Cardiovascular Diseases Part 2 of 2: New Frontiers in CVD Treatment (2020–2025)

Summary

The cardiovascular treatment landscape is shifting fast—with five major FDA approvals between 2020 and 2025 transforming how heart disease is managed across comorbid, high-risk populations. These therapies target new mechanisms, carry higher costs, and increasingly show up in complex claims—especially where diabetes, heart failure, or occupational risk factors collide. For workers’ comp payers and clinicians, understanding the impact of these medications is essential for cost control, medical appropriateness, and outcome-driven oversight.

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While heart disease remains the leading cause of death in the U.S. and worldwide, the therapeutic arsenal is expanding rapidly. In just the past five years, the FDA has approved a slate of breakthrough medications—and expanded indications for others—that offer new hope for patients and a more complex claims landscape for payers and professionals navigating high-cost care (1,2,3).

Here’s a roundup of the most notable new approvals shaping cardiovascular care—and by extension, influencing complex medical claims in comp.

1. Inpefa® (sotagliflozin)

Approved: May 26, 2023 (3)

Indication:
Inpefa is approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or Type 2 diabetes mellitus, chronic kidney disease, or other cardiovascular risk factors (4).

Mechanism:
Sotagliflozin is a dual SGLT1 and SGLT2 inhibitor—the first of its kind. By targeting both sodium-glucose transporters, it improves glycemic control while offering renal and cardiac protection. It reduces fluid overload, improves heart function, and protects kidneys by enhancing glucose and sodium excretion (4,5).

Notable:
Inpefa is the first dual inhibitor in its class to be approved for heart failure. Other SGLT2-only agents in this category include Jardiance® (empagliflozin) and Farxiga® (dapagliflozin) (6,7).

2. Wegovy® (semaglutide)

Initial Approval: June 4, 2021 (for chronic weight management) (8)
New Indication Approved: March 8, 2024 – Reduction of major adverse cardiovascular events (MACE) in adults with established CVD and overweight/obesity (9)

Mechanism:
Semaglutide, a GLP-1 receptor agonist, promotes satiety, slows gastric emptying, and boosts insulin secretion. Its cardiovascular benefits stem from systemic effects: improved glucose control, reduced inflammation, improved vascular function, decreased platelet aggregation, and lowered blood pressure and lipids (10,11).

Notable:
This is the first weight-loss medication with FDA approval for cardiovascular risk reduction—marking a turning point in the integration of obesity treatment into heart disease prevention (9).

3. Entresto® (sacubitril/valsartan)

Expanded Indication Approved: February 16, 2021 (3)

Indication:
Originally approved for HFrEF, Entresto’s indication now includes treatment for adults with heart failure and left ventricular ejection fraction (LVEF) below normal—expanding its reach into patients with HFpEF (12).

Mechanism:
This combination of a neprilysin inhibitor and angiotensin receptor blocker enhances natriuretic peptides while suppressing the renin-angiotensin system (13). It lowers blood pressure, reduces fluid retention, and lightens cardiac workload.

Notable:
Entresto is now the first therapy approved for both HFrEF and many cases of HFpEF, offering a dual-pathway solution for a population long underserved by traditional meds (12).

4. Camzyos® (mavacamten)

Approved: April 28, 2022 (3)

Indication:
Camzyos treats adults with symptomatic NYHA class II–III obstructive hypertrophic cardiomyopathy (oHCM), improving exercise capacity and functional status (14).

Mechanism:
A cardiac myosin inhibitor, mavacamten directly reduces hypercontractility and LVOT obstruction, allowing the heart to pump more efficiently with less resistance (14).

Notable:
Camzyos is the first and only FDA-approved myosin inhibitor—offering a targeted therapy for oHCM that previously lacked disease-specific pharmacologic options (15).

5. Verquvo® (vericiguat)

Approved: January 19, 2021 (3)

Indication:
Verquvo is indicated for adults with symptomatic chronic heart failure and LVEF <45% following a recent episode of decompensation requiring hospitalization or outpatient IV diuretics (16).

Mechanism:
As a soluble guanylate cyclase (sGC) stimulator, Verquvo amplifies nitric oxide signaling, resulting in vasodilation and reduced cardiac workload (16). It helps blood vessels relax and supports improved heart function.

Notable:
Verquvo is the first sGC stimulator approved for heart failure, filling a therapeutic gap for patients post-decompensation—one of the highest-risk phases in chronic HF management (17).

