SGLT2 Inhibitors in Patients Without Diabetes at Risk of HF

Expert cardiologists discuss the value-based cost benefit and the role for SGLT2 inhibitors in the prevention of HF in patients with and without diabetes.

Transcript

Neil Minkoff, MD: Dr Murillo, you’re wearing a couple of hats. You’re a cardiologist, you’re working on the urgent and emergent care issues you mentioned earlier, and your organization is a payer organization. How do you view some of these changes and the role of SGLT2 inhibitors, both for patients with and without diabetes?

Jaime Murillo, MD: It’s very simple. I don’t know if the answer is that simple, but it’s exactly what we’ve been talking about. When Steve made that comment, he knew I was going to jump in. He’s always 2 moves ahead of us. The reality is, look at the perspective, just to reinforce the point. We spend $13 billion in heart failure patients. I’m not saying every penny is heart failure related, but overall that’s a huge amount. We spend, so far, let’s say $100 million in SGLT2 inhibitors. Look at the proportion, right? What’s the real value that this medication will bring to lower the total cost among heart failure patients? That’s the perspective that we need to take into account—the pharmacoeconomics that are brought out by SGLT2 inhibitors right now.

What we have done are 2 things. One, as soon as the FDA got the approval, and I happen to be part of the pharmacy and therapeutics committee as well—we went ahead and approved these medications for what they are for. That includes those related to noncardiovascular benefits on nondiabetic patients. We’re already going along with what we have seen in the literature because it’s strong. No one will argue that those results are very strong.

Neil Minkoff, MD: Let me just clarify. You feel as if that’s the new standard of care, and your payment policies reflect that?

Jaime Murillo, MD: Our payment policies approve that for the particular concept. Interestingly enough, over the weekend, I was reviewing our next meeting in July, where we’re going to actually set exactly a protocol of how the SGLT2 inhibitors will be used for patients with heart failure, regardless of the DAPA-HF study. That’s a step forward when it comes to a payer. We’re not saying, “Well, it’s for diabetes, but…” We’re not waiting. We actually say there should be a group of it.

Here’s the other point that we alluded to. Are they just add-ons when you fail other recognized therapies on the list? We may need to start with that step. Who’s to say that 6, 12, or 18 months from now, we’re not going to say, “Listen, they can be first-line therapy because they’re that good”? That certainly is something that is worth considering. We’re not going to be foreign to that concept, because at the end of the day, you have to look at the broad perspective of how to treat those people. There’s no question that SGLT2 inhibitors are coming to make a difference.

Neil Minkoff, MD: Let me ask Dr Desai, and I’ll come right back to you, Steve. Let me ask Dr Desai, where do you put the SGLT2 inhibitors in your treatment protocol or paradigm, and who are the patients you look to put on those therapies? How does diabetes affect that decision? Then I’ll open that up because Steven had a comment as well.

Nihar Desai, MD, MPH: Thanks, Neil. It’s a great area for us to explore. I’m curious what others are doing and thinking. For us, we use them in the way that the evidence would suggest and that the guidelines have then recommended. If you have a patient who has diabetes and atherosclerotic cardiovascular disease, these would be part of the cornerstone of therapy. Just as we think about statins and antiplatelet drugs, you have to think about an SGLT2 inhibitor for that patient who has diabetes and atherosclerotic cardiovascular disease. Similarly, on the heart failure side, what we’ve seen so far with DAPA-HF, and what hopefully will be extended in EMPEROR and other clinical trials, is that the SGLT2 inhibitors have a very important role to play in heart failure.

One of the real frustrations that we have all felt, me included, is that there is this disconnect between the world of the evidence and the guidelines, and then what happens in terms of access and adoption. Despite our interest in trying to get patients on these therapies, they do face a substantial cost-sharing component, and that is a burden that we can’t avoid talking about when we think about the patients we’re here to serve. I hope we get to a place where we move away from using drugs that may have a lower cost. But when you look at total cost and you look at the value of the therapy, the benefits we’ve seen from SGLT2 inhibitors—reducing death, reducing rates of atherosclerotic events, reducing hospitalizations for heart failure—are incredibly costly and important burdens for patients and caregivers. When you put all that together, these drugs deserve to be front and center, and the guidelines will continue to evolve if the evidence continues to pile up in the way we expect and hope it will.

Neil Minkoff, MD: I want to come back to guidelines, but I want to open it up now because Steven had some comments, and I believe he has a perspective on this that’s unique as well.

Steven Nissen, MD: I just wanted to add that there is a special case. It’s something that everyone here recognizes and that we see a lot. That’s the patient with reduced renal function. Take someone who has a creatinine clearance of around 50 L/min. Because of this interplay between heart and kidney, there’s now accumulating evidence that SGLT2 inhibitors reduce albuminuria, but they also reduce the progression of renal insufficiency in the diabetic patient. Those end-stage renal disease patients are also our heart failure patients, because they can’t get rid of salt and water. They’re very difficult to treat, and there’s rather impressive evidence of renal benefits of SGLT2 inhibitors. When you think about the value proposition, they lower blood sugar and they prevent heart failure, but they also seem to prevent progression of renal disease. Nihar, I’m not sure how much of those data you’ve reviewed, but what I’ve reviewed suggest that it’s an impressive effect, and 1 that should be considered in deciding whom to treat. If you have a creatinine clearance of 90 or 100 L/min, that’s 1 thing. If you’re at 50 L/min, it’s easy to get from 50 to 30 to 0 L/min, and we want to prevent that.

Nihar Desai, MD, MPH: Yes, Steve, you’re exactly right. Again, that’s been a signal that has emerged with all the SGLT2 inhibitors. To your point, we’ve seen reductions in albuminuria, prevention of progression of kidney disease, and potentially avoidance of dialysis. When you think about the cost burden and the quality-of-life implications, the enthusiasm around SGLT2 inhibitors for our cardiology-renal or cardiology-metabolic patients is because the evidence has emerged and is incredibly compelling.