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Combination Therapy and Payer Perspective on CKD Therapies


Dr Bertram Pitt explains the possibility of combining SGLT2 inhibitors and MRAs when treating CKD and CV, and Paul Sapia, MHA, discusses how payers balance cost of care with disease progression and health disparities.

Ryan Haumschild, PharmD, MS, MBA: Dr Pitt, building on that, SGLT2 inhibitors and finerenone have improved outcomes for patients with CKD [chronic kidney disease]. We’ve discussed this in the clinical trial results. Is there a potential role to use these agents in combination to promote a reduction in disease progression or in CV [cardiovascular] risk?

Bertram Pitt, MD: It’s still very early in the game, but there are preclinical data that if you take a low dose of finerenone and a low dose of an SGLT2 inhibitor, such as empagliflozin, at least in an animal model, you get better results than with either one alone, and you reduce mortality. We’ve already talked about the fact that when you add an SGLT2 to an MRA [mineralocorticoid receptor antagonist], you have less hyperkalemia. There are lots of reasons to think that this combination is going to be very useful in not only treating CKD and heart failure but also preventing them.

I’d like to make a few comments [regarding things] that maybe were already alluded to. Dr Agarwal talked about hyperkalemia, but of people who discontinue these agents, only about 1% or so discontinue the agents because of hyperkalemia. With our old friends, the steroidal MRAs, it was a much higher percentage who discontinue, and many people don’t start. If you aren’t on an MRA, at least with heart failure, you have a tremendous increase in risk. The increased tolerability that you get with agents such as finerenone is important.

Another thing I’d like to mention is that when you start an agent such as finerenone, you sometimes have a rise in creatinine, which is a hemodynamically mediated effect because of the small drop in blood pressure. Some clinicians have become nervous and stop agents because of the rise in creatinine, but if you persist, you protect the kidneys and the heart. This is transient hemodynamics. This is an important point. You shouldn’t get nervous when you see a slight increase in creatinine when you start these agents because [it helps] in the long run.

We’ve said a lot of good things about these agents. Dr Agarwal said that maybe there isn’t much new, but there’s a need for new things. We talked about these patients with diabetes, and Dr Feldman said all the good things that we do, but one thing that we haven’t done is reduce stroke. There isn’t any evidence that SGLT2 inhibitors have reduced stroke, nor did we find that finerenone reduces stroke. In a patient with diabetes, especially with renal disease or heart failure, stroke is a major thing that we have to think about. There are new drugs and opportunities coming that will be able to reduce stroke. The game isn’t [over]. It’s very exciting, but there’s more to come.

Ryan Haumschild, PharmD, MS, MBA: Excellent overview. It’s exciting. There’s more to come, and we have to modernize the way we’re treating these patients early.

I now want to hear from our payer colleague, Paul, because as we introduce new therapies, we provide great outcomes for patients, but we also introduce new costs when we think about managing the covered lives and the per member, per million standpoint. Paul, how are payers balancing these high costs of new treatments for CKD with the risk of disease progression and total cost of care? Are there barriers from a utilization management standpoint? Are there patients who could benefit from these therapies but might not have access due to utilization management strategies or payer policies?

Paul Sapia, MHA: That’s a great question, Ryan. It isn’t really what I work in on the utilization management point, and not being a clinician, I probably shouldn’t answer the clinical questions. We have 3 great clinical panelists here. But the talk about utilization management is looking at the appropriateness of care and making sure our providers understand the testing, screenings, and the new therapies that are available. One thing we have to do as a payer is balance the cost of care with the treatment of the member to make sure it’s the appropriate care for the member. We have clinical experts throughout Humana who look at that. That isn’t something I work on. But it’s making sure we’re educating providers on the appropriateness and what’s the right medication.

All of our physician colleagues here have talked about the challenges, such as medication adherence. When we look at a member, we’re looking at how likely they are to understand why they’re doing that therapy, why they’re taking that medication, the risks, how they need to change behavior to make sure those medications remain appropriate, and that they aren’t doing something that counteracts the medication or fights against what they’re doing. Utilization management from our standpoint is looking at the appropriateness and making sure physicians are educated on the right end. I’ll let the clinical people on our end talk about those patients who could benefit from it who aren’t able to get it for whatever reason. I’ll leave it at that. It’s looking at appropriateness and making sure there’s education and helping the physicians and providers understand the why behind what’s being offered to the member.

Transcript edited for clarity.

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