CurrentCentenePolicy CP.PCH.52

Sacubitril Valsartan (Entresto) coverage

Defines Centene's medical necessity and prior authorization criteria for sacubitril/valsartan (Entresto) for members with chronic heart failure across specified lines of business.

Policy Summary

PayerCentene

PolicySacubitril Valsartan (Entresto) coverage

Policy CodePolicy CP.PCH.52

Change TypeNo material changes

Effective DateSep 1, 2024

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation showing member meets initial or continued therapy criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

II-IVNYHA classes eligible under initial criteria

194/206 mgMaximum daily combined dose specified

12 monthsApproval duration (initial)

Commercial, HIMApplies to

Coverage Criteria for Sacubitril/Valsartan (Entresto)

Initial Therapy (Heart Failure)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Heart Failure Criteria: 1) Diagnosis of chronic heart failure classified as NYHA Class II, III, or IV; 2) Prescribed by or in consultation with a cardiologist; 3) Age consistent with FDA indication (adult or pediatric per FDA labeling); 4) At the time of request, member has none of the following contraindications: concurrent use with an ACE inhibitor, and for members with diabetes, concomitant use with aliskiren; and no history of angioedema related to ACE/ARB therapy; 5) For members with LVEF ≥ 41% (heart failure with mildly reduced or preserved ejection fraction), failure of empagliflozin (Jardiance) or dapagliflozin (Farxiga) unless both are contraindicated or not tolerated; 6) Requested dose does not exceed sacubitril 194 mg / valsartan 206 mg per day and does not exceed 2 adult tablets per day.

Approval duration: 12 months

Continuation Therapy

Continued therapy covered when ALL of the following are met:

Continued Therapy: 1) Member is currently receiving Entresto via the Centene benefit, or documentation shows the member has received Entresto for at least 30 days; 2) Member is responding positively to therapy; 3) Requested dose does not exceed sacubitril 194 mg / valsartan 206 mg per day and, if the request is for a dose increase, does not exceed 2 adult tablets per day.

Non‑FDA approved indications for sacubitril/valsartan (Entresto) are not authorized under this policy unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for commercial lines and HIM.PA.154 for health insurance marketplace) or as allowed by the member's evidence of coverage. Failure to provide this documentation may result in denial of coverage for off‑label indications.

Coverage determinations under this clinical policy are a guide to medical necessity and are used to assist in making coverage decisions and administering benefits. This policy does not guarantee payment and is subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract). Plan‑level administrative policies, state and federal requirements, and applicable legal or regulatory obligations also govern final coverage decisions.

Use of Entresto for indications that are not FDA‑approved will be considered not medically necessary unless the request is supported by documentation meeting the Health Plan's off‑label use criteria (see CP.CPA.09 and HIM.PA.154). Additionally, known contraindications (for example, history of angioedema related to ACE/ARB therapy, concomitant use with an ACE inhibitor, or use with aliskiren in patients with diabetes) must be avoided; such contraindications affect medical necessity determinations.

Product Codes and Dosing Information

Product codesNDC

NDC not listed

NDCs not specified in this document

Maximum daily dose — Sacubitril/Valsartan

Maximum daily combined doseSacubitril 194 mg / Valsartan 206 mg per day

Adult tablet limitMaximum of 2 adult tablets per day (per policy dosing guidance)

Dose check for approvalsRequested dose must not exceed sacubitril 194 mg/valsartan 206 mg per day for initial or continued therapy

Starting adult dose (typical)

Typical starting adult dose49/51 mg PO BID

Titration target doseTitrate to 97/103 mg PO BID after 2–4 weeks as tolerated

Alternate initiationInitiation at 24/26 mg PO BID is recommended for patients not on an ACE inhibitor/ARB, with severe renal impairment, or moderate hepatic impairment

Provider Requirements and Authorization Processes

Prior Authorization

Prior Authorization Required

Prior authorization is required. Coverage decisions and benefit administration are subject to the member's Evidence of Coverage (EOC) and applicable Health Plan-level policies. Providers must obtain prior authorization with submission of supporting clinical documentation; both initial and continued therapy criteria must be met for approval.

Prior authorization required for initial and continued therapy
Coverage and benefit administration subject to member EOC and plan-level policies

Documentation Required

Documentation Requirement

Provider must submit documentation (such as office chart notes, lab results, imaging, or other clinical information) supporting that the member has met all approval criteria. Failure to submit required documentation may result in denial of the request.

