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Post by prcgorman2 on Aug 18, 2023 8:09:26 GMT -5
If you are on Medicare and pay $35 for afrezza, does the government pay the rest of the full cost or does mnkd subsidize some of the cost? Yesterday MC mentioned that mnkd matches the $35 cost for non-medicare patients also. In this case, is mnkd subsidizing some of the cost? As near as I can figure out it is a RUSE. I believe I learned, if someone has health insurance, it is status quo.The only thing that changed was the co-pay. The insurance company bills the same amount and the pharmacy purchasing managers are still getting their rebates for meeting quotas. I believe if you do not have health insurance, you get your insulin at 35 dollars, and some of the bill is covered by the government coffers. In the USA Medicare is the only entity that can negotiate medication drug prices. For the people that do not have medical insurance, I believe this comes into play. - as I understand it Medicare (i.e., the US government) subsidizes the difference between $35 and the covered cost of the drug. I don’t know the specifics of the MannKind program for people without (adequate?) insurance coverage, but they’re saying they will sell (or discount) Afrezza to the $35 copay. My guess is behind the scenes there is some process of discount rebates between the pharmacies and MannKind where MannKind makes the pharmacy whole for the cost of the Afrezza sold to uninsured (or underinsured) for $35. peppy - Medicare (CMS) is not the only entity that can negotiate medication drug prices. There’s a good article on GoodRx about drug pricing and negotiations. www.goodrx.com/hcp/providers/how-does-drug-pricing-work-in-the-us#:~:text=While%20some%20chain%20pharmacies%20negotiate,cases%2C%20bypassing%20the%20distributor%20altogether. That link looks like it might not work properly so I will share that I Google searched “Do pharmacies negotiate drug prices?”. That brought up numerous articles on drug price negotiation in the US. |
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Post by agedhippie on Aug 18, 2023 8:21:59 GMT -5
If I remember correctly the IRA originally had form "inhaled" included in the language but the last draft removed it and turned the responsibly back to CMS. So while form "inhaled" is not legally required it gave CMS the responsibility. In the bid packages which went out for 2023 in April of 2022 afrezza was not included for bid. If I go to Medicare.gov and select afrezza the below banner is included even though its not on any 2023 coverage. IMPORTANT! New insulin benefit: Started January 1, 2023 $35 cap for a one-month supply of each Medicare Part D-covered insulin This new $35 cap may not be reflected when you compare 2023 plans In the 2024 bid packages which went out in April of 2023 I am pretty sure I saw afrezza included. Its not about what the insurer "are compelled to sell". Its about what CMS is going to pay for and what they asked for during the bid process. At this point we know 3 things. First is it was not included for 2023. Second, to get around this CMS leveraged the pre auth process which allows the insurers to get paid. Third is we are two months away from the public availability of what CMS accepted for 2024 and will see on Medcare.gov what insurers if any provide afrezza coverage without pre auths. The references to inhaled insulin was a call out to the change in the IRS tax code that bought inhaled insulin into scope for high co-pay plans. It was not a requirement to provide inhaled insulin, but to avoid people using it being taxed for buying it rather than RAA. The CMS sets the low bar for the formularies. Insurers must meet or exceed that bar. They are compelled to provide that minimum. The idea that CMS used pre-auth steps as a way of paying insurers Afrezza is wrong. In the current (2023) formulary the insurer is at liberty to offer Afrezza with or without pre-auth and CMS will pay. The issue for Afrezza is that it's a lot more expensive than RAA and insurers don't want that eating into their profits so most put pre-auths on it. If anything pre-auths will become more common because insulin is $35 whether it's in the preferred or non-preferred section of an insurers formulary. This is assuming they keep Afrezza in the formulary and don't just drop it to avoid having to cover it at the lower rate and reduce the number of items with pre-authorization (which looks good to CMS). |
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Post by akemp3000 on Aug 18, 2023 8:49:09 GMT -5
Wonder if pediatric approval will require pre-auth? If not, it would make the chess game more interesting and should work to Mannkind's favor.
