Prior Auth Protocol

FDA Approved Indications:

For use in the reduction of the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure NYHA (New York Heart Association) Class II-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 blockers (ARB)

Health Net Approved Indications and Usage Guidelines:

Diagnosis of chronic heart failure of NYHA (New York Heart Association) Class II-IV

AND

AND

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Entresto is typically administered in conjunction with other heart failure therapies (beta blockers, loop diuretics, hydralazine-nitrates, aldosterone antagonists, and digoxin) and in place of ACE inhibitor or other ARB
Concomitant use of Entresto with an ACE inhibitor is contraindicated because of the increased risk of angioedema
Concomitant use of Entresto and ARB should be avoided since Entresto contains an ARB

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
ACE Inhibitor captopril (Capoten^TM)	6.25 mg PO TID	150 mg/day
enalapril (Vasotec^TM)	2.5 mg PO BID	40 mg/day
fosinopril (Monopril^TM)	5 to 10 mg PO QD	40 mg/day
lisinopril (Zestril^TM)	2.5 to 5 mg PO QD	40 mg/day
perindopril (Aceon^TM)	2 mg PO QD	16 mg/day
quinapril (Accupril^TM)	5 mg PO BID	40 mg/day
ramipril (Altace^TM)	1.25 to 2.5 mg PO QD	10 mg/day
trandolapril (Mavik^TM)	1 mg PO QD	4 mg/day
benazepril (Lotensin^TM)	20 to 40 mg PO QD	80 mg/day
moexipril (Univasc^TM)	7.5 to 30 mg PO QD	60 mg/day
ARB candesartan (Atacand^TM)	4 to 8 mg PO QD	32 mg/day
losartan (Cozaar^TM)	25 to 50 mg PO QD	150 mg/day
valsartan (Diovan^TM)	20 to 40 mg PO BID	320 mg/day
irbesartan (Avapro^TM)	150 mg PO QD	300 mg/day
Benicar^TM (olmesartan)	20 mg PO QD	40 mg/day
Edarbi^TM (azilsartan)	40 to 80 mg PO QD	80 mg/day
telmisartan (Micardis)	80 mg PO QD	80 mg/day
eprosartan (Teveten^TM)	400 to 800 mg PO QD	800 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Entresto^TM (sacubitril/valsartan)	Patients transitioning from an ACE-I or ARB: Start on 49 mg/51 mg PO BID. Double dose every 2 to 4 weeks as tolerated by patient to a maximum of 97 mg/103 mg PO BID Patients not taking ACE-I or ARB or transitioning from a low dose of an ACE-I or ARB: Start on 24 mg/26 mg PO BID. Double dose every 2 to 4 weeks as tolerated by patient to a maximum of 97 mg/103 mg PO BID	Length of Benefit

Product Availability:

Tablet: 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg

References:

1. Entresto [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceutical; July 2015.

2. McMurray JJ, Packer M, Desai AS, Angiotensinneprilysin inhibition versus enalapril in heart failure. N Engl J Med 371.11 (2014): 993-1004.