Blue Cross Blue Shills Insurance Coverage—Afrezza

[mango]

In this thread I will express my opinion of what I consider a fundamental flaw with our healthcare system. That flaw is illustrated below, and this information was taken from a random state and insurance. They are all much alike, and for the majority of them, they all work the same way. In other words—they are all flawed.

Blue Cross Blue Shield of Michigan
April 2017

Prior Authorization and Step Therapy Coverage Criteria
There are hundreds of different medications, and more are becoming available every day. Blue Cross Blue Shield of Michigan works to make sure you get the safest, most effective and most reasonably priced prescription drugs. Our pharmacists do this in many different ways. Prior authorization and step therapy are two of our tools.

What is prior authorization?
The Blues require review of certain drugs before your plan will cover them, which is called prior authorization. This ensures that you have tried the preferred alternatives — drugs with a proven track record that may be better tolerated, less expensive or less likely to cause interactions — and the drug is being prescribed appropriately. If your doctor doesn’t get prior authorization when required, your drug may not be covered. You should consult with your doctor about an alternative therapy in those cases.

What is step therapy?
Under step therapy, the Blues pharmacy computer system performs an automated review of your drug history to determine whether you’ve tried the preferred alternatives first for your condition. This ensures all clinically sound and cost-effective treatment options are tried before more expensive drugs are prescribed. If your prescribed drug does not meet the step therapy criteria, it may not be covered. You should consult with your doctor about an alternative therapy.

What kinds of drugs need prior authorization or step therapy?
• Drugs that have dangerous side effects or can be harmful when combined with other drugs
• Drugs that should only be used for certain health conditions
• Drugs that can be misused or abused
• Drugs that are prescribed when there are other drugs available that are less expensive and just as effective

The criteria for drugs that need prior authorization or step therapy are based on current medical information and the recommendations of the Blues’ Pharmacy and Therapeutics Committee, a group of physicians, pharmacists and other experts.

Drug
Afrezza

Blue Cross Coverage Criteria
Coverage will be provided for the following:
1. Age ≥ 18 years of age
2. Type 2 DM or Type1 DM on long acting insulin
3. Trial and failure of short acting insulin
4. Must not have chronic lung disease including asthma or COPD
5. Must not be a current smoker

Prior Authorization and Step Therapy Programs
1. Custom Drug List—checkmark
2. Clinical Drug List—checkmark
3. Custom Select Drug List—NC
4. Lite PA—checkmark
5. Preferred Therapy—blank
6. Off-Label/High-Cost Specialty—blank

• Afrezza BCBS Michigan Insurance Coverage


• What is the fundamental problem represented here?
—Clinicians are significantly influenced by such "criteria" which is created by a group of "experts" that subsequently are regulating and governing the medical decision making, and this can result in poor health and poor care of the patient, because, as we already know—these experts can majority consist of biased paid shills.

• Here is some proof of that:

mnkd.proboards.com/thread/7301/exposing-corruption-2017-endo-consensus

mnkd.proboards.com/thread/7382/lawsuit-filed-sanofi-nordisk-lilly

mnkd.proboards.com/post/97908


• Patients in Michigan cannot receive insurance coverage if the clinician wishes to start the patient out on Afrezza because a group of "experts" that work directly for BCBS, also better known as, the Blues’ Pharmacy and Therapeutics Committee, a group of physicians, pharmacists and other experts, came to the Consensus that the patient must 1) have a successful trial and failure of a short acting insulin, and 2) that patient who is either a T2D or T1D patient must be on long acting insulin.

Did I read this correctly? A Type 2 on a long acting insulin shall receive insurance coverage for Afrezza? What happens when that patient is not on a long acting insulin?

2. Type 2 DM or Type1 DM on long acting insulin


[agedhippie]

You got that right.

If you are on BCBS you have to follow the standard of care and use a basal insulin before a meal time insulin. That's hardly shocking - it's the standard of care.

And if you want to use Afrezza you have to follow stepwise protocols (fail with the preferred drug) which they can enforce as the drugs are equivalent according to FDA approval.

