Arni Entresto denied as non-formulary by Blue Cross Blue Shield?

Blue Cross Blue Shield's specific coverage criteria for arni entresto are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

## Why BCBS Denied Entresto as Non-Formulary

Entresto (sacubitril/valsartan) may be placed on a non-preferred tier or excluded from certain BCBS formularies, particularly in plans that have an ACE inhibitor or ARB as the preferred heart failure agent at a lower cost tier. A non-formulary denial means the plan's drug list does not include Entresto at any tier, or includes it only with restrictions that were not satisfied. This does not mean the drug is clinically inappropriate — it means a formulary exception is required.

## Why This Is Appealable

All ACA-compliant and ERISA plans must have a formulary exception process. A formulary exception allows coverage of a non-formulary drug when a clinician establishes that the formulary alternatives are medically inappropriate for a specific patient. For Entresto, the exception argument typically rests on: (1) the patient has already tried and cannot tolerate or does not respond adequately to the formulary alternative(s), or (2) the formulary alternative is contraindicated based on the patient's specific clinical circumstances (consult the current prescribing labels for both Entresto and the formulary alternative for the applicable information). The treating cardiologist must document the clinical basis in detail.

## Federal Appeal Framework

• Formulary exception request: This is the first step — submit a formal exception request with clinical documentation before or alongside the internal appeal.
• Internal appeal: If the exception request is denied, file a formal internal appeal within the deadline on the denial letter.
• ACA §2719 external review: Available after exhausting internal remedies. IRO reviewers assess whether denial of the exception was clinically appropriate. Window is approximately four months from the final internal denial.
• Expedited review: Available for urgent situations where delay in obtaining Entresto could cause serious deterioration.
• ERISA §503: For employer-sponsored plans, requires disclosure of the exception criteria and a full-and-fair review process.

## What to Gather

• Formulary alternative trial history: For each drug on the BCBS formulary in this therapeutic class, document whether it was tried (dates, doses attempted per prescriber records), what the outcome was, and why it is no longer appropriate.
• Prescriber exception letter: A detailed letter from the treating cardiologist stating why each formulary alternative is clinically inadequate for this patient and why Entresto is necessary. Reference the applicable ACC/AHA guideline organization's recommendation.
• Diagnosis and functional-status documentation: Echo, clinical notes, and relevant studies supporting the severity and subtype of heart failure.
• FDA labeling references: For both Entresto and any formulary alternatives, note the labeled indications and any relevant prescribing information that supports the exception argument — without asserting specific numbers.

## Criteria-Mapping Structure

Obtain BCBS's formulary exception criteria from the plan documents or by calling member services. List each criterion and address it with the corresponding clinical fact. The prescriber letter is the centerpiece — it should be specific to this patient, not a generic template.