Progression of Treatment in Diabetes

Peter Salgo, MD: Let’s talk about the progression of treatment. In other words, you start out [with] maybe diet and exercise. Then you move on to an inexpensive oral drug. Then you move on to something else. Is that based on maximum dose failure?

Helena W. Rodbard, MD: No. Actually, it depends on what the practitioner does. But most guidelines recommend not waiting to max out the dose. Because the different drugs work by different mechanisms of action. So it’s actually very appropriate to use different drugs without maxing out any specific drug. And just to have the benefit of different drugs working by different mechanisms and addressing different [pathophysiology].

Peter Salgo, MD: You know, what I hear from payers is, “Look, you haven’t really reached the maximum benefit from therapy A. We’re going stepwise here, so don’t start being, ‘Don’t tell us to pay for B before A has reached the end of its rope.’ ” You hear that, don’t you?

James T. Kenney, RPh, MBA: Yeah, I think all insurers approach it differently. Some just require a step through a particular group of products, so you might have to try and fail. Obviously you have to try and fail metformin as the first-line [therapy]; that’s pretty standard across the board. But perhaps if you want to use a GLP-1 [glucagon-like peptide-1], which is another injectable—although an oral just got approved or is about to get approved—you may have to step through another oral before you get that. I’m not sure if [insurance] plans always push, though, to max dose for all these. I think it’s more, “Try a drug from that category. If it works well, great. If it doesn’t, you can move on and try another category.” But clearly, what plans are looking for is kind of a logical approach through what they put together as their preferred formulary that are the most cost-effective options, and work through it that way with the patient.

Peter Salgo, MD: But providers, it seems to me, don’t work that way. You can correct me if I’m wrong. The insurance companies want to go, “There’s A. There’s B. There’s C.” It’s just a very account-friendly, accounting-friendly kind of way of dealing with this. But you guys are dealing with a plastic disease that’s always changing. How do you do it?

Om P. Ganda, MD: We really have to go with the patient’s profile and how the patient is progressing. We’re very fortunate that we have the new drugs, but the cost is still a factor. And we really go very methodically what a given patient needs on top of metformin, let’s say. And now we have more and more data, actually good trials, evidence based, for the past 4 years, which dictate to us which patient should get which drug next. We didn’t have that until 4 or 5 years ago. Now we have it.

James T. Kenney, RPh, MBA: Well, there’s a lot of support from the [insurance] plans, I think, for the cardiovascular outcomes trials with these products as well.

Om P. Ganda, MD: Exactly.

James T. Kenney, RPh, MBA: We’re allowing and promoting those drugs as valid options. But what happens is we’re also trying to balance the cost side of the equation. So if we have 4 drugs in a category, we’re choosing 1 or 2 that are most cost effective for the [insurance] plan. The challenge is the plan down the road; they have 2 different products. They’re the most cost effective for that plan because of competing contracting and other things in competing formularies.

Om P. Ganda, MD: And that makes it very difficult for us [in] our daily life.

James T. Kenney, RPh, MBA: Absolutely.

Om P. Ganda, MD: Even including insulin. One year we’re using this particular short-acting or rapid-acting insulin. The next year we’ll be asked to switch it to something else, depending upon the patient’s [insurance] plan. So this is another enigma [that] I’d like to see solved in the future.

Peter Salgo, MD: I’m [going to sound] very naïve, I know. And I’m doing this on purpose to just cause trouble. But why should cost [affect] the treatment plan for diabetes? Why? We have these drugs. People have insurance. This is a life-threatening and life-changing disease. Why do they have to change insulin suppliers because the cost changed? Why can’t we just say, “You’ve got diabetes. Here’s the medically approved plan. We’ll pay for it.”

James T. Kenney, RPh, MBA: Well, the challenge is [that] we have limited resources. We don’t have unlimited dollars, and we’re talking about [only] diabetes at the moment, right? We’re not talking about cardiovascular disease and COPD [chronic obstructive pulmonary disease] and asthma and everything else. So it’s really a challenge for a formulary manager and [a] health [insurance] plan to try to manage all those costs because we have limited dollars. You know we have our premiums we charge. The employers don’t want to pay increased premiums. They say, “Wait a minute, your premiums are going up.” So what do you do? You adjust the benefit. So now you’ve got a drug benefit that had a $20 co-pay last year for a preferred drug, and now we raised it to $30. Why? Because the employer says, “I can’t afford to increase my premiums, what can we do?” Well, we can change the drug benefit. We can change the out-of-pocket [cost] for the patient. And then it’s just kind of a viscous spiral. And now you’ve got a patient who was paying $300 a month for drugs last year, and because their plan changed based on their employer’s choice, it’s now $400 a month, or $500 a month.

Peter Salgo, MD: That’s not insignificant. You know, between $400 and $500 is $100, 25%.

James T. Kenney, RPh, MBA: Absolutely.

Peter Salgo, MD: That’s huge.

