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Pharmacy Clinical Policy Bulletins
Subject: Contraceptives (see attached list for generic/brand)
Important Note
This Pharmacy Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefits plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their health care providers will need to consult the member's benefits plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the following website: http://www.cms.hhs.gov/center/coverage.asp.
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:
- Precertification Criteria
Under some plans, including plans that use an open or closed formulary, oral contraceptives (except for Seasonale) indicated in the table below are subject to precertification quantity limits.
| Quantity Limits: |
Manufacturer oral contraceptive package inserts recommend 1 tablet be taken per day for 21 days; no tablets are taken for 7 days or 7 inert or iron-containing tablets are 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 (except for Seasonale). |
For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of contraceptives will be considered medically necessary for those members who meet the following criterion:
- Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.
- Medical Exception Criteria
Certain contraceptives are currently included on the Aetna Formulary Exclusions List (see list below).* These Formulary Excluded contraceptives therefore 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 documented:
- Contraindication to one preferred alternative from the same subcategory (see table below) OR,
- Intolerance to one preferred alternative from the same subcategory (see table below)
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.
Table: Oral Contraceptives, listed by subcategory
| Generic name |
Label Name |
Brand/Generic Availability (B-Brand; G-Generic) |
Status |
PR-QL |
| Monophasic |
ethinyl estradiol 30 mcg, desogestrel 0.15mg |
solia |
G |
P |
X |
| apri |
G |
P |
X |
| reclipsen |
G |
P |
X |
| Desogen® |
B |
FE |
X |
| Ortho-Cept® |
B |
FE |
X |
ethinyl estradiol 30 mcg drospirenone 3 mg |
Yasmin® |
B |
FE |
X |
ethinyl estradiol 35 mcg, ethynodiol diacetate 1mg |
Demulen 1/35® |
B |
FE |
X |
| zovia 1/35 |
G |
P |
X |
| kelnor 1/35 |
G |
P |
X |
ethinyl estradiol 50 mcg, ethynodiol diacetate 1 mg |
Demulen 1/50® |
B |
FE |
X |
| zovia 1/50 |
G |
P |
X |
| ethinyl estradiol 20 mcg, levonorgestrel 100 mcg |
Levlite® |
B |
FE |
X |
| aviane |
G |
P |
X |
| Alesse® |
B |
FE |
X |
| lutera |
G |
P |
X |
| lessina |
G |
P |
X |
| ethinyl estradiol 30 mcg, levonorgestrel 0.15 mg |
Levlen |
B |
FE |
X |
| Nordette® |
B |
FE |
X |
| levora |
G |
P |
X |
| portia |
G |
P |
X |
| ethinyl estradiol 35 mcg, norethindrone 0.4 mg |
Ovcon-35® |
B |
FE |
X |
| balziva |
G |
P |
X |
| ethinyl estradiol 35 mcg, norethindrone 0.5mg |
Modicon® |
B |
FE |
X |
| Brevicon® |
B |
FE |
X |
| necon .5/35 |
G |
P |
X |
| nortrel .5/35 |
G |
P |
X |
| ethinyl estradiol 35 mcg, norethindrone 1 mg |
Ortho Novum 1-35® |
B |
FE |
X |
| Norinyl 1-35® |
B |
FE |
X |
| necon 1-35 |
G |
P |
X |
| nortrel 1-35 |
G |
P |
X |
| ethinyl estradiol 50 mcg, norethindrone 1 mg |
Ovcon-50® |
B |
FE |
X |
| ethinyl estradiol 20 mcg, norethindrone acetate 1 mg |
Loestrin 1-20® |
B |
FE |
X |
| microgestin 1-20 |
G |
P |
X |
| junel 1/20 |
G |
P |
X |
| ethinyl estradiol 30 mcg, norethindrone acetate 1.5 mg |
Loestrin 1.5-30® |
B |
FE |
X |
| microgestin 1.5-30 |
G |
P |
X |
| junel 1.5/30 |
G |
P |
X |
| mestranol 50 mcg, norethindrone 1 mg |
Ortho-Novum 1-50® |
B |
FE |
X |
| necon 1-50 |
G |
P |
X |
