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Post by notamnkdmillionaire on Jan 3, 2015 11:52:46 GMT -5
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Post by xoxoxoxo on Jan 3, 2015 12:02:55 GMT -5
Honestly, this is kind of awesome. What I read from this criteria is there won't be any hoops to jump through for patients requesting it. The patient just has to say they're unwilling to administer injectable insulin and then the doctor can get it approved. The prohibition on smokers is probably a good thing as it eliminates a lot of potential lung cancer scare tactics from the shorts.
APPROVAL CRITERIA
Requests for Afrezza (insulin human) may be approved if the following criteria are met (either I, II, or III) AND (IV, V, and VI):
I. Individual has been on the Afrezza (insulin human) in the previous 180 days; OR
II. Individual has had a previous trial of one preferred rapid‐acting insulin (Novolog or Humalog) in the previous 180 days.; OR
III. Individual is requesting Afrezza and is unable or unwilling to administer injectable insulin.
AND
IV. Individual is 18 years of age or older; AND
V. Individual has a diagnosis of diabetes mellitus and one of the following:
a. For type 1 diabetes, individual will be using concurrently with long‐acting insulin;
OR
b. For type 2 diabetes, individual has inadequate control, intolerance, or contraindication to at least 2 oral anti‐diabetic medications;
AND
VI. Individual has had a physical examination including detailed medical history to identify potential lung disease.
Afrezza (insulin human) may not be approved for the following:
I. Individuals with a diagnosis of chronic lung disease, such as asthma or chronic obstructive pulmonary disease; OR
II. Individuals who smoke cigarettes or who recently (within 6 months) quit smoking; OR
III. As a treatment for diabetic ketoacidosis.
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Post by liane on Jan 3, 2015 12:06:55 GMT -5
I like the approval criteria - a very easy hoop to jump through - can be as simple as an adult diabetic without lung disease who wants to try it and doesn't like needles.
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Post by alcc on Jan 3, 2015 12:23:20 GMT -5
Great news. Basically just per the label. Much better than the Regence guidance posted earlier.
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Post by dreamboatcruise on Jan 3, 2015 14:53:00 GMT -5
I like the approval criteria - a very easy hoop to jump through - can be as simple as an adult diabetic without lung disease who wants to try it and doesn't like needles. It is not quite that easy for a type 2. They must be on second oral and have inadequate control. So this seems to preclude Afrezza being true second line choice after metformin. I'd be interested in any of the medical professionals thoughts on the practical meaning of these criteria. It would seem the criteria of being "unwilling" to inject is a pretty low bar and that many doctors might say to patients "I really would like to start you on prandial insulin now, and if you're unwilling to inject we do have an inhalable option". That may not be consistent with the spirit of the requirement that a patient "request" Afrezza, but I assume that doctors probably do that sort of thing without hesitation if they believe it will benefit their patients? As for the needing to have run through 2 orals with inadequate control... is the criteria for "inadequate" likely to be at the doctor's discretion or is there some generally agreed criteria (A1C, fasting glucose, ?) that the insurer would likely use. If the criteria are left to the doctor and a particular doctor wanted to use Afrezza more aggressively then they might choose post prandial levels where Afrezza would likely be much closer to a healthy person than someone taking any of the second line orals with metformin... though that is a guess. Would love to hear opinions on what this criteria would likely mean in practice. |
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Post by liane on Jan 3, 2015 15:23:52 GMT -5
You're right dbc - I read it too quick. As for "inadequate control" - they have not specified any criteria - so that does leave open a door wide enough to drive a truck through. The insurer is not asking for proof of adherence to any particular protocol. So that would leave it to the physician and patient how aggressively they want to treat.
As for patient unwillingness to inject - you've got it exactly right:
Physician: "I think it's time to talk about starting you on insulin. Now we can either do an injectable insulin, or if you are not willing to inject, we have this nifty inhalable insulin."
Patient: "What - are you crazy? I'll take what's behind door number 2!"
