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Post by mnholdem on Feb 2, 2018 10:32:31 GMT -5
FINALLY! Some movement on coverage in the Commercial channel for Afrezza.
+2% increase in Unrestricted Access coverage for Afrezza - now at 30% nationwide. +2% increase in Restricted/Preferred Restricted Coverage for Afrezza - now at 37% nationwide.
Notables by State • New Jersey increased +17% and now has 40% unrestricted access • West Virginia increased 20% and now has 47% unrestricted access • Oregon +4% Unrestricted Access and moved 10% from Covered (PA/ST) to Preferred (PA/ST)
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Medicare coverage for Afrezza is still stalled but we see some movement within the State Medicaid channel: • Alabama 100% Unrestricted Access - previously 100% Covered (PA/ST) • New Jersey 100% Preferred - previous 100% unrestricted access • Pennsylvania 100% Unrestricted Access - previously 100% Covered (PA/ST)
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Health Exchange Channel - Afrezza coverage: • District of Columbia 100% Preferred - previously 100% Unrestricted Access • Michigan -48% Unrestricted Access - previously 50% Unrestricted Access • West Virginia +86% Unrestricted Access - previously No Coverage • Maryland 19% Preferred and 71% Unrestricted Access = 90% total Unrestricted Access • North Dakota +35% Covered (PA/ST) - previously No Coverage • South Dakota +44% Covered (PA/ST) - previously No Coverage • Virginia 15% Preferred and 6% Unrestricted = 21% Unrestricted Access plus 47% Covered (PA/ST)
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Managed Medicaid channel has modest growth in coverage for Afrezza.
Nationwide: • 2% Preferred • 86% Covered (PA/ST) • 4% Preferred (PA/ST)
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Soon I may have to breakout the Unrestricted Access column into two separate columns: Preferred and Covered.
Read more: mnkd.proboards.com/thread/3729/formulary-tracker-plan-coverage-afrezza#ixzz55xtNQgAc
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Post by centralcoastinvestor on Feb 2, 2018 10:46:46 GMT -5
As many here believe, I think lack of good insurance coverage has been a huge drag on script sales. I know Mike C. understands how important it is but has been hampered by the cozy relationship between PBMs and large pharma. I never realized how hard it would be to get insurance to cover the best insulin in the world. Who knew? I truly believe there has been a lot of behind the scenes shenanigans that has intentionally impeded or slowed adoption by insurance. But Mike and us shareholders are persistent and we will triumph in the end.
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Post by tiberious on Feb 2, 2018 11:19:26 GMT -5
Newbie question here.. what does Preferred actually mean? Nationwide @ 2% for example... does this mean that 2% of Payer nationwide are saying Afrezza is a better treatment option than the rest of the junk out there?
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Post by mnholdem on Feb 2, 2018 12:25:02 GMT -5
If "Better" were the criteria, Afrezza would have it's name on formularies of the largest PBMs. In layman's terms, "Preferred" generally means that a formulary placed a drug as its first choice. However, there can be more than one insulin brand tiered at the "Preferred" level on a formulary. For example, Afrezza and Novolog may be Preferred drugs, while Humalog and Apidra are not.
A drug's placement on a formulary is not synonymous with how well it works compared to others. There are often contracts (i.e. $$$) involved along with other factors. Sometimes I wonder if being "better" is even considered by 3rd party payers.
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Post by dreamboatcruise on Feb 2, 2018 13:18:42 GMT -5
Newbie question here.. what does Preferred actually mean? Nationwide @ 2% for example... does this mean that 2% of Payer nationwide are saying Afrezza is a better treatment option than the rest of the junk out there? The % listed on formularylookup.com is based on number of people within the category, so 2% of Medicare would mean plans covering 2% of all the people on Medicare. Preferred basically means a lower co-pay. Almost always a generic, if one is available, would be preferred to a brand name.
