Entresto (sacubitril/valsartan) is a cornerstone medication for heart failure with reduced ejection fraction. Despite ACC/AHA guideline recommendations, insurers frequently require step therapy or impose prior authorization barriers.
Why Entresto Gets Denied
- Step therapy requiring ACE inhibitor or ARB first
- Prior authorization requirements
- High cost (~$600/month without assistance)
- Formulary restrictions
The Clinical Case for Entresto
PARADIGM-HF Trial
- 20% reduction in cardiovascular death vs. enalapril
- 21% reduction in heart failure hospitalization
- Benefit seen across all subgroups
- Considered practice-changing evidence
Guideline Recommendations
- ACC/AHA: Class I recommendation for HFrEF (highest level)
- Should REPLACE ACE inhibitor/ARB, not just be added
- Recommended in all patients with NYHA Class II-IV HFrEF with EF ≤40%
Building Your Appeal
- Echo/imaging showing reduced ejection fraction (≤40%)
- NYHA functional class documentation
- List of current heart failure medications
- BNP/NT-proBNP levels
- Cardiologist letter citing PARADIGM-HF and guideline recommendations
- Documentation of any ACE inhibitor/ARB trial (if step therapy is required)
- Note the 36-hour washout requirement when switching from ACE inhibitors
Cost Assistance
- Novartis Co-Pay Card: Eligible patients may pay as little as $10/month
- Novartis Patient Assistance Foundation for uninsured patients