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Post by jpg on Jun 14, 2015 16:37:13 GMT -5
But looks like it will take a while before AFREZZA can be prescribed, i.e. at least a 90 day lag time. For Type 1 "• Failure to achieve hemoglobin A1C ≤ 7 % in 90 days of a rapid or shortacting subcutaneous (SC) insulin product or clinically significant adverse effects experienced with SC rapid or short-acting insulin unexpected to occur with inhaled insulin For Type 2 "• Failure to achieve hemoglobin A1C ≤ 7 % in 90 days of a rapid or short-acting SC insulin product or clinically significant adverse effects experienced with SC rapid or short-acting insulin unexpected to occur with inhaled insulin" Any type 1 except those diagnosed in the last 3 months can qualify today if they have an HbA1C > 7 % (they are all by definition on a short-acting SC insulin product).
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Post by dreamboatcruise on Jun 14, 2015 17:04:20 GMT -5
... I am an avid Chess player, and part of the game is to think ahead to not only what my next 10 moves may be, but also my opponents. Point of this is I try to think of why this is so heavily shorted, and again, being the knucklehead I am, I never thought of poor insurance coverage as a reason. I was told on YMB that I was considered an idiot over here, but I will post from time to time until Lianne blocks me I guess the thought is-------"IS insurance the big hurdle nobody want to talk about?" I knew there is a reason I no longer even look at YMB. I think the insurance formulary issue is one that allows the shorts to operate, but I don't think it is the "reason" they short. Anyone that knows pharma knows that there is nothing out of the ordinary about the initial tier 3 with restrictions we're seeing. That's just common practice these days. Times have changed in past decade. That said, the shorts can point to it and imply that for various reasons SNY might not be successful in getting better placement. Things we do know... - Sanofi has a dedicated organization that deals with "access". These are separate from drug reps going to doctors. The "access" group is basically selling Afrezza to the insurers and pharmacy benefit management companies. Some people on proboards might have even more to contribute about the decision process regarding formulary with regard to influence of insurer vs PBM vs employer if a large company plan. But the bottom line is that this is an issue that all the pharma companies including Sanofi deal with on a day to day bases and take very seriously. - Sanofi has seemed to price Afrezza higher than what was implied would be done by MNKD management before they were signed on as a partner. It appears that it is at a premium to rapid acting SC's. Since MNKD implied that it would be comparable to SC's it seems reasonable to assume that the manufacturing costs would allow it to be... in fact the simplicity of the device may mean it is actually cheaper compared to injection pen. So that leaves a few reasons Sanofi would decide to price high... 1) they anticipate that getting good formulary placement will be difficult and consider Afrezza a niche product and therefore need to get as much as possible over a smaller patient pool or 2) they believe that the clinical benefits of Afrezza are so compelling that they will get preferred formulary status and a higher price (jackpot for Sanofi and us investors) or 3) the higher price is simply a bargaining chip that is used as part of the negotiating strategy with insurers/PBM in the tactical dance of negotiation. I don't believe #1 is the case. #2 could be good for SNY and MNKD shareholders in long run, but it also could lead to delays in formulary progress... and thus opportunity for shorters to sell the idea that something is wrong. I trust that Sanofi knows what they are doing and is playing this to maximize long term value for themselves, and subsequently for me.
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Post by jpg on Jun 14, 2015 19:01:04 GMT -5
I was told on YMB that I was considered an idiot over here, but I will post from time to time until Lianne blocks me I guess the thought is-------"IS insurance the big hurdle nobody want to talk about?" I wouldn't take what is said on Yahoo to seriously. Especially the one nasty poster who I would guess said this. As for insurance it is what it is and this is true for most new drugs. Time (and some work with studies to back it up) should and will take care of that. There are many pieces yet to be moved. Things tend to move slowly in the medical world. A lot slower than in the investment world.
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Post by yossarian on Jun 14, 2015 21:58:14 GMT -5
Postaholic, still have to show other insulins don't work before can AFREZZA covered, no? If so, that a tough row to how, no?
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Post by jpg on Jun 14, 2015 22:22:33 GMT -5
Postaholic, still have to show other insulins don't work before can AFREZZA covered, no? If so, that a tough row to how, no? Who you calling a postaholic? Oh right... Me or the lizard? For type 1s all you have to show is that their A1c is above 7. Not that rare an event. If your A1C is below that you probably need to sub optimally treat yourself (smart right...) for a month or 2 or say you are needle phobic I guess. With time this should get easier. For type 2 you need to be at an advanced state of diabetes to get Afrezza. By far not a rare patient population. I don't know the DoD system well (at all actually) so don't know if this is only for active service members or for Veterans also? Do Vas fall under this coverage? If so there should be some significant opportunity to use the '2 oral agents and not well controlled' option.
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Post by BD on Jun 15, 2015 3:29:20 GMT -5
Who you calling a postaholic? Oh right... Me or the lizard? That's actually a common point of confusion on ProBoards, to mistake the "member rank" for a member's handle. The ranks are automatically assigned by the system based on a member's post count, but if somebody is not already familiar with the various rank labels, they can easily think they're looking at a member's ID (especially when the ID is somewhat cryptic...such as "jpg". I keep thinking of you as a graphics image...)