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Post by Deleted on Feb 2, 2018 13:32:11 GMT -5
As many here believe, I think lack of good insurance coverage has been a huge drag on script sales. I know Mike C. understands how important it is but has been hampered by the cozy relationship between PBMs and large pharma. I never realized how hard it would be to get insurance to cover the best insulin in the world. Who knew? I truly believe there has been a lot of behind the scenes shenanigans that has intentionally impeded or slowed adoption by insurance. But Mike and us shareholders are persistent and we will triumph in the end. It's not just a big potential that lack of insurance coverage is hurting their sales; it's a guarantee. My sig other, for example, would have gotten on Afrezza years ago if it had ever been available to her. Every single year though, she has to get new insurance because the company she signed up with year before moves on in their rotation - they nix all the insulin versions they covered the year before, and adopt a handful of cheaper, newer versions. So, she has to go on to the next company to try and get the same insulin she has been using covered by them. She has never once found an insurance that offered coverage on Afrezza; and finds it far too stressful just maintaining her access to humalog. 2 years back, they ACTUALLY told her they wouldn't cover humalog anymore and they were going to start replacing their humalog patients with the 'nearest swine appropriate insulin'... WTF!@#!@!!! That should literally be a criminally-punishable offense. CEO's & Insurance Co board members need to start 'paying' for the big squeezes they put on the medical industry, and patients who benefits from life-saving products of any variety.
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Post by sportsrancho on Feb 2, 2018 13:40:36 GMT -5
So sorry to hear that! I wish there were a way, if people could prove that they cannot get insurance coverage that MNKD would give them Afrezza at cost.
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Post by Deleted on Feb 2, 2018 13:42:34 GMT -5
So sorry to hear that! I wish there were a way, if people could prove that they cannot get insurance coverage that MNKD would give them Afrezza at cost. I would say that will come someday; but until MNKD can stabilize it would be tooooo great of a risk to the company, and Afrezza, to head down that route. They need strength before they can shift toward more humanitarian focuses like that. It's just a shame that the insurance companies/big pharma refuse to allow MNKD to attain stability.
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Post by matt on Feb 2, 2018 14:10:24 GMT -5
A drug's placement on a formulary is not synonymous with how well it works compared to others. There are often contracts (i.e. $$$) involved along with other factors. Sometimes I wonder if being "better" is even considered by 3rd party payers. Better is considered by a medical team at each payor (but not at the PBMs who are more commercially focused). Rarely, if ever, will a payor deem a product superior to another unless the FDA has allowed the manufacturer to label the drug as superior. This is why a non-inferiority label is a distinct disadvantage in any market with more than one product available because the manufacturer cannot market on that basis.
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Post by tiberious on Feb 2, 2018 14:36:34 GMT -5
thanks for the explanation
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Post by dreamboatcruise on Feb 2, 2018 14:53:55 GMT -5
A drug's placement on a formulary is not synonymous with how well it works compared to others. There are often contracts (i.e. $$$) involved along with other factors. Sometimes I wonder if being "better" is even considered by 3rd party payers. Better is considered by a medical team at each payor (but not at the PBMs who are more commercially focused). Rarely, if ever, will a payor deem a product superior to another unless the FDA has allowed the manufacturer to label the drug as superior. This is why a non-inferiority label is a distinct disadvantage in any market with more than one product available because the manufacturer cannot market on that basis. Though it seems insulins would be a bit more complicated than that. Certainly there is some general understanding that speed of action is important for a prandial... why else would Novo have spent so much money developing Fiasp. Afrezza's pk/pd profile is now clearly differentiated in the label from the three old school RAAs. The FDA hasn't yet decided to take the step of defining a new category of faster than rapid, but they clearly believe speed of action is something important as can be seen in the labels for Afrezza and Fiasp that highlight it. Non-inferior vs superior is in regard to particular metrics, such as A1c, isn't it? For a class of drug where speed of action is important, isn't a label showing quicker action something that would be deemed superior?
