Subject: Hormone Replacement (oral estrogens-combinations)

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	estradiol
C	estropipate
C	Gynodiol® (estradiol)
C	Ortho-est®(estropipate)
C	Premarin®  (conjugated estrogens)
C	Premphase®  (conjugated estrogens- mpa)
C	Prempro®  (conjugated estrogens- mpa)
NC	Activella®  (estradiol & norethindrone acetate)						X
NC	Angeliq®  (estradiol & drospirenone)						X
NC	Cenestin®  (synthetic conjugated estrogens)						X
NC	Enjuvia®  (synthetic conjugated estrogens)						X
NC	Estrace®  (estradiol)						X
NC	FemHRT®  (norethindrone acetate-ethinyl estradiol)						X
NC	FemHRT low®  (norethindrone acetate-ethinyl estradiol)						X
NC	Femtrace®  (estradiol)						X
NC	Menest®  (esterified estrogens)						X
NC	Ogen®  (estropipate)						X
NC	Prefest®  (estradiol-norgestimate)						X

Policy:

1. Precertification Criteria


 

2. Medical Exception Criteria

Activella, Angeliq, Cenestin, Enjuvia, Estrace, FemHRT, FemHRT low, Femtrace, Menest, Ogen, and Prefest currently are Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Activella, Angeliq, Cenestin, Enjuvia, Estrace, FemHRT, FemHRT low, Femtrace, lowMenest, Ogen, Prefest, to be medically necessary for those members who meet the following criteria:

A. A documented

• Contraindication to one covered alternative agent indicated for the member's condition OR
• Intolerance to one covered alternative agent indicated for the member's condition OR
• Allergy to one covered alternative agent indicated for the member's condition OR
• Failure of an adequate trial of one month of one covered alternative agent indicated for the member's condition
  

Place of Service:

Outpatient

The above policy is based on the following references:

1. Product Information Insert Gynodiol® Tablets, Fielding Pharmaceutical Company St Louis, MO. January 1999.
2. Product Information Insert. Cenestin® Tablets Duramed Pharmaceuticals, Cincinnati, OH 2003.
3. Product Information Insert. Estrace® Tablets and cream, Bristol-Myers Squibb Company, Princeton, NJ May 1999.
4. Product Information Insert. Menest® Tablet Monarch Pharmaceuticals, Bristol, TN 1999.
5. Product Information Insert. Premarin® Tablets, Wyeth-Ayerst Laboratories, Philadelphia, PA. April 2004
6. Thomson Micromedex USPDI; Estrogens-Progestins: (CD-ROM electronic library updated quarterly). Montvale, NJ. 2002.
7. McEvoy GK, editor. American Hospital Formulary Service First Professional Edition (online updated). Bethesda, Maryland 2003
8. Thomson Physicians Desk Reference; (online updated). Montvale, NJ. 2003.
9. Abramowicz M, ed. Hormone Replacement Therapy. The Medical Letter on Drugs and Therapeutics. 2002; 44(1138): 78.
10. 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
11. Hulley S Noncardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study follow-up (HERS II).JAMAJul-2002; 288(1): 58-66.
12. Hlatky MA Quality-of-life and depressive symptoms in postmenopausal women after receiving hormone therapy: results from the Heart and Estrogen/Progestin Replacement Study (HERS) trial. JAMA Feb-2002; 287(5): 591-7.
13. FDA Talk Paper: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01210.html  FDA Revises Findings on Estrogen/Androgen Combination Products in the Treatment of Hot Flashes. April 10,2003
14. Michels, Karin, B; Manson JoAnne, Editorial: Postmenopausal Hormone Therapy: A Reversal of Fortune. Circulation 2003; 107:1830-1833.
15. Hays, Jennifer , Ockene, Judith, et.al. Effects of Estrogen plus Progestin on Health-Related Quality of Life. The New England Journal of Medicine. (not yet published) May 8 2003; 348(19).
16. 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
17. The North American Menopause Society. Report from the NAMS Advisory Panel on Postmenopausal Hormonal Therapy. Available at www.menopause.org/news.html/#advisory. Published Oct 2002.
18. American Heart Association. Q&A About Hormone Replacement Therapy. Available at http://216.185.112.5/presenter.jhtml?identifier=3004068 Published October 2002.
19. Sadovsky R. Recent analysis of hormone replacment therapy. Available at: www.aafp.org/afp/20000101/tips/17.html. Published June 2002.
20. WHI Findings Summary Estrogen plus Progestin Effects on Bone Density and the Risk of Fractures found http://www.whi.org/findings/summary_bone.asp JAMA 290(13)October  2003, 1729-1738.
21. American Association of Clinical Endocrinologists (AACE) www.aace.com
22. The Endocrine Society www.endo-society.org
23. The Pink Sheet Premarin WHI Results May Mean Additional Labeling Changes, FDA Says. . F-D-C Reports, Inc. 2004; March 08; 66 (10) 23.
24. Menopause and Hormone Therapy accessed at  http://www.4woman.gov/menopause/index2.htm March 2004.
25. Women’s Health Initiative Memory Study (WHIMS)  http://www.wfubmc.edu/whims/  accessed March 12,2004.
26. Adam L. Hersh et.al. National Use of Postmenopausal Hormone Therapy Annual Trends and Response to Recent Evidence JAMA. 2004;291:47-53.
27. FDA Updates Hormone Therapy Information for Post Menopausal Women. FDA Press Release.   (Posted 2/10/2004)
28. Stephen B. Hulley and Deborah Grady   The WHI Estrogen-Alone Trial--Do Things Look Any Better JAMA 2004;291 1769-1771.
29. Warren MP. A comparative review of the risks and benefits of hormone replacement therapy regimens. Am J Obstet Gynecol. 2004 Apri; 190(4): 1141-67
30. Fick DM, Cooper JW, Wade WE, et al.  Updating the Beers criteria for potentially inappropriate medication use in older adults.  Arch Intern Med. 2003;163:2716-24.
31. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.

Property of 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.

September 20, 2007