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Post by daduke38 on Jun 15, 2015 9:56:05 GMT -5
I was told on YMB that I was considered an idiot over here, but I will post from time to time until Lianne blocks me I guess the thought is-------"IS insurance the big hurdle nobody want to talk about?" I think whoever said that on YMB is the idiot! Thanks! I know there are some pretty astute people on this board, so I just wanted to make sure
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Post by harryx1 on Jun 15, 2015 11:09:57 GMT -5
unityhealth.com/docs/default-source/docs/unitydrugformulary.pdfhuman insulin-inhaled (Afrezza) PA C90 - Tier 3 (page 12) Choice90 (C90) Medications listed with C90 have been designated as maintenance medications by a national database and may qualify for a 3 month supply fill at the pharmacy. The drug must have been filled at the same dose and quantity for the previous 3 fills, cost less than $1000 per month, and the member’s Unity drug coverage must not term in the next 3 months. Three copays will be charged for the 3 month supply. All additional restrictions will apply. The pharmacy must be participating in Unity’s Choice90 pharmacy network to qualify. Medications included in the specialty pharmaceuticals program (SP) are not eligible for Choice90.
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Post by dreamboatcruise on Jun 15, 2015 11:29:17 GMT -5
Once a postaholic, always a postaholic. I admit I have a problem... only 11 more steps
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Post by harryx1 on Jun 15, 2015 17:08:05 GMT -5
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Post by Deleted on Jun 15, 2015 18:54:19 GMT -5
Could Afrezza be too good? Causing addiction like symptoms.
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Post by Deleted on Jun 15, 2015 18:56:02 GMT -5
Could Afrezza be too good? Causing addiction like symptoms. Which brings up a question. Will pricing be an issue going forward?
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Post by otherottawaguy on Jun 16, 2015 7:00:49 GMT -5
Could Afrezza be too good? Causing addiction like symptoms. Only for buyers of common shares, and readers of these boards. ..
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Post by peppy on Jun 16, 2015 7:46:01 GMT -5
To my eyes he would present as a type one. Lean. I do not see any tell tale signs of a continuous glucose monitor, pump or injection sites on his arms in the picture shown. I would like to see his glucose levels, his diet, his medication list and his afrezza dose logs. The whole elephant. Wonder what type of control he had with a prior regimen.
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Post by spiro on Jun 16, 2015 8:14:25 GMT -5
Spiro wants to know what this guy eats? He could be living on a cruise ship. www.diabetesnet.com/food-diabetes/carb-counting/500-ruleThe 500 Rule The 500 Rule (aka 450 Rule) from Using Insulin and the Pocket Pancreas is a great way to estimate how many grams of carbohydrate will be covered by one unit of Humalog or Novolog insulin. This is your insulin to carb ratio or your carb factor. Once you know this, you can count the grams of carb in the food you want to eat and divide by your carb factor to find how many units of bolus insulin are needed to cover the carbs. This allows flexibility in your food choices because any number of carbs can be covered with a matching dose of insulin. The 500 Rule used to determine your carb factor depends on accurately knowing your TDD. As with basal doses, an accurate carb factor can be determined only after you've calculated an accurate TDD for yourself. The 500 Rule: estimates grams of carb per unit of Humalog or Novolog insulins (the 450 Rule is used with Regular insulin) 500 divided by your TDD (Total Daily Dose of insulin) = grams of carb covered by one unit of Humalog or Novolog Lets you keep your post meal readings normal! Example: Someone's TDD = 50 units (i.e., the total amount of say Humalog and Lente insulins they used per day). 500/50 = 10 grams of carbohydrate covered by each unit of Humalog insulin TDD = all fast insulin taken before meals, plus all long-acting insulin used in a day. If Humalog is used everyday to correct high readings, this may also need to be factored into the TDD. For instance, if someone's TDD is "30 units" (5 H before each meal, plus 15 Lantus at bedtime), but they need 8 to 12 units more almost every day to bring down highs, at least some of this 8 to 12 units will need to be factored into a new TDD. Caution: The 500 Rule will be most accurate for those who make no insulin of their own and receive 50% to 60% of their TDD as basal insulin. It works best for those who are using a basal/bolus approach. For others, such as those who use two injections a day with the morning basal insulin covering carbs at lunch, the 500 Rule works only as a rough guide for matching carbohydrate. The 500/450 Rules 500 Rule 450 Rule Total Daily Insulin Dose Carb Covered by 1 Unit of Humalog Carb Covered by 1 Unit of Regular 20 25 grams 23 grams 25 20 grams 18 grams 30 17 grams 15 grams 35 14 grams 13 grams 40 13 grams 11 grams 50 10 grams 9 grams 60 8 grams 8 grams Modified from Using Insulin © 2003, J Walsh PA, R Roberts MA, T Bailey MD, and C Varma MD Caution: This Rule works best for those with Type 1 diabetes who have no insulin production. With Type 2 diabetes, there is usually extra internal insulin production plus resistance to insulin. Although these factors make it harder to know the exact "total insulin" (injected plus internally produced), the result is that insulin doses may be underestimated in Type 2, giving lower doses than actually needed. A good control program uses blood sugar tests in an organized way to adjust insulin doses. With your physician's help, long-acting insulin doses are first matched to your background insulin need. This keeps the blood sugar level while fasting. Then the table can be used to estimate how many grams of carbohydrate will be covered by each unit of Humalog or Regular insulin. When someone is using Multiple Daily Injections (MDI) or an insulin pump, the 500 Rule provides a good guide to how much Humalog or Novolog is needed to match carbohydrates. For those who are not using MDI but who take fast insulin for breakfast and dinner, the Rule can be used as a rough guide to match the carbohydrate in these meals. But here, it's accuracy isn't as great as with true MDI, because some long-acting insulin is actually covering some of the meal carbohydrates. Updated date: Tue, 06/02/2015 - 15:32
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