ENTRESTO (sacubitril and valsartan)

ENTRESTO (sacubitril and valsartan)

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)
• Treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older

Patients must meet the following criteria for the indications above:

• Chronic Heart Failure (NYHA class II to IV) and reduced ejection fraction, AND
• 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

• Previously taking a moderate to high dose ACE-I (e.g., ≥ 0.2 mg/kg/day or 10 mg/day of enalapril or equivalent) or ARB
  • < 40 kg (oral suspension): initial 1.6 mg/kg/dose twice daily; titrate dose in 2 weeks to 2.3 mg/kg/dose twice daily, then 2 weeks later to 3.1 mg/kg/dose twice weekly
  • 40 to <50 kg (tablets): initial Sacubitril 24 mg/Valsartan 26 mg twice daily; titrate dose in 2 weeks to Sacubitril 49 mg/Valsartan 51 mg twice daily, then 2 weeks later to Sacubitril 72 mg/Valsartan 78 mg (three 24/26 mg tablets) twice daily
  • ≥ 50 kg (tablets): initial Sacubitril 49 mg/Valsartan 51 mg twice daily, titrate dose in 2 weeks to Sacubitril 72 mg/Valsartan 78 mg (three 24/26 mg tablets) twice daily, then 2 weeks later to Sacubitril 97 mg/Valsartan 103 mg twice daily
• Not currently taking an ACE-I or an ARB or previously taking low doses of an ACE-I (e.g., 0.1 mg/kg/day or 5 mg/day of enalapril or equivalent) or ARB
  • ≤ 50 kg (oral suspension): initial 0.8 mg/kg/dose twice daily; titrate dose in 2 weeks to 1.6 mg/kg/dose twice daily, then 2 weeks later 2.3 mg/kg/dose twice daily, then 2 weeks later to 3.1 mg/kg/dose twice daily
  • > 50 kg (tablets): initial Sacubitril 24 mg/Valsartan 26 mg twice daily; titrate dose in 2 weeks to Sacubitril 49 mg/Valsartan 51mg twice daily, then 2 weeks later to Sacubitril 72 mg/Valsartan 78 mg (three 24/26 mg tablets) twice daily, then 2 weeks later to Sacubitril 97 mg/Valsartan 103 mg twice daily

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: Reduce the usual starting dose by 50%, then follow the recommended dose escalation to titrate the dose

Hepatic function impairment

• Mild impairment (Child-Pugh class A): No dosage adjustment necessary
• Moderate impairment (Child-Pugh class B): Reduce the usual starting dose by 50%, then follow the recommended dose escalation to titrate the dose

Approval:

One year