| Norinyl 1-50® |
B |
FE |
X |
| ethinyl estradiol 30mcg, norgestrel 0.3 mg |
low-ogestrel |
G |
P |
X |
| Lo-Ovral® |
B |
FE |
X |
| cryselle |
G |
P |
X |
| ethinyl estradiol 50 mcg,norgestrel 0.5 mg |
ogestrel |
G |
P |
X |
| Ovral® |
B |
FE |
X |
| ethinyl estradiol 35 mcg, norgestimate 0.25 mg |
Ortho-Cyclen® |
B |
FE |
X |
| sprintec |
G |
P |
X |
| mononessa |
G |
P |
X |
| previfem |
G |
P |
X |
ethinyl estradiol 20 mcg, norethindrone acetate 1mg + ferrous fumarate 75 mg |
Loestrin FE 1-20® |
B |
FE |
X |
| microgestin FE 1-20 |
G |
P |
X |
| junel FE 1-20 |
G |
P |
X |
| ethinyl estradiol 30 mcg, norethindrone acetate 1.5 mg + ferrous fumarate 75 mg |
Loestrin FE 1.5-30® |
B |
FE |
X |
| microgestin FE 1.5-30 |
G |
P |
X |
| junel FE 1.5-30 |
G |
P |
X |
| Biphasic |
- ethinyl estradiol 20 mcg and desogestrel 0.15 mg (21d);
- ethinyl estradiol 10 mcg (5d)
|
Mircette® |
B |
FE |
X |
| kariva |
G |
P |
X |
- ethinyl estradiol
35 mcg, norethindrone 0.5 mg
- ethinyl estradiol
35 mcg, norethindrone 1 mg
|
Ortho Novum 10-11® |
B |
FE |
X |
| necon 10-11 |
G |
P |
X |
| Triphasic |
- ethinyl estradiol
25 mcg, desogestrel 0.100 mg
- ethinyl estradiol
25 mcg, desogestrel 0.125 mg
- ethinyl estradiol
25 mcg desogestrel 0.150 mg
|
Cyclessa® |
B |
FE |
X |
| velivet |
G |
P |
X |
| cesia |
G |
P |
X |
- ethinyl estradiol
30 mcg, levonorgestrel 0.05 mg
- ethinyl estradiol
40 mcg, levonorgestrel 0.075 mg
- ethinyl estradiol
30 mcg, levonorgestrel 0.125 mg
|
trivora |
G |
P |
X |
| Triphasil® |
B |
FE |
X |
| enpresse |
G |
P |
X |
| Tri-levlen® |
B |
FE |
X |
- ethinyl estradiol
35 mcg, norethindrone 0.5 mg
- ethinyl estradiol
35 mcg, norethindrone 0.75 mg
- ethinyl estradiol
35 mcg, norethindrone 1 mg
|
Ortho Novum 7-7-7® |
B |
FE |
X |
| necon 7/7/7 |
G |
P |
X |
| nortrel 7/7/7 |
G |
P |
X |
- ethinyl estradiol
35 mcg, norethindrone 0.5 mg
- ethinyl estradiol
35 mcg, norethindrone 1 mg
- ethinyl estradiol
35 mcg, norethindrone 0.5 mg
|
Tri-Norinyl® |
B |
FE |
X |
| leena |
G |
P |
X |
| aranelle |
G |
P |
X |
- ethinyl estradiol
35 mcg, norgestimate 0.18 mg
- ethinyl estradiol
35 mcg, norgestimate 0.215 mg
- ethinyl estradiol
35 mcg, norgestimate 0.25 mg
|
Ortho Tri-Cyclen® |
B |
FE |
X |
| tri-sprintec |
G |
P |
X |
| trinessa |
G |
P |
X |
| tri-previfem |
G |
P |
X |
- ethinyl estradiol
25 mcg, norgestimate 0.18 mg
- ethinyl estradiol
25 mcg, norgestimate 0.215 mg
- ethinyl estradiol
25 mcg, norgestimate 0.25 mg
|
Ortho Tri-Cyclen Lo® |
B |
FE |
X |
- ethinyl estradiol
20 mcg, norethindrone acetate 1 mg
- ethinyl estradiol
30 mcg, norethindrone acetate 1 mg
- ethinyl estradiol
35 mcg, norethindrone acetate 1 mg
|
Estrostep/ Estrostep FE® |
B |
FE |
X |
| Extended Cycle |
| ethinyl estradiol
20 mcg drospirenone 3 mg |
Yaz® 24/4 |
B |
FE |
X |
| ethinyl estradiol 20mcg, norethindrone acetate 1mg + ferrous fumarate 75mg |
Loestrin 24 FE® 24/4 |
B |
FE |
X |
| EE 30 mcg, levonorgestrel 0.15 mg |
Seasonale® |
B |
P |
|
| Progestin Only |
| norethindrone 0.35 mg |
Ortho-Micronor® |
B |
FE |
|
| Nor-QD® |
B |
FE |
|
| camila |
G |
P |
|
| nora-Be |
G |
P |
|
| errin |
G |
P |
|
| jolivette |
G |
P |
|
| Emergency Contraceptives |
| levonorgestrel 0.75 mg |
Plan B® |
B |
NP |
|
| Vaginal Ring Contraceptives |
etonogestrel 0.12 mg/day, ethinyl estradiol 0.015 mg/day |
NuvaRing® |
B |
FE |
|
| Transdermal Contraceptives |
norelgestromin 0.15 mg/day, ethinyl estradiol 0.02 mg/day |
Ortho-Evra® - 3-pack only |
B |
FE |
|
*P = Preferred; FE = Formulary Excluded; NP = Nonpreferred
PR = Precertification; QL = Quantity Limits; AL = Age Limits; ST = Step-Therapy
‡M EX = