|
|
Post by cretin11 on Jan 27, 2023 11:48:12 GMT -5
I love this board. Good investigation of important questions and great dialogue. Such a stark contrast to StockTwits and Yahoo! Conversations (which I’ve not checked in years but last I did some idiot was still impersonating my avatar to post FUD). I hope ProBoards and the moderators benefit accordingly. Of course, now aged and sayhey are the bad guys on Stocktwits🤣#TheNateCrew #TheyStalkUs Seems getting to the truth is irritating for some people, but I think it’s productive. And we are given the platform here to be able to do it. LOL, i can't see his posts over there (a blessing), is he still demanding that you "apologize" for all the damage you have caused over here on PB, sports? Not surprised he and the minions see aged and sayhey as bad guys. That's how they view anyone who dares to suggest improvements can be made. This PB platform is superior in every way to ST. #thedupedest 🤣 |
|
|
|
Post by sportsrancho on Jan 27, 2023 17:56:10 GMT -5
LMAO…😂
No, I thought that was you🤣
Let’s face it, you’re just too pragmatic:-)
|
|
|
|
Post by stevil on Jan 28, 2023 0:47:04 GMT -5
Already have 1 denial from one Humana MAP, nonformulary. This new Afrezza Assist group is way better than the previous. I’ve learned how to document better to get Afrezza approved but they must be doing something different because this one got approved. I was expecting it to because the guy is struggling to get control with novolog and is hypoglycemic often overnight but his A1c was 6.7 so I thought might deny it simply because his diabetes is technically “well controlled”. Maybe there is hope for humanity after all. |
|
|
|
Post by sayhey24 on Jan 28, 2023 8:11:54 GMT -5
Already have 1 denial from one Humana MAP, nonformulary. This new Afrezza Assist group is way better than the previous. I’ve learned how to document better to get Afrezza approved but they must be doing something different because this one got approved. I was expecting it to because the guy is struggling to get control with novolog and is hypoglycemic often overnight but his A1c was 6.7 so I thought might deny it simply because his diabetes is technically “well controlled”. Maybe there is hope for humanity after all. WHOOOO!!! - stop the presses. Are you saying Humana approved the appeal for Medicare for afrezza and now your patient is getting $35 afrezza? Maybe CMS was right when they said 80% plus would get approved. IDK what happened and I don't know what impact CMS could have had on this "in general" with "ALL" the providers such as Humana but maybe having the right lawyers talk with them may have helped. Sports - maybe this is Stocktwits worthy that Stevil got the $35 coverage after working with Afrezza Assist and his PWD had a 6.7 A1c!! |
|
|
|
Post by sportsrancho on Jan 28, 2023 9:45:20 GMT -5
This new Afrezza Assist group is way better than the previous. I’ve learned how to document better to get Afrezza approved but they must be doing something different because this one got approved. I was expecting it to because the guy is struggling to get control with novolog and is hypoglycemic often overnight but his A1c was 6.7 so I thought might deny it simply because his diabetes is technically “well controlled”. Maybe there is hope for humanity after all. WHOOOO!!! - stop the presses. Are you saying Humana approved the appeal for Medicare for afrezza and now your patient is getting $35 afrezza? Maybe CMS was right when they said 80% plus would get approved. IDK what happened and I don't know what impact CMS could have had on this "in general" with "ALL" the providers such as Humana but maybe having the right lawyers talk with them may have helped. Sports - maybe this is Stocktwits worthy that Stevil got the $35 coverage after working with Afrezza Assist and his PWD had a 6.7 A1c!! Posted:-) I just saw Mike talking this morning about how difficult they were. This is a huge win. “Why Humana makes peoples lives difficult is frustrating. We have tried many times of the years to make it easier but they make too much in rebates and choose block competition.” |
|
|
|
Post by agedhippie on Jan 28, 2023 9:58:19 GMT -5
Already have 1 denial from one Humana MAP, nonformulary. This new Afrezza Assist group is way better than the previous. I’ve learned how to document better to get Afrezza approved but they must be doing something different because this one got approved. I was expecting it to because the guy is struggling to get control with novolog and is hypoglycemic often overnight but his A1c was 6.7 so I thought might deny it simply because his diabetes is technically “well controlled”. Maybe there is hope for humanity after all. I take it the A1c was influenced by the nighttime hypos and so it could be argued that, in addition to QoL, the A1c was higher in reality? Did Humana cover Afrezza in the formulary with PA, or not cover it at all? stevil |
|
|
|
Post by stevil on Jan 28, 2023 10:36:43 GMT -5
It is still non formulary but it got approved with PA. I don’t know the copay amount yet, just got the email it was approved.
