CurrentUnitedHealthcarePolicy N/A

Entresto (valsartan‑sacubitril) prior authorization

Prior authorization and notification requirements for Entresto (valsartan‑sacubitril) for members covered under UnitedHealthcare pharmacy programs; affects prescribers and pharmacists requesting coverage. Applies where state mandates and member benefit plans allow.

Policy Summary

PayerUnitedHealthcare

PolicyEntresto (valsartan‑sacubitril) prior authorization

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateAug 1, 2025

Next Review DateMay 20, 2025

Key ActionObtain prior authorization — approvals issued for 12 months for qualifying adult or pediatric diagnoses.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

5/2015–5/2025policy review history range

age ≥1pediatric coverage

Coverage Criteria for Entresto (valsartan‑sacubitril)

Initial and reauthorization criteria

Covered when ONE of the following is met:

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Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Entresto. Approval will be granted for 12 months when the member meets the coverage criteria (e.g., chronic adult heart failure or pediatric heart failure with systemic left ventricular systolic dysfunction that is symptomatic).

Approval duration: 12 months

Documentation Required

Required Checks Before Submission

State mandates, federal regulatory requirements, the member's specific benefit plan coverage, and other UnitedHealthcare policies or utilization management programs may affect approval decisions. Review applicable state/federal mandates and the member’s plan benefits before submitting an authorization request.

Note

Automated Approval Limitations

Automated approval and re-approval processes may be used where available, but use varies by program and therapeutic class. Approvals may be granted based solely on previous claim/medication history, diagnosis codes (ICD-10), and claim logic; missing histories, incomplete codes, or program limits may prevent automated processing and require manual review.

Step Therapy

Supply Limits / Step Therapy Note

Supply limits may be applied to Entresto; specific quantity or duration limits (e.g., days’ supply or refill frequency) depend on plan rules and prior authorization determinations. Step therapy requirements may also apply where specified by the member’s plan.

Initial Approval Criteria

Initial approval

Initial approval criteria

Diagnosis criterion: Diagnosis of chronic adult heart failure OR diagnosis of symptomatic pediatric heart failure with systemic left ventricular systolic dysfunction.

Authorization term 12 months.

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization rules

Reauthorization duration: Authorization will be issued for 12 months; reauthorization may be granted under the same diagnosis criteria or per program automated processes.

Supply limits, state mandates, and automated re-approval procedures may apply.

Quantity and Supply Limits

Entresto (valsartan‑sacubitril) — Supply limits may apply

Quantity limit summarySupply limits may be applied to Entresto (valsartan‑sacubitril).

Application frequencyLimits may be enforced on a per‑month basis as part of plan utilization management.

Program variabilitySupply limits are subject to program‑level variation and may differ by member benefit plan and state mandates.

Relation to automated processesSupply limits may remain in effect even when automated approval or re‑approval processes are used.

Definitions

Chronic heart failure — definition / clinical context

DefinitionChronic heart failure — a long‑term condition in which the heart cannot pump sufficiently; often associated with reduced left ventricular ejection fraction (LVEF).

Clinical significanceEntresto is indicated to reduce cardiovascular death and hospitalization in patients with chronic heart failure, with benefits most evident when LVEF is below normal.

Pediatric considerationPediatric patients: symptomatic heart failure with systemic left ventricular systolic dysfunction in children aged ≥1 year is a covered indication for Entresto.

Policy implicationA diagnosis of chronic adult heart failure qualifies a member for prior authorization approval of Entresto under the policy (authorization issued for 12 months).

Background

Entresto (valsartan‑sacubitril) is an angiotensin receptor neprilysin inhibitor (ARNI) indicated to reduce cardiovascular death and hospitalization in patients with chronic heart failure, with the greatest benefit observed in patients with reduced left ventricular ejection fraction. It is also indicated for symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged 1 year and older.

Prior authorization is required for Entresto. Approval is provided when the member meets one of the diagnosis-based criteria: a diagnosis of chronic adult heart failure OR a diagnosis of symptomatic pediatric heart failure with systemic left ventricular systolic dysfunction (age ≥ 1 year). When approved, the authorization term is 12 months.

Supply limits and program-specific automated approval processes may apply; UnitedHealthcare may in some cases approve initial or reauthorization requests based solely on prior claim or medication history, diagnosis codes, and/or claim logic.