Insight on the unmet needs in management of heart failure, specifically regarding access to therapeutic agents that can alter the course of disease.
Rajiv Agarwal, MD, MS: I’ve been surprised how, many times, our large health care systems require prior authorization for SGLT2 inhibitors, whereas they don’t require prior authorizations for many of the other diabetes drugs. In the place I practice, the cost of these drugs is less than a month’s supply of insulin. If these drugs have so many cardioprotective benefits, they ought to be used by a broader population of patients, and they ought to be used by all the specialists who treat patients who are vulnerable, especially those with kidney disease and HFpEF [heart failure with preserved ejection fraction] and HFrEF [heart failure with reduced ejection fraction].
The insurance companies need to rethink their strategy and ask, what is best for the patient? If the patient is less short of breath and out of the hospital, it saves the patient the misery of coming into the hospital. Also, heart failure hospitalization is a very expensive therapy for patients and payers. If we can access this therapy at an earlier stage of disease and keep patients out of the hospital, it would be best for all people concerned. Let’s not forget, the patient is the center of the universe here; it’s not about the payers or the prescribers or the partnership between the payers and the prescriber. It’s really about the patients, and they ought to get this therapy now and not 2 years from now because we will lose lives and see patients on dialysis or in the hospital short of breath if we don’t start prescribing these drugs.
HFpEF is a totally under-researched field right now. With HFrEF, we have made great strides, and we have all kinds of recommendations. I participated in a conference with NHLBI [National Heart, Lung, and Blood Institute] as a nephrologist, and looked at the data for 2 or 3 days, mostly presented by cardiologists on HFpEF. I was sobered to see that, despite years of research, there’s not much out there for patients with HFpEF. With such a robust result in HFpEF with empagliflozin, I think that times are changing, and I hope that this drug will meet success and get approved for this indication because it’s really an unmet need in patients with HFpEF. These are patients who are a much larger population compared to HFrEF. But I’m intrigued by the data from the FIDELITY analysis. It’s not HFrEF, it’s not HFpEF. It’s really stage B heart failure, an earlier stage of heart failure, which is the subclinical systolic dysfunction in type 2 diabetes and CKD [chronic kidney disease] that’s simply detected by the presence of albuminuria.
You don’t even need an echocardiogram to estimate the ejection fraction. All you need is to test the urine, and we can reduce the risk of heart failure hospitalization by a good 22% in this population if we simply prescribe finerenone. This is an earlier-stage population that has really poor HFrEF, which really drives the outcomes. Only 7.7% of the patients in the FIDELITY analysis had HFrEF. We are talking about stage B heart failure, and we are talking about cardiovascular protection. I believe that the FINEARTS-HF study, which is being done in HFpEF with finerenone, will provide more provocative data regarding the role of finerenone and HFpEF. But as far as I’m concerned, if you have type 2 diabetes and albuminuria, you don’t even need an ejection fraction. You just need albuminuria, and you can prescribe this and reduce the risk of heart failure. Actually, in the same session of the European Society of Cardiology meeting, we had a presentation of data that showed therapies that can affect people with HFpEF, but also stage B heart failure, which is a precursor of any heart failure. You can achieve reduction in heart failure hospitalization. That’s truly incredible news for people with heart failure.
Transcript edited for clarity.