|
|
|
|
Post by prcgorman2 on Jan 28, 2023 10:57:40 GMT -5
So I write a big long ass rant about needing full-scale attack on the ADA Standard Of Care (SoC) and then come to this thread to find I might be wrong? WOOHOO! Please God let me be wrong in a BIG way.
|
|
|
|
Post by stevil on Jan 28, 2023 14:11:22 GMT -5
I don’t think we need a SoC change until data supports one.
What we do need is better insurance coverage for Afrezza. Shouldn’t need to get a PA for every insulin dependent diabetic.
|
|
|
|
Post by peppy on Jan 28, 2023 14:47:30 GMT -5
This new Afrezza Assist group is way better than the previous. I’ve learned how to document better to get Afrezza approved but they must be doing something different because this one got approved. I was expecting it to because the guy is struggling to get control with novolog and is hypoglycemic often overnight but his A1c was 6.7 so I thought might deny it simply because his diabetes is technically “well controlled”. Maybe there is hope for humanity after all. I take it the A1c was influenced by the nighttime hypos and so it could be argued that, in addition to QoL, the A1c was higher in reality? Did Humana cover Afrezza in the formulary with PA, or not cover it at all? stevil Perhaps the A1c does reflect " the probability of complications." What is the probability of complication from frequent nighttime hypos that you only know about with a continuous glucose monitor? Aged wrote, "Diabetes is a disease where area under the graph matters, and the easiest way to measure that is an A1c. The medical world has well established and researched charts giving the probability of complications against A1c - it's why they pick 7 as a target for A1c (and why I pick 6.5!) You don't want to wait 20 years to see how a treatment plays out so you look at the A1c that the treatment achieves and say from the data that you expect complications to change by X%. |
|
|
|
Post by hopingandwilling on Jan 28, 2023 15:45:00 GMT -5
How a Drug Company Made $114 Billion by Gaming the U.S. Patent System - The New York Times (nytimes.com)
In this article, the writer explains the problem for many people on Medicare. Abbvie’s Humira represents 1/3 of their revenue based on the drug being initially approved for RA. However, they would tweak the drug by various means, like getting it approved for another indication—like Crohn’s disease and getting a new patent, thus getting a patent extension. This new patent prevents another company from offering a cheaper version. When Medicare patients use insulin and they hear they can get a refill for the most expensive insulin product on the market (Afrezza ) and pay only $35.00, they forget there is an insurance company or company with a self-insured healthcare plan for their employees that will make up the difference in the $35.00 and the actual cost the drug company is selling their drug.
In this article, they explain one case where the patient’s company was a self-insured healthcare plan. They would pay the difference in the co-pay or special cap-on-cost of the drug, like the $35.00 insulin situation. But in the case of this article, the patient was using Humira, and the company was paying the total price for Humira, which is about $70,000.00 per year. This employee wasn’t even making $70,000.00 a year. The company offered her a special deal that would save the company 10s of thousands of dollars by letting her still get her Humira drug, plus she would get a vacation deal at no cost. The company would fly her to the Bahamas, she would see a medical doctor there, and the doctor would write her a prescription for a cheaper version of Humira for a four-month supply. So, the employer fly’s her to the Bahamas three times a year and they are saving a bundle of money by doing this.
