Under some plans, including plans that use an open or closed formulary, Vivelle, Vivelle-Dot , Estraderm, estradiol, Climara, Alora, Esclim, Menostar, Climara Pro and Combipatch are subject to precertification quantity limits. If precertification quantity limit requirements apply Aetna considers Vivelle, Vivelle-Dot , Estraderm, estradiol, Climara, Alora, Esclim, Climara Pro and Combipatch to be medically necessary for those members who meet the following precertification criteria:
According to the manufacturer, the transdermal hormone replacement agents Vivelle, Vivelle-Dot, Estraderm, estradiol, Climara, Alora, Esclim, Menostar, Climara Pro and Combipatch can be dosed at the interval(s) as indicated in the table(s) below. A quantity of each drug will be considered medically necessary as indicated in the table(s) below:
For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of transdermal hormone replacement agents Vivelle, Vivelle-Dot, Estraderm, estradiol, Climara, Alora, Esclim, Menostar, Climara Pro and Combipatch will be considered medically necessary for those members who meet the following criteria:
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose OR
Member requires a dose that includes half-patch dosing (only matrix patches) (Matrix patches include: Climara, Climara Pro, Vivelle, Vivelle Dot, Fempatch, Menostar, Combipatch, Esclim, Alora)
Infertility:
For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of transdermal hormone replacement agents Vivelle, Vivelle-Dot , Estraderm, estradiol, Climara, Alora, Esclim, Menostar, Climara Pro and Combipatch will be considered medically necessary for those members who meet the following criteria:
Member is being treated for infertility, additional quantities may be approvable if the member's plan covers infertility meds OR
Members diagnosis is gender reassignment, male to female gender change, or hermaphrodism/testicular feminization (characteristics of both sexes exist in same individual) OR
Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
Medical Exception Criteria
Alora, Climara, Elestrin, Esclim, Estraderm, Estrasorb, Estrogel, Menostar, Climara Pro ,Combipatch , Vivelle and Vivelle Dot are currently listed on the Aetna Formulary Exclusions List.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted. Aetna considers Alora, Climara, Elestrin, Esclim, Estraderm, Estrasorb, Estrogel, Menostar, Climara Pro, Combipatch, Vivelle and Vivelle Dot to be medically necessary for those members who meet any of the following criteria:
For Alora, Climara, Elestrin, Esclim, Estraderm, Estrasorb, Estrogel, Menostar, Vivelle and Vivelle Dot
A. A documented:
Contraindication to one preferred transdermal hormone replacement therapy OR
Intolerance to one preferred transdermal hormone replacement therapy OR
Allergy to one preferred transdermal hormone replacement therapy OR
Failure of an adequate trial of 4 weeks of one preferred transdermal hormone replacement therapy
For Climara Pro , Combipatch A. A documented:
Contraindication to one preferred transdermal hormone replacement therapy OR
Intolerance to one preferred transdermal hormone replacement therapy OR
Allergy to one preferred transdermal hormone replacement therapy OR
Failure of an adequate trial of 4 weeks of one preferred transdermal hormone replacement therapy OR
Patient has an intact uterus and has tried a preferred estrogen only transdermal in combination with an oral progestin and is intolerant to the oral progestin.
Place of Service:
Outpatient
The above policy is based on the following references:
1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically
6. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
7. Rossouw JE. Writing Group for the Women’s Health Initiative Investigators. Risks and Benefits of Estrogen Plus Progest in Healthy Postmenopausal Women: Principal Results from the Women’s Health Initiative Randomized Controlled Trial. JAMA. July 2002; 288: 321-333
8. Hulley S Noncardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study follow-up (HERS II). JAMA Jul-2002; 288(1): 58-66.
9. American College of Obstetricians and Gynecologists. Position Statement to Women’s Health Initiative Study Results by the American College of Obstetricians and Gynecologists. August 9, 2002
10. Sare GM, Gray LJ, Bath PM. Association between hormone replacement therapy and subsequent arterial and venous vascular events: a meta-analysis. Eur Heart J. 2008 Jul 3.
11. AACE Menopause Guidelines Revision Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
*P = Preferred
FE = Formulary Excluded
NP = Nonpreferred
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.
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