Subject: Contraceptives

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
Monophasic
P	solia- (ethinyl estradiol 30mcg, desogestrel 0.15mg)
P	apri-(ethinyl estradiol 30mcg, desogestrel 0.15mg)
P	emoquette-(ethinyl estradiol 30mcg, desogestrel 0.15mg)
P	reclipsen- (ethinyl estradiol 30mcg, desogestrel 0.15mg)
FE	Desogen®  (ethinyl estradiol 30mcg, desogestrel 0.15mg)					X
FE	Ortho-Cept®  (ethinyl estradiol 30mcg, desogestrel 0.15mg)					X
FE	ocella-(ethinyl estradiol 30 mcg, drospirenone 3 mg)					X
P	zarah (ethinyl estradiol 30 mcg, drospirenone 3 mg)
FE	Yasmin®  (ethinyl estradiol 30 mcg, drospirenone 3 mg)					X
FE	Safyral™  (ethinyl estradiol 30 mcg, drospirenone 3 mg. levomefolate 0.451 mg)					X
FE	Demulen 1/35®  (ethinyl estradiol 35mcg, ethynodiol diacetate 1mg)					X
P	zovia 1/35- (ethinyl estradiol 35mcg, ethynodiol diacetate 1mg)
P	kelnor 1/35- (ethinyl estradiol 35mcg, ethynodiol diacetate 1mg)
FE	Demulen 1/50®  (ethinyl estradiol 50mcg,ethynodiol diacetate 1mg)					X
P	zovia 1/50- (ethinyl estradiol 50mcg, ethynodiol diacetate 1mg)
P	aviane- (ethinyl estradiol 20mcg, levonorgestrel 100mcg)
P	lutera- (ethinyl estradiol 20mcg, levonorgestrel 100mcg)
P	lessina- (ethinyl estradiol 20mcg, levonorgestrel 100mcg)
P	sronyx - (ethinyl estradiol 20mcg, levonorgestrel 100mcg)
FE	Nordette®  (ethinyl estradiol 30mcg, levonorgestrel 0.15mg)					X
P	altavera (ethinyl estradiol 30mcg, levonorgestrel 0.15mg)
P	levora- (ethinyl estradiol 30mcg, levonorgestrel 0.15mg)
P	marlissa -(ethinyl estradiol 30mcg, levonorgestrel 0.15mg)
P	portia- (ethinyl estradiol 30mcg, levonorgestrel 0.15mg)
FE	Ovcon-35®  (ethinyl estradiol 35mcg, norethindrone 0.4mg)					X
FE	Balziva  (ethinyl estradiol 35mcg, norethindrone 0.4mg)					X
FE	FemCon-35® FE chew  (ethinyl estradiol 35mcg, norethindrone 0.4mg FE chew)					X
P	zeosa chewable
P	zenchent fe chew
FE	Generess FE chew®  (ethinyl estradiol 25mcg, norethindrone 0.8mg FE chew)
FE	Modicon®  (ethinyl estradiol 35mcg, norethindrone 0.5mg)					X
FE	Brevicon®  (ethinyl estradiol 35mcg, norethindrone 0.5mg)					X
P	necon .5/35- (ethinyl estradiol 35mcg, norethindrone 0.5mg)
P	nortrel .5/35- (ethinyl estradiol 35mcg, norethindrone 0.5mg)
FE	Ortho Novum 1-35®  (ethinyl estradiol 35mcg, norethindrone 1 mg)					X
FE	Norinyl 1-35®  (ethinyl estradiol 35mcg, norethindrone 1 mg)					X
P	necon 1-35- (ethinyl estradiol 35mcg, norethindrone 1 mg)
P	nortrel 1-35 - (ethinyl estradiol 35mcg, norethindrone 1 mg)
FE	Ovcon-50®  (ethinyl estradiol 50mcg, norethindrone 1mg)					X
FE	Loestrin 1-20®  (ethinyl estradiol 20mcg, norethindrone acetate 1mg)					X
P	microgestin 1-20- (ethinyl estradiol 20mcg, norethindrone acetate 1mg)
P	junel 1/20- (ethinyl estradiol 20mcg, norethindrone acetate 1mg)
FE	Loestrin 1.5-30®  (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg)					X
P	microgestin 1.5-30- (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg)
P	junel 1.5/30- (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg)
FE	Ortho-Novum 1-50®  (mestranol 50mcg, norethindrone 1mg)					X
