Anthem has Afrezza listed

[babaoriley]

Jan 3, 2015 20:50:40 GMT -5 BlueCat said:

Shouldn't this be, like, news? Isn't this one of the short battle cries?

Q2U, have I mentioned how happy I am that you got rid of that piano playing (or whatever the heck it was doing) feline!  I swear that thing made me dizzy!

[babaoriley]

Jan 3, 2015 20:57:13 GMT -5 lynn said:

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

Lynn, great work!  Perhaps your pharmacist can be quite helpful in deciphering some of this language and in explaining whether or not there are restrictions placed on the us of Afrezza by MediCal.  I'm pretty sure he/she has nothing better to do in his/her spare time, especially since I'm pretty sure you and Coco have already gotten them invested!

[BlueCat]

Jan 3, 2015 23:28:06 GMT -5 babaoriley said:

Jan 3, 2015 20:50:40 GMT -5 BlueCat said:

Shouldn't this be, like, news? Isn't this one of the short battle cries?

Q2U, have I mentioned how happy I am that you got rid of that piano playing (or whatever the heck it was doing) feline!  I swear that thing made me dizzy!

Typing!



Yea, but gotta say - mnkdmillionaire's is worse!

[gwb]

Jan 3, 2015 12:02:55 GMT -5 xoxoxoxo said:

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.

Here the form to file out: It looks very understandable .

www.anthem.com/provider/noapplication/f0/s0/t0/pw_e229089.pdf?na=pharminfo

CONTAINS CONFIDENTIAL PATIENT INFORMATION
Afrezza (insulin human) inhalation
Prior Authorization of Benefits (PAB) Form
Complete form in its entirety and fax to:
Prior Authorization of Benefits Center at (800) 601- 4829
1. PATIENT INFORMATION
2. PHYSICIAN INFORMATION
Patient Name: _________________________________
Patient ID #: _________________________________
Patient DOB: _________________________________
Date of Rx: _________________________________
Patient Phone #: ______________________________
Patient Email Address: __________________________
Prescribing Physician: ____________________________
Physician Address: _____________________________
Physician Phone #: _____________________________
Physician Fax #: _____________________________
Physician Specialty: ____________________________
Physician DEA: ____________________________
Physician NPI #: _____________________________
Physician Email Address: ___________________________
3. MEDICATION
4. STRENGTH
5. DIRECTIONS
6. QUANTITY PER 30 DAYS
Afrezza (insulin human) inhalation
_______________
____________________
Specify:________________
7. DIAGNOSIS: ___________________________________________________________________________________
8. APPROVAL CRITERIA: CHECK ALL BOXES THAT APPLY
NOTE: Any areas not filled out are considered not applicable to your patient & MAY AFFECT THE OUTCOME of this request.
□ Yes □ No Patient has been on Afrezza (insulin human) in the previous 180 days
□ Yes □ No Patient has had a previous trial of one preferred rapid-acting insulin (Novolog or Humalog) in the
previous 180 days
□ Yes □ No Patient is unable or unwilling to administer injectable insulin
□ Yes □ No Patient has a diagnosis of diabetes mellitus
□ Yes □ No Patient has type 1 diabetes
□ Yes □ No Afrezza (insulin human) is being used concurrently with long-acting insulin
□ Yes □ No Patient has type 2 diabetes
□ Yes □ No Patient has inadequate control, intolerance, or contraindication to at least 2 oral anti-
diabetic medications
□ Yes □ No Patient has had a physical examination including detailed medical history to identify potential lung
disease
□ Yes □ No Patient has a diagnosis of chronic lung disease, such as asthma or chronic obstructive pulmonary
disease
□ Yes □ No Patient smokes cigarettes or recently (within 6 months) quit smoking
□ Yes □ No Patient is 18 years of age or older
9. PHYSICIAN SIGNATURE
____________________________________________________________ __________________________________________
Prescriber or Authorized Signature Date
Prior Authorization of Benefits is not the practice of medicine or the substitute for the independent medical judgment of a treating physician. Only a treating physician can determine what medications are appropriate for a patient. Please refer to the applicable plan for the detailed information regarding benefits, conditions, limitations, and exclusions. The submitting provider certifies that the information provided is true, accurate, and complete and the requested services are medically indicated and necessary to the health of the patient.
Note: Payment is subject to member eligibility. Authorization does not guarantee payment.
The document(s) accompanying this transmission may contain confidential health information that is legally privileged. This information is intended only for the use of the individual or entity named above. The authorized recipient of this information is prohibited from disclosing this information to any other party unless required to do so by law or regulation.
If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution, or action taken in reliance on the contents of these documents is strictly prohibited. If you have received this information in error, please notify the sender immediately and arrange for the return or destruction of these documents.

[daduke38]

Jan 3, 2015 15:23:52 GMT -5 liane said:

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!"

