Prior Authorization Guideline

Prior Authorization Guideline
Guideline: Cover Colorado - Aceon, Mavik
Therapeutic Class: Cardiovascular Agents
Therapeutic Sub-Class: ACE Inhibitors
Client: CC
Approval Date: 1/1/2006
Revision Date:
I.
BENEFIT COVERAGE
Table 1. Formulary status
Non-Formulary Products
Aceon (Perindopril)*
Mavik (Trandolapril)*
Formulary Products
Accupril (Quinapril)
Altace (Ramipril)
Capoten (Captopril)
Lotensin (Benazepril)
Monopril (Fosinopril)
Vasotec (Enalapril)
Zestril (Lisinopril)
Univasc (Moexipril)
*Subject to Prior Authorization
FDA Approved Indication(s):
ACE inhibitors are indicated for the treatment of hypertension, either alone or in combination with other
antihypertensive agents. ACE inhibitors may be used as initial therapy in hypertensives with congestive
heart failure (CHF), diabetes mellitus or renal impairment. See Table 1 for list of FDA approved
indications
Table 2: FDA Approved Indications
HTN Heart Failure
Accupril
Aceon
Altace
Capoten
Lotensin
Mavik
Monopril
Univasc
Vasotec
Zestril
♥
X
X
X
X
X
X
X
X
X
X
Myocardial
Infarction
Left Ventricular
Dysfunction
Diabetic
Neuropathy
X♥
X
X
X♥
X♥
X
X♥
X
X
X
X
Post MI
Guideline(s):
I.
Aceon or Mavik will be approved based on one of the following criteria:
A.
As continuation of therapy
-OR-
B.
Contraindication, intolerance or history of failure to at least one (1) formulary agent
Contraindications:
•
Angioedema with previous ACE inhibitor: ACE inhibitors are contraindicated in patients with
history of angioedema related to previous treatment with an ACE inhibitor.
•
Pregnancy: ACE inhibitors are contraindicated in pregnancy. (Category C first trimester, and
Category D second and third trimesters). When pregnancy is detected, discontinue the ACE
inhibitor as soon as possible.
Warnings:
•
Neutropenia/agranulocytosis has been associated with the use of Captopril, and rarely with
enalapril or lisinopril, and in one patient on quinapril. Most cases are reversible upon withdrawl
of the drug, however, fatalties have resulted in patients with pre-existing serious illness such as
collagen vascular disease, renal failure, heart failure, or immunosuppressant therapy.
•
Angioedema has occurred in patients treated with ACE inhibitors. It may occur at any time
during treatment. Angioedema associated with laryngeal edema may be fatal. Patients with
history of angioedema unrelated to ACE inhibitor therapy may be at increased risk. Black
patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of
angioedema than non-blacks.
•
Proteinuria of >1 gm urinary proteins/day has been associated with captopril, (0.7% of patients).
Nephrotic syndrome occuredd in 20% of cases. In most cases, proteinuria cleared within 6
months, regardless if captopril was continued.
•
Hypotension: ACE inhibitors may cause a profound fall in blood pressure following the first
dose, especially in patients who are salt/volume depleted or treated with diuretics.
•
Renal Function Impairment: Increases in BUN and serum creatinine have been reported in
hypertensives with unilateral or bilateral renal artery stenosis in 20% of patients on enalapril.
Twenty percent of patients on long-term captopril therapy with heart failure develop stable
elevations in BUN and creatinine of >20% from baseline.
•
Hepatic Function Impairment: Rarely ACE inhibitors have been associated with a syndrome of
cholestatic jaundice progressing to fulminant hepatic necrosis and possible death. Patients who
develop jaundice or marked elevations in liver enzymes should discontinue the ACE inhibitor
therapy.
•
Lactation: Do not administer trandolapril (Mavik®) or ramipril (Altace®) to nursing mothers. It
is not know if lisinopril (Zestril®) or moexipril (Univasc®) is excreted in breast milk.
•
Children: Safety and efficacy have not been established. However, there is limited experience
with Captopril in children. Dosage, on a weight basis, is comparable to or less than that used in
adults.
