Three Standards of the Diabetes Industry are about to FALL..
Nov 21, 2017 12:52:29 GMT -5
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sportsrancho, sla55, and 4 more like this
Post by mango on Nov 21, 2017 12:52:29 GMT -5
Thanks so much for starting this thread. I hope there are counterpart discussions like this on medical blogs and other health professional forums with potential to influence actual standard development.
I agree with your first item, and with the spirit and intent of items 2 and 3. I think the standards can and will change, but I hope not at the same pace as building standards. As you say lives depend upon it. But that can be taken both as a rationale for speeding up the updating of standards and slowing down such change, ostensibly with the goal of patient safety paramount.
Another reason for slowing down change is to preserve "order and stability" in the drug production and drug/healthcare delivery system. The parentheses around order and stability are obviously referencing suspicion, common on the board and elsewhere, that entry of disruptive tech and innovation into drug markets will be delayed or altogether quashed to benefit existing markets for older drugs.
This is also a time of rapid change and innovation of markets. The first human subject of DNA editing, to treat Hunters Syndrome condition, was treated last week. This patient is being treated using gene insertion predating the more recent CRISPER technology. How soon until the first human subject using CRISPER-or CRISPER's successor?
It is a fact of life that, in this environment, at this time, virtuous innovators, well meaning regulators and perverse market actors all influence standard of care and treatment of disease. I may be cynical and out of my depth in saying; but, I think that, as you imply in item 2, Afrezza is the new heir apparent for the standard of care for type 2 diabetes. The studies to support that may not be quite ready; but those of us watching from the board probably are correct in assuming in won't be long until Afrezza's superiority is proven. However, in my opinion we would be wrong in assuming that Afrezza's superiority will make it the standard of care. The current standard of care for early detected cases of type 2 diabetes could just as easily be diet and exercise changes. the reason that metformin is first line is both that humans resist behavior modification and an inexpensive pill is an easier behavior fix.
Afrezza is easier than injecting and probably better for most people's health than metformin. Some users will just not want to change therapies or inhale their medicine, or have some other reason not to use a new product. But cost will be a key barrier to its promotion as a first line medication for Type 2 diabetics.
Cost is the largest source of drag on Afrezza's rise to the category of a first line or standard of care medication. Afrezza must rise to that level BEFORE THE NEXT DIABETES INNOVATION RENDERS AFREZZA OBSOLETE. The first strokes of that unfortunate rendering may begin within a very brief lapse of time, say 6 months(?); that is UNLESS the price of Afrezza is dropped to undercut the current price of the most popular RAA prandial injectables.
And it must also be mentioned that the current packaging of Afrezza is far less than ideal. The current packs are standardized to be equivalents to the famiar 1080 units per vial of liquid injectable that seemed to have worked for "most" diabetics. We have really little idea why that volume "worked" for most diabetics. No doubt it did not work for a lot of diabetics. Most probalby just adjusted their diets or exercise regimens, which is never a bad idea but, I would argue, nobody's business but but their own. Who tells my son's endo's that they cannot eat apple pie?
Every time my son eats a donut I know he will need at least 12u of Afrezza. Because we pay our of pocket for all of his Afrezza I know that means the fifty cent donut he just ate cost us $16 in insulin. And my son needs 2000 units of Afrezza a month.
I suspect that many other diabetics will also need as much insulin as my son. You wonder why script renewals dropped off in the past? Well it probably was, as the company has acknowledged, that titration is hard to figure out. What the company is either unaware of or not acknowledging is that the amount of Afrezza many patients need is well above what they were receiving from their Afrezza package prescriptions. They could not make the numbers work either with preconceptions based on other user reports and experiences, or the company guidance, with their budgets or with HMOs un-willing to encourage widespread adoption due to the foregoing cost and dose factors.
If we and the company want to see scripts go hyper drive, Mannkind will have to get a little more "liberal" it its pricing and dose volume size of its tiration AND packaging!
So as to item 3 on HMO adoption, you have to figure that, though the HMO's cost of providing insulin is lower than mine, they are very aware that how a person eats affects their bottom line in terms of insulin costs. Boom! A perverse incentive has just been created. And the real crime of it is, through no fault of my son's, another kid might only need 4 or 8 units of afrezza to eat that same donut. And all later stage type 2 diabetics may well need 16 or 20 units for my son's donut.
IMHO this all adds up to a somewhat negative forecast for widespread adoption of Afrezza. Dreaming about this promotion of Afrezza to the standard of care may keep us hopeful and committed to a great drug, but we should not kid ourselves. I don't know what Mannkind's internal plan and strategy recommends as price and dose targets are. I am pretty sure those plans will be ineffective if the package dose equivalent volutme is less than 2000 units and the price does not undercut the price for a 1080 vial of brand labeled prandial RAA injectable. I hope that Mannkind does not follow the lead of other phrmacuetical companies and price Afrezza based on some exclusionary model of adoption in the US or internationally. But even if they do, because cheaper, albeit nominally inferior insulins are already on the market, they should have the sense to bid low as newcomers, and implement the price maximization market research and pricing AFTER becoming firmly ensconced in the market via HMO's and doctor's practices through more liberal pricing and packaging.
Your son is a diabetic and therefore should NOT be eating a donut...or fried chicken....or french fries. Fried foods are a disaster for blood glucose levels. Fried foods with simple sugars involved is a multiplier of negatives.
Your son doesn't need donuts. No offense but those are just the facts. My two cents.
A person diagnosed with diabetes that uses Afrezza and restores their early phase insulin response also is restoring glucose homeostasis. When it is dialed in and non-diabetic numbers are maintained, these people are no longer a diabetic. They are someone who uses exogenous insulin to maintain glucose homeostasis.
Glucose homeostasis is dysregulated in a person with diabetes, that is a fact. I also know for a fact that Sprio, a T2D, wouldn't be able to eat Mallomars and receive his best A1C since using Afrezza if he were not maintaining glucose homeostasis via the restoration of the early-phase insulin response. Spiro's A1C is largely dependant on post-prandial plasma glucose levels, because once A1C is <7.3%, post-prandial plasma glucose plays a role of upwards of 70%. Sprio isn't a diabetic in my mind, he is someone that just uses Afrezza to maintain glucose homeostasis via restoring the early-phase insulin response.
Eating a donut or fried foods during a state of balance is perfectly fine. The balance is maintained with Afrezza. When I drink a glass of water, it contains numerous harmful and deadly contaminants that make a donut look healthier than water. All the contaminants found in water effect metabolic flow patterns and can cause acute and chronic health conditions and even death. I received a nice E. coli infection from drinking my town's water (E. coli was confirmed to be present via samples collected at residents homes and tested).
Conclusion: you might have to take some Afrezza after eating a fried chicken sandwich, but you migh be sick for a couple of weeks if you drink water. Point is—live life and enjoy it. Afrezza provides that for people.