United Therapeutics is the master of doing what Abbvie is doing. For United, it is their major drug-Tyvaso. Times are changing---the gouging of drug companies is going to change, or our nation will go broke. For Abbvie, the deal they cut to keep competitors from launching their cheaper drug ended last month.
|
|
|
|
Post by sayhey24 on Jan 28, 2023 16:22:01 GMT -5
I don’t think we need a SoC change until data supports one. What we do need is better insurance coverage for Afrezza. Shouldn’t need to get a PA for every insulin dependent diabetic. You won't get better insurance coverage until it has better representation in the SoC. Medicare just worked out because of the IRA. Back in 2021 MNKD joined the Senior Saver Model and this $35 afrezza was suppose to be available in 2022. It was not even put in the 2023 bid packages let alone the 2022 where it should have been. I never heard of anyone getting $35 afrezza in 2022. For 2023 Mike thought it was being covered as part of the new law and said so on the 3Q call. In reality as Aged correctly pointed out no one was covering. The good news is we had some timely follow-up before 2023 and when $35 insulin guidance was being issued for the new law. In a way I guess we owe the $35 afrezza to Aged and him telling us it was not being covered. At least with Medicare for 2023 we have a work around which CMS says should work 80% plus of the time. I will be very sad if the bid packages in 2023 do not require form "inhalable". That would be squarely on MNKD dropping the ball. For non-Medicare insurance they are not going to cover until they are forced to by the SoC. Dave Kendall told us that and I believe Dave was correct. Then again I believed Dave when he said this was the easiest job he ever had. Then again maybe he did and it was just bad timing with Mounjaro. For the T1s we are just going to need to wait for the kids unless Mike wants to go after a rescue product with Lane from Nudge. The kids study will move the SoC for the T1s. If it was up to me I would go after the rescue product but I am a bid more aggressive. I would also try the T2 "Treat to Target" with Lane. I know Mike has thought about a Mounjaro study but thats a long term thing and will cost. Maybe we will hear some plans about it next month during the call. The reality is he needs something to take to ADA2023. BTW - the "Treat to Target" as a full blown study could be done with a partner funding most it it. The name Robert Ford comes to mind and he wants to break into the T2 market in the worst way. There is nothing wrong with doing a Nudge NB study followed by a large scale study. |
|
|
|
Post by hellodolly on Jan 28, 2023 16:53:30 GMT -5
I don’t think we need a SoC change until data supports one. What we do need is better insurance coverage for Afrezza. Shouldn’t need to get a PA for every insulin dependent diabetic. You won't get better insurance coverage until it has better representation in the SoC. Medicare just worked out because of the IRA. Back in 2021 MNKD joined the Senior Saver Model and this $35 afrezza was suppose to be available in 2022. It was not even put in the 2023 bid packages let alone the 2022 where it should have been. I never heard of anyone getting $35 afrezza in 2022. For 2023 Mike thought it was being covered as part of the new law and said so on the 3Q call. In reality as Aged correctly pointed out no one was covering. The good news is we had some timely follow-up before 2023 and when $35 insulin guidance was being issued for the new law. In a way I guess we owe the $35 afrezza to Aged and him telling us it was not being covered. At least with Medicare for 2023 we have a work around which CMS says should work 80% plus of the time. I will be very sad if the bid packages in 2023 do not require form "inhalable". That would be squarely on MNKD dropping the ball. For non-Medicare insurance they are not going to cover until they are forced to by the SoC. Dave Kendall told us that and I believe Dave was correct. Then again I believed Dave when he said this was the easiest job he ever had. Then again maybe he did and it was just bad timing with Mounjaro. For the T1s we are just going to need to wait for the kids unless Mike wants to go after a rescue product with Lane from Nudge. The kids study will move the SoC for the T1s. If it was up to me I would go after the rescue product but I am a bid more aggressive. I would also try the T2 "Treat to Target" with Lane. I know Mike has thought about a Mounjaro