|
|
Post by uvula on Aug 8, 2023 9:34:58 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?
|
|
|
|
Post by prcgorman2 on Aug 8, 2023 10:16:23 GMT -5
For the first case, I don't remember the exact answer but it is either the government or the insurer (or perhaps a combination).
For the second case, I assume MannKind eats the cost but it's only an assumption. There may be a patient-hardship subsidy involved I'm not aware of.
|
|
|
|
Post by sayhey24 on Aug 8, 2023 18:12:05 GMT -5
Medicare Plan D goes through a bid process between the government and the insurers. The insurers base their proposed bid to Medicare based on their cost for the drug. Mannkind is not giving away afrezza to the Medicare market. In the end the government is paying. Here is an overview www.cms.gov/newsroom/fact-sheets/medicare-part-d-direct-and-indirect-remuneration-dirThe big question is did Mike keep his eye on the ball for Medicare 2024 without pre auths. From yesterdays call we know Mike attributed the increase in afrezza sales to Medicare $35 coverage. We never got a straight answer for 2024 but got a maybe 2024 or maybe 2025. What I do know is this time last year the idea of Medicare covering afrezza at all was not in Mike's wildest dreams and we got V-Go for the T2s. Afrezza on 2024 Medicare formularies and not needing pre auths would be huge. |
|
|
|
Post by prcgorman2 on Aug 9, 2023 6:31:21 GMT -5
Mike did emphasize how difficult it had been to get Medicare coverage for Afrezza and that they had collaborated (I’lll say because I don’t remember the phrase Mike used) with the CMS. I’ve assumed MannKind kept their eye on the ball, otherwise Afrezza would not have been included, again. I also had a little difficulty following what the exact story there is with respect to 2024 formularies and prior authorizations, but got the sense that the Ped, Cipla, and pump-switch trials were going to play into the formulary/coverage picture somehow, so I think your “2024 or maybe 2025” view is probably correct.
|
|
|
|
Post by sayhey24 on Aug 9, 2023 6:49:00 GMT -5
Don't even get me started on this as I personally got involved. When I first asked, maybe last November about how Mannkind was getting included in the $35 pricing I got crickets. After several months and some work CMS said about 80% will get approved but they will need to go through the pre auth for 2023. The number has been over 90% approval but it takes work and most T2s won't even try.
If the pre auth gets dropped its a game changer. It opens the T2 market. Afrezza will make Tyvaso DPI look like an after thought. There are about 20M T2s on Medicare. Robert Ford and Kevin Sayer both want an easy way to sell CGMs to Medicare T2s. They need insulin. GLP1s don't do it. Icodec will once approved but has little value with the CGM.
It was included in the bid packages but we will need to see what makes the cut.
|
|
|
|
Post by agedhippie on Aug 9, 2023 8:03:33 GMT -5
... What I do know is this time last year the idea of Medicare covering afrezza at all was not in Mike's wildest dreams and we got V-Go for the T2s. Afrezza on 2024 Medicare formularies and not needing pre auths would be huge. Medicare has covered Afrezza for years, insurers providing Medicare cover have been a lot more reluctant. It has been available to low income Medicare recipients for $35 since 2022 with Mannkind announcing this a year earlier in 2021 so I really hope Mike wasn't taken by surprise (https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-participate-2022-medicare-part-d-senior-savings-model). What we are seeing here is Medicare patients using Afrezza in the same proportion (28% of revenue) as with RAAs. It does overstate the case though because currently pediatrics are not using Afrezza whereas they are using RAA. This means the rate will probably continue to rise since the weighting is to the older end, and will revert to 28% when the pediatrics approval goes though. |
|
|
|
Post by sayhey24 on Aug 9, 2023 15:53:11 GMT -5
