Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • NPI Medicare & Medicaid
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.28
    OpenPayerPolicy UpdatesCardiologyallcareadvantage Entresto Prior Auth Coverage | Op…
    Ask Trek AI about this page
    CurrentallcareadvantagePolicy 091.3

    sacubitril-valsartan (Entresto) prior authorization

    Customize your policy alerts

    Sign up for allcareadvantage Policy 091.3 alerts

    Get alerted when Policy 091.3 changes without checking for updates manually.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    Defines coverage and prior authorization criteria for sacubitril-valsartan (Entresto) for adults with chronic heart failure with reduced ejection fraction (NYHA II-IV), including approval length, dosing expectations, and quantity limits.

    Policy Summary
    Payerallcareadvantage
    Policysacubitril-valsartan (Entresto) prior authorization
    Policy CodePolicy 091.3
    Change TypeNo material changes
    Effective DateAug 9, 2022
    Last ReviewAug 8, 2024
    Next Review DateAug 8, 2024
    Key ActionSubmit prior authorization confirming member is ≥18 with chronic HFrEF (NYHA II-IV) and prior tolerance to an ACE‑I or ARB.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    18+age group covered
    Up to 1 yearapproval length
    97/103 mgtarget maintenance dose
    2/dayquantity limit

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Coverage Criteria for Sacubitril‑Valsartan (Entresto)

    Initial Therapy

    Covered when ALL of the following are met

    Initial Approval: Member is >=18 years old; confirmed diagnosis of chronic heart failure with reduced ejection fraction (NYHA class II-IV) or condition consistent with the FDA‑approved indication; patient is being followed by a cardiologist or therapy was initiated in a hospital setting; patient has previously tolerated an ACE inhibitor or ARB with no known history of angioedema related to prior ACE‑I or ARB therapy; no hypersensitivity to any component; and it is clear sacubitril‑valsartan will not be used concomitantly with contraindicated agents.

    Continuation/Renewal Therapy

    Renewal covered when ANY of the following are met per policy flow

    Renewal: (1) Patient is currently taking sacubitril‑valsartan at the target dose of 97/103 mg twice daily — approve;
    Renewal: (2) There is a clinical reason the drug has not been titrated to the target dose — approve for 6 months with the applicable quantity limit.
    Renewal: (3) If neither condition is met, outreach to the prescriber to determine if dosing can be increased to target; limited approval (up to 6 months) may be granted while awaiting response per policy flow.

    Requests that do not meet the policy criteria will be denied. Common reasons for denial include absence of a confirmed diagnosis of chronic heart failure with reduced ejection fraction consistent with NYHA class II–IV or the FDA indication, lack of documentation that the patient is followed by a cardiologist or that therapy was initiated in a hospital setting, failure to document prior tolerance of an ACE inhibitor or ARB (including no known history of angioedema related to prior ACE‑I/ARB therapy), or unclear plans to avoid concomitant use with contraindicated agents. These deficiencies should be addressed in the prior authorization submission to avoid denial.

    Use of sacubitril‑valsartan outside the FDA‑approved indication or without meeting the specified clinical requirements is considered not medically necessary. Specifically, requests will be considered not medically necessary when the patient does not meet the required clinical criteria (confirmed chronic heart failure with reduced ejection fraction NYHA class II–IV, cardiology follow‑up or hospital initiation, and prior ACE‑I/ARB tolerance) or when concomitant use contraindications are not resolved.

    Dosing and Quantity Limits

    Target dose
    Target maintenance dose97/103 mg twice daily
    Recommended starting dose (for context)49/51 mg orally twice daily
    Approval implicationRenewal approval given if patient is taking target dose (97/103 mg twice daily)
    Quantity limit
    Daily quantity limit2 tablets per day
    Limiting authorityQuantity Limits set by HICL
    Renewal noteIf not at target dose for clinical reasons, renewal may be approved for 6 months with quantity limit

    Provider Requirements and Documentation

    Prior Authorization

    Prior authorization required; coverage limited to adults with HFrEF (NYHA II–IV)

    Prior authorization is required for sacubitril‑valsartan (Entresto). Coverage is limited to members age 18 years and older with chronic heart failure with reduced ejection fraction (NYHA class II–IV) when all policy criteria are met; approvals are issued for up to 1 year.

    • Covered population: members ≥18 years with heart failure with chronic reduced ejection fraction (NYHA II–IV).
    • Approval length: up to 1 year.
    Step Therapy

    Prior ACE‑I/ARB tolerance required (no angioedema history)

    Patient must have previously tolerated an ACE inhibitor or an ARB with no known history of angioedema related to prior ACE‑I or ARB therapy before sacubitril‑valsartan will be approved.

    Documentation Required

    Required documentation to support PA request

    Provide documentation confirming: diagnosis of chronic heart failure with reduced ejection fraction (NYHA II–IV); that the patient is followed by a cardiologist or therapy was initiated in a hospital setting; prior tolerance of an ACE‑I or ARB with no history of angioedema; and that sacubitril‑valsartan will not be used concomitantly with contraindicated agents.

    Denial Risk

    Denial triggers — missing required criteria or contraindications

    Requests will be denied if the policy criteria are not met, including absence of a confirmed diagnosis of chronic heart failure with reduced ejection fraction (NYHA II–IV), lack of prior ACE‑I/ARB tolerance or a history of angioedema related to ACE‑I/ARB, or failure to demonstrate that the drug will not be used with contraindicated concomitant agents.

    Background

    Indication: Sacubitril‑valsartan (Entresto) is used to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure and reduced ejection fraction consistent with NYHA class II–IV. Prior authorization is required for coverage. Covered population: Members 18 years and older with a confirmed diagnosis of heart failure with reduced ejection fraction (NYHA II–IV) when all initial criteria are met (cardiology follow‑up or hospital initiation, prior tolerance of an ACE‑I/ARB with no history of angioedema, and assurance the drug will not be used with contraindicated agents). Renewal/approval length: Approvals may be issued for up to 1 year; renewal is approved when the patient is at the target dose of 97/103 mg twice daily or when there is a documented clinical reason the patient has not been titrated to target dose, in which case limited renewal may be granted with applicable quantity limits.

    Key Definitions and Indications

    FDA approved indication
    FDA approved indicationTo reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
    Covered populationMembers 18 years and older with chronic heart failure with reduced ejection fraction (NYHA II-IV)
    Clinical dosing guidanceTarget maintenance dose is 97/103 mg twice daily as tolerated
    Policy Summary
    Payerallcareadvantage
    Policysacubitril-valsartan (Entresto) prior authorization
    Policy CodePolicy 091.3
    Change TypeNo material changes
    Effective DateAug 9, 2022
    Last ReviewAug 8, 2024
    Next Review DateAug 8, 2024
    Key ActionSubmit prior authorization confirming member is ≥18 with chronic HFrEF (NYHA II-IV) and prior tolerance to an ACE‑I or ARB.
    SourceLink
    On This Page
    Coverage Criteria for Sacubitril‑Valsartan (Entresto)Dosing and Quantity LimitsProvider Requirements and DocumentationBackgroundKey Definitions and Indications