Prior Authorization Guideline - OptumRx

Guideline: CSD - Estrasorb, EstrogelPrior Authorization GuidelineTherapeutic Class: Endocrine/MetabolicAgentsTherapeutic Sub-Class: Estradiol TopicalClient: County of San DiegoApproval Date: 10/4/2004 Revision Date: 10/1/2005Non-formulary ProductEstrasorb® (estradiol topical emulsion)EstroGel® (estradiol gel)Formulary ProductOralEstrace® tablet (estradiol tablet)Estratab® (esterified estrogen)Menest® (estrogen, esterified)Ogen® (estropipate)Ortho-Est® (estropipate)Premarin® (conjugated estrogen)TransdermalAlora® (estradiol transdermal patch)Estraderm® (estradiol patch)Vivelle® (estradiol transdermal patch)Vivelle-Dot® (estradiol transdermal patch)Indication(s):VaginalPremarin® Vaginal Cream (conjugatedestrogen)Estrace® (estradiol) Vaginal Cream (estradiol)Estrasorb ® and EstroGel ® are indicated for the treatment of moderate to severe vasomotorsymptoms associated with menopause.EstroGel ® is also indicated for the treatment of moderate to severe symptoms of vulvar and vaginalatrophy associated with menopause. When prescribing solely for the treatment of symptoms ofvulvar and vaginal atrophy, topical vaginal products should be considered.Guideline(s):I. Estrasorb ® will be approved based on one of the following criteria:A. Failure or intolerance to formulary oral estrogen products: Estrace ® ,Estratab ® , Menest ® , Ogen ® , Ortho-Est ® , or Premarin ®-OR-B. Failure, intolerance, or problems with adhesive to formulary transdermal

estrogen products: Alora ® , Estraderm ® , Vivelle ® or Vivelle-Dot ®II.EstroGel ® will be approved based on one of the following criteria:A. Failure or intolerance to formulary oral estrogen products: Estrace ® , Estratab ® ,Menest ® , Ogen ® , Ortho-Est ® , or Premarin ®-OR-B. Failure, intolerance, or problems with adhesive to formulary transdermalestrogen products: Alora ® , Estraderm ® , Vivelle ® or Vivelle-Dot ®-OR-C. Failure or intolerance to one of the following formulary vaginal estrogen creamsfor vulvar and vaginal atrophy: Premarin ® Vaginal Cream or Estrace ® VaginalCream.Contraindications and Warnings:WARNINGESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER.Close clinical surveillance of all women taking estrogens is important. Adequate diagnosticmeasures, including endometrial sampling when indicated, should be undertaken to rule outmalignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding.There is currently no evidence that the use of “natural” estrogens results in a differentendometrial risk profile than synthetic estrogens at equivalent estrogen dose.CARDIOVASCULAR AND OTHER RISKSEstrogens with or without progestins should not be used for the prevention ofcardiovascular disease.The Women’s Health Initiative (WHI) study reported increased risks of myocardialinfarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis inpostmenopausal women during 5 years of treatment with conjugated equine estrogens(0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo.Other doses of conjugated estrogens and medroxyprogesterone acetate, and othercombinations of estrogens and progestins were not studied in the WHI and, in the absenceof comparable data, these risks should be assumed to be similar. Because of these risks,estrogens with or without progestins should be prescribed at the lowest effective doses andfor the shortest duration consistent with treatment goals and risks for the individual woman.Dosing Recommendation(s):Estrasorb ®Dose:3.48 grams daily (two 1.74 gram pouches daily)Apply one pouch per leg. Rub emulsion into entire thigh and left calf forthree minutes until thoroughly absorbed. Rub any excess materialremaining on both hands on the buttocks.

How Supplied:Estrasorb ® is packaged in foil-laminated pouches. A daily dose ofEstrasorb ® is two-foil laminated pouches. Each pouch contains 1.74grams. Each 1.74-gram pouch contains 4.35mg of estradiol hemihydrate.Each box of Estrasorb contains fourteen 1.74-gram, pouches, packaged in a1-month supply of 56 pouches.EstroGel ®Dose:How Supplied:1.25 grams dailyPrime the pump before first time use. Apply at the same time each day.Apply the gel to one arm. Spread the gel as thinly as possible over theentire area on the inside and outside of arm from wrist to shoulder.EstroGel ® is a clear, colorless, hydroalcoholic 0.06% estradiol gel suppliedin a non-aerosol metered-dose pump. Each individually packaged pumpcontains 93 grams of gel and is capable of delivering 64 metered 1.25 gdoses.References:1. Estrasorb ® Prescribing Information, Novavax, Inc., October 2003.2. EstroGel® Prescribing Information, Solvay Pharmaceuticals Inc., March 2004.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 PriorAuthorization 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 notreplace 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 PrescriptionSolutions and Health Plan employees and applicable contracted providers and practitioners only. The information contained in thisPrior Authorization Guideline is confidential and proprietary to Prescription Solutions and shall not be used, reproduced, or transferredin whole or in part without Prescription Solutions’ prior written consent.