Examples of acceptable documentation: office visit notes, cardiology consultation notes, echocardiogram reports showing LVEF, relevant lab results, medication history
For continued therapy, documentation must show treatment duration (minimum 30 days when applicable) and clinical benefit or stability as specified in criteria

Step Therapy

Step Therapy for LVEF ≥ 41%

For members with left ventricular ejection fraction (LVEF) ≥ 41% (heart failure with mildly reduced or preserved ejection fraction), step therapy requires documented trial and failure (or intolerance or contraindication) of empagliflozin (Jardiance) or dapagliflozin (Farxiga) prior to approval unless these agents are contraindicated or clinically not appropriate.

Step therapy applies only when LVEF ≥ 41%
Document trial of empagliflozin or dapagliflozin, including dosing and reason for discontinuation if applicable

Note

Policy Change Rights and Coverage Terms

The Health Plan retains the right to change, amend, or withdraw this clinical policy at any time. Additional clinical or administrative policies (including step therapy or other utilization management requirements) may be adopted as needed. Coverage determinations remain subject to all terms, conditions, exclusions and limitations of the member's coverage documents.

Policy subject to modification or withdrawal by the Health Plan
Coverage determinations governed by member contract terms and applicable laws/regulations

Note

Professional Judgment Reminder

Providers are expected to exercise professional judgment when treating members; this clinical policy is a guide to coverage and does not replace individualized clinical decision-making.

Clinical judgment should be used when applying policy criteria
This policy does not guarantee payment; benefits are administered per the member's coverage documents

Background

Entresto is a fixed‑dose combination of a neprilysin inhibitor (sacubitril) and an angiotensin II receptor blocker (valsartan). It is FDA‑approved to reduce cardiovascular death and heart failure hospitalizations in adults with chronic heart failure — with the clearest benefit demonstrated in patients with reduced left ventricular ejection fraction — and is also approved for symptomatic systolic dysfunction in pediatric patients aged ≥ 1 year. Recommended adult dosing typically starts at 49/51 mg PO twice daily with titration to 97/103 mg PO twice daily as tolerated, and the policy specifies a maximum combined daily dose of sacubitril 194 mg / valsartan 206 mg. Clinical trials and guideline sources (e.g., PARAGON‑HF and current AHA/ACC/HFSA guidance) were considered in developing these recommendations.

Definitions and Abbreviations

HFrEF

DefinitionHeart failure with reduced ejection fraction (HFrEF) — commonly defined as left ventricular ejection fraction (LVEF) < 40% per referenced guidelines

Clinical contextHFrEF is a clinical diagnosis referenced in current AHA/ACC/HFSA guidance

Guideline source2022 AHA/ACC/HFSA guideline defining HFrEF as LVEF < 40%

LVEF

TermLeft ventricular ejection fraction (LVEF)

Use in policyLVEF is used to classify heart failure phenotype (e.g., HFrEF) and to determine step-therapy requirements

Referenced in appendicesLVEF thresholds and trial criteria are described in policy appendices and trial summaries

NYHA

TermNew York Heart Association (NYHA) functional classification

Policy useNYHA class (II–IV) is used in initial approval criteria for chronic heart failure

Appendix referencePARAGON-HF and other appendices reference NYHA classes II–IV in trial populations

Clinical policy

RoleClinical policy: a guide to medical necessity developed from current standards of practice, literature, guidelines, and expert opinion; not a contract or guarantee of payment

ScopeUsed to assist coverage decisions and benefit administration but does not dictate clinical practice

LimitationsCoverage remains subject to terms, exclusions, and plan-level administrative policies and procedures

Provider status

StatusProviders referenced in this policy are independent contractors who exercise independent clinical judgment and are not employees or agents of the Health Plan

ResponsibilityProviders are expected to exercise professional medical judgment and are solely responsible for member care

Relationship to Health PlanHealth Plan has no control or right of control over providers described in this policy

Revision History and References

2024-06-06policy_created

Policy created per June SDC (creation date recorded).

2024-08-24approval

Policy approval date recorded in June SDC review cycle.

2024-11-04references_reviewed

1Q 2025 annual review: references reviewed and updated (no significant clinical changes).

2025-02-25review_approvalLatest

1Q 2025 annual review approval date noted; no significant clinical policy statement changes.