Dennis P. Scanlon, PhD: We certainly are always concerned about access, and access is appropriate. Bob, you wrote a very interesting op-ed last year in the American Journal of Managed Care^® about this “insulin pricing conundrum,” I guess, for lack of a better term. And I think you really identified that there are multiple pieces to this. Talk about what you said.

Robert Gabbay, MD, PhD, FACP: From the patient level, it’s, in some ways, a travesty, really. People with type 1 diabetes depend on insulin to stay alive, and the cost of insulin has skyrocketed over the last decade (driven by a lot of different factors). I think the challenge is teasing out. There isn’t one bad guy or one bad player in all of this, it’s sort of a series of different pieces.

There’s pharmacy cost from the pharmaceutical companies. Some of that is required to generate new treatments and reinvest. So, they have their vantage point. There are formularies that compete, and then the pharmacy benefit managers also negotiate a variety of different arrangements. So, it makes it difficult to point a finger, so to speak.

I think the solution, or first step, would be rate of transparency, because that would allow everyone to sort of say, “What’s going on here?” Unfortunately, this is one of those situations where the patient loses in the end. The good news is that there’s enough of an outcry around this, and it’s been documented, now, in a number of studies to show the plot of increasing insulin costs versus other drugs. We’re on the verge, I think, of seeing something happen to mitigate this issue.

Dennis P. Scanlon, PhD: Mary Ann, you’re kind of in the trenches with patients as an educator. What’s your opinion on the question of whether current access is appropriate? What are you seeing with the patients you work with?

Mary Ann Hodorowicz, RDN, MBA, CDE: What we’re seeing is that the type of insulin we want (if we’re talking about just insulin), or the type of insulin we think is best (when working with the physician and the endocrinologist), we come to an understanding as part of a healthcare team in individualizing their treatment, only to find out (per this discussion) that the insurance doesn’t pay for it. And then, we have to swing back and maybe not give the insulin, period. We have to go to non-insulin injectables, or back to orals. But, on top of that, we have to really focus on lifestyle changes. But there, again, is the patient’s lifestyle going to be consistent? How the lifestyle is, is that going to sync in with the type of insulin that’s on the formulary? So, if the formulary is focusing on a fixed ratio of 70/30, 50/50, but that’s not the best for the patient…

Kenneth Snow, MD, MBA: I would be surprised if there’s too many formularies that do that though. I really would.

Dennis P. Scanlon, PhD: What about out-of-pocket costs, too? Is that an issue?

Robert Gabbay, MD, PhD, FACP: It’s huge.

Mary Ann Hodorowicz, RDN, MBA, CDE: The one study I looked at last night is that the average cost for the average type 2 patient on insulin is anywhere from $120 to $400 a month. That’s out-of-pocket.

Robert Gabbay, MD, PhD, FACP: And that’s just one drug they’re on.

Mary Ann Hodorowicz, RDN, MBA, CDE: Exactly.

Dennis P. Scanlon, PhD: Are we seeing, maybe, using of less than adequate or desired dosing? Equivalent to pill splitting?

Zachary Bloomgarden, MD: In very, very high doses, it truly occurs. Fortunately, most people with type 1 diabetes use relatively low total daily insulin doses—let’s say averaging 40-60 units per day, and many, far less. Many patients with type 2 diabetes who are insulin-requiring will use upwards of 100 units of insulin a day, and it’s not unusual for people to use 200 units per day.

Mary Ann Hodorowicz, RDN, MBA, CDE: Which drives up the cost.

Zachary Bloomgarden, MD: And the cost is simply per-unit of insulin. In that setting, I have unfortunately seen people who simply say, “I won’t use more than 1 syringe worth of insulin,” (which is whatever, 80 units or so, and that’s it). It really is a dilemma. I take care of lots of older people who have Medicare, and there, it’s even more of a travesty than in any other group because of this bizarre donut hole that they have to deal with. They’ll be going along, blissfully, saying everything is covered. Then, at a certain point, nothing is covered. Their out-of-pocket expenditure is thousands of dollars until they get to the end of that donut hole.

Mary Ann Hodorowicz, RDN, MBA, CDE: And they’re on a fixed income.

Zachary Bloomgarden, MD: Of course.

Mary Ann Hodorowicz, RDN, MBA, CDE: And a lot of them are widows and widowers, and they live alone. It’s, “Do I pay for my insulin?” or, “Do I pay my rent?” or, “Do I pay my mortgage?”

Kenneth Snow, MD, MBA: It gets even more complicated. One of the things that Dr. Bloomgarden had led off with was that some of the studies that are done show that one insulin is better than the other. They are designed as a treat-to-target, and hence, there is the concern about hypoglycemia. But, for some patients, there’s not a concern for hypoglycemia. They’re older. They’re not being aimed for tight glycemic control. They’re being aimed for good glycemic control for any number of appropriate clinical reasons. And yet, this message that one insulin is better than the other, can be so ingrained that folks will then use a more expensive insulin, which in some populations would be absolutely right, but in some populations is really adding no benefit to them but adding a significant amount of cost. You wind up having a complete absence of insulin. So, in the goal of seeking excellence, what’s occurred is you’ve really created that excellence and you become the enemy of the good. Folks, then, completely miss their insulin and they have A1Cs glycated hemoglobin of 11%.

Zachary Bloomgarden, MD: Everyone treated with insulin is subject to hypoglycemia. I’ve written about this, and you’ve been involved in this, Mary Ann. Fear of hypoglycemia is truly a major concern for everyone receiving insulin. Also, sulfonylureas are a big culprit here. It’s not that I’m saying that these insulin formulations that cause less hypoglycemia aren’t sometimes going to be really wonderful. They do work better for many patients.

Kenneth Snow, MD, MBA: Agreed. For some populations, that benefit is present and is of value, but for some populations, that benefit is really not there because of the particulars of that patient, or it’s so unlikely to occur that it’s a huge expense. And particularly, if it’s coming from the member’s pocket and they, then, start reducing dose or omitting dose because of it, then for that person, that benefit really didn’t add much other than driving them to worse control.