P	necon 1-50- (mestranol 50mcg, norethindrone 1mg)
FE	Norinyl 1-50®  (mestranol 50mcg, norethindrone 1mg)					X
P	low-ogestrel- (ethinyl estradiol 30mcg, norgestrel 0.3mg)
FE	Lo-Ovral®  (ethinyl estradiol 30mcg, norgestrel 0.3mg)					X
P	cryselle- (ethinyl estradiol 30mcg, norgestrel 0.3mg)
P	ogestrel- (ethinyl estradiol 50mcg,norgestrel 0.5mg)
FE	Ovral®  (ethinyl estradiol 50mcg,norgestrel 0.5mg)					X
FE	Ortho-Cyclen®  (ethinyl estradiol 35mcg, norgestimate 0.25mg)					X
P	sprintec- (ethinyl estradiol 35mcg, norgestimate 0.25mg)
P	mononessa-(ethinyl estradiol 35mcg, norgestimate 0.25mg)
P	norgestimate & ethinyl estradiol
P	previfem-(ethinyl estradiol 35mcg, norgestimate 0.25mg)
FE	Loestrin FE 1-20®  (ethinyl estradiol 20mcg, norethindrone acetate 1mg + ferrous fumarate 75mg)					X
P	microgestin FE 1-20- (ethinyl estradiol 20mcg, norethindrone acetate 1mg + ferrous fumarate 75mg)
P	junel FE 1/20- (ethinyl estradiol 20mcg, norethindrone acetate 1mg + ferrous fumarate 75mg)
P	gildess FE 1/20 - (ethinyl estradiol 20mcg, norethindrone acetate 1mg + ferrous fumarate 75mg)
FE	Loestrin FE 1.5-30®  (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg + ferrous fumarate 75mg)					X
P	microgestin FE 1.5-30- (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg + ferrous fumarate 75mg)
P	junel FE 1.5-30- (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg + ferrous fumarate 75mg)
P	gildess FE 1.5-30 (ethinyl estradiol 30mcg, norethindrone acetate 1.5mg + ferrous fumarate 75mg)
FE	Lo Loestrin FE®  (ethinyl estradiol 10mcg, norethindrone acetate 1mg + ferrous fumarate 75mg)					X
FE	Lo Minastrin Pak FE®  (norethin-eth estrad-fe chew/tab 1 mg-10 mcg/10 mcg ther pak)					X
FE	Minastrin 24 FE®  (ethinyl estradiol 20mcg, norethindrone acetate 1mg + ferrous fumarate 75mg)					X
Biphasic
P	kariva (I.ethiny estradiol 20mcg and desogestrel 0.15mg (21d) ;II.ethinyl estradiol 10mcg (5d)
P	viorele (I. ethinyl estradiol 20mcg and desogestrel 0.15mg (21d); II. ethinyl estradiol 10mcg (5d)
FE	Mircette®  (I.ethinyl estradiol 20mcg and desogestrel 0.15mg (21d);II.ethinyl estradiol 10mcg (5d))					X
P	necon 10/11 (I. ethinyl estradiol 35mcg, norethindrone 0.5mg; II. ethinyl estradiol 35mcg, norethindrone 1mg)
FE	Ortho Novum 10/11®  (I. ethinyl estradiol 35mcg, norethindrone 0.5mg; II. ethinyl estradiol 35mcg, norethindrone 1mg)					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
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
P	trivora (I.ethinyl estradiol 30mcg, levonorgestrel 0.05mg, II. ethinyl estradiol 40mcg, levonorgestrel 0.075mg, III. ethinyl estradiol 30 mcg, levonorgestrel 0.125mg)
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
P	enpresse (I.ethinyl estradiol 30mcg, levonorgestrel 0.05mg, II. ethinyl estradiol 40mcg, levonorgestrel 0.075mg, III. ethinyl estradiol 30 mcg, levonorgestrel 0.125mg)
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
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
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