 The portion for Type 2's in Section V.b  concerns me. That is an "AND" at the top. Makes it sound like "A' would be the 3rd preference for the Insurance Co.

I hate to say it, but that is how I am understanding it. I really hope I am mis-interpreting that, but I don't think I am.
Could you please explain how that is a wide open door.  TIA And please show me I am wrong :-)

[daduke38]

□ Yes □ No Patient has inadequate control, intolerance, or contraindication to at least 2 oral anti-

diabetic medications



The above is from the Questionaire.  Not trying to be a kill joy, but this sounds like they have "A' as a third choice.  Hope to heck I am wrong, but if I am reading it this way, I am sure others will.  Just trying to stay objective.  How do you get around that question?  

[liane]

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.

So the path of least resistance for a T2 (assuming not already on insulin) is this:

III: Physician recommends insulin, says we have injectable or inhaled, explains benefits and risks of each, asks patient what he/she would like to do. Patient says, "Well, I really don't want to inject; I would like to try A".

They still have to meet IV, V, and VI - so:

> age 18
inadequate control or intolerance or contraindication to 2 oral anti-diabetic meds
physical exam, rule out lung disease.

For a newly diagnosed T2, yes, they will have to try 2 oral meds first. But for the existing T2's, they are already on 1 or more meds. Many are not well controlled or want better control. So many of the oral meds have side effects causing causing patient intolerance. Many patients have put up with the side effects just so they can delay going on insulin and having to inject.

I can't tell you how wide a door that is. What I can tell you is that physicians already know how to jump through the hoops to get the best medication for their patients. It would not surprise me to see even fewer restrictions on Afrezza 1 year down the road as improved patient compliance and control come into play.

[daduke38]

Thanks Liane!  And a great point about a year down the road!

[savzak]

My carrier is BCBS but it's a Highmark company. I found this from October referencing Afrezza among many other drugs. If I'm reading it correctly Afrezza is tier 3.

host1.medcohealth.com/art/prc/Highmark_4th_Qtr_2014_Formulary.pdf

[liane]

Yes, it looks like Tier 3, but that's usually were new drugs start out.

[liane]

So just to attempt to throw some statistics out here:

In 2012 in the US:

29 M diabetics, 21 M are diagnosed, 8.1 M undiagnosed.

use insulin only        2.9 M        14.0%
insulin + oral            3.1 M        14.7%
oral only                11.9 M        56.9%
neither                    3.0 M        14.4%

So over half the diabetics are on oral meds only; 0ver 70% oral or oral + insulin.

www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf

Now, from a different source, and different year (2007) regarding A1c testing and control:

13-22% don't get tested

Of those who get tested and have poor control (A1c > 9):

29.6% of the commercial population
27.3% of the Medicare population
48.7% of the Medicaid population

So roughly a quarter to half of the diabetics who do get tested are in poor control.

www.hrsa.gov/quality/toolbox/measures/diabetes/

So what I am giving you here, even though it's a bit of apples and oranges, is there are a lot of diabetics already on oral meds, and a lot of those are in poor control. It won't take much for physicians to find a qualifying reason to try Afrezza.

[traderdennis]

Jan 3, 2015 15:32:55 GMT -5 dreamboatcruise said:

Hi DBC,


If you query Levitra for example, it does show that it is in the lexi db, but you will pay full price for the drug.  KP will also use sidnefil (generic viagra) first to save costs.  I spoke with an endocrinologist at KP who said the department voted against prescribing Afrezza at this time.  As soon as they post the 1/2015 revision for the formulary will be a much bigger milestone to find out their intent.


I am long in MNKD - 30 2016 leaps, but 10 short term Jan 9 contracts.  I tried to get them to write a script for me, the endo would not consider it.








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

[jpg]

Hi Traderdennis,



You said:
I am long in MNKD - 30 2016 leaps, but 10 short term Jan 9 contracts.  I tried to get them to write a script for me, the endo would not consider it.

How would anyone prescribe a medication that isn't even available? I don't get that. I also have not often seen a whole department say that hey will not collectively prescribe something by vote? To me that goes against every principle of physician autonomy I have seen over the years. Again very unusual?

JPG

[Deleted]

Not quite sure where the anthem discussion is going but not sure it makes much difference. This is likely what you will see from the majority of insurance companies out of the gate and exactly in line with the group that SNY will be targeting with a controlled launch.

All 3.1 million of them.

[babaoriley]

The way I look at it is that enough people will begin to take it, word will get around that they like it, and then other diabetics will go to their docs and say "you gotta get me on this stuff." The doc will then find a way. Of course, this won't happen in every case, but we don't need all diabetics to use Afrezza, just a decent slice of the market, especially within the first year or so. If the pioneers like it, many more will follow all in good time.