As for the panel of experts - that's just CYA by the BCBS to say that their decisions are medically sound - a particularly low bar.

[mango]

Apr 2, 2017 17:56:38 GMT -5 agedhippie said:

You got that right.

If you are on BCBS you have to follow the standard of care and use a basal insulin before a meal time insulin. That's hardly shocking - it's the standard of care.

And if you want to use Afrezza you have to follow stepwise protocols (fail with the preferred drug) which they can enforce as the drugs are equivalent according to FDA approval.

As for the panel of experts - that's just CYA by the BCBS to say that their decisions are medically sound - a particularly low bar.

It is not a panel of anything, it is a BCBS derived Committee. The insurance company uses a Consensus Committee to establish its regulations and guidelines in which it oversees prescription coverage. It is really that simple, and they even tell us this themselves:

The criteria for drugs that need prior authorization or step therapy are based on current medical information and the recommendations of the Blues’ Pharmacy and Therapeutics Committee, a group of physicians, pharmacists and other experts.

And to suggest that T2D should all be on long-acting insulin, and that it is the standard of care is rather ludicrous. The so called standards of care that you are referring to are the same ones designed by none other than paid shills for pharmaceutical companies, and that is illustated in CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM – 2017 EXECUTIVE SUMMARY and this The Federal Class Action Lawsuit Against Sanofi, Novo Nordisk, Eli Lilly and PBMs for Collusion in Insulin Price Fixing.

How do clinicians practice effectively, safely, and in the patient's best interests if he/she is regulated, governed, and influenced by pharmaceutical and insurance companies? 

And whatever the Committee's Consensuses are for recommended management algorithms is not an acceptable answer.

[agedhippie]

Apr 2, 2017 19:15:04 GMT -5 mango said:

Apr 2, 2017 17:56:38 GMT -5 agedhippie said:

You got that right.

If you are on BCBS you have to follow the standard of care and use a basal insulin before a meal time insulin. That's hardly shocking - it's the standard of care.

And if you want to use Afrezza you have to follow stepwise protocols (fail with the preferred drug) which they can enforce as the drugs are equivalent according to FDA approval.

As for the panel of experts - that's just CYA by the BCBS to say that their decisions are medically sound - a particularly low bar.

It is not a panel of anything, it is a BCBS derived Committee. The insurance company uses a Consensus Committee to establish its regulations and guidelines in which it oversees prescription coverage. It is really that simple, and they even tell us this themselves:

The criteria for drugs that need prior authorization or step therapy are based on current medical information and the recommendations of the Blues’ Pharmacy and Therapeutics Committee, a group of physicians, pharmacists and other experts.

And to suggest that T2D should all be on long-acting insulin, and that it is the standard of care is rather ludicrous. The so called standards of care that you are referring to are the same ones designed by none other than paid shills for pharmaceutical companies, and that is illustated in CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM – 2017 EXECUTIVE SUMMARY and this The Federal Class Action Lawsuit Against Sanofi, Novo Nordisk, Eli Lilly and PBMs for Collusion in Insulin Price Fixing.

How do clinicians practice effectively, safely, and in the patient's best interests if he/she is regulated, governed, and influenced by pharmaceutical and insurance companies? 

And whatever the Committee's Consensuses are for recommended management algorithms is not an acceptable answer.

The committee's role is simply to ensure oversight, it is not to override the Standard of Care (actually they cannot - it would put them in legal jeopardy). BCBS says what they want to do, and the committee tell them if it is medically defensible. At a point in the future BCBS can point at the committee and say that a panel of qualified medical professionals said it was ok - it's about assigning risk.

Standard of Care? It is an evidence based document. If you have data from trials that says it is wrong and have medical standing have at it. If you don't then you may as well howl at the moon for all the difference it will make. Again, it's that simple.

The class action is ambulance chasing over pricing to PBMs (and since when does being sued automatically make you wrong?). I don't see a link to superiority, etc.

