Regence RX Pharmacy Benefit Management, ID, OR, UT, WA

[kc]

Feeling the Blues this Holiday weekend........

Seems that this company part of the Blue's has Afrezza ready to launch when they can in 2015.  policy and link below.


blue.regence.com/trgmedpol/drugs/dru371.pdf

Medication Policy Manual
Policy No: dru371
Topic: Afrezza®, inhaled insulin
Date of Origin: October 21, 2014
Committee Approval Date: November 13, 2014
Next Review Date: May 2015
Effective Date: November 13, 2014

Description
Inhaled insulin (Afrezza®) is a self-administered, rapid-acting insulin used to improve glycemic control in adult patients with type 1 or type 2 diabetes mellitus. It is supplied as a dry powder and is administered via a breath-powered inhalation device. Upon inhalation, the dry powder is aerosolized and delivered to the lung. © 2014 RegenceRx. All rights reserved.
dru371.0 Page 1 of 6
Policy/Criteria
I. Most contracts require prior authorization approval of inhaled insulin (Afrezza) prior to coverage. Inhaled insulin (Afrezza) may be considered medically necessary in patients with type 1 or type 2 diabetes mellitus when criteria A or B below are met:
A. There is a diagnosis of type 1 diabetes mellitus and both criteria 1 and 2 below are met:
1.Treatment with an injectable insulin regimen containing a prandial insulin (See Appendix 1) is ineffective in reducing A1C to goal of 7% or less after 90 days of therapy, unless it is contraindicated or not tolerated.
AND
2.Inhaled insulin (Afrezza) is used concurrently with a basal insulin (See Appendix 1).
OR
B. There is a diagnosis of type 2 diabetes mellitus and both criteria 1 and 2 below are met:
1.Treatment with metformin is ineffective in reducing A1C to goal of 7% or less after 90 days of therapy, unless contraindicated or not tolerated.
AND
2.Treatment with an injectable insulin regimen containing a prandial insulin (See Appendix 1) is ineffective for reducing A1C to goal of 7% or less after 90 days of therapy, unless contraindicated or not tolerated.
II. Administration and Authorization Period
A. RegenceRx considers inhaled insulin (Afrezza) to be a self-administered medication.
B. Authorization may be reviewed at least annually to confirm that current medical necessity criteria are met and that the medication is effective.






About Regence


RegenceRx is a division of Regence, which is the largest affiliation of health care plans in the Pacific Northwest/Mountain State region. Regence includes:

Regence BlueShield of Idaho
Regence BlueCross BlueShield of Oregon
Regence BlueCross BlueShield of Utah
Regence BlueShield (Washington)
Asuris Northwest Health (not a Blue Cross Blue Shield licensee).
Collectively, these five plans serve nearly 3 million people in four states with more than $6.5 billion in combined revenue.

Our Vision
To be the company consumers choose to provide access for their health care needs.

Our Mission
To provide customers with the best value in health, dental, vision and life insurance benefits, and administrative services. We are customer focused and market driven, using the strengths and opportunities created by Regence health plans.

It is our responsibility to ensure the availability of affordable, quality health plans in our service area. We are dedicated to effectively manage costs and provide customers a choice of competitively priced health plans in return for their investment.

We are committed to keeping health care costs as low as possible for our customers by continually negotiating fair rates for health care services.

At RegenceRx, we are dedicated to these principles on behalf of our customers.

[dreamboatcruise]

Hmmm... not as good as I'm sure many had hoped for since it requires prior approval and seems to need justification. Would "contraindicated or not tolerated" include those that refuse to go on prandial when they really should to avoid needles?

Seems strange that they would issue this back in mid Nov. Doesn't seem like SNY would have had time to negotiate pricing and it seems that prior approval with justification would only be required if Afrezza costs more than the prandial pens.

Thoughts?

[BlueCat]

Good questions DBC. My initial response was that it seemed just a little more negative than I would have liked. They seemed a bit critical of the trials.

And yea. Define "tolerated." There are plenty who would say they will not tolerate (deal with) injecting themselves several times daily.

[kc]

Look at it in a different way.   They were early adapters to adding Afrezza before they knew all the details.   Regence jumped on board.  This actually shows their confidence to take on a radically different new drug.    They didn't have much of the details about cost or how It would be marketed by Sanofi.   They just jumped the shark to be leader in what they could offer their consumer.   How much info could they have had on October 21, 2014.




Medication Policy Manual
Policy No: dru371
Topic: Afrezza®, inhaled insulin
Date of Origin: October 21, 2014
Committee Approval Date: Nrovember 13, 2014
Next Review Date: May 2015
Effective Date: November 13, 2014

[jpg]

Maybe rose colored glasses but I think this is pretty good.

1. Next review May 2015...

2. I would also (and especially) point out this is second line indication after Metformin. Now that is a pretty big market. I wonder if this 'first line insulin after Metformin' they are referring to isn't 'out of a vial' and not pens? That small detail would be a big deal to know obviously.

JPG

[liane]

Dec 20, 2014 23:37:38 GMT -5 BlueCat said:

Good questions DBC. My initial response was that it seemed just a little more negative than I would have liked. They seemed a bit critical of the trials.

