R which is over 40 years old. I'm sure the new drugs cost more to produce. No wonder MNKD is down. So much for the days of 90% Profit Margins. That was short lived. No matter what the advertisement says, there is very little difference between insulin on the market for greater than 7 years and now. Humalog, Novolog, FIASP, a different adjuvant, changing the time from subq to blood stream by nothing very noticeable. The reason afrezza is different is it's delivery. the alveoli, the left atrium, the left ventricle, the blood stream. |
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Post by Thundersnow on Mar 6, 2023 10:29:10 GMT -5
I think the Gov't screwed this up. They should have clarified which insulin gets the $35 price tag. They should have said any insulin that has been on the market for 7+ years will cost $35. I don't see the BIG 3 offering their latest and greatest insulin at $35. This will kill innovation to make better insulin in the future. When Biden said it costs $10 bucks to make a vial he was talking about Humulin N/R which is over 40 years old. I'm sure the new drugs cost more to produce. No wonder MNKD is down. So much for the days of 90% Profit Margins. That was short lived. No matter what the advertisement says, there is very little difference between insulin on the market for greater than 7 years and now. Humalog, Novolog, FIASP, a different adjuvant, changing the time from subq to blood stream by nothing very noticeable. The reason afrezza is different is it's delivery. the alveoli, the left atrium, the left ventricle, the blood stream. There might be little difference in performance but the cost is huge. You can't tell me Tresiba costs $10 per vial to make? Same with Afrezza.....Even though performance is superior it costs more than $10 per "??" (can't say vial...LOL) Maybe this is why NOVO and Sanofi has not matched Lily's announcement. |
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Post by sayhey24 on Mar 6, 2023 10:32:39 GMT -5
I think the Gov't screwed this up. They should have clarified which insulin gets the $35 price tag. They should have said any insulin that has been on the market for 7+ years will cost $35. I don't see the BIG 3 offering their latest and greatest insulin at $35. This will kill innovation to make better insulin in the future. When Biden said it costs $10 bucks to make a vial he was talking about Humulin N/R which is over 40 years old. I'm sure the new drugs cost more to produce. No wonder MNKD is down. So much for the days of 90% Profit Margins. That was short lived. The legislation included all insulins of form vial, pen and inhaled but then pushed the implementation back to CMS for approved drugs on the formularity. For 2023 it was what was already awarded by CMS to the insurance companies. It was too late to do anything more. The vendors are not supplying all these insulins for $35. They are supplying them at whatever their price is - it could be $1000 for a box of afrezza. CMS through the bid process is picking up the cost for the Plan D insurers. The U.S. tax payers are picking up the cost. For 2023 afrezza never made the formularities and needs to go through a pre auth process which means the doctor can not just write the script. They have to justify it and it needs to be approved. Hopefully in 2024 afrezza will be on the formularity and its MNKDs job to make sure it is. I see it on the spreadsheet which CMS asked the insurance companies to bid on. Assuming it is - its a totally different game. Abbott and Dexcom will have a much easier sell job having doctors write a script for afrezza as an add-on for T2s. Mike just needs to get them some study data for the GLP1s which were not part of Affinity 2. Which insulin are you looking for that you are saying the BIG 3 are not offering their latest and greatest insulin. What gets included is proposed to CMS by the insurance companies. 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. |
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Post by peppy on Mar 6, 2023 10:33:07 GMT -5
I didn't tell you tresiba cost $10 per vial to make.
Tresiba was a new basal a few years ago correct? all the rage, a smoother basal.
The only reason Lilly is good, is it cost Lilly very little to make, their MEAL TIME insulin.
Fermenters and all.
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Post by Thundersnow on Mar 6, 2023 10:56:52 GMT -5
I didn't tell you tresiba cost $10 per vial to make. Tresiba was a new basal a few years ago correct? all the rage, a smoother basal. The only reason Lilly is good, is it cost Lilly very little to make, their MEAL TIME insulin. Fermenters and all. WADR....you're missing "my" point. The Gov't should have announced a TIERED Pricing program. The OLDER insulins which are cheap to make should be priced at $35. It's not advantageous for drug companies to charge $35 for newer drugs which costs more to make. We're kinda talking about 2 different issues. It's all good. |
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Post by lennymnkd on Mar 6, 2023 11:00:51 GMT -5
From seyhey :
The vendors are not supplying all these insulins for $35. They are supplying them at whatever their price is - it could be $1000 for a box of afrezza. CMS through the bid process is picking up the cost for the Plan D insurers. The U.S. tax payers are picking up the cost.
So pharma is being subsidized… we had this discussion
Awhile back .
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Post by agedhippie on Mar 6, 2023 12:32:57 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. |
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Post by prcgorman2 on Mar 6, 2023 13:32:17 GMT -5
Agree. Trying to hang your hat on one or two references in legislation and regulatory language is not recommended. sayhey is right. Affirmative advocacy is appropriate.
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Post by peppy on Mar 6, 2023 14:08:45 GMT -5
Agree. Trying to hang your hat on one or two references in legislation and regulatory language is not recommended. sayhey is right. Affirmative advocacy is appropriate.I don't even know what that means. Is that a campaign slogan? Insulin and Outsulin? www.michelizzi.com/inhaled-insulin-afrezza-outsulin/ |
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Post by prcgorman2 on Mar 6, 2023 14:43:32 GMT -5
Agree. Trying to hang your hat on one or two references in legislation and regulatory language is not recommended. sayhey is right. Affirmative advocacy is appropriate.I don't even know what that means. Is that a campaign slogan? Insulin and Outsulin? www.michelizzi.com/inhaled-insulin-afrezza-outsulin/Sorry. Sometimes I indulge in alliteration. How about "advocacy is appropriate"? i.e., don't wait around and hope things work out. Get after it. |
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