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
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
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
P	tri-previfem- I. ethinyl estradiol 35mcg, norgestimate 0.18mg; II. ethinyl estradiol 35mcg, norgestimate 0.215mg; III. ethinyl estradiol 35mcg, norgestimate 0.25mg
P	trinessa- I. ethinyl estradiol 35mcg, norgestimate 0.18mg; II. ethinyl estradiol 35mcg, norgestimate 0.215mg; III. ethinyl estradiol 35mcg, norgestimate 0.25mg
P	tri-sprintec- I. ethinyl estradiol 35mcg, norgestimate 0.18mg; II. ethinyl estradiol 35mcg, norgestimate 0.215mg; III. ethinyl estradiol 35mcg, norgestimate 0.25mg
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
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
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
Four-Phasic
FE	Natazia®  (estradiol valerate-dienogest 3 mg /2-2 mg/2-3 mg/1 mg)					X
Extended Cycle
P	LoSeasonique®  (Levonorgestrel-0.1 mg Ethinyl Estradiol 20 mcg x 84 days; EE- 10 mcg x 7 days )
P	amethia lo (Levonorgestrel-0.1 mg Ethinyl Estradiol 20 mcg x 84 days; EE- 10 mcg x 7 days)
P	camrese lo (Levonorgestrel-0.1 mg Ethinyl Estradiol 20 mcg x 84 days; EE- 10 mcg x 7 days)
FE	Beyaz™  (ethinyl estradiol 20 mcg, drospirenone 3mg x 24 days levomefolate 0.451 mg X 4 days)					X
P	amethyst (Ethinyl estradiol 20mg, levonorgestrel 90mcg X 28 days)
FE	Lybrel®  ((ethinyl estradiol 20mg, levonorgestrel 90mcg X 28 days -continuous cycle))					X
FE	Yaz 24/4®  (ethinyl estradiol 20 mcg drospirenone3 mg x 24 days; Placebo X 4 days)					X
P	Gianvi (ethinyl estradiol 20 mcg drospirenone 3 mg x 24 days Placebo X 4 days)
P	loryna (ethinyl estradiol 20 mcg drospirenone 3 mg x 24 days Placebo X 4 days)
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)]
FE	Loestrin FE 24/4®  ((ethinyl estradiol 20mcg, norethindrone acetate 1 mg x 24 days + ferrous fumarate 75mg x 4 days))					X
FE	Seasonale®  ([levonorgestrel-0.15 mg; Ethinyl Estradiol 30 mcg x 84 days; Placebo x 7 days (91 days)])					X
P	Seasonique®  (levonorgestrel-0.15 mg Ethinyl Estradiol 30 mcg x 84 days; EE- 10 mcg x 7 days (91-Day))
P	Camrese (Levonorgestrel-0.15 mg Ethinyl Estradiol 30 mcg x 84 days; EE- 10 mcg x 7 days)
FE	Quartette™  (levonor-eth est tab 0.15-0.02/0.025/0.03 mg & eth est 0.01 mg)				X	X
Progestin Only
P	camila- (norethindrone 0.35mg)
P	norethindrone (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
P	levonorgestrel
NP	Plan B®  (levonorgestrel 1.5 mg)
FE	Ella®  (Ulipristal Acetate 30 mg)					X
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
Injectable Contraceptives
P	medroxyprogesterone acetate im susp 150 mg/ml
NP	DEPO-PROVERA®  (medroxyprogesterone acetate im susp 150 mg/ml)
Note: NOTE:  For OTC emergency contraceptives-Even though these products do not require a prescription based upon FDA guidelines, Aetna will require a prescription from an authorized prescriber to consider coverage of the generic OTC emergency contraceptive under an Aetna health plan that complies with healthcare reform.