... What I do know is this time last year the idea of Medicare covering afrezza at all was not in Mike's wildest dreams and we got V-Go for the T2s. Afrezza on 2024 Medicare formularies and not needing pre auths would be huge. Medicare has covered Afrezza for years, insurers providing Medicare cover have been a lot more reluctant. It has been available to low income Medicare recipients for $35 since 2022 with Mannkind announcing this a year earlier in 2021 so I really hope Mike wasn't taken by surprise (https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-participate-2022-medicare-part-d-senior-savings-model). What we are seeing here is Medicare patients using Afrezza in the same proportion (28% of revenue) as with RAAs. It does overstate the case though because currently pediatrics are not using Afrezza whereas they are using RAA. This means the rate will probably continue to rise since the weighting is to the older end, and will revert to 28% when the pediatrics approval goes though. I said don't get me started on this. This is a sore subject with me. Yes, afrezza was included in the senior saving model which ends 12/31/2023 thanks to the IRA. Did Mannkind sell any afrezza through it - I doubt it. If they did it was not much. You say Mike was not caught off guard, well go back and listen to the 3Q call. He was not prepared for the IRA, so much so he bought V-Go so he had something to put in the sales reps bags for the T2 market. Going forward the IRA and $35 Medicare insulin is a potential game changer. The 2023 pre auth process to get the $35 insulin is not the best but it is better than nothing and it is actually helping to grow scripts, as Mike said on Monday. Are these T1 or T2 scripts? I would think mostly T1s. Mike danced on Monday around 2024 and 2025. I guess the 2024 info is publicly available in October so we will know for sure in a few months. |
|
|
|
Post by agedhippie on Aug 9, 2023 17:23:37 GMT -5
I said don't get me started on this. This is a sore subject with me. Yes, afrezza was included in the senior saving model which ends 12/31/2023 thanks to the IRA. ... I think your timelines are muddled. The Medicare Part D Senior Savings Model had absolutely nothing to do with the IRA. Not least because it started two years prior to the IRA (Mannkind joined in the second year in March 2021 - see my earlier link) and Mannkind commenced coverage at $35 in January 2022 under that plan. The IRA only became law in August 2022 so Afrezza had already been sold for $35 under the model for eight months at that point, and continued to do so for the rest of the year when the IRA provisions kicked in. This makes it hard to say that Mike had no idea that $35 insulin was coming given that they were already selling it. |
|
|
|
Post by sayhey24 on Aug 9, 2023 18:41:58 GMT -5
As I said - afrezza was included in the senior saving model which ends 12/31/2023. It was started years before the IRA but because of the IRA and the $35 insulin its ending this year. Without the IRA the SSM would not be ending and afrezza would still not be selling. The SSM for Mannkind and afrezza was an epic fail.
IMO, Mike was totally caught off guard with what the IRA was about to mean for afrezza. He bought V-Go. Do I need to say more? I am not even sure he fully realized how V-Go and afrezza are competing products. However, the reality was he had no plan for afrezza in the T2 space let alone the Medicare T2 space and V-Go plugged the hole and now he had something to put in the reps "bags". He was very proud on numerous call of being able to put V-Go in the sales reps "bags".
What in the world is he going to do with it once pre auths are no longer required for afrezza? On Monday he was still talking about "stabilizing" it. Great, now its not losing that much money and he is "hoping" its going to start growing soon. Its never going to be a growth product and with icodec coming there is not much room in the T2 market. For meal time control we already have a superior solution for the T2s. The new T2 SoC is becoming pretty clear; get the T2 on a GLP1 asap to lose some weight and reduce A1c; add the afrezza to control the meal time spikes and sell CGMs and backstop the GLP1s for when they stop using in a year; and add the icodec if the T2 is in really bad shape.
|
|
|
|
Post by cretin11 on Aug 9, 2023 21:36:16 GMT -5
Agree. Ditch V-Go. Afrezza is far superior and we don’t need to compete against it ourselves. Maybe we could find a sucker… I mean buyer to take V-Go and put it another company’s bag.
|
|
|
|
Post by mymann on Aug 9, 2023 23:06:08 GMT -5
V-Go is a success, it gave Mike well deserved gift of million shares for his purchase. Hamburgers dropping from the sky and with V-Go that's all it takes to eat a berger for diabetics.
