Entresto Insurance Denied? How to Appeal Your Sacubitril/Valsartan Denial

Entresto (sacubitril/valsartan) is one of the most important advances in heart failure treatment in decades. It is FDA-approved for heart failure with reduced ejection fraction (HFrEF) and has been shown to reduce cardiovascular death and hospitalization compared to older ACE inhibitor therapy. Despite this landmark clinical evidence and Class I guideline recommendations, insurance companies regularly deny Entresto — forcing patients to either pay out of pocket or remain on inferior therapy. If you've been denied, here's how to mount an effective appeal.

What Entresto Treats and Why Patients Need It

Entresto is an angiotensin receptor-neprilysin inhibitor (ARNI) used to treat adults with chronic heart failure and reduced ejection fraction (HFrEF, typically defined as ejection fraction ≤40%). It works by simultaneously blocking the angiotensin II receptor and inhibiting neprilysin, an enzyme that breaks down beneficial natriuretic peptides.

The pivotal PARADIGM-HF trial demonstrated that Entresto reduced cardiovascular death and heart failure hospitalizations by 20% compared to enalapril — a drug previously considered standard of care. Based on this evidence, the ACC/AHA Heart Failure Guidelines now give Entresto a Class I, Level A recommendation — the highest possible — for HFrEF patients who tolerate ACE inhibitors or ARBs.

For patients with HFrEF, Entresto is not a luxury — it is guideline-recommended medicine that reduces the risk of dying.

Common Denial Reasons for Entresto

Step therapy requirements: Insurers typically require patients to try and fail an ACE inhibitor (like lisinopril or enalapril) or ARB (like losartan or valsartan) before approving Entresto. This is despite guidelines recommending transitioning stable HFrEF patients to ARNI therapy.

Prior Authorization Denied: How to Appeal" class="auto-link">Prior authorization not approved: Entresto almost universally requires prior authorization. Insufficient documentation of ejection fraction, prior ACE inhibitor use, or symptom burden often leads to denial.

Formulary exclusion or non-preferred tier: Some plans don't cover Entresto or place it on a specialty tier with prohibitive cost-sharing.

ACE inhibitor contraindication not documented: If a patient can't take an ACE inhibitor (due to cough, angioedema, or renal function), some plans deny Entresto because they argue the step therapy hasn't been completed — even if it's medically unsafe.

"Not medically necessary": Insurers may argue that an ACE inhibitor provides equivalent benefit, despite head-to-head trial evidence showing Entresto's superiority.

Step-by-Step: How to Appeal an Entresto Denial

Step 1: Get your denial in writing and identify the reason. Common reasons are step therapy not completed, insufficient documentation, or formulary exclusion.

Step 2: Have your cardiologist write a detailed Letter of Medical Necessity. The LMN should include your ejection fraction (from recent echocardiogram), NYHA functional class, current medications, history of ACE inhibitor or ARB use (and any adverse effects), and the rationale for transitioning to ARNI therapy.

Step 3: Document ACE inhibitor history thoroughly. If you've tried an ACE inhibitor and experienced side effects (especially chronic cough or angioedema), document this clearly. Angioedema is an absolute contraindication to ACE inhibitors and a strong basis for skipping that step.

Step 4: Include echocardiogram results. An ejection fraction measurement is essential. Most plans require documented EF ≤40% for HFrEF coverage.

Step 5: File the internal appeal. Submit your appeal with all documentation. Your cardiologist should request a peer-to-peer review with the plan's medical director.

Step 6: Escalate to external appeal if the internal appeal fails.

What to Include in Your Entresto Appeal Letter

• Policy number, claim reference, and date of denial
• Identification of medication: Entresto (sacubitril/valsartan), dose
• Echocardiogram report confirming ejection fraction ≤40%
• NYHA functional class documentation
• Prior ACE inhibitor/ARB trial history with dates, doses, and outcomes
• Documentation of any contraindications to ACE inhibitors
• Letter of Medical Necessity from cardiologist
• PARADIGM-HF trial reference
• ACC/AHA Heart Failure Guideline citation: Class I, Level A recommendation for ARNI therapy
• Request for peer-to-peer review with plan medical director

Success Tips for Entresto Appeals

Lead with the guidelines. The ACC/AHA Class I, Level A recommendation for Entresto in HFrEF is one of the strongest endorsements in medicine. Quoting this directly in your appeal letter is powerful and difficult for an insurer's medical reviewer to dismiss.

Document ACE inhibitor intolerance clearly. If the denial is based on step therapy, the fastest path forward is demonstrating you've already tried ACE inhibitor therapy and experienced adverse effects. Even if cough seems minor, document it as a reason the step was clinically inappropriate to continue.

Use cardiologist authority. Heart failure management is a subspecialty. If your cardiologist is prescribing Entresto, their clinical judgment carries substantial weight in a peer-to-peer review. Push hard for this call.

File an expedited appeal if clinically urgent. If you are hospitalized or clinically deteriorating, you can request an expedited appeal with a 72-hour turnaround under federal law.

Consider the Novartis patient assistance program. While the appeal is pending, Novartis's EntresTogether program may offer free drug or co-pay assistance.

Fight Back With ClaimBack

Entresto is a life-saving medication that you and your cardiologist have determined you need. An insurance denial shouldn't stand in the way of evidence-based heart failure care. ClaimBack helps you build a compelling, professionally organized appeal.

Start your Entresto appeal at ClaimBack

Related Reading

• How to Write an Insurance Appeal Letter
• What Is Medical Necessity?
• Internal vs. External Insurance Appeals