What This Means for Clinical Oversight and Comp Claims

These new therapies reflect a broader trend in cardiovascular medicine: precision treatment tailored to specific mechanisms, not just symptoms. For payers and claims professionals, that means:

• Higher costs per episode when these newer agents are involved

• More complex pharmacologic profiles—especially in multi-drug regimens

• Need for targeted clinical review when new meds appear in comp claims tied to heart disease, comorbid diabetes, or chronic kidney disease

Specialty Nexus was designed for precisely these moments—when high-cost drugs, specialty indications, and occupational risk factors intersect. Whether you’re managing a firefighter’s cardiovascular claim or a diabetic truck driver with compounding risks, knowing which therapies are approved, how they work, and what alternatives exist isn’t optional—it’s essential.

Stay tuned. The cardiovascular pipeline is just getting started.

By Alyssa Obrien

PharmD Candidate (P4)

LinkedIn

For questions, e-mail pharmd@prodigyrx.com

Citations

1.  Centers for Disease Control and Prevention. (2024, October 25). FASTSTATS - leading causes of death. Centers for Disease Control and Prevention. https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm 

2. Centers for Disease Control and Prevention. (2024a, August 5). Heart disease deaths - health, United States. Centers for Disease Control and Prevention. https://www.cdc.gov/nchs/hus/topics/heart-disease-deaths.htm#:~:text=The%20content%20on%20this%20page,the%20NCHS%20Data%20Query%20System.&text=Heart%20disease%20has%20been%20the,excessive%20alcohol%20use%20(2)

3. Center for Drug Evaluation and Research. (n.d.). Novel drug approvals at FDA. U.S. Food and Drug Administration. https://www.fda.gov/drugs/development-approval-process-drugs/novel-drug-approvals-fda 

4. Inpefa (sotagliflozin) [package insert]. The Woodlands, Texas: Lexicon Pharmaceuticals; 2023 https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216203s000lbl.pdf 

5. Cefalo, C.M.A., Cinti, F., Moffa, S. et al. Sotagliflozin, the first dual SGLT inhibitor: current outlook and perspectives. Cardiovasc Diabetol 18, 20 (2019). https://doi.org/10.1186/s12933-019-0828-y

6. Jardiance (empagliflozin) [package insert] Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals; 2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s033lbl.pdf 

7. Farxiga (dapagliflozin) [package insert] Wilmington, DE: AstraZeneca Pharmaceuticals; 2023 https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf 

8. FDA. (June 4, 2021). FDA approves new drug treatment for Chronic Weight Management, first since 2014. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014 

9. FDA. (March 8, 2024) FDA approves first treatment to reduce risk of serious heart problems specifically in adults with obesity or overweight. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or 

10. Wegovy (semaglutide) [package insert] Bagsvaerd, Denmark: Novo Nordisk; 2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s007lbl.pdf 

11. Billingsley, A. (2024, May 2). Is Wegovy Good for Your Heart? What to Know About Semaglutide’s Cardiovascular Benefits. GoodRx. https://www.goodrx.com/wegovy/wegovy-and-heart-health 

12. Novartis Entresto® granted expanded indication in chronic heart failure by FDA. Novartis. (2021, February 16). https://www.novartis.com/news/media-releases/novartis-entresto-granted-expanded-indication-chronic-heart-failure-fda 

13. Entresto (sacubitril/valsartan) [package insert] East Hanover, New Jersey: Novartis Pharmaceuticals Corporation; 2024 https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207620s025,218591s000lbl.pdf

14. Camzyos (mavacamten) [package insert] Brisbane, Ca: MyoKardia, INC; 2022 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214998s000lbl.pdf 

15. Braunwald, E., Saberi, S., Abraham, T. P., Elliott, P. M., & Olivotto, I. (2023). Mavacamten: a first-in-class myosin inhibitor for obstructive hypertrophic cardiomyopathy. European heart journal, 44(44), 4622–4633. https://doi.org/10.1093/eurheartj/ehad637 

16. Verquvo (vericiguat) [package insert] White House Station, NJ; Merck Sharp & Dohme Corp; 2021 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214377s000lbl.pdf 

17. Tran, B. A., Serag-Bolos, E. S., Fernandez, J., & Miranda, A. C. (2023). Vericiguat: The First Soluble Guanylate Cyclase Stimulator for Reduction of Cardiovascular Death and Heart Failure Hospitalization in Patients With Heart Failure Reduced Ejection Fraction. Journal of pharmacy practice, 36(4), 905–914. https://doi.org/10.1177/08971900221087096