|
|
|
|
Post by agedhippie on Aug 10, 2023 8:17:19 GMT -5
As I said - afrezza was included in the senior saving model which ends 12/31/2023. It was started years before the IRA but because of the IRA and the $35 insulin its ending this year. Without the IRA the SSM would not be ending and afrezza would still not be selling. The SSM for Mannkind and afrezza was an epic fail. ... What in the world is he going to do with it once pre auths are no longer required for afrezza? On Monday he was still talking about "stabilizing" it. Great, now its not losing that much money and he is "hoping" its going to start growing soon. Its never going to be a growth product and with icodec coming there is not much room in the T2 market. For meal time control we already have a superior solution for the T2s. The new T2 SoC is becoming pretty clear; get the T2 on a GLP1 asap to lose some weight and reduce A1c; add the afrezza to control the meal time spikes and sell CGMs and backstop the GLP1s for when they stop using in a year; and add the icodec if the T2 is in really bad shape. Let's keep that time line straight. Mannkind sold through the SSM for only a year before the IRA kicked in so while SSM started earlier that's irrelevant to Afrezza sales. As to exactly what those sales looked like; to the best of my knowledge the impact has never been divulged but it may be in a 10Q or transcript somewhere that I have not seen (is it?) Why will pre-auths no-longer be required? The requirement is to sell formulary insulin for $35, not to eliminate pre-auth and sell for $35. Let's be clear on this - you believe that insurers will be compelled to sell Afrezza without pre-authorization, and I think that is an incorrect reading of the IRA on your part. Right now we are waiting to see if everyone has Afrezza without pre-auth in their formulary which I don't believe will happen because the IRA does not require it, not because Mike is falling down on his job. A new SoC for T2 requires data and proper trials. I have seen nothing like that out there and absent that the SoC will remain unchanged. |
|
|
|
Post by prcgorman2 on Aug 10, 2023 9:00:29 GMT -5
As I said - afrezza was included in the senior saving model which ends 12/31/2023. It was started years before the IRA but because of the IRA and the $35 insulin its ending this year. Without the IRA the SSM would not be ending and afrezza would still not be selling. The SSM for Mannkind and afrezza was an epic fail. ... What in the world is he going to do with it once pre auths are no longer required for afrezza? On Monday he was still talking about "stabilizing" it. Great, now its not losing that much money and he is "hoping" its going to start growing soon. Its never going to be a growth product and with icodec coming there is not much room in the T2 market. For meal time control we already have a superior solution for the T2s. The new T2 SoC is becoming pretty clear; get the T2 on a GLP1 asap to lose some weight and reduce A1c; add the afrezza to control the meal time spikes and sell CGMs and backstop the GLP1s for when they stop using in a year; and add the icodec if the T2 is in really bad shape. Let's keep that time line straight. Mannkind sold through the SSM for only a year before the IRA kicked in so while SSM started earlier that's irrelevant to Afrezza sales. As to exactly what those sales looked like; to the best of my knowledge the impact has never been divulged but it may be in a 10Q or transcript somewhere that I have not seen (is it?) Why will pre-auths no-longer be required? The requirement is to sell formulary insulin for $35, not to eliminate pre-auth and sell for $35. Let's be clear on this - you believe that insurers will be compelled to sell Afrezza without pre-authorization, and I think that is an incorrect reading of the IRA on your part. Right now we are waiting to see if everyone has Afrezza without pre-auth in their formulary which I don't believe will happen because the IRA does not require it, not because Mike is falling down on his job. A new SoC for T2 requires data and proper trials. I have seen nothing like that out there and absent that the SoC will remain unchanged. No studies to speak of? Non-inferior? More expensive? Hmmm, prior authorization (and historically, in many cases, STEP) required. Have a nice day.
The Peds, pump-switch, and Cipla approval trials are key. I've also read the relevant content in the Inflation Reduction joke, er, Act, and agree there is no requirement to cover Afrezza without prior authorization specifically.
|
|
|
|
Post by sayhey24 on Aug 18, 2023 5:55:38 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.
|
|
|
|
Post by peppy on Aug 18, 2023 6:36:02 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. |
|
