Have you read the Insulin Access Affordability Working Group convened by the American Diabetes Association


#1

I’m curious on how many members here use human insulins? And would love to hear everyone’s opinions on the ADA’s conclusions.


#2

Thanks for bringing this advocacy piece to our attention, Mila. The Beyond Type 1 writer, Dana Howe, writes an excellent explanation for what’s going on with insulin access.

The American Diabetes Association is undermining our access to modern insulin analogs like Humalog, Novolog, and Apidra. These modern insulins also include basal analogs like Lantus, Basaglar, Toujeo, Levemir and Triseba.

The ADA set up the Insulin Access Affordability Working Group and its recently published findings, instead of championing wide and affordable access to all the modern insulins, provides a convenient rationale for the greedy and unscrupulous insurance companies and pharmacy benefit managers to deny access to better insulin therapy and sentences many of us to using old fashioned Regular and NPH, insulin used before 1996.

I have lived with Regular and NPH and they seriously erode quality of life. They require exacting observance of eating to the insulin or suffer debilitating hypoglycemia including episodes of painful social and professional embarrassment.

Regular insulin, for example, would require a 30-90 minute prebolus time in order to match well with a meal. I once fell asleep after taking Regular while waiting for my 60-minute prebolus time to elapse. I woke up on the floor a few hours later in severe hypoglycemia. While this insulin can be safely used, its slow onset and peak, together with its longer duration degrade quality of life. Ignore the extended pre-bolus timing and you’ll take a permanent ride on the notorious glucose roller coaster.

ADA, I am disappointed in this tenor of “advocacy.” Whose side are you on?


#3

From the article:

But this ADA publication doesn’t reinforce the importance of analog insulin to patients living with diabetes. It opens the door to calculated cost-benefit decisions made by stakeholders who are not incentivized by the patient’s best interests. It does not double down on the safety and wellbeing benefits provided by newer insulins. As an organization claiming to represent the interests of people living with diabetes it is irresponsible not to raise these concerns.

Is it out of the question to fear the moment an insurance company decides to remove analog insulin from their formulary and decide only to cover a cheaper human insulin? When pressed, that company will be able to use this report as source material. That’s wrong.

About three years ago I started with a new endo, and at our first meeting gave her the thumbnail version of my (then) 32 years’ experience with T1. I told her how I’d been on R/N for 20 years, and how changing to Lantus-Novolog MDI had been like being released from prison, much more life-changing than moving to a pump later on, and shared with her my pet term for the R/N regimen: Eat Now Or DIE. She laughed, but she wrote it down to share with her endo colleagues, she told me, because there was a lot of discussion going on about a recent study showing that, in terms of outcomes, analog-based MDI was statistically not an improvement over R/N. She was in conference with other D professionals discussing the study and its implications, which were all exclusively “outcome” focused, and said my term might help in making the point that “outcomes,” so narrowly defined, were far from the only consideration from the patient’s point of view, the point of view of overall wellbeing.

What the article describes is precisely the thing I was most concerned about. I harbor quite a bit of resentment about the YDFLNCA (You’re Doing Fine Let’s Not Change Anything) attitude that kept me stuck with R/N for years after analog-based MDI had become the standard–an attitude blinkered to every consideration outside A1C. I understand where it comes from, and why it’s so deeply baked into the medical-professional mindset. Measurability matters, and I agree with that. But in terms of health care, in terms of patient care, it’s not the only thing. I didn’t feel released from prison because analog treatment was more convenient, though it certainly was. I felt that way because it considerably lowered my FEAR level, something I lived with day in/day out for 20 years, and the source of that fear was not my disease but my f’r cripesake TREATMENT.

So to see this door left open by the premier advocacy group that is meant to represent my interests, not the interests of the private insurers’ stockholders, is more than a little upsetting.


#4

I opened the pdf document published by the ADA. I haven’t read through it but skimmed to find out who the authors are. They seem to be all professionals, mostly MDs. They are investigating an economic and medical situation that plays a crucial role in our ability to survive. No wonder that they didn’t weigh quality of life issues!

I am insulted about this arrogant assumption that they think they can advocate well for us. It’s likely that not a one of them has lived a day with diabetes, much less experienced the primitive essential threat of hypoglycemia.