The trial data says that Humalog, Novolog, Apidra, and Afrezza are all equivalent. Therefore they can be used interchangeably so specifying any one of them will have no impact on the outcome and hence the patient's best interests. If you have a trial showing superiority then that changes, but of course that doesn't exist. You can argue until you are blue in the face but the trail data says otherwise. Want do fix that? Do the superiority trial.

[mango]

Apr 2, 2017 20:38:10 GMT -5 agedhippie said:

Apr 2, 2017 19:15:04 GMT -5 mango said:

It is not a panel of anything, it is a BCBS derived Committee. The insurance company uses a Consensus Committee to establish its regulations and guidelines in which it oversees prescription coverage. It is really that simple, and they even tell us this themselves:
And to suggest that T2D should all be on long-acting insulin, and that it is the standard of care is rather ludicrous. The so called standards of care that you are referring to are the same ones designed by none other than paid shills for pharmaceutical companies, and that is illustated in CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM – 2017 EXECUTIVE SUMMARY and this The Federal Class Action Lawsuit Against Sanofi, Novo Nordisk, Eli Lilly and PBMs for Collusion in Insulin Price Fixing.

How do clinicians practice effectively, safely, and in the patient's best interests if he/she is regulated, governed, and influenced by pharmaceutical and insurance companies? 

And whatever the Committee's Consensuses are for recommended management algorithms is not an acceptable answer.

The committee's role is simply to ensure oversight, it is not to override the Standard of Care (actually they cannot - it would put them in legal jeopardy). BCBS says what they want to do, and the committee tell them if it is medically defensible. At a point in the future BCBS can point at the committee and say that a panel of qualified medical professionals said it was ok - it's about assigning risk.

Standard of Care? It is an evidence based document. If you have data from trials that says it is wrong and have medical standing have at it. If you don't then you may as well howl at the moon for all the difference it will make. Again, it's that simple.

The class action is ambulance chasing over pricing to PBMs (and since when does being sued automatically make you wrong?). I don't see a link to superiority, etc.

The trial data says that Humalog, Novolog, Apidra, and Afrezza are all equivalent. Therefore they can be used interchangeably so specifying any one of them will have no impact on the outcome and hence the patient's best interests. If you have a trial showing superiority then that changes, but of course that doesn't exist. You can argue until you are blue in the face but the trail data says otherwise. Want do fix that? Do the superiority trial.

What is superior?

1
:  situated higher up :  upper

2
:  of higher rank, quality, or importance

3
:  courageously or serenely indifferent

4

a :  greater in quantity or numbers

b :  excellent of its kind

5
:  being a superscript

6

a : of an animal structure :  situated above or anterior or dorsal to another and especially a corresponding part a superior artery

b : of a plant structure :  situated above or near the top of another part: such as (1) of a calyx :  attached to and apparently arising from the ovary (2) of an ovary :  free from the calyx or other floral envelope

7
:  more comprehensive a genus is

8
:  affecting or assuming an air of superiority :  supercilious


• I can go ahead and tell you with, zero evidence pointing against it, that the simple fact that Afrezza does not cause any amyloid deposits makes it superior. If you want to disagree with that, provide a scientific document that proves otherwise. Until that day comes, the only scientific evidence you will find proves injectable insulins are amyloidogenic and Afrezza is not. That in my brain makes it vastly superior already.

—Every complication one can get from injecting is thrown out of reality

—Self-conscious diabetics are no longer stigmatized

—Ease of use has never been easier

—Fear of hypos is blown from existence

• Superior, yes, real life evidence proves this. Clinical trials are already significantly flawed. Real life evidence will always be superior to a controlled experiment. And that is what clinical trials are, controlled experiments with humans.

[agedhippie]

Apr 2, 2017 21:21:17 GMT -5 mango said:

• Superior, yes, real life evidence proves this. Clinical trials are already significantly flawed. Real life evidence will always be superior to a controlled experiment. And that is what clinical trials are, controlled experiments with humans.

