Subject: Hormone Replacement (oral estrogens-combinations)

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

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Cenestin, Enjuvia, estropipiate, FemHRT, FemHRT low, Menest, Ogen, Ortho-est, Premarin, Premphase and Prempro are subject to precertification for members greater than or equal to 65 years of age.  Aetna considers to be medically necessary for those members who meet the following precertification criteria: 

A.  A documented:

A.  Member has tried and failed alternative drugs that are appropriate in the elderly to
      treat the condition. OR
B.  Member has been stabilized on the drug for an extended period of time OR
C.  Discontinuation of the drug or change in drug therapy might result in physical and/or
      mental impairment OR
D.  Member is in a critical or terminal state and disruption of therapy would be inappropriate
      OR
E.  It is medically necessary that the member receive the drug AND Member is being 
      monitored AND Member has no known history of emergency department visits and/or hospital
      admissions from use of the drug OR
F.  Member received a prescription for the drug from an emergency room physician or from a
     physician in an acute care setting and will only be using the drug for a short duration of time.

 

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. 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. 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
7. 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.
8. 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.
9. Michels, Karin, B; Manson JoAnne, Editorial: Postmenopausal Hormone Therapy: A Reversal of Fortune. Circulation 2003; 107:1830-1833.
10. Hays, Jennifer , Ockene, Judith, et.al. Effects of Estrogen plus Progestin on Health-Related Quality of Life. The New England Journal of Medicine. May 8 2003; 348(19).
11. 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
12. 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.
13. Adam L. Hersh et.al. National Use of Postmenopausal Hormone Therapy Annual Trends and Response to Recent Evidence JAMA. 2004;291:47-53.
14. Stephen B. Hulley and Deborah Grady   The WHI Estrogen-Alone Trial--Do Things Look Any Better JAMA 2004;291 1769-1771.
15. 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
16. 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.
17. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.

ARCHIVE VERSION

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.

August 06, 2009