And yea. Define "tolerated." There are plenty who would say they will not tolerate (deal with) injecting themselves several times daily.

All the physician has to do is document that the patient "did not tolerate injecting". We do this all the time with getting prior authorizations. Unfortunately, the insurance companies make us jump through hoops - making us try 1, 2, even 3 drugs before we can prescribe the one we really want to prescribe. But we know how to get what we want. It's unfortunate and wasteful of my time and the patient's time, but it's the system we have right now. I even go so far as to tell the patient - I want to give you drug A, but your insurance wants me to try drug B first. So let's see how that goes, and if you can't tolerate drug A, I can prescribe drug B.

[liane]

Keep in mind, there already may be many patients out there who have already met the criteria - they are not well controlled on metformin and they can't or won't inject. It's not like they have to document 90 days going forward on metformin.

[jpg]

Dec 21, 2014 6:14:23 GMT -5 liane said:

Keep in mind, there already may be many patients out there who have already met the criteria - they are not well controlled on metformin and they can't or won't inject. It's not like they have to document 90 days going forward on metformin.

Hi Lianne,

Do you think the second line they are comparing to are pens or out of the vial?

JPG

[liane]

jpg,

I'm confused - I'm not sure what you are getting at. My point would be that there is a huge population, not well controlled on metformin. They may or may not be on other oral agents. They may or may not have tried injectable insulin in whatever form. All it would take is the patient saying "I cannot tolerate injecting myself 3 times a day" for whatever reason - lifestyle, needlephobia, simple dislike of the procedure. I don't think it will be long for physicians to find a way to get these patients on Afrezza.

[dreamboatcruise]

Dec 21, 2014 1:30:35 GMT -5 jpg said:

Maybe rose colored glasses but I think this is pretty good.

1. Next review May 2015...

2. I would also (and especially) point out this is second line indication after Metformin. Now that is a pretty big market. I wonder if this 'first line insulin after Metformin' they are referring to isn't 'out of a vial' and not pens? That small detail would be a big deal to know obviously.

JPG

May review does seem good.  I wonder if anyone can contribute any past experience as to whether it is common for these drug guidelines to come out early for a drug with default "restrictive" conditions and then be quickly changed.

So what your asking is whether the pens have this same designation as Afrezza requiring that they also only be prescribed after patients have failed to control A1c on vials or "not tolerated" it, whatever that means.

[jpg]

Dec 21, 2014 12:15:58 GMT -5 liane said:

jpg,

I'm confused - I'm not sure what you are getting at. My point would be that there is a huge population, not well controlled on metformin. They may or may not be on other oral agents. They may or may not have tried injectable insulin in whatever form. All it would take is the patient saying "I cannot tolerate injecting myself 3 times a day" for whatever reason - lifestyle, needlephobia, simple dislike of the procedure. I don't think it will be long for physicians to find a way to get these patients on Afrezza.

Hi Lianne,

Agreed as to your take on how to get medications we want in the hands of patients.
My question is what would you think their standard insulin (first line after Metformin) would be: pens or vial insulin? Not certain we can tell with the above info but what would eventually be harder for patients to get in the above plan: Afrezza or insulin pens?

JPG

[jpg]

So what your asking is whether the pens have this same designation as Afrezza requiring that they also only be prescribed after patients have failed to control A1c on vials or "not tolerated" it, whatever that means.


hi DBC,

Yes. Which would be harder to get through these insurers? If it is as 'hard' as getting a pen it shouldn't be a huge hurdle. And the currently available 2nd line pills after Metformin aren't exactly cheap (or particularly trustworthy).

JPG

[dreamboatcruise]

Dec 21, 2014 12:15:58 GMT -5 liane said:

jpg,

I'm confused - I'm not sure what you are getting at. My point would be that there is a huge population, not well controlled on metformin. They may or may not be on other oral agents. They may or may not have tried injectable insulin in whatever form. All it would take is the patient saying "I cannot tolerate injecting myself 3 times a day" for whatever reason - lifestyle, needlephobia, simple dislike of the procedure. I don't think it will be long for physicians to find a way to get these patients on Afrezza.

I guess this comes down to whether it is as simple as documenting a patients objections and one phone call, or whether it takes 3 attempts and wasted time to get the approval.

Do you have any real world experience with patient simply saying they won't "tolerate" a particular option... i.e. they simply say they aren't even willing to try something because of the side effects or risk profile or whatever?  Do insurers use sticks or carrots for doctors to avoid "over prescribing" drugs that are not first tier on formulary?  Is there typically a link between needing authorization as in this guideline and there being a higher co-pay for patients... or is that likely not linked?

[liane]

jpg,

OK, now I see what you are asking. I clicked on the link for this plan, and they do not seem to specify how the prandial insulin is to be supplied; just which brands are preferred and non-preferred.

[liane]

dbc,

It varies all over the place. Most times, sending a FAX documenting patient intolerance or other objection is enough. Other times, they make you have a phone conversation with their medical adviser. Most times, you can get what you want, but they try to wear you out 1st.