Download Prior Authorization Protocol ENTRESTO™ (sacubitril

Prior Authorization Protocol
ENTRESTO (sacubitril/valsartan)
NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with
or refer to the Evidence of Coverage document.
I.
FDA Approved Indications:


II.
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

Prescribed by or in consultation with a Cardiologist
AND

III.
Coverage is Not Authorized For:

IV.
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:



V.
Left ventricular ejection fraction less than 40%
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
6.25 mg PO TID
150 mg/day
2.5 mg PO BID
40 mg/day
ACE Inhibitor
captopril
(Capoten)
enalapril
(Vasotec)
Confidential and Proprietary
Draft Prepared: 07.15.15 S.Chan
Approved by Health Net Pharmacy & Therapeutics Committee: 11.18.15
Revised: 08.26.15 N.Nguyen, 09.30.15 N Nguyen, 06.16.16 S Ara
Page
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Prior Authorization Protocol
ENTRESTO (sacubitril/valsartan)
NATL
Drug
Dosing Regimen
Dose/Limit/Maximum Dose
fosinopril
(Monopril)
5 to 10 mg PO QD
40 mg/day
lisinopril
(Zestril)
2.5 to 5 mg PO QD
40 mg/day
perindopril
(Aceon)
2 mg PO QD
16 mg/day
quinapril
(Accupril)
5 mg PO BID
40 mg/day
1.25 to 2.5 mg PO QD
10 mg/day
1 mg PO QD
4 mg/day
benazepril
(Lotensin)
20 to 40 mg PO QD
80 mg/day
moexipril
(Univasc)
7.5 to 30 mg PO QD
60 mg/day
4 to 8 mg PO QD
32 mg/day
losartan
(Cozaar)
25 to 50 mg PO QD
150 mg/day
valsartan
(Diovan)
20 to 40 mg PO BID
320 mg/day
150 mg PO QD
300 mg/day
20 mg PO QD
40 mg/day
40 to 80 mg PO QD
80 mg/day
80 mg PO QD
80 mg/day
ramipril
(Altace)
trandolapril
(Mavik)
ARB
candesartan
(Atacand)
irbesartan
(Avapro)
Benicar
(olmesartan)
Edarbi
(azilsartan)
telmisartan
Confidential and Proprietary
Draft Prepared: 07.15.15 S.Chan
Approved by Health Net Pharmacy & Therapeutics Committee: 11.18.15
Revised: 08.26.15 N.Nguyen, 09.30.15 N Nguyen, 06.16.16 S Ara
Page
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Prior Authorization Protocol
ENTRESTO (sacubitril/valsartan)
NATL
Drug
Dosing Regimen
Dose/Limit/Maximum Dose
(Micardis)
eprosartan
400 to 800 mg PO QD
(Teveten)
*Requires Prior Authorization
VI.
800 mg/day
Recommended Dosing Regimen and Authorization Limit:
Drug
Entresto
(sacubitril/valsart
an)
Dosing Regimen
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
Authorization Limit
Length of Benefit
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
VII.
Product Availability:
Tablet: 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg
VIII.
References:
1. Entresto [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceutical; July 2015.
2. McMurray JJ, Packer M, Desai AS, Angiotensin–neprilysin inhibition versus enalapril in heart
failure. N Engl J Med 371.11 (2014): 993-1004.
3. Micromedex® Healthcare Series [Internet database]. Greenwood Village, CO: Thomson
Healthcare. Updated periodically. Accessed June 16, 2016.
The materials provided to you are guidelines used by this health plan to authorize, modify, or determine
coverage for persons with similar illnesses or conditions. Specific care and treatment may vary
depending on individual needs and the benefits covered under your contract.
Confidential and Proprietary
Draft Prepared: 07.15.15 S.Chan
Approved by Health Net Pharmacy & Therapeutics Committee: 11.18.15
Revised: 08.26.15 N.Nguyen, 09.30.15 N Nguyen, 06.16.16 S Ara
Page
-3