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.

Background Health Care Reform- Women’s Preventive Services Requirements: The guidelines issued by the Health Resources Services Administration (HRSA) for contraceptive services recommend the full range of FDA-approved contraceptive methods, including drugs for women with reproductive capacity. The Affordable Care Act allows plans and issuers to apply reasonable medical management techniques to determine the frequency, method, treatment or setting for an item or service to the extent not specified in the preventive recommendation.

Pharmacy Benefit Plans with Contraceptive coverage:

1. Step Therapy Criteria

Under some plans, including plans that use an open or closed formulary, Quartette is subject to step-therapy.  Aetna considers this medication to be medically necessary for those members who meet the following step-therapy criteria:

For Quartette 

• A documented trial of one month of one preferred generic extended-cycle 91-day contraceptive alternative, i.e. Amethia, Daysee, Jolessa

If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member, a person appointed to manage the member’s care, or the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria below).

2. Medical Exception Criteria

Formulary Excluded contraceptives are excluded from coverage for members enrolled in 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 criteria listed below:

Formulary Excluded contraceptives are Non-Preferred Brand contraceptives and have a higher copay for members enrolled in prescription drug benefit plans that use an open formulary. In accordance with the Healthcare Reform Act, Non-preferred brand contraceptives are eligible to some members at zero copay. Aetna considers Non-Preferred Brand oral contraceptives medically necessary for members who meet ANY of the following criteria listed below:

Quartette is currently listed on the Aetna Formulary Exclusion and Step Therapy lists. Therefore, this medication is excluded from coverage for members enrolled in prescription drug benefit plan that uses a closed formulary or that requires step-therapy criteria, unless a medical exception is granted. Aetna considers this medication to be medically necessary for those members who meet the criteria below:

For Quartette 

• A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of one preferred generic extended-cycle 91-day contraceptive alternative, i.e. Amethia, Daysee, Jolessa

For all other Formulary Excluded, Non-Preferred Brand Oral Contraceptives

• A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of one preferred alternative 

For all Formulary Excluded, Non-Preferred Brand Non-Oral Contraceptives (i.e. OrthoEvra, Nuvaring) 

• A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of one preferred generic alternative OR 
• A documented mental or physical handicap preventing the reasonable use of an oral contraceptive

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
  

Special Notes:

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

Note: In accordance with the Healthcare Reform Act, claims for Non-Preferred Brand, Formulary Excluded contraceptives that meet medical exception criteria above are eligible to some members at zero copay. Providers can use the appeal process if determined that a preferred oral or non-oral contraceptive is not medically appropriate for a reason not included in criteria above, outlined in initial denial communication to request a case review by a medical director.

Place of Service:

Outpatient

The above policy is based on the following references:

1. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
2. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
3. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
4. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically
5. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
6. Edelman AB, Gallo MF, Jensen JT et al. Continuous or extended cycle vs cyclic use of combined contraceptives for contraception. Cochrane Database System Review 2005:CD004695.
7. Lopez LM, Newsmann SJ, Grimes DA et al. Immediate start of hormonal contraceptive for contraception. Cochrane Database System Rev 2008:CD006260.
8. Abramowicz M. In Brief: Plan B for 17-Year Olds. The Medical Letter. 2009;(Issue 1312) p.40.
9. Spencer AL, Bonnema R, McNamara MC. Helping women choose appropriate hormonal contraception: update on risks, benefits, and indications.  Am J Medicine 2009;122:497-506.
10. Arowojulu AO, Gallo MF, Lopez LM et al. Combined oral contraceptives pills for treatment of acne. Cochrane Database System Review 2009:CD004425.
11. Meyer S. Contraceptive path and vaginal path vs combined oral contraceptives. Am Fam Physician 2009;80:232.
12. 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.

November 15, 2013