study but thats a long term thing and will cost. Maybe we will hear some plans about it next month during the call. The reality is he needs something to take to ADA2023. BTW - the "Treat to Target" as a full blown study could be done with a partner funding most it it. The name Robert Ford comes to mind and he wants to break into the T2 market in the worst way. There is nothing wrong with doing a Nudge NB study followed by a large scale study. I think a multi-prong approach looking at Afrezza-R, a "Treat To Target" study, etc. AFTER the kids and India studies are complete could just be the icing Mike is waiting for to possibly unlock offers from partners on the sidelines. Maybe I'm off-base with that inclination? |
|
|
|
Post by agedhippie on Jan 29, 2023 0:41:05 GMT -5
I take it the A1c was influenced by the nighttime hypos and so it could be argued that, in addition to QoL, the A1c was higher in reality? Did Humana cover Afrezza in the formulary with PA, or not cover it at all? stevil Perhaps the A1c does reflect " the probability of complications." What is the probability of complication from frequent nighttime hypos that you only know about with a continuous glucose monitor? If you have frequent nightime hypos you will not need a CGM to know about them! (Unless you are hypo unaware which is relatively rare and a whole order of magnitude more difficult) |
|
|
|
Post by peppy on Jan 29, 2023 4:51:49 GMT -5
How a Drug Company Made $114 Billion by Gaming the U.S. Patent System - The New York Times (nytimes.com) In this article, the writer explains the problem for many people on Medicare. Abbvie’s Humira represents 1/3 of their revenue based on the drug being initially approved for RA. However, they would tweak the drug by various means, like getting it approved for another indication—like Crohn’s disease and getting a new patent, thus getting a patent extension. This new patent prevents another company from offering a cheaper version. When Medicare patients use insulin and they hear they can get a refill for the most expensive insulin product on the market (Afrezza ) and pay only $35.00, they forget there is an insurance company or company with a self-insured healthcare plan for their employees that will make up the difference in the $35.00 and the actual cost the drug company is selling their drug. In this article, they explain one case where the patient’s company was a self-insured healthcare plan. They would pay the difference in the co-pay or special cap-on-cost of the drug, like the $35.00 insulin situation. But in the case of this article, the patient was using Humira, and the company was paying the total price for Humira, which is about $70,000.00 per year. This employee wasn’t even making $70,000.00 a year. The company offered her a special deal that would save the company 10s of thousands of dollars by letting her still get her Humira drug, plus she would get a vacation deal at no cost. The company would fly her to the Bahamas, she would see a medical doctor there, and the doctor would write her a prescription for a cheaper version of Humira for a four-month supply. So, the employer fly’s her to the Bahamas three times a year and they are saving a bundle of money by doing this. United Therapeutics is the master of doing what Abbvie is doing. For United, it is their major drug-Tyvaso. Times are changing---the gouging of drug companies is going to change, or our nation will go broke. For Abbvie, the deal they cut to keep competitors from launching their cheaper drug ended last month. "the doctor would write her a prescription for a cheaper version of Humira for a four-month supply" What cheaper version than Humira? What was she prescribed in the Bahamas? HUM IRA (adalimumab) Injection, has a black box warning. www.accessdata.fda.gov/drugsatfda_docs/label/2011/125057s0276lbl.pdf-----.-INDICA TIONS AND USAGE------ HUMIRA is a tumor necrosis factor (TN of: Rheumatoid Arthritis (RA) (1.1) F) blocker indicated for treatment . Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. Juvenile Idiopathic Arthritis(JIA) (1,2) . Reducing signs and symptoms of moderately to severely active polyarticular JIA in pediatiic patients 4 years of age and older. Psoriatic Arthritis (PsA) (1.3) . Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. Ankylosing Spondylitis (AS) (1.4) . Reducing signs and symptoms in adult patients with active AS. Crohn's Disease (CD) (1.5) . Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to inflixiinab. |
|
