MannKind Corp. (MNKD)

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FROM [e-mail]
May explains why AFREZZA is not catching on ?

As a physician (IM PCP)--I have attempted for the past few years to really prescribe Afrezza. I have a very large diabetes practice and have a good handle to the current status of diabetes management in America. You have to do spirometry (a breathing test) on every patient before you prescribe Afrezza-that is a significant barrier. Patients (and physicians) of course have a ton of questions and resistance with the thought of evaluating their lung function before a prescription is written (why would I have to do that?? could it damage my lungs??). Sure, many other meds have significant and harming potential side effects, but when you have the patient actually have to take a test which entails blowing into a machine, just too much, thanks but no thanks.
DM-II, the largest segment of diabetes. New treatment regimens and guidelines suggest other therapy rather than insulin. We really try to avoid insulin unless absolutely needed. Patients are resistant to insulin and we and truth is, we are going away from pushing this complicated mealtime/prandial coverage, and sometimes insulin in general. I try many of my patients off insulin if they are type II diabetes (if they are DM-II, not speaking to Type I which is a much smaller segment and Type I it is mandatory to be on insulin). Aggressively managing their obesity (even with newer and safer, reversible surgical techniques) in combination with other newer therapeutic options which often avoid the weight gain side effects of insulin and don't contribute to hypoglycemia. Physicians and patients will take anything that avoids hypoglycemia-and we have other options (especially GLP and we have plenty of options and choices now) Other patient that have to be on meal-time/prandial insulin whom may be on insulin pumps or pen injections, really have no desire to switch, and prefer the small needle pen injection delivery devices. Even when insulin needs to be started, patients and physicians generally prescribe once daily basal insulins along with Metformin, SGLT (PO meds which promotes weight loss), and combine this with once daily or even once weekly GLP drugs (Trulicity, Victoza, Byetta, Bydureon) which promote weight loss. This combination of GLP, SGLT, Metformin +/- a once daily basal insulin is becoming the standard. We try to avoid mealtime insulin whether injection or inhaled--most patient are non-compliant anyway with providing meal-time insulin regimens. Adding mealtime insulin with all of the new therapies should be less of a need in the future-I rarely add mealtime insulin to patients anymore. Therefore, inhaled insulin would fit a very small segment of the diabetic population. Not even discussing the cost, but if cost is an issue for mealtime insulin: most will go with a cheaper vial or pen injection, and some of the generic mealtime insulins will be going generic at some point in the future.
Most patients dismiss inhaled insulin. They simply are not interested in it and generally have major concerns about inhaling a medication. I don't see patients overcoming this barrier. It is what it is, even with the clinically utility show in the literature.
Beside, when insulin is needed, insulin pump technology is rapidly changing and will compete. The combination of realtime glucose monitoring with 'intelligent' insulin pumps will dramatically change the landscape of diabetes management.
The scripts are low, to nonexistent to this point for all of these reasons. Physicians just aren't interested, and for so many reasons, it is just a pain to order spirometry. You have to have more staff around to perform this test, again, the spirometry requirement is a huge barrier. Our time is precious and community clinic physicians honestly just don't want to stop and pause, have another test done, interpret this, etc, and it requires more education and discussion with l-just too cumbersome and annoying to write. I really don't see this changing.
DM is exploding. But, I would hope we are peaking--and like we did with smoking cessation, we start seeing dramatic culture and lifestyle changes with a new generation that needs to be educated to avoid all the triggering factors for diabetes in the first place
23 Sep 2016, 08:35 PM

My comments:
Who really knowns why the re new rate is so low?