I realize that we need non-Ds, especially doctors, to help us live a full and meaningful life. But I sure wish they were enlightened enough to consider the patient point of view, even in a professional paper.


#5

Not surprising, true. But “quality of life” is not just about “I get to live as if I didn’t have T1 at all!!!” As Howe points out, it includes some pretty hard-edged considerations, like safety for one.


#6

What does this mean for us exactly? human insulin? Does anyone know? Will I not be able to get novolog? My ins company stated I have that covered for life, I hope that will stand. Why don’t they just lower the prices, we know it doesnt production cost anyhwhere near what they charge and it’s sold for much less in other countries.


#7

We really need the government to step in and do something about these insane drug prices. There’s little difference between these prices, scalping tickets outside a venue, and charging X times the normal price for essentials like gasoline or water, when there is a crisis. It’s illegal to scalp, it’s illegal to price gouge during disasters. It should be illegal to gouge anyone in need of life-saving drugs.


#8

I read the original ADA doc that the Dana Howe article is about. The inference the article draws from it is that the recommendations open the door to making insulin more “affordable” by pushing more patients toward cheaper insulins, which is to say, R and N. If anything, I think that inference could be stated more strongly.

Providers should prescribe the lowest-priced insulin required to effectively and safely achieve treatment goals.

  • This may include using human insulin in appropriately selected patients.
  • Providers should be aware of the rising cost of insulin preparations and how this negatively impacts adherence to the clinical treatment by people with diabetes.
  • Providers should be trained to appropriately prescribe all forms of insulin preparations based on evidence-based medicine.

I’ve gone through the thing several times and the more I read it, the more I realize that it boils down to bringing R/N back into the formulary as the primary way of reining in costs. They address two other approaches: increased competition from biosimilar insulins, and exempting insulin from deductibles. As for the former, there are lots of barriers in the way and

As of this writing, there are no biosimilar insulins on the market, but to date, three follow-on biologic human insulin analogs have been approved by the FDA (40–42). Discussion with stakeholders revealed differing opinions on how much biosimilars would lower the price of insulin. Currently, the only follow-on biologic insulin on the market was introduced with a list price approximately 15% less than the original version (43,44).

As for the latter:

Health plans noted that out-of-pocket insulin costs could be lower for some people with diabetes if health savings account–eligible high-deductible health plans could exempt insulin from the deductible. Manufacturers agree that exempting insulin from the plan’s deductible is a critical step in lowering out-of-pocket insulin costs.

But, alas, there isn’t such a plan:

Until there is a systematic plan that addresses a change in benefit design to lower out-of-pocket insulin costs for people with diabetes, human insulin may be a valid alternative to more expensive analog insulins for some patients (19,37). In this regard, there would need to be significant education of people with diabetes and health care providers on the appropriate use of human and analog insulins, and careful selection of people who may benefit from analog insulin.

Among many oddities in this document, that last phrase stands out. I almost want to say it must be a typo. It looks like they’re saying the standard should be R/N, and only “carefully selected” people would get to use the analogs, but that can’t be right… can it?

The whole document is strangely indirect and mealy-mouthed about what they’re actually recommending, and there’s a huge amount of contextual information–including a “schematic of insulin supply chain” that looks like one of those jokey decision flowchart memes people post on Facebook–that doesn’t actually narrow to a point about what should be done. They back into the recommendation that human insulins should play a greater role without ever adducing evidence that they are as effective, even though the phrase “evidence based” pops up, as in the bullet above:

  • Providers should be trained to appropriately prescribe all forms of insulin preparations based on evidence-based medicine.

Well, sure, but which insulins and what evidence? I’d summarize it like this:

There’s competition, but here’s why that doesn’t work; there’s excepting insulin from deductibles, but there’s no plan for that. Here’s a bunch of general information about “value-based insurance design, wherein cost-sharing is linked to population health outcomes,” but we don’t want to actually point to any studies that say which insulin is best from that point of view. In the end R/N is cheaper than anything else, so let’s have more of that, m’kay?


#9

In their conception, what wise benevolent arm of the market will bestow fairy dust on the excepted few who get to use the more recent formulations? What adjucticative body will make this call? This aspect is not well thought through.

Does the ADA get any Pharma funding? I’m off to search.

