CurrentColorado Rocky Mountain Health PlansPolicy N/A

Entresto (valsartan‑sacubitril) prior authorization and medical necessity

Criteria and authorization rules for coverage of Entresto for members, including initial approval, reauthorization, pediatric indications, prescriber requirements, and treatment conditions. Applies to Colorado Rocky Mountain Health Plans' clinical pharmacy prior authorization program.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyEntresto (valsartan‑sacubitril) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 15, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, LVEF, NYHA class, ACE inhibitor washout, cardiology involvement, and titration to 97 mg/103 mg BID for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

≤40%EF threshold

97 mg/103 mg BIDtitration target

≥1 yrpediatric age

Coverage Criteria for Entresto (valsartan‑sacubitril)

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Initial Therapy

Covered when ANY of the following initial-therapy pathways are met:

Initial therapy pathways

Inpatient continuation: Continuation of therapy initiated during an inpatient stay
Authorization will be issued for 12 months

Pediatric pathway

Pediatric symptomatic LV systolic dysfunction: Diagnosis of pediatric heart failure with systemic left ventricular systolic dysfunction which is symptomatic
Cardiology involvement: Prescribed by or in consultation with a cardiologist

Adult heart failure pathway

Heart failure diagnosis: Diagnosis of heart failure (with or without hypertension)
EF / structural heart disease
- Reduced EF: Ejection fraction is less than or equal to 40 percent
- Preserved EF with structural disease: Ejection fraction greater than 40 percent AND patient has structural heart disease (e.g., left atrial enlargement or left ventricular hypertrophy)
NYHA class: Heart failure classified as NYHA Class II OR III OR IV
No angioedema history: Patient does not have a history of angioedema
ACE inhibitor/ARB discontinuation: Patient will discontinue any use of concomitant ACE inhibitor or ARB before initiating treatment; ACE inhibitors must be discontinued at least 36 hours prior to initiation of Entresto
No aliskiren: Patient is not concomitantly on aliskiren therapy
Cardiology involvement: Entresto is prescribed by or in consultation with a cardiologist

Reauthorization

Reauthorization covered when ALL of the following are met:

Reauthorization criteria

Dose titration: Entresto dose has been titrated to 97 mg/103 mg twice daily OR to the maximum labeled dose for pediatric patients OR to the maximum dose tolerated by the patient97 mg/103 mg BID target
Clinical response: Documentation of positive clinical response to therapy

Patients with a history of angioedema are excluded from coverage for Entresto. Additionally, authorization may be denied if documentation shows concomitant use of an ACE inhibitor or ARB without the required washout (ACE inhibitors must be discontinued at least 36 hours before initiating Entresto), concomitant use of aliskiren, or if the medication is not prescribed by or in consultation with a cardiologist when required by the criteria. These clinical exclusions and concomitant-therapy restrictions must be clearly documented in the prior authorization request to avoid denial.

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Entresto. Authorizations may be granted as continuation of therapy initiated during an inpatient stay or when initial therapy criteria are met. Authorization will be issued for 12 months when approved.

Initial approval pathways: continuation of inpatient-initiated therapy; or meeting specified pediatric/adult heart failure diagnostic and clinical criteria
Authorization duration: 12 months

Note

Automated Approvals & Supply Limits

Automated approval pathways may be used in certain programs based on prior claim or medication history, diagnosis codes (ICD-10), and claim logic. When automated approval is available, it may apply to both initial approvals and reauthorizations. Supply limits may apply.

Automated approvals may rely solely on prior claims/medication history, ICD-10 diagnosis codes, and claim logic
Supply limits may be imposed

Documentation Required

Required Clinical Documentation

Required clinical documentation to support approval includes documentation of inpatient initiation when applicable; diagnosis of pediatric heart failure with systemic left ventricular systolic dysfunction (if used under pediatric criteria) and evidence of consultation or prescribing by a cardiologist; documentation of heart failure diagnosis, ejection fraction (with numeric value), NYHA class, and evidence of structural heart disease when applicable. Documentation must also support that the patient will discontinue ACE inhibitor or ARB (ACE inhibitors stopped at least 36 hours prior) and is not on concomitant aliskiren.

Inpatient initiation: hospital record showing Entresto started during inpatient stay
Pediatric diagnosis: note confirming pediatric heart failure with systemic left ventricular systolic dysfunction and cardiology involvement
Ejection fraction: recent imaging report with EF value
NYHA class: clinical note documenting Class II–IV status
Structural heart disease: imaging or cardiology report showing LAE or LVH when EF >40%
Medication reconciliation: documentation ACE inhibitor/ARB discontinued (ACE inhibitors discontinued ≥36 hours prior) and no concurrent aliskiren

Denial Risk

Triggers for Denial

Triggers for denial include a documented history of angioedema, continued concomitant use of an ACE inhibitor, ARB, or aliskiren when contraindicated, failure to provide required clinical documentation (diagnosis, EF, NYHA class, cardiology involvement, medication reconciliation), or not meeting the specified diagnostic/ejection fraction/NYHA criteria.

History of angioedema — denial risk
Concomitant contraindicated therapies (ACE inhibitor/ARB not discontinued, concurrent aliskiren) — denial risk
Missing or insufficient clinical documentation (diagnosis, EF, NYHA class, cardiology consult) — denial risk
Failure to meet diagnostic or objective criteria (EF and NYHA class/structural heart disease requirements) — denial risk

Background

Entresto (valsartan‑sacubitril) is intended to reduce the risk of cardiovascular death and heart-failure hospitalization and is used for patients with symptomatic heart failure, including pediatric patients with systemic left ventricular systolic dysfunction aged one year and older. Coverage is intended for situations such as continuation of inpatient-initiated therapy or when patients meet specified heart-failure criteria (including NYHA Class II–IV, left ventricular ejection fraction thresholds or structural heart disease) and when required safety conditions are met (no history of angioedema, appropriate ACE inhibitor washout of at least 36 hours, no concurrent aliskiren, and cardiology prescribing/consultation). When criteria are met, authorization is issued for 12 months.

Definitions and Key Terms

Structural heart disease (examples)

Left atrial enlargement (LAE)Listed as an example of structural heart disease used in adult pathway

Left ventricular hypertrophy (LVH)Listed as an example of structural heart disease used in adult pathway

Role in eligibilityPresence of structural heart disease (e.g., LAE or LVH) allows approval when EF > 40% if other criteria met

ACE inhibitor washout and related requirements

Minimum ACE inhibitor washoutACE inhibitors must be discontinued at least 36 hours prior to initiation of Entresto

Requirement contextDiscontinuation of concomitant ACE inhibitor or ARB is required before initiating Entresto

Concomitant therapy exclusionPatient must not be concomitantly on aliskiren therapy

OpenPayer

Entresto (valsartan‑sacubitril) prior authorization and medical necessity

Coverage Criteria for Entresto (valsartan‑sacubitril)

Coding and Clinical Thresholds

Provider Actions, Documentation, and Authorization

Background

Definitions and Key Terms