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Post by agedhippie on Aug 18, 2023 9:13:42 GMT -5
Wonder if pediatric approval will require pre-auth? If not, it would make the chess game more interesting and should work to Mannkind's favor. This will vary from insurer to insurer depending on their formulary. I would expect their pre-auth policy for kids will track whatever their policy, pre-auth required or not, is for adults. |
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Post by sayhey24 on Aug 18, 2023 14:20:39 GMT -5
If I remember correctly the IRA originally had form "inhaled" included in the language but the last draft removed it and turned the responsibly back to CMS. So while form "inhaled" is not legally required it gave CMS the responsibility. In the bid packages which went out for 2023 in April of 2022 afrezza was not included for bid. If I go to Medicare.gov and select afrezza the below banner is included even though its not on any 2023 coverage. IMPORTANT! New insulin benefit: Started January 1, 2023 $35 cap for a one-month supply of each Medicare Part D-covered insulin This new $35 cap may not be reflected when you compare 2023 plans In the 2024 bid packages which went out in April of 2023 I am pretty sure I saw afrezza included. Its not about what the insurer "are compelled to sell". Its about what CMS is going to pay for and what they asked for during the bid process. At this point we know 3 things. First is it was not included for 2023. Second, to get around this CMS leveraged the pre auth process which allows the insurers to get paid. Third is we are two months away from the public availability of what CMS accepted for 2024 and will see on Medcare.gov what insurers if any provide afrezza coverage without pre auths. The references to inhaled insulin was a call out to the change in the IRS tax code that bought inhaled insulin into scope for high co-pay plans. It was not a requirement to provide inhaled insulin, but to avoid people using it being taxed for buying it rather than RAA. The CMS sets the low bar for the formularies. Insurers must meet or exceed that bar. They are compelled to provide that minimum. The idea that CMS used pre-auth steps as a way of paying insurers Afrezza is wrong. In the current (2023) formulary the insurer is at liberty to offer Afrezza with or without pre-auth and CMS will pay. The issue for Afrezza is that it's a lot more expensive than RAA and insurers don't want that eating into their profits so most put pre-auths on it. If anything pre-auths will become more common because insulin is $35 whether it's in the preferred or non-preferred section of an insurers formulary. This is assuming they keep Afrezza in the formulary and don't just drop it to avoid having to cover it at the lower rate and reduce the number of items with pre-authorization (which looks good to CMS). Aged - are you going to be OK if in fact when open enrolled starts in October we see afrezza being covered? There is that chance even though you keep insisting its not happening. Mike did hedge for 2025 but we will see. It was in the spreadsheet I saw in the original bid package although things could change. If what you are saying is correct and CMS "sets the low bar" then I am getting a little concerned for you. Then again I wonder how many drugs not included in the bid package are being added as "perks". Perks like "silver sneakers" I understand the selling point. Something like afrezza could get real expensive fast unless Uncle Sam is footing the bill. |
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Post by agedhippie on Aug 18, 2023 20:06:07 GMT -5
Aged - are you going to be OK if in fact when open enrolled starts in October we see afrezza being covered? There is that chance even though you keep insisting its not happening. Mike did hedge for 2025 but we will see. It was in the spreadsheet I saw in the original bid package although things could change. If what you are saying is correct and CMS "sets the low bar" then I am getting a little concerned for you. Then again I wonder how many drugs not included in the bid package are being added as "perks". Perks like "silver sneakers" I understand the selling point. Something like afrezza could get real expensive fast unless Uncle Sam is footing the bill. Afrezza is already covered by Medicare and covered by some insurers. If what you are talking about is universal coverage, yes I would be surprised but also perfectly fine with it - I believe diabetics should have choice. I am definitely correct that CMS sets the low bar - they set the minimum requirements for a formulary I suspect the spreadsheet you saw was the Formulary Reference File. That is a list of every drug that Medicare has approved, not a list of every drug that the insurer must cover. The FRF exists so there is a common taxonomy with the insurers, and for that reason Afrezza has been on it for a few years (it's a Medicare approved drug.) |
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Post by sayhey24 on Aug 19, 2023 5:57:46 GMT -5
What I saw was several afrezza products listed with many other drugs which comprised what I thought was the bid package. My personal non-Medicare experience has been if the RFP includes it as a "shall" or "must" the vendor needs to include it in their offer. What happens during negotiations is another story.
If afrezza did not make the cut then it was a lobbying failure on the part of MNKD and BP was once again able to convince the power to be to squash it. Mike's 2025 hedging is a little concerning and I think they had a layup for this. At this point we will just wait and see as we are only a few months away.
I think Mike has now realized the potential for the Medicare channel is huge. Thats a good thing. As I have said before, for afrezza in the T2 market all he needs to do is focus on the Medicare market and leverage the Medicare CGMs.
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Post by agedhippie on Aug 19, 2023 10:37:03 GMT -5
What I saw was several afrezza products listed with many other drugs which comprised what I thought was the bid package. My personal non-Medicare experience has been if the RFP includes it as a "shall" or "must" the vendor needs to include it in their offer. What happens during negotiations is another story. ... That definitely sounds like the FRF and is a list of all drugs Medicare will cover. The Medicare bid package never specifies actual drugs and instead requires ("must") coverage for each therapeutic class in the USP-NF (a slight oversimplification; the insurer can use their own class system but CMS make your life difficult if you do so everyone uses the USP-NF.) A class is defined by it's therapeutic use so Insulin, Rapid Acting includes both Afrezza and the RAA insulins. TLDR; Medicare will not require insurers to include Afrezza provided they have at least two RAA insulins in their bid package. |
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