Subject: Contraceptives

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
Monophasic
P	solia- (ethinyl estradiol 30mcg, desogestrel 0.15mg)		X
P	apri-(ethinyl estradiol 30mcg, desogestrel 0.15mg)		X
P	reclipsen- (ethinyl estradiol 30mcg, desogestrel 0.15mg)		X
FE	Desogen®  (ethinyl estradiol 30mcg, desogestrel 0.15mg)		X			X
FE	Ortho-Cept®  (ethinyl estradiol 30mcg, desogestrel 0.15mg)		X			X
FE	ocella-(ethinyl estradiol 30 mcg, drospirenone 3 mg)		X			X
FE	Yasmin®  (ethinyl estradiol 30 mcg, drospirenone 3 mg)		X			X
FE	Demulen 1/35®  (ethinyl estradiol 35mcg, ethynodiol diacetate 1mg)		X			X
P	zovia 1/35- (ethinyl estradiol 35mcg, ethynodiol diacetate 1mg)		X
P	kelnor 1/35- (ethinyl estradiol 35mcg, ethynodiol diacetate 1mg)		X
FE	Demulen 1/50®  (ethinyl estradiol 50mcg,ethynodiol diacetate 1mg)		X			X
P	zovia 1/50- (ethinyl estradiol 50mcg, ethynodiol diacetate 1mg)		X
FE	Levlite®  (ethinyl estradiol 20mcg, levonorgestrel 100mcg)		X			X
P	aviane- (ethinyl estradiol 20mcg, levonorgestrel 100mcg)		X
FE	Alesse®  (ethinyl estradiol 20mcg, levonorgestrel 100mcg)		X			X
P	lutera- (ethinyl estradiol 20mcg, levonorgestrel 100mcg)		X
P	lessina- (ethinyl estradiol 20mcg, levonorgestrel 100mcg)		X
P	spronyx- (ethinyl estradiol 20mcg, levonorgestrel 100mcg)		X
FE	Levlen®  (ethinyl estradiol 30mcg, levonorgestrel 0.15mg)		X			X
FE	Nordette®  (ethinyl estradiol 30mcg, levonorgestrel 0.15mg)		X			X
P	levora- (ethinyl estradiol 30mcg, levonorgestrel 0.15mg)		X
P	portia- (ethinyl estradiol 30mcg, levonorgestrel 0.15mg)		X
FE	Ovcon-35®  (ethinyl estradiol 35mcg, norethindrone 0.4mg)		X			X
FE	Balziva  (ethinyl estradiol 35mcg, norethindrone 0.4mg)		X			X
FE	FemCon-35® FE chew  (ethinyl estradiol 35mcg, norethindrone 0.4mg FE chew)		X			X
FE	Modicon®  (ethinyl estradiol 35mcg, norethindrone 0.5mg)		X			X
FE	Brevicon®  (ethinyl estradiol 35mcg, norethindrone 0.5mg)		X			X
P	necon .5/35- (ethinyl estradiol 35mcg, norethindrone 0.5mg)		X
P	nortrel .5/35- (ethinyl estradiol 35mcg, norethindrone 0.5mg)		X
FE	Ortho Novum 1-35®  (ethinyl estradiol 35mcg, norethindrone 1 mg)		X			X
FE	Norinyl 1-35®  (ethinyl estradiol 35mcg, norethindrone 1 mg)		X			X
P	necon 1-35- (ethinyl estradiol 35mcg, norethindrone 1 mg)		X
P	nortrel 1-35 - (ethinyl estradiol 35mcg, norethindrone 1 mg)		X
FE	Ovcon-50®  (ethinyl estradiol 50mcg, norethindrone 1mg)		X			X
FE	Loestrin 1-20®  (ethinyl estradiol 20mcg, norethindrone acetate 1mg)		X			X
P	microgestin 1-20- (ethinyl estradiol 20mcg, norethindrone acetate 1mg)		X
P	junel 1/20- (ethinyl estradiol 20mcg, norethindrone acetate 1mg)		X
FE	Loestrin 1.5-30®  (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg)		X			X
P	microgestin 1.5-30- (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg)		X
P	junel 1.5/30- (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg)		X
FE	Ortho-Novum 1-50®  (mestranol 50mcg, norethindrone 1mg)		X			X
P	necon 1-50- (mestranol 50mcg, norethindrone 1mg)		X
FE	Norinyl 1-50®  (mestranol 50mcg, norethindrone 1mg)		X			X
P	low-ogestrel- (ethinyl estradiol 30mcg, norgestrel 0.3mg)		X
FE	Lo-Ovral®  (ethinyl estradiol 30mcg, norgestrel 0.3mg)		X			X
P	cryselle- (ethinyl estradiol 30mcg, norgestrel 0.3mg)		X
P	ogestrel- (ethinyl estradiol 50mcg,norgestrel 0.5mg)		X