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Post by digger on Feb 2, 2018 20:41:25 GMT -5
Better is considered by a medical team at each payor (but not at the PBMs who are more commercially focused). Rarely, if ever, will a payor deem a product superior to another unless the FDA has allowed the manufacturer to label the drug as superior. This is why a non-inferiority label is a distinct disadvantage in any market with more than one product available because the manufacturer cannot market on that basis. Though it seems insulins would be a bit more complicated than that. Certainly there is some general understanding that speed of action is important for a prandial... why else would Novo have spent so much money developing Fiasp. Afrezza's pk/pd profile is now clearly differentiated in the label from the three old school RAAs. The FDA hasn't yet decided to take the step of defining a new category of faster than rapid, but they clearly believe speed of action is something important as can be seen in the labels for Afrezza and Fiasp that highlight it. Non-inferior vs superior is in regard to particular metrics, such as A1c, isn't it? For a class of drug where speed of action is important, isn't a label showing quicker action something that would be deemed superior? I imagine Novo is sweating the appearance of biosimilars. Basaglar's success so far suggests Sanofi's admelog could become a potent competitor. No doubt Novo is looking for some edge. The problem is that no one has actually proven that speed of action is important. Fiasp's trial results don't look all that impressive: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004046/WC500220890.pdf
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Post by dreamboatcruise on Feb 2, 2018 20:57:46 GMT -5
Though it seems insulins would be a bit more complicated than that. Certainly there is some general understanding that speed of action is important for a prandial... why else would Novo have spent so much money developing Fiasp. Afrezza's pk/pd profile is now clearly differentiated in the label from the three old school RAAs. The FDA hasn't yet decided to take the step of defining a new category of faster than rapid, but they clearly believe speed of action is something important as can be seen in the labels for Afrezza and Fiasp that highlight it. Non-inferior vs superior is in regard to particular metrics, such as A1c, isn't it? For a class of drug where speed of action is important, isn't a label showing quicker action something that would be deemed superior? I imagine Novo is sweating the appearance of biosimilars. Basaglar's success so far suggests Sanofi's admelog could become a potent competitor. No doubt Novo is looking for some edge. The problem is that no one has actually proven that speed of action is important. Fiasp's trial results don't look all that impressive: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004046/WC500220890.pdfWhat is still up for debate is how fast is needed. Certainly RAAs were proven better at mealtime than injected RHI because of their quicker action. Further, some of the benefits of fast action are self evident. The label, for instance, shows that Afrezza is cleared out of the system much faster than RAA. Since an insulin induced hypo can only be caused while the insulin is still active it is self evident that the period of time over which a hypo can occur is reduced with Afrezza. It would be nice if we also had data showing improvement of A1c and time in range, but there are benefits to speed beyond that.
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Post by mnholdem on Feb 2, 2018 21:54:26 GMT -5
Obviously, a separate classification would have solved a bunch of obstacles. Non-inferior on the label would no longer matter since Afrezza would be in a class of its own. Is it possible that the ADA and/or AACE will wake up and extol the benefits of ultra rapid-acting insulin? It's possible, even if it's a long shot.
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Post by mango on Feb 2, 2018 22:04:52 GMT -5
What is still up for debate is how fast is needed. Certainly RAAs were proven better at mealtime than injected RHI because of their quicker action. Further, some of the benefits of fast action are self evident. The label, for instance, shows that Afrezza is cleared out of the system much faster than RAA. Since an insulin induced hypo can only be caused while the insulin is still active it is self evident that the period of time over which a hypo can occur is reduced with Afrezza. It would be nice if we also had data showing improvement of A1c and time in range, but there are benefits to speed beyond that. Who is debating that and what are they debating over? Afrezza is able to restore/replace the first-phase insulin response because it reaches peak serum insulin concentration in 12-15 minutes. It must be that fast in order to mimic endogenous prandial insulin secretion. The first-phase insulin response is a homeostatic response that is vital for regulating glucose homeostasis. I don't see how there can be any debate about this, Afrezza is the answer.
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