Prior Authorization Guideline Guideline: MEDPD - Altace (SPAP) Therapeutic Class: Cardiovascular Agents Therapeutic Sub-Class: ReninAngiotensin-Aldosterone System Inhibitors (ACE Inhibitors) Client: PDP SPAP Approval Date: 5/17/2005 Revision Date: 12/12/2005 Formulary Products Tier 1 Capoten (Captopril) 1 Lotensin (Benazepril) 1 Vasotec (Enalapril) 1 Zestril (Lisinopril) 1 Tier 2 Univasc (Moexipril) Tier 3 Altace (Ramipril) 2 1 2 Generic is formulary Subject to Prior Authorization FDA Approved Indication(s): Hypertension Altace® is indicated for the treatment of hypertension. It may be used alone or in combination with thiaziade diuretics. Heart Failure Post Myocardial Infarction Altace® is indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of Altace® to such patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risks of failure-related hospitalization and progression to severe/resistant heart failure. Reduction in Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes Altace is indicated in patients 55 years or older at high risk of developing major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented micoralbuminuria), to reduce the risk of myocardial infarction, stroke or death from cardiovascular causes. Altace can be used in addition to other needed treatment (such as antihypertensive, antiplatelet, or lipid-lowering therapy). Guideline(s): I. For Treatment of Hypertension or Heart Failure 1. Altace® will be approved based on the following criterion: 1. II. Contraindication, intolerance or history of failure to at least two (2) of the following: Benazepril, Captopril, Enalapril, Lisinopril, or Univasc®. For Prevention of Cardiovascular Events A. Altace will be approved based upon the following criteria: 1. Documented risk profile as demonstrated by one of the following: 1. 2. 3. d. Coronary artery disease (CAD) History of stroke History of peripheral vascular disease (PVD) Diabetes Contraindications: Black Box Warning: When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, Altace® should be discontinued as soon as possible. Altace® is contraindicated in patients who are hypersensitive to this product or any other angiotensin converting enzyme inhibitor (e.g. patient who has experienced angioedema during therapy with any other ACE inhibitor). Angioedema: 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: 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. Dosing Recommendation(s): Altace Hypertension Initial Dose: Dose range: Heart Failure Post MI Initial Dose and Target Dose: 2.5 mg once daily (if not receiving a diuretic) 2.5 to 20 mg once daily or in two equally divided doses 2.5 mg twice daily (5 mg per day) Reduction in Risk of MI, Stroke, and Death from CV Causes Initial Dose: 2.5 mg once daily. Maintenance dose: Start with 2.5 mg once daily for 1 week, 5 mg once daily for the next 3 weeks, and then increased as tolerated to a maintenance dose of 10mg once daily. May be given in divided doses. Table 1 : Dosage Adjustment in Renal Impairment (CrCl < 40 ml/min) Initial Dose Maximum Dose Hypertension 1.25 mg daily 5 mg daily Heart Failure Post MI 1.25 mg daily 2.5 mg twice daily References: 1. Altace® Prescribing Information, Monarch Pharmaceuticals, Inc., September 2004. 2. Chobanian AV, Bakris GL, Black HR, et al, and the National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003;289:2560-2572. 3. Yusuf S et al. Effects of an angiotensin coverting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N Eng J Med 2000;342(3):145-153. 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.