FE	Ovral®  (ethinyl estradiol 50mcg,norgestrel 0.5mg)		X			X
FE	Ortho-Cyclen®  (ethinyl estradiol 35mcg, norgestimate 0.25mg)		X			X
P	sprintec- (ethinyl estradiol 35mcg, norgestimate 0.25mg)		X
P	mononessa-(ethinyl estradiol 35mcg, norgestimate 0.25mg)		X
P	previfem-(ethinyl estradiol 35mcg, norgestimate 0.25mg)		X
FE	Loestrin FE 1-20®  (ethinyl estradiol 20mcg, norethindrone acetate 1mg + ferrous fumarate 75mg)		X			X
P	microgestin FE 1-20- (ethinyl estradiol 20mcg, norethindrone acetate 1mg + ferrous fumarate 75mg)		X
P	junel FE 1/20- (ethinyl estradiol 20mcg, norethindrone acetate 1mg + ferrous fumarate 75mg)		X
P	glidess FE 1/20 - (ethinyl estradiol 20mcg, norethindrone acetate 1mg + ferrous fumarate 75mg)		X
FE	Loestrin FE 1.5-30®  (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg + ferrous fumarate 75mg)		X			X
P	microgestin FE 1.5-30- (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg + ferrous fumarate 75mg)		X
P	junel FE 1.5-30- (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg + ferrous fumarate 75mg)		X
P	glidess FE 1.5-30 (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg + ferrous fumarate 75mg)		X
Biphasic
P	kariva (I.ethiny estradiol 20mcg and desogestrel 0.15mg (21d) ;II.ethinyl estradiol 10mcg (5d)		X
FE	Mircette®  (I.ethinyl estradiol 20mcg and desogestrel 0.15mg (21d);II.ethinyl estradiol 10mcg (5d))		X			X
P	necon 10/11 (I. ethinyl estradiol 35mcg, norethindrone 0.5mg; II. ethinyl estradiol 35mcg, norethindrone 1mg)		X
FE	Ortho Novum 10/11®  (I. ethinyl estradiol 35mcg, norethindrone 0.5mg; II. ethinyl estradiol 35mcg, norethindrone 1mg)		X			X
Triphasic
P	cesia- I.ethinyl estradiol 25 mcg, desogestrel 0.100 mg II. ethinyl estradiol 25 mcg, desogestrel 0.125 mg III. ethinyl estradiol 25 mcg, desogestrel 0.150 mg		X
P	velivet- I.ethinyl estradiol 25 mcg, desogestrel 0.100 mg II. ethinyl estradiol 25 mcg, desogestrel 0.125 mg III. ethinyl estradiol 25 mcg, desogestrel 0.150 mg		X
P	trivora (I.ethinyl estradiol 30mcg, levonorgestrel 0.05mg, II. ethinyl estradiol 40mcg, levonorgestrel 0.075mg, III. ethinyl estradiol 30 mcg, levonorgestrel 0.125mg)		X
FE	Cyclessa®  (I.ethinyl estradiol 25 mcg, desogestrel 0.100 mg II. ethinyl estradiol 25 mcg, desogestrel 0.125 mg III. ethinyl estradiol 25 mcg, desogestrel 0.150 mg®)		X			X
P	enpresse (I.ethinyl estradiol 30mcg, levonorgestrel 0.05mg, II. ethinyl estradiol 40mcg, levonorgestrel 0.075mg, III. ethinyl estradiol 30 mcg, levonorgestrel 0.125mg)		X
FE	Triphasil®  (I.ethinyl estradiol 30mcg, levonorgestrel 0.05mg, II. ethinyl estradiol 40mcg, levonorgestrel 0.075mg, III. ethinyl estradiol 30 mcg, levonorgestrel 0.125mg)		X			X
FE	Tri-levlen®  (I.ethinyl estradiol 30mcg, levonorgestrel 0.05mg, II. ethinyl estradiol 40mcg, levonorgestrel 0.075mg, III. ethinyl estradiol 30 mcg, levonorgestrel 0.125mg)		X			X
P	necon 7-7-7- I.ethinyl estradiol 35mcg, norethindrone 0.5mg; II.ethinyl estradiol 35mcg, norethindrone 0.75mg; III. ethinyl estradiol 35mcg, norethindrone 1mg		X
P	nortrel 7-7-7- I.ethinyl estradiol 35mcg, norethindrone 0.5mg; II.ethinyl estradiol 35mcg, norethindrone 0.75mg; III. ethinyl estradiol 35mcg, norethindrone 1mg		X
FE	Ortho Novum 7-7-7®  (I.ethinyl estradiol 35mcg, norethindrone 0.5mg; II.ethinyl estradiol 35mcg, norethindrone 0.75mg; III. ethinyl estradiol 35mcg, norethindrone 1mg)		X			X