James T. Kenney, RPh, MBA: And we heard Helena say we’ve got these patients on 8 or 9 drugs for different things.

Peter Salgo, MD: And take a look at the payer population. You’re dealing with an aging population, many of whom are now on fixed incomes, right?

James T. Kenney, RPh, MBA: Sure.

Peter Salgo, MD: So either they’ve got a plan with insurance, or as you say, they’re on Medicare. Those fixed incomes aren’t all that elastic when it comes to healthcare costs. And yet their disease is real. It’s there; they can’t avoid it. What do you do?

James T. Kenney, RPh, MBA: You’re absolutely correct. I mean, as [an insurance] plan, you try to work cooperatively with the patients. You try to find assistance programming [when] appropriate. You try to match the patients up with better benefits if [you] can—from Medicare you’ve got supplemental programs. They can get supplemental insurance, and that helps cover the cost of co-pays. That’s very helpful for some of those seniors who are on multiple drugs.

The other advantage is if they do spend enough money, and they make it to the catastrophic piece of the benefit for Medicare Part D, then they get some significant price relief. Because very often when you get to that level, if a plan is using co-pays rather than coinsurance, they pay $6 for generic and maybe $12 for a branded drug. So they get all their drugs relatively inexpensively until January 1 when it all resets again. And now they’ve got to make their way through the benefit.

Peter Salgo, MD: You’ll forgive me, but my eyes turn into helicopters just thinking about this sort of thing. And somebody who’s 70 years old, worked all of his or her life, just wants his or her medicine [and] has got to jump through hoops. That means your office is probably on the phone.

Om P. Ganda, MD: Absolutely.

Peter Salgo, MD: Doing what, getting exceptions?

Om P. Ganda, MD: Prior authorizations.

Peter Salgo, MD: Prior authorizations.

Om P. Ganda, MD: Even sometimes, I think, additional letters. And you know, talking about a cholesterol drug. Some people can’t tolerate statins, for example. Now try to get their PCSK9 inhibitor. That’s the extreme example how expensive the drugs are, besides insulin.

James T. Kenney, RPh, MBA: Sure.

Helena W. Rodbard, MD: In my practice we dread January 1 because come January 1, people’s insurance changes, the benefits change, and all of a sudden drug A—[which] was approved and [is] doing a great job with a reasonable co-pay—becomes out of reach. And we have to decide [if we’re] either going to preauthorization, which is very time consuming and not always successful, I have to say.

Peter Salgo, MD: How many patients, how many folks in your office, spend all day long phoning for prior [authorizations]?

Helena W. Rodbard, MD: I have 1 person.

Peter Salgo, MD: Your dedicated employee. What about you?

Om P. Ganda, MD: Same thing. We are a large group, and we have several people working on this, but in addition to that, we have to look at everything, and we have to write letters, and that takes initial time.

Helena W. Rodbard, MD: Oh yes.

Peter Salgo, MD: Now, if I were to say that there is a healthcare cost to the personnel in man and woman hours involved in trying to get prior authorizations on January 1, is that figured in by the [insurance] plan?

James T. Kenney, RPh, MBA: Well, absolutely. And we have a lot of benefit changes the first of the year [and] formulary changes the first of the year. So we have the same problem, right? We have a lot of staff resources. One area we can move positively in would be to move toward electronic prior authorizations. Not all prior authorizations are electronic. The No 1 reason they get rejected is the information isn’t complete. It’s not that the patient wouldn’t qualify. It’s that, [for] whatever reason, as it was filled out, something was missing, and then it has to obviously come back again. But if we had electronic prior [authorization], just [as] when you’re trying to order something on Amazon, if you don’t check the right box it tells you right away, “Hey, hit this button,” and you clear and you get it through it a lot more quickly.

Peter Salgo, MD: All I know is [that] I hear this all the time. People who apply on paper, and they get some anonymous person with a green eyeshade and the little thing on his arm or her arm. “Excuse me, sir, you forgot page 132, subset A, paragraph 2, paragraph 1, line 3.” Rejected. Now that’s crazy.

James T. Kenney, RPh, MBA: It’s crazy, but in theory the criteria are very specific, and if the patient doesn’t meet the criteria from the [insurance] plan’s view, then they would be a candidate for something else. So they’re trying to make sure that this patient clearly is an appropriate candidate. If we look at the GLP-1s, they have weight loss as a benefit if you will. But what if a person doesn’t have diabetes and wants to use the GLP-1 for weight loss? Well, the plans don’t want that. So the plans put a prior authorization in to say, “Does the patient have diabetes?” It’s like question No 1. If they do, OK, then they’re going to be OK with them using a GLP-1, provided that they’ve tried something else first so they don’t go immediately to those, because they’re more expensive than the insulin in some cases. So they’re trying to work their way through, you know, cost-wise, logical steps—trying to spread the value across the benefit as best [as] they can—but not have somebody jump immediately to the most expensive, latest, greatest therapy in the mix.