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:
Abramowicz M, ed. Hormone Replacement Therapy. The Medical Letter on Drugs and Therapeutics. 2002; 44(1138): 78.
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
Hulley SNoncardiovascular 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.
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.
Michels, Karin, B; Manson JoAnne, Editorial: Postmenopausal Hormone Therapy: A Reversal of Fortune. Circulation 2003; 107:1830-1833.
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).
AmericanCollegeof Obstetricians and Gynecologists. Position Statement to Women’s Health Initiative Study Results by the American College of Obstetricians and Gynecologists. August 9, 2002
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.
WHI Findings SummaryEstrogen plus Progestin Effects on Bone Density and the Risk of Fracturesfound http://www.whi.org/findings/summary_bone.aspJAMA 290(13)October 2003, 1729-1738.
American Association of Clinical Endocrinologists (AACE) www.aace.com
Adam L. Hersh et.al. National Use of Postmenopausal Hormone Therapy Annual Trends and Response to Recent EvidenceJAMA. 2004;291:47-53.
FDA Updates Hormone Therapy Information for Post Menopausal Women. FDA Press Release. (Posted 2/10/2004)
Stephen B. Hulley and Deborah Grady The WHI Estrogen-Alone Trial--Do Things Look Any Better JAMA 2004;291 1769-1771.
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
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.
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.
*C = Covered, copay amount depends on benefits plan
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
§TOC = Transition of Coverage
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.