FE	Tri-Norinyl®  (I. ethinyl estradiol 35mcg, norethindrone 0.5mg; II ethinyl estradiol 35mcg, norethindrone 1mg; III ethinyl estradiol 35mcg, norethindrone 0.5mg)		X
P	aranelle- I. ethinyl estradiol 35mcg, norethindrone 0.5mg; II ethinyl estradiol 35mcg, norethindrone 1mg; III ethinyl estradiol 35mcg, norethindrone 0.5mg
P	leena- I. ethinyl estradiol 35mcg, norethindrone 0.5mg; II ethinyl estradiol 35mcg, norethindrone 1mg; III ethinyl estradiol 35mcg, norethindrone 0.5mg		X
P	tri-previfem- I. ethinyl estradiol 35mcg, norgestimate 0.18mg; II. ethinyl estradiol 35mcg, norgestimate 0.215mg; III. ethinyl estradiol 35mcg, norgestimate 0.25mg		X
P	trinessa- I. ethinyl estradiol 35mcg, norgestimate 0.18mg; II. ethinyl estradiol 35mcg, norgestimate 0.215mg; III. ethinyl estradiol 35mcg, norgestimate 0.25mg		X
P	tri-sprintec- I. ethinyl estradiol 35mcg, norgestimate 0.18mg; II. ethinyl estradiol 35mcg, norgestimate 0.215mg; III. ethinyl estradiol 35mcg, norgestimate 0.25mg		X
FE	Ortho-Tri-Cyclen®  (I. ethinyl estradiol 35mcg, norgestimate 0.18mg; II. ethinyl estradiol 35mcg, norgestimate 0.215mg; III. ethinyl estradiol 35mcg, norgestimate 0.25mg)		X			X
FE	Ortho Tri-Cyclen Lo®  (I. ethinyl estradiol 25mcg, norgestimate 0.18mg; II. ethinyl estradiol 25mcg, norgestimate 0.215mg; III. ethinyl estradiol 25mcg, norgestimate 0.25mg)		X			X
FE	tri-lo-sprintec (I. ethinyl estradiol 25mcg, norgestimate 0.18mg; II. ethinyl estradiol 25mcg, norgestimate 0.215mg; III. ethinyl estradiol 25mcg, norgestimate 0.25mg)		X
FE	Estrostep/Estrostep FE®  (I. ethinyl estradiol 20mcg, norethindrone acetate 1mg; II; ethinyl estradiol 30mcg, norethindrone acetate 1mg; III. ethinyl estradiol 35mcg, norethindrone acetate 1mg)		X			X
Extended Cycle
FE	Yaz 24/4®  (ethinyl estradiol 20 mcg drospirenone3 mg x 24 days; Placebo X 4 days)		X			X
P	Lybrel®  ((ethinyl estradiol 20mg, levonorgestrel 90mcg X 28 days -continuous cycle))
FE	Loestrin FE 24/4®  ((ethinyl estradiol 20mcg, norethindrone acetate 1 mg x 24 days + ferrous fumarate 75mg x 4 days))		X			X
FE	LoSeasonique®  (Levonorgestrel-0.1 mg Ethinyl Estradiol 20 mcg x 84 days; EE- 10 mcg x 7 days )		X
FE	Seasonale®  ([levonorgestrel-0.15 mg; Ethinyl Estradiol 30 mcg x 84 days; Placebo x 7 days (91 days)])					X
P	Quasense- [levonorgestrel-0.15 mg; Ethinyl Estradiol 30 mcg x 84 days; Placebo x 7 days (91 days)]
P	Jolessa- [levonorgestrel-0.15 mg; Ethinyl Estradiol 30 mcg x 84 days; Placebo x 7 days (91 days)]
P	Seasonique®  (levonorgestrel-0.15 mg Ethinyl Estradiol 30 mcg x 84 days; EE- 10 mcg x 7 days (91-Day))
Progestin Only
P	camila- (norethindrone 0.35mg)
P	errin- (norethindrone 0.35mg)
P	jolivette- (norethindrone 0.35mg)
P	nora-be- (norethindrone 0.35mg)
FE	Ortho-Micronor®  (norethindrone 0.35mg)					X
FE	Nor-QD®  (norethindrone 0.35mg)					X
Emergency Contraceptives
NP	Plan B®  (levonorgestrel 0.75 mg)
P	Next Choice
NP	Plan B®  (levonorgestrel 1.5 mg)
Vaginal Ring Contraceptives
FE	NuvaRing®  (etonogestrel 0.12mg/day, ethinyl estradiol 0.015 mg/day)					X
Transdermal Contraceptives
FE	Ortho-Evra-3-pack only®  (norelgestromin 0.15mg/day, ethinyl estradiol 0.02mg/day)					X
Note: Plan B is considered a COC exclusion for female members 17 years of age and older.

