Population Health Implications of Cardiorenal Metabolic Syndrome - Episode 7
Nihar R. Desai, MD, MPH; Neil Minkoff, MD; and Om P. Ganda, MD, discuss SGLT2 inhibitor utilization and managed care considerations in cardiorenal metabolic syndrome.
Neil Minkoff, MD: I’m assuming that the move to SGLT2 has become the standard of care across the different components of the disease states and cardiorenal metabolic syndrome. Is that accurate? How do we see the standard of care progressing? Dr Desai?
Nihar R. Desai, MD, MPH: One of the key questions for us and the audience is that, despite all the evidence that has come out, the SGLT2 inhibitors are still not used in the way we would suggest they should be—or as commonly and frequently as the patients who would derive a benefit need. There’s evidence in some papers that have been published to suggest that 5% or 10% of the eligible patients for SGLT2 inhibitors are prescribed them. For all the promise that they hold, for our patients with cardiorenal and cardiometabolic disease, it’s up to the providers—from primary care providers to endocrinologists, nephrologists, and cardiologists—as part of a care team to support a patient and start thinking about how we develop care pathways. How do we develop collaborative teams that will allow us to deliver these therapies to patients? Neil, how do we facilitate access to these things? What does that mean in terms of co-pays and access and coverage? How do we think about what seem to be very high-value therapies in terms of reducing adverse events, reducing hospitalizations, improving clinical outcomes for some of the most challenging patients that we have? How do we make it easier for providers to write for these therapies and then for patients to get on them and appear to them?
Neil Minkoff, MD: That’s an interesting question because one of the things I’m seeing is that the bar to SGLT2s for diabetes has been consistently lowering. Over the last 24 months or so, the bar for CHF [congestive heart failure] has also been dropping. I don’t think payers have the understanding; that’s one of the reasons we’re doing these things. Payers have the understanding about the differentiation between CHF and diabetes and maybe a more comprehensive diagnosis, as we’re talking about with this cardiorenal metabolic syndrome.
One of the things that’s hard for payers is taking clinical discussions and turning them into an implementable set of rules that can be worked through at the point of service at the pharmacy or on the way to the pharmacy. Was the drug prescribed by a nephrologist or a cardiologist? Does the patient have diabetes or a history of CHF? Once you get beyond that—codifying it for high risk for cardiac disease but maybe without an actual diagnosis—that gets a lot harder to implement and kicks out to a prior authorization, which we know you hate. The physician attestation about why this is right. When there’s information coming fast in a case like this about multiple options as expansion is occurring in the disease states for them, it’s complicated enough for the payer to have a drug, to understand where it fits as those indications are changing—changing in a way that wasn’t intuitive when you were approving SGLT2 for diabetes—and then expand it to CHF and cardiometabolic syndrome and so on.
When picking which drug goes to which patient, the payers—I’ve been guilty of this, looking at class effect and looking at drugs as… I don’t want to say a commodity, because I don’t think they’ve been commoditized as though it’s 1 of multiple generic penicillins or something, but are there enough data to support 1 over the others in a clinical setting, or does it default into a price discussion in terms of trying to define value? The payers have some work to do. At least 1 of you has mentioned that these products aren’t being used as widespread as you would hope. How much of that is coming from clinical inertia versus patient inertia, and how much are payers a barrier to that? I’m not putting anybody on the spot, but if anybody wants to say it’s all my fault, I’m happy to accept the criticism.
Om P. Ganda, MD: The only way we can make them widely available to people who really need it, and there are a lot of people who need it, is to make all these drugs generic. I know it’s not going to happen. Cost is one of the biggest factors driving this, and that’s why there are so many PAs [pulmonary arterial tests]. I don’t mind doing a PA if it’s quick, but sometimes you really have to reapply and write letters. We learned this in PCSK9 inhibitor in liquid field. This is a problem that requires us to employ a dedicated pharmacist on board if we can afford to. Those are things we have to think about.
Education is very important. Primary care physicians should be part of the game. They should be able to use it in some of the clear-cut situations, but they have so much to deal with, and there are some misconceptions about the adverse effects we didn’t talk about too. For example, DKA [diabetic ketoacidosis] with SGLT2 inhibitors. Look at the data. It generally occurs in people with type 1 diabetes. In type 2 diabetes, if they have long-standing diabetes on multiple insulin injections, they’re almost like patients with type 1 diabetes, so you have to be careful.
With patients coming to the hospital, you have to stop these drugs 5 days in advance, not 3 days. It’s 5 days because there are case reports of DKA with these drugs. These are still small numbers, and there’s a lot of misinterpretation of these data and other adverse effects. The only adverse effect you need to think about is a mycotic infection rate of about 10%, 15% in some female patients, but in men, not as much—2% to 3%. That’s another misconception. Early on, we thought these drugs might cause distal amputations in the lower extremities [toward the ankle level] with canagliflozin during CANVAS, but that label has now been dropped because these drugs in other studies have shown that’s not true. Some of these misconceptions have to be dealt with.
Transcript edited for clarity.