From ADA website:

Banting Circle Supporters

The Banting Circle Elite is the American Diabetes Association’s highest level of recognition for companies that develop medicines and devices to help individuals living with diabetes. It is named for Sir Frederick Grant Banting, a Canadian medical scientist, doctor, Nobel Laureate, and co-discoverer of insulin. The annual total support for companies reaching the Banting Circle Elite level is at least $1,000,000. This includes sponsorship, educational grants, advertising in Association publications and exhibiting at the Annual Scientific Sessions and/or the Annual Advanced Postgraduate Course. Companies whose support total is at least $500,000 are recognized at the Banting Circle level.

AstraZeneca
BD Medical-Diabetes Care
Boehringer Ingelheim Pharmaceuticals
Eli Lilly
Janssen Pharmaceuticals
Medtronic
Merck
Novo Nordisk
Pfizer
Sanofi


#10

Part of what is so remarkable about this is that within the last year or so a major study came out showing that the life expectancy of people with diabetes has improved significantly in the last generation. Now the factors which might have made a difference are the availability of glucose monitors (and more recently CGMs) and more effective insulin regimes and insulins.

This “study” is a fine companion to the recent position paper that optimum A1c range is between 7 and 8 for many patients. Not merely the very elderly and frail.

We already have a two tier health care system for diabetes. Those with good insurance and/or sufficient income get to see endos and use the latest tools. The poor get whatever is cheap and then get blamed for bad outcomes.

Nice,

Maurie


#11

For some reason I feel like the rug has been pulled from under PWD. I don’t believe that the ADA is so naïve to believe this will not affect quality of life and quality of care.

The bottom dollar is not what’s important to us. The only one that cares is the insurance industry. Does the ADA believe that this report will not be used by insurance to justify their greed. I doubt it.

Who knows this report may have the desired effect of stopping the ever present price gouging that is happening to the price of insulin. It a large majority of PWD are forced away from modern insulins the price of these insulins will most likely fall due to decrease in market demand.

My question is how many lives will be impacted, how many will have their health compromised, how many will have their quality of life eroded. All this to tame the price of insulin. Surely there must be a better way.


#12

Most infuriating thing to me is that bit about exempting insulin from deductibles in high-deductible plans, which they (or at least the Manufacturers) say would be the most effective approach. Well, geez, there isn’t a plan for that, they say, so heck with it, let’s go back to prescribing R/N. If this is supposed to be an “advocacy” document, how about, y’know, advocating for that, then? How about recommending a cooperative effort with the manufacturers to push for that? Especially since they start the whole thing off with anecdotals indicating the deductible issue is a major source of the problem?


#13

They probably have never had to choose between a mortgage payment and staying alive…


#14

I know that researchers, scientists, and medical doctors have a legitimate point of view on the subject of diabetes. I would not like to live in a world where this level of expertise and competence did not study diabetes and its treatments.

Having said that, I wish they would always try to weave in the patient perspective. Otherwise I often feel patronized and the wholeness of who I am, especially the psychological and emotional, gets marginalized. In an ideal world I see the patient perspective as crucial to producing a fully credible project. Does that make any sense?


#15

Absolutely.

My mother passed away last year. For several years before her death, she had a progressing type of dementia. Doctors blamed it on sleep apnea, on medications, on her diabetes, on her obesity, etc. - the list goes on. Around 10 months before her death, she had an incident that landed her in the ER, where she was misdiagnosed as having had a mild heart attack. HER PCP told the hospital to do a colonoscopy - they refused. Her hemoglobin was very - so they gave her transfusions and iron and investigated nothing - after all, she was "old’ and had dementia… Over the next 3 months, things got worse - she moved less and less and stopped eating – So they treated that - with a feeding tube, and more transfusions… FINALLY, we had her admitted to her PCP’s hospital where he did that colonoscopy – and found a significant cancerous tumor in her colon!

The hospital surgeon refused to do surgery - after all, she’s old, had dementia -what kind of life would she have? Why add pain to the mix – of course, when pressed he admitted that the cancer would cause significantly MORE pain over time… We had the surgery done at another hospital. The recovery was NOT easy, and was hindered by the MRSA she contracted at a rehab home (PIT!). HOWEVER, the surgery was absolutely the right thing to do! Within days of the surgery, her mind began to clear – she could have meaningful conversations, like she hadn’t had in years! Those last few months were not easy - but her overall quality of life was immeasurably better despite the infection and incision and all that went with that.