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Post by dreamboatcruise on Jan 3, 2015 15:32:55 GMT -5
Just looked Afrezza up on Kaiser's online formulary database. It really isn't on yet, but I found it very curious that it had a hit because of being included as an index term for the entry covering other rapid acting insulins. A short could probably spin that as bad saying that it indicates that Kaiser has made a decision that Afrezza is not covered and doctors must use one of the other prandial insulins. That seems highly unlikely. online.lexi.com/lco/action/doc/retrieve/docid/kaifoc_con/1166497------------------------------------------------------------------------------------- Insulin Regular (Kaiser Permanente Southern CA - Consumer) U.S. Brand Names HumuLIN R U-500 (CONCENTRATED); HumuLIN R [OTC]; NovoLIN R ReliOn [OTC]; NovoLIN R [OTC] Generic Available No Pharmacologic Category Insulin, Short-Acting Commercial Formulary, Dosage Forms Injection, solution: HumuLIN® R: 100 units/mL (3 mL, 10 mL) Injection, solution [concentrate]: Humulin® R U-500: 500 units/mL (20 mL vial) NovoLIN® R: 100 units/mL [Deleted: implementation date pending] Formulary Alternative Novolin R is no longer on the Formulary. The Formulary alternative is Humulin R. Index Terms Afrezza; Regular Insulin |
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Post by lynn on Jan 3, 2015 19:46:06 GMT -5
I work for Kaiser & just had our pharmacist confirm that as of 1/1/15 Afrezza is on our formulary list without restrictions & it's also covered by MediCal  |
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Post by liane on Jan 3, 2015 19:49:08 GMT -5
lynn,
That's excellent news!
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Post by jpg on Jan 3, 2015 20:30:10 GMT -5
Thank you for checking.
Kaiser and Medi-Cal! Wow.
Medi-Cal without restrictions?
Does anyone know how to look for other states?
JPG
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Post by liane on Jan 3, 2015 20:34:05 GMT -5
I just looked up Maine, and it's not listed yet (no surprise). I'm guessing you would have to look it up state by state under their medicaid 2015 drug lists.
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Post by BlueCat on Jan 3, 2015 20:50:40 GMT -5
Shouldn't this be, like, news? Isn't this one of the short battle cries?
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Post by jpg on Jan 3, 2015 20:55:56 GMT -5
Shouldn't this be, like, news? Isn't this one of the short battle cries? Could the information about Kaiser and/or Medi-Cal and/or other providers have come out on January 2nd and caused a few big players to buy and/or to cover and cause the marked stock price rise? JPG |
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Post by lynn on Jan 3, 2015 20:57:13 GMT -5
JPG,
I'm not sure if MediCal is without restrictions , it says MediCal part D : Tiered . I'm not sure what that means though . And the only Boxed Warning I see is : Risk of Acute Broncospasm in patients with Chronic Lung Disease
Lynn
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Post by noonen on Jan 3, 2015 23:09:14 GMT -5
I like the approval criteria - a very easy hoop to jump through - can be as simple as an adult diabetic without lung disease who wants to try it and doesn't like needles. It is not quite that easy for a type 2. They must be on second oral and have inadequate control. So this seems to preclude Afrezza being true second line choice after metformin. I'd be interested in any of the medical professionals thoughts on the practical meaning of these criteria. It would seem the criteria of being "unwilling" to inject is a pretty low bar and that many doctors might say to patients "I really would like to start you on prandial insulin now, and if you're unwilling to inject we do have an inhalable option". That may not be consistent with the spirit of the requirement that a patient "request" Afrezza, but I assume that doctors probably do that sort of thing without hesitation if they believe it will benefit their patients? As for the needing to have run through 2 orals with inadequate control... is the criteria for "inadequate" likely to be at the doctor's discretion or is there some generally agreed criteria (A1C, fasting glucose, ?) that the insurer would likely use. If the criteria are left to the doctor and a particular doctor wanted to use Afrezza more aggressively then they might choose post prandial levels where Afrezza would likely be much closer to a healthy person than someone taking any of the second line orals with metformin... though that is a guess. Would love to hear opinions on what this criteria would likely mean in practice. dbc, I initially thought the exact same thing, and maybe I'm making things up re the wording but I don't think they have to be on two orals. under Section V for type 2: Individual has a diagnosis of diabetes mellitus and one of the following: b. For type 2 diabetes, individual has inadequate control, intolerance, or
contraindication to at least 2 oral anti‐diabetic medications; I think that "or" in b. and some conspicuously absent prepositions are the keys and "inadequate control" and "intolerance" don't mean while on 2 orals. If all 3 had to do with 2 orals, I think it would state "inadequate control with, intolerance of, or contraindication to at least 2 oral anti-diabetic medications..." I also could be completely looney. i just posted about grammar on a stock message board. it's pretty ridiculous the amount of brain time I spend on every little piece of news about this company! edit: yeah i'm crazy. what would the inadequate control or intolerance be related to if it wasn't talking about 2 orals. well, it was worth a shot. |
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