Currentmedical mutual - ohioPolicy N/A

Entresto (sacubitril and valsartan) coverage

Pharmacy benefit prior authorization policy for Entresto for adults and pediatric patients with symptomatic heart failure (systemic left ventricular systolic dysfunction), specifying initial and continuation criteria and recommended approval durations.

Policy Summary

Payermedical mutual - ohio

PolicyEntresto (sacubitril and valsartan) coverage

Policy CodePolicy N/A

Change TypeAnnual review — no material clinical changes

Effective DateN/A

Next Review DateJun 19, 2025

Key ActionObtain prior authorization and ensure initial prescription is by or in consultation with a cardiologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

NYHA II-IVAdult indication

>=1 yrPediatric min age

1 yrInitial approval

97/103 mg BIDMax dose

Coverage Criteria for Entresto (sacubitril/valsartan)

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inv-02: Chronic Heart Failure (HF), Adults - continuation of therapy

Covered when ALL of the following are met

Adult continuation criteria: A. Provider attests that patient achieving clinical benefit while taking Entresto (i.e. decreased hospitalizations, improved heart failure symptoms, improved quality of life, etc); AND B. Entresto is prescribed by or in consultation with a cardiologist; AND C. Entresto is not being used in combination with an ACE inhibitor, an ARB, or aliskiren (Tekturna) in patients with diabetes

inv-03: Heart Failure (HF), Pediatric Patients - initial therapy

Covered when ALL of the following are met

Pediatric initial therapy criteria: A. The patient is >= 1 year of age; AND B. Entresto is being used for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction; AND C. Prescribed by or in consultation with a cardiologist; AND D. Entresto will not be used concomitantly with ACE inhibitors, ARBs, or with aliskiren (Tekturna) in patients with diabetes; AND E. The dose of Entresto will not exceed 97/103 mg twice daily.

inv-04: Heart Failure (HF), Pediatric Patients - continuation of therapy

Covered when ALL of the following are met

Pediatric continuation criteria: A. The patient is >= 1 year of age; AND B. Entresto is being used for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction; AND C. Prescribed by or in consultation with a cardiologist; AND D. Entresto will not be used concomitantly with ACE inhibitors, ARBs, or with aliskiren (Tekturna) in patients with diabetes; AND E. Provider attests the patient is achieving clinical benefit while taking Entresto (i.e. decreased hospitalizations, improved heart failure symptoms, improved quality of life, etc)

Coverage is not recommended for uses of Entresto that are not explicitly listed in the Recommended Authorization Criteria. This list is not exhaustive and will be updated as new published data become available. Providers should refer to the specific initial and continuation criteria for adults and pediatric patients when requesting authorization.

Requests for Entresto that do not meet the recommended authorization criteria, or that lack required supporting documentation, may be denied as not medically necessary. The Company may also deny reimbursement if use is investigational/experimental, not within member benefits, or if a pattern of inappropriate or excessive billing or documentation practices is identified. Additional documentation supporting medical necessity (for example, patient records, test results, or provider credentials) must be provided upon request.

Coding and Dosage Information

Automation ICD-10 Codes for Heart FailureICD-10

I50.1*	Heart Failure (specified in automation note)
I50.2*	Heart Failure (specified in automation note)

inv-08: Maximum dose — 97/103 mg twice daily

Maximum recommended dose (adults and pediatrics)Do not exceed 97/103 mg twice daily

Dose context in adult initial criteriaCriterion D: The dose of Entresto will not exceed 97/103 mg twice daily

Dose context in pediatric initial criteriaCriterion E: The dose of Entresto will not exceed 97/103 mg twice daily for patients ≥ 1 year

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for pharmacy coverage of Entresto. Initial approval requires the drug to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., cardiologist).

Initial prescribing or consultation by a cardiologist required for initial therapy (adults and pediatrics).
Automation: when available, ICD-10 codes for Heart Failure (I50.1*, I50.2*) may be used for automation to allow approval for patients ≥ 18 years.

Note

Specialist Prescribing Requirement

Initial therapy must be prescribed by or in consultation with a specialist (cardiologist). This applies to adult and pediatric heart failure initial therapy.

Adults: Prescribed by or in consultation with a cardiologist (NYHA Class II or greater).
Pediatrics: Prescribed by or in consultation with a cardiologist (patients ≥ 1 year with symptomatic left ventricular systolic dysfunction).

Documentation Required

Supporting Documentation May Be Requested

The Company may request additional documentation to support coverage determinations. Providers should be prepared to supply medical records, test results, and provider credentials when requested.

Documentation may include patient records, diagnostic test results, and credentials of the ordering or performing provider.
Failure to provide sufficient documentation may result in denial of reimbursement.
The Company may deny reimbursement if the drug or services are deemed not medically necessary, investigational/experimental, not within the member's benefits, or if a pattern of inappropriate or excessive billing/practice is identified.

Denial Risk

Denial Risk Conditions

Coverage may be denied under several circumstances. Providers should verify benefit scope and supply complete documentation to reduce denial risk.

Not medically necessary or not within scope of member benefits.
Investigational or experimental use (not supported by evidence for the requested indication).
Insufficient documentation to support medical necessity (patient records, test results, provider credentials).
Pattern of inappropriate or excessive billing or practice.
Requests for uses not listed in the policy will be reviewed case-by-case and may be denied if efficacy/necessity is not demonstrated.

Background and Rationale

Entresto is a fixed combination of sacubitril (a neprilysin inhibitor) and valsartan (an angiotensin II receptor blocker) designed to reduce cardiovascular death and heart failure hospitalizations in patients with heart failure with reduced ejection fraction. Clinical evidence and guideline-based recommendations support its benefit in adults with chronic symptomatic heart failure (NYHA Class II–IV) and in pediatric patients aged ≥1 year with symptomatic heart failure due to systemic left ventricular systolic dysfunction. When considered for coverage, the policy requires specialist involvement (prescription by or in consultation with a cardiologist) and adherence to dose and concomitant-therapy restrictions to ensure appropriate use and maximize clinical benefit.

Key Definitions

inv-14: Indication — intended clinical indication and NYHA class summary

Primary indication (adults)Reduce risk of cardiovascular death and hospitalization for heart failure in chronic heart failure with reduced ejection fraction (NYHA Class II-IV)

Primary indication (pediatrics)Treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in patients ≥ 1 year of age

NYHA class requirementAdults must have heart failure staged as NYHA Class II or greater

inv-15: Specialist prescribing — requirement that initial approval be prescribed by or in consultation with a specialist (cardiologist)

Specialist requirement for initial approvalInitial approval requires Entresto be prescribed by or in consultation with a cardiologist

RationaleSpecialist involvement is required because of specialized skills for evaluation, diagnosis, monitoring of adverse events, and long-term efficacy

Applies toApplies to adult and pediatric initial therapy criteria

Policy Summary

Payermedical mutual - ohio

PolicyEntresto (sacubitril and valsartan) coverage

Policy CodePolicy N/A

Change TypeAnnual review — no material clinical changes

Effective DateN/A

Next Review DateJun 19, 2025

Key ActionObtain prior authorization and ensure initial prescription is by or in consultation with a cardiologist.

SourceLink

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