sacubitril and valsartan (Entresto®)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

  • Reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA class II to IV) and reduced ejection fraction; usually administered in conjunction with other heart failure therapies, in place of an angiotensin-converting enzyme (ACE) inhibitor or other angiotensin II receptor blocker (ARB)

Patients must meet the following criteria for the indications above:

  • Chronic Heart Failure (NYHA class II to IV) and reduced ejection fraction
  • Diagnosis of CHF NYHA class II to IV AND
  • Patient is being followed by (care coordinated by) a cardiologist

The Following Conditions Do Not Meet the Criteria for Use as Established by the WHA P & T Committee:

  • All non-FDA approved uses not listed in the approved indications

Dosing:

Adult Usual dosage

  • Sacubitril 97 mg/valsartan 103 mg twice daily
  • Initial dosage:   Patients previously taking greater than enalapril 10 mg/day or greater than valsartan 160 mg/day or equivalent dose of another ACE inhibitor or ARB: Sacubitril 49 mg/valsartan 51 mg twice daily
  • Patients previously taking low doses of an ACE inhibitor (enalapril 10 mg/day or less or an equivalent dose of another ACE inhibitor) or ARB (valsartan 160 mg/day or less or an equivalent dose of another ARB): Sacubitril 24 mg/valsartan 26 mg twice daily
  • Patients not currently taking an ACE inhibitor or an ARB: Sacubitril 24 mg/valsartan 26 mg twice daily
  • Dosage titration: Double the dose as tolerated every 2 to 4 weeks to the target maintenance dose of sacubitril 97 mg/valsartan 103 mg twice daily
  • Concomitant therapy: Concomitant use of an ACE inhibitor is contraindicated; allow a 36-hour washout period when switching from or to an ACE inhibitor

Pediatric

  • Safety and efficacy have not been established

Renal function impairment

  • Estimated glomerular filtration rate 30 mL/min/1.73 m2 or more: No dosage adjustment necessary
  • Estimated glomerular filtration rate less than 30 mL/min/1.73 m2: Initiate with sacubitril 24 mg/valsartan 26 mg twice daily

Hepatic function impairment

  • Mild impairment (Child-Pugh class A): No dosage adjustment necessary
  • Moderate impairment (Child-Pugh class B): Initiate with sacubitril 24 mg/valsartan 26 mg twice daily

Approval:

One year


  

Last review date: July 24, 2016