Dosing Recommendation(s):
Comparative Dosing for hypertension
Medication
Accupril
Aceon
Initial Dose∗
10 mg QD
4 mg QD
Dosage Range∗
10-80 mg/day
4-8 mg/day
Altace
Capoten
Lotensin
Mavik
Monopril
Univasc
Vasotec
Zestril
2.5 mg QD
25 mg BID/TID
10 mg QD
1 mg QD
10 mg QD
7.5 mg QD
5 mg QD
10 mg QD
2.5-20 mg/day
25-150 mg BID/TID
10-80 mg/day
2-4 mg/day
10-80 mg/day
7.5-30 mg/day
10-40 mg/day
10-80 mg/day
∗
Dosing recommendations are for treatment of hypertension in patients with normal renal function not
receiving a diuretic. For patients on a diuretic, start with half the recommended initial dose.
Comparative Dosing for CHF
Medication
Accupril
Altace
Capoten
Monopril
Vasotec
Zestril
Initial Dose
5 mg BID
2.5mg BID
25 mg TID♦
10 mg QD
2.5 mg QD/BID
5 mg QD
Dosage Range
10-40 mg/day
1.25mg-5 mg/day
150-450 mg/day
20-40 mg/day
10-40 mg/day
5-20 mg/day
♦
Lower doses (6.25 to 12.5 milligrams 3 times daily) may minimize the hypotensive effect in patients
with normal or low blood pressure and those who may be hyponatremic and/or hypovolemic (Packer &
Cohn, 1999; Prod Info Capoten(R), 2000; Lang et al, 1994.
Table 3 : RENAL IMPAIRMENT DOSAGE RECOMMENDATIONS
DRUG
CrCl
Initial Dose
Recommended
> 75 mL/min
25 mg
Capoten (Captopril)
35 - 75 mL/min.
25 mg
20 - 34 mL/min
25 mg
8 - 19 mL/min
25 mg
5 - 7 mL/min
25 mg
> 60 mL/min.
10 mg
Lotensin (Benazepril)
30 - 60 mL/min
10 mg
10 - 30 mL/min
5 mg
< 10
5 mg
3.75 mg
Univasc (Moexipril)
≤ 40 mL/min

> 30 mL/min
10 mg
Zestril (Lisinopril)
10 - 30 mL/min
5 mg
< 10 mL/min
2.5 mg
Interval
q8h
q12h to q24h
q24h to q48h
q48h to q72h
q72 to q108h
q24h
q24h
q24h
q24h
q24h
q24h
q24h
q24h
References:
1. Micromedex Inc.,2001.
2. Drug Facts and Comparisons, February 2001.
3. AHFS Drug Information, 2001.
4. The HOPE study investigators, Effects of an angiotensin coverting-enzyme inhibitor, ramipril, on
cardiovascular events in high risk patients. NEJM 2000;342:145-153.
5. Heel RC, Brogden RN, Speight TM et al: Captopril: a preliminary review of its pharmacological properties
and therapeutic efficacy. Drugs 1980; 20:409-452.
6. Sica DA, Gehr TWB & Fernandez A: Risk-benefit ratio of angiotensin antagonists versus ACE inhibitors in
end-stage renal disease. Drug Saf 2000; 22(5):350-360.
7.
8.
9.
10.
Zestril (lisinopril), Product info AstraZeneca, February 2000.
Univasc (moexipril), Product info Schwarz, February 2000.
Lotensin (benzepril), Product info Novartis, May 2000.
Capoten (captopril), Product info Bristol-Myers Squibb, 9/2000.
This Prior Authorization Guideline represents the recommendation of Prescription Solutions’ Pharmacy and Therapeutics (P&T)
Committee. It is based upon the P&T Committee’s review of the available evidence as of the date of drafting or revision of this Prior
Authorization Guideline. It is subject to updating from time to time, based upon changes in scientific knowledge and information.
This Prior Authorization Guideline is intended as a resource for making coverage decisions for Health Plan members, but it does not
replace an individualized case-by-case review and medical necessity determination for each Health Plan member.
Copyright © 2005 by Prescription Solutions. All rights reserved. This Prior Authorization Guideline is intended for use by Prescription
Solutions and Health Plan employees and applicable contracted providers and practitioners only. The information contained in this Prior
Authorization Guideline is confidential and proprietary to Prescription Solutions and shall not be used, reproduced, or transferred in whole
or in part without Prescription Solutions’ prior written consent.