Right there you have the only evidence the medical profession cares about - clinical trial data. A doctor's personal experience is the only thing which will override it. You might not like it, but that's just the way it is, and right now the trial data says they have the same outcome. Want to change that? Run a trial to prove superiority, and currently the outcome of choice is HbA1c reduction although if you want to finance CGMs for the trial you could use time in range.

[peppy]

Apr 2, 2017 17:56:38 GMT -5 agedhippie said:

You got that right.

If you are on BCBS you have to follow the standard of care and use a basal insulin before a meal time insulin. That's hardly shocking - it's the standard of care.

And if you want to use Afrezza you have to follow stepwise protocols (fail with the preferred drug) which they can enforce as the drugs are equivalent according to FDA approval.

As for the panel of experts - that's just CYA by the BCBS to say that their decisions are medically sound - a particularly low bar.

aged and all, what do you think might happen standards wise if afrezza gets the ultra-rapid label change secondary to the euglycemic clamp technique?

www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf

Onset of activity for TI occurred ca. 25-35 minutes earlier than for
Lispro. TI duration of action is about 2 hours shorter than an equivalent
dose of Lispro. Dose-response was almost linear up to 48U TI and 30 U Lispro.

• Afrezza’s onset of action is faster than Lispro’s
• Afrezza’s duration is shorter than Lispro’s
• Afrezza’s labeled dose over-estimates its effect
• A single conversion factor does not fully describe Afrezza’s
effect relative to SC insulin
• For safety, initial conversion to Afrezza tends to underestimate
dose
• Titration to appropriate dose is essential

============================================================

Does that get us on the preferred?

"What is step therapy?
Under step therapy, the Blues pharmacy computer system performs an automated review of your drug history to determine whether you’ve tried the preferred alternatives first for your condition.  This ensures all clinically sound and cost-effective treatment options are tried before more expensive drugs are prescribed."

The physicians are forced to prescribe what insurance covers?

Labels in hand saying prove it.

[agedhippie]

Apr 3, 2017 9:14:15 GMT -5 peppy said:

Apr 2, 2017 17:56:38 GMT -5 agedhippie said:

You got that right.

If you are on BCBS you have to follow the standard of care and use a basal insulin before a meal time insulin. That's hardly shocking - it's the standard of care.

And if you want to use Afrezza you have to follow stepwise protocols (fail with the preferred drug) which they can enforce as the drugs are equivalent according to FDA approval.

As for the panel of experts - that's just CYA by the BCBS to say that their decisions are medically sound - a particularly low bar.

aged and all, what do you think might happen standards wise if afrezza gets the ultra-rapid label change secondary to the euglycemic clamp technique?

www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf

Onset of activity for TI occurred ca. 25-35 minutes earlier than for
Lispro. TI duration of action is about 2 hours shorter than an equivalent
dose of Lispro. Dose-response was almost linear up to 48U TI and 30 U Lispro.

• Afrezza’s onset of action is faster than Lispro’s
• Afrezza’s duration is shorter than Lispro’s
• Afrezza’s labeled dose over-estimates its effect
• A single conversion factor does not fully describe Afrezza’s
effect relative to SC insulin
• For safety, initial conversion to Afrezza tends to underestimate
dose
• Titration to appropriate dose is essential

============================================================

Does that get us on the preferred?

"What is step therapy?
Under step therapy, the Blues pharmacy computer system performs an automated review of your drug history to determine whether you’ve tried the preferred alternatives first for your condition.  This ensures all clinically sound and cost-effective treatment options are tried before more expensive drugs are prescribed."

The physicians are forced to prescribe what insurance covers?

Labels in hand saying prove it.

The problem for Afrezza with the ultra change is that the focus is on outcomes rather than how you get there. The trial data for Afrezza says it makes no difference to the outcome. 

The intent of step therapy if debatable, the implementation of step therapy can often be disingenuous. The argument is that it is a good thing because it allows you to try drugs that would otherwise simply not be in the formulary (efficiency vs. cost rules them out). The problem is that PBMs also uses step therapy as an obstruction to push people in a certain direction.