Policy:

Aetna covers contraceptives where mandated by law, in certain non-HMO plans, and under our contraceptives option to the pharmacy rider. Unless otherwise required by law and if covered as indicated above, Aetna will cover contraceptives in accordance with the criteria below.

Pharmacy Benefit Plans with Contraceptive coverage:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, oral contraceptives (except for Quasense, Jolessa, Lybrel and Seasonale, Seasonique) indicated in the table above are subject to precertification quantity limits.

Manufacturer oral contraceptive package inserts recommend 1 tablet containing a combination of hormones be taken per day for 21 days; no tablets are taken for 7 days or 7 inert or iron-containing tablets are taken or 24 days of a combination of hormones be taken per day with 4 iron or placebo -containing tablets or 28 days of continuous combination of hormones be taken to permit continuous daily dosage during the entire 28-day cycle for maximum contraceptive efficacy. A quantity limit of 1.4 tablets per day for 28-day supply will be considered medically necessary for oral contraceptives


2. Medical Exception Criteria

Certain contraceptives are currently included on the Aetna Formulary Exclusions List (see list above). Therefore, these Formulary Excluded contraceptives are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is obtained. Aetna considers the Formulary Excluded oral contraceptives to be medically necessary for members who meet ANY of the following criteria:

A. A documented:

• Contraindication to one preferred alternative from the same subcategory (see table above) OR,
• Intolerance to one preferred alternative from the same subcategory (see table above) OR
• Failure of an adequate trial of three months of one preferred alternative contraceptive when using for the treatment of hirsutism or dysfunctional uterine bleeding /improving cycle control (for ocella, Yaz, Yasmin only) OR
• Failure of an adequate trial of one month of one preferred alternative contraceptive when using for the treatment of acne resistant to other treatments (for ocella, Yaz, Yasmin only)

Pharmacy Benefit Plans without Contraceptive coverage:
Medical Necessity Review

Based on available clinical literature, contraceptives may be considered medically necessary for any of the following documented conditions:

• Acne, recalcitrant (resistant to treatment)
• Amenorrhea (absence of menstruation)
• Dysfunctional uterine bleeding (DUB) is characterized by abnormal uterine bleeding in pattern, frequency, regularity or quantity and can include:
  • Hypermenorrhea: cycles regular and menses of normal duration, but blood loss excessive (>80mL per cycle)
  • Menorrhagia: interval normal but duration and flow excessive
  • Metrorrhagia: interval irregular, duration and flow excessive
  • Menometrorrhagia: interval irregular, duration and flow excessive and intermenstrual bleeding
  • Oligomenorrhea: interval >35 days, normal flow
  • Polymenorrhea: interval <21 days, normal flow
  • Hypomenorrhea: cycles regular, but blood loss abnormally decreased
• Dysmenorrhea (painful or difficult menstruation)
• Endometriosis
• Hirsutism secondary to ovarian dysfunction (excessive hairiness)
• Polycystic ovary syndrome (many cysts on the ovary/cystic ovaries)
• Perimenopausal symptoms - hormone replacement for menopause
  
  

Note: Aetna does not cover contraceptives for treatment of headaches or
premenstrual syndrome (PMS), except as noted above.

Note: Plan B is considered a COC exclusion for female members 17 years of age and older .

Place of Service:

Outpatient

The above policy is based on the following references:

1. Goldman: Cecil Textbook of Medicine, 21st ed. 2000 W.B. Saunders pg 1342.
2. Rakel: Conn’s Current Therapy 2000, 52nd edition.
3. The Medical Letter, Vol. 42 (Issue 1070) January 24, 2000: 10.
4. Rosenberg M. Current Issues in Oral Contraceptive Therapy: Causes and Consequences of Oral Contraceptive Noncompliance. The American Journal of Obstetrics and Gynecology. 1999; 180: 6-9.
5. Gold, MA. Adolescent Gynecology, Part II: The Sexually Active Adolescent: Prescribing and Managing Oral Contraceptive Pills and Emergency Contraception for Adolescents. Pediatric Clinics of North America, August 1999; 46(4): 696-719.
6. Derman RJ. An overview of the noncontraceptive benefits and risks of oral contraception. Int J Fertil 1992;37 Suppl 1:19-26
7. Stergachis A. Epidemiology of the noncontraceptive effects of oral contraceptives. Am J Obstet Gynecol 1992;167:1165-70.
8. Weisberg E. Prescribing oral contraceptives. Drugs 1995; 49 (2): 224-31.
9. Shaw JC. Antiandrogen therapy in dermatology. Int J Dermatol 1996; 35 (11): 770-778.
10. Ruggiero RJ. Contraception. In: Young LY, Koda-Kimble MA, eds. Applied Therapeutics: The Clinical Use of Drugs, 6th edition. Vancouver: Applied Therapeutics, Inc, 1995.
11. Darney PD. OC practice guidelines: minimizing side effects. Int J Fertil 1997; 42 (Suppl 1):158-169.
12. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
13. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
14. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
15. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
16. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically
17. Duramed Pharmaceuticals (Barr Laboratories). Seasonale (ethinyl estradiol 0.03 mg and levonorgestrel 0.15 mg) prescribing information. Available online at: http://www.seasonale.com. (Accessed November 2003).
18. Product Information accessed at http://seasonique.com/ August 3, 2006.
19. Product Information Ovcon-35 chew.  Warner Chilcott. Nov 14, 2003.
20.  FDA information on Plan B accessed 9-22-06 at http://www.fda.gov/CDER/drug/infopage/planB/default.htm
21. Product information for YAZ. Berlex, Inc. Monteville, NJ 07045. March 2006.
22. Product information for Loestrin-24 Fe. Warner-Chilcott (US), Inc. Rockaway, NJ 07866. February 2006
23. Product information for Lybrel™ accessed 6-19-07  at http://www.wyeth.com/content/showlabeling.asp?id=489
24. Product information for LoSeasonique® accessed 3-20-09 at http://www.fda.gov/cder/foi/label/2008/022262lbl.pdf.

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.

August 21, 2009