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Diabetes Therapy and Cardiovascular Outcomes: An Update

Cost-Effectiveness and Coverage Decisions in Diabetes

Zachary Bloomgarden, MD; Robert Gabbay, MD, PhD, FACP; Silvio Inzucchi, MD; Dennis P. Scanlon, PhD; and Kenneth Snow, MD, MBA, provide additional insight on clinical data and the management of patients with diabetes at risk for cardiovascular events, and consider how the costs of emerging agents affect payers’ decisions regarding coverage for therapy.


Dennis P. Scanlon, PhD: Results presented at a recent meeting of the Academy of Managed Care Pharmacy showed that giving empagliflozin in patients with type 2 diabetes and established cardiovascular disease produced savings by year 3, and substantial savings by year 5. How do studies of cost-effectiveness affect coverage decisions for payers?

Kenneth Snow, MD, MBA: The coverage decision starts with the question of the scientific evidence. In any type of therapy, drug, technology, device, is there coverage or not? And that’s really separate, or divorced, from the cost (either the cost of the therapy or even savings). Once the scientific data is established (that it’s effective), then the question comes is, “What is that cost, and how is it going to fit into a benefits plan?” And so, obviously, it’s about something that, in addition to being scientifically valid, also saves money.

Well, that’s about as easy as it gets. Those that are scientifically valid and cost some money. Those are very likely to still be approved. And those that are scientifically valid but cost a lot of money may still well be approved, but they may get more scrutiny to make sure that they’re being utilized for the appropriate patient in the appropriate way (so that there’s not misuse or abuse). But the decision of whether there’s coverage or not starts at, is it a scientifically valid or validated therapy that makes sense for folks to be using? And then, from there, it moves off into the, “OK, once you’ve said yes, now how do we pay for it?”

Dennis P. Scanlon, PhD: What about the time horizon? Does that enter into thinking about when those savings accrue and who they accrue to, especially for the payer?

Kenneth Snow, MD, MBA: Well, it certainly is an issue. Once you’ve made that decision and you start looking at the finances behind it, or the finances going forward, the timeframe obviously plays a role. We know that members move on for any number of reasons. If they’re getting their coverage through their employer and they change jobs, through no desire, they may very well change payers. And this may happen several times. So, that does enter into how the cost-effectiveness issue enters into a decision. As I said, that’s only coming after the concept of whether it should be paid for in the first place.

Zachary Bloomgarden, MD: This gets back to the discussion that we had earlier on how fractured the American healthcare system is. And when we have long-term illnesses, such as diabetes, where what you do for the next week is of relatively little consequence (unless you’re going to prevent a heart failure episode with a SGLT2 [sodium-glucose co-transporter 2]), our concept is that we really want long-term care delivered over, perhaps, decades. And we have to somehow say to ourselves, “How can we change the system so that a treatment, once established, can be continued in a relatively seamless fashion when it’s appropriate?” It’s hard enough for our poor patients.

Robert Gabbay, MD, PhD, FACP: I think, from the provider and patient perspective, it brings to the forefront this issue of class effect or not, because typically, if a drug is found to be effective, it will be covered by payers (for the most part). But they may choose 1 of the analogs based on price and etcetera. And if all of them are shown to be equally effective, then that’s great. But if it turns out that there’s ambiguity there, and right now, we’re still in an area of some ambiguity, it makes that much more problematic. That’s really where I think we’ll have a sense, over the coming months, of whether studies now confirm that there’s a class effect or not. For most other drugs, that has been the case.

Dennis P. Scanlon, PhD: This has been a great discussion, and I really appreciate all of you joining me for this, and your insight. But, before we end, I wanted to open the floor and get some final thoughts from each of you. Dr Bloomgarden, we’ll start with you.

Zachary Bloomgarden, MD: I would simply say that this is an extraordinary and exciting time to be in the diabetes field, and I feel fortunate to have been involved long enough to see this come to pass.

Dennis P. Scanlon, PhD: Dr Gabbay?

Robert Gabbay, MD, PhD, FACP: I echo that this is a tremendously exciting time, and I think the 2 big headlines here is that there have been 2 drugs shown to reduce cardiovascular mortality. That’s a big step forward in the field of diabetes because, in the end, that’s why our patients with diabetes die.

Dennis P. Scanlon, PhD: Dr Inzucchi?

Silvio Inzucchi, MD: I’m equally as excited as my colleagues. I’m also excited because this observation of improving cardiovascular outcomes with glucose lowering medications, which has perplexed us (as I mentioned before) for decades, is now forcing our scientific colleagues to look at this relationship between diabetes and heart disease. And I don’t think it’s a relationship that we fully understand. It’s really at the intersection between our understanding the vascular biology and metabolism that I think is fascinating. Why does liraglutide reduce cardiovascular outcomes? Is it simply because it reduces weight, and blood pressure, and glucose? My sense is probably not. Why does an SGLT2 inhibitor like empagliflozin improve cardiovascular mortality within months, and heart failure hospitalization? Is it simply because it’s a diuretic? Our cardiology colleagues would say there’s no other diuretic that does that. Some have proposed that there may be a ketone mechanism—that a slight micromolar increase in beta-Hydroxybutyrate may feed the heart substrates that it enjoys eating more than free fatty acids and glucose. So, I’m excited in our ability to help our patients. Getting this monkey off our back, frankly, of glucose lowering drugs not improving cardiovascular outcomes. But also, I’m excited about this new need to understand diabetic heart disease.

Dennis P. Scanlon, PhD: There is lots of opportunity for science. Finally, Dr Snow?

Kenneth Snow, MD, MBA: Diabetes has always been one of those situations in medicine where there was just a very negative association with it. It’s increasing in frequency. The prevalence of diabetes is increasing. Folks will develop microvascular complications. They die of macrovascular complications, and the news is always bad. And what’s happened over the last decade, or 2 decades, and now, is progressing, is that we have slowly chipped away at that through better understanding of what we’re trying to achieve through better therapies that are available, and through better care that’s provided. We have chipped away at the microvascular complications and we’ve chipped away at the macrovascular complications, and now we have even further agents that look like we’ll be able to chip away at this big chip much more. And so, we can really give our patients an upscale message that, yes, it’s diabetes, but you can live a long and healthy life despite having diabetes.

Dennis P. Scanlon, PhD: Great. Thank you, all, for joining me, and thank you for your contributions. On behalf of our panel, we thank you for joining us and we hope you have found this AJMC® Peer Exchange® to be informative.

 
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