There are better ways to deal with this such as payment by results. In the UK the NHS pays for certain drugs on a patient by patient basis. As an example a cancer drug (most of them are cancer drugs) has to works for the pharma to get paid for that patient. No cure no pay.

Physicians can prescribe anything but insurers don't have to pick up the bill. We have plenty of examples of doctors writing prescriptions for Afrezza and insurers not covering. The patient always has the option to pay for that prescription themself, it's just that the patient doesn't want it that badly.

[zuegirdor]

Apr 3, 2017 11:08:58 GMT -5 agedhippie said:

Apr 3, 2017 9:14:15 GMT -5 peppy said:

aged and all, what do you think might happen standards wise if afrezza gets the ultra-rapid label change secondary to the euglycemic clamp technique?

www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf

Onset of activity for TI occurred ca. 25-35 minutes earlier than for
Lispro. TI duration of action is about 2 hours shorter than an equivalent
dose of Lispro. Dose-response was almost linear up to 48U TI and 30 U Lispro.

• Afrezza’s onset of action is faster than Lispro’s
• Afrezza’s duration is shorter than Lispro’s
• Afrezza’s labeled dose over-estimates its effect
• A single conversion factor does not fully describe Afrezza’s
effect relative to SC insulin
• For safety, initial conversion to Afrezza tends to underestimate
dose
• Titration to appropriate dose is essential

============================================================

Does that get us on the preferred?

"What is step therapy?
Under step therapy, the Blues pharmacy computer system performs an automated review of your drug history to determine whether you’ve tried the preferred alternatives first for your condition.  This ensures all clinically sound and cost-effective treatment options are tried before more expensive drugs are prescribed."

The physicians are forced to prescribe what insurance covers?

Labels in hand saying prove it.

The problem for Afrezza with the ultra change is that the focus is on outcomes rather than how you get there. The trial data for Afrezza says it makes no difference to the outcome. 

The intent of step therapy if debatable, the implementation of step therapy can often be disingenuous. The argument is that it is a good thing because it allows you to try drugs that would otherwise simply not be in the formulary (efficiency vs. cost rules them out). The problem is that PBMs also uses step therapy as an obstruction to push people in a certain direction.

There are better ways to deal with this such as payment by results. In the UK the NHS pays for certain drugs on a patient by patient basis. As an example a cancer drug (most of them are cancer drugs) has to works for the pharma to get paid for that patient. No cure no pay.

Physicians can prescribe anything but insurers don't have to pick up the bill. We have plenty of examples of doctors writing prescriptions for Afrezza and insurers not covering. The patient always has the option to pay for that prescription themself, it's just that the patient doesn't want it that badly.

We are people of action. Acquiescence does not become us. The system is BROKEN and borderline CORRUPT. We deserve better. We must be the "disrupt" in the disrurtive technology that is Afrezza.

[peppy]

Apr 2, 2017 22:20:28 GMT -5 agedhippie said:

Apr 2, 2017 21:21:17 GMT -5 mango said:

• Superior, yes, real life evidence proves this. Clinical trials are already significantly flawed. Real life evidence will always be superior to a controlled experiment. And that is what clinical trials are, controlled experiments with humans.

Right there you have the only evidence the medical profession cares about - clinical trial data. A doctor's personal experience is the only thing which will override it. You might not like it, but that's just the way it is, and right now the trial data says they have the same outcome. Want to change that? Run a trial to prove superiority, and currently the outcome of choice is HbA1c reduction although if you want to finance CGMs for the trial you could use time in range.

And there lies the apex of the problem in the case of afrezza.

Quote: Right there you have the only evidence the medical profession cares about - clinical trial data.

Reply: We have to pretend we are blind and can not see?

How stupid is this. and we all obey.

Afrezza

subq

[agedhippie]

Apr 3, 2017 15:01:54 GMT -5 peppy said:

Apr 2, 2017 22:20:28 GMT -5 agedhippie said:

Right there you have the only evidence the medical profession cares about - clinical trial data. A doctor's personal experience is the only thing which will override it. You might not like it, but that's just the way it is, and right now the trial data says they have the same outcome. Want to change that? Run a trial to prove superiority, and currently the outcome of choice is HbA1c reduction although if you want to finance CGMs for the trial you could use time in range.