Taking the actual best interest of the patient into consideration is essential for effective healthcare! Too few doctors actually do that today. (The surgeon that performed my mom’s surgery, will, though – he learned a LOT about how dementia can be reversed by taking action instead of doing nothing!)


#16

From December 1986 through September 2017, I used Humulin N and R. I wholeheartedly agree with the everything-is-fine-so-why-change-anything comment (sorry if I got the wording wrong, but you all know what I mean). I didn’t realize what my options even were! For the last 1 1/2 years before getting my pump, I tried to get a CGM, but my insurance wouldn’t cover it. I wasn’t sick enough - I hadn’t been repeatedly put in the hospital for hypoglycemia, so I obviously didn’t need a CGM???!!!???!!!

I was enduring perimenopausal hormone swings that were making it harder and harder to deal with the Humulin N/R rigidity, and I didn’t know what to do. Kaiser changed its mind about CGMs, and I got one in May 2017, and discovered that my overnight BGs were reaching into the 400s on a regular basis, for several hours at a time. My endo, CDE, and I were hoified, and started to consider alternative regimines. I requested an insulin pump as soon as I found out that the basal insulin was programmable, and that there were things called Temporary Basals for short-term crazy hormonal swings.

But it took time to get there, and I had 2 severe hypoglycemic episodes between getting the CGM and getting the pump. I became a nervous wreck every time that I had to do a shot because I didn’t know if the insulin would absorb properly either. I had serious problems with injection sites by then. If I hit a really good spot, my BG would drop like a rock, and if not, I might not eat for hours because my BG would stay high.

After I got the pump, it WAS like being released from prison. And, BTW, just from not having to chase low BGs with tons of sugar, and with no real effort on my part, I have lost over 35 lbs in the last 10 months! So, even if nothing else was measurable, that certainly is.

So, NO, I DON’T THINK THE HUMULIN N/R IS A VIABLE OPTION FOR MY CONTINUED GOOD HEALTH!!! … physically or mentally. The loss of most of the background anxiety from having my BGs constantly rising and falling is like having a loud source of white noise turned down to almost nothing.


#17

But as long as you crash into enough life-threatening hypos your A1C will be just fine–let’s not change anything!

Glad you finally got off that stuff.


#18

I changed from NPH to Lantus about 4 years ago. Ended up that I required about half the units per day. Still happy with the more stable BGs.
I changed from Regular to Apidra about 3 years ago and found I had to use about a quarter less units than Regular. Recently had to revert back to Regular. Apidra does work slightly quicker than Regular but not fast enough to make any significant difference to me.


#19

I used to refer to NPH as “the Devil’s insulin”.


#20

A while back I had to swap from Novus Ultratard to Lantus, not because Ultratard didn’t work but because it had been discontinued and there was no human insulin with a comparable action time. So I went from something that I could buy over-the-counter to something with, so far as I could determine, a shorter acting time that I had to have a prescription for.

Since then I’ve found a far better solution, as a couple of people who replied above imply; I’m using a pump. Now I don’t need any chemically modified insulin for my basal, I can use a totally unmodified one which is just dripped into me. Except, of course, I can’t; I use Humalog, not Humalin, in the pump because that’s what it is designed for.

I can’t see any real benefit from the Humalog over Humalin. Maybe it does absorb a few minutes faster, but I almost invariably use a “delayed” bolus for a significant part of my meals because the non-carb part takes a lot longer than either to absorb.

Neither insulin is fast enough to deal with any starches I eat; if I bolus when I eat and my meal contains the “normal” (i.e. any) amount of starches I see a peak. Maybe it is lower with Humalog, I don’t know since I’ve never used Humalin in the pump, but it is still there.

The only answer I know is to not eat starches, but the social resistance to this is enormous. I remember my mother, who had been a nurse all her life, telling me that I had to eat potatoes because otherwise I wouldn’t have a balanced diet, and that would be bad for me. She became upset when my wife insisted to her that I couldn’t because I was a diabetic.

So, conclusion, yes; humalog is important because it addresses a problem that is caused by social pressures, but no, it’s not that important. Pumps and CGMs are far more important, and it is about time that pumps were designed to use Humalin so that we can spend our limited resources in the way that is best for us.

John Bowler