And there lies the apex of the problem in the case of afrezza.

Quote: Right there you have the only evidence the medical profession cares about - clinical trial data.

Reply: We have to pretend we are blind and can not see?

How stupid is this. and we all obey.

Afrezza

subq

And right there you have the problem - sample size. That's one person, what about all the others? Are they doing the same, better, worse? It's the chief purpose of a trial - get a lot of average people together and see if the treatment flies.

BTW. That first CGM shows two hypos which is probably why you have a couple of those spikes as they treated the hypos.

[agedhippie]

Apr 3, 2017 13:06:16 GMT -5 zuegirdor said:

Apr 3, 2017 11:08:58 GMT -5 agedhippie said:

The problem for Afrezza with the ultra change is that the focus is on outcomes rather than how you get there. The trial data for Afrezza says it makes no difference to the outcome. 

The intent of step therapy if debatable, the implementation of step therapy can often be disingenuous. The argument is that it is a good thing because it allows you to try drugs that would otherwise simply not be in the formulary (efficiency vs. cost rules them out). The problem is that PBMs also uses step therapy as an obstruction to push people in a certain direction.

There are better ways to deal with this such as payment by results. In the UK the NHS pays for certain drugs on a patient by patient basis. As an example a cancer drug (most of them are cancer drugs) has to works for the pharma to get paid for that patient. No cure no pay.

Physicians can prescribe anything but insurers don't have to pick up the bill. We have plenty of examples of doctors writing prescriptions for Afrezza and insurers not covering. The patient always has the option to pay for that prescription themself, it's just that the patient doesn't want it that badly.

We are people of action. Acquiescence does not become us. The system is BROKEN and borderline CORRUPT. We deserve better. We must be the "disrupt" in the disrurtive technology that is Afrezza.

I'm not quite sure what that means. Are you objecting to something I wrote? I would agree that the system is broken, although I would argue that it's dysfunctional rather than corrupt.

[zuegirdor]

Apr 3, 2017 15:28:33 GMT -5 agedhippie said:

Apr 3, 2017 13:06:16 GMT -5 zuegirdor said:

We are people of action. Acquiescence does not become us. The system is BROKEN and borderline CORRUPT. We deserve better. We must be the "disrupt" in the disrurtive technology that is Afrezza.

I'm not quite sure what that means. Are you objecting to something I wrote? I would agree that the system is broken, although I would argue that it's dysfunctional rather than corrupt.

Dread Pirate Roberts? The six fingered Man?

Does it matter if any of us object to anything?

[agedhippie]

Apr 3, 2017 17:25:20 GMT -5 zuegirdor said:

Apr 3, 2017 15:28:33 GMT -5 agedhippie said:

I'm not quite sure what that means. Are you objecting to something I wrote? I would agree that the system is broken, although I would argue that it's dysfunctional rather than corrupt.

Dread Pirate Roberts? The six fingered Man?

Does it matter if any of us object to anything?

Generally I find objecting is seldom an issue, it's the expectations you place on the objection where things come unglued. I object to broccoli but I fully expect people to keep on growing the wretched stuff over my objections.  

[careful2invest]

Apr 3, 2017 15:28:33 GMT -5 agedhippie said:

Apr 3, 2017 13:06:16 GMT -5 zuegirdor said:

We are people of action. Acquiescence does not become us. The system is BROKEN and borderline CORRUPT. We deserve better. We must be the "disrupt" in the disrurtive technology that is Afrezza.

I'm not quite sure what that means. Are you objecting to something I wrote? I would agree that the system is broken, although I would argue that it's dysfunctional rather than corrupt.

The system is certainly Dysfunctional
And
The system is certainly corrupt!

Even a minimal amount of DD will enlighten one to realize that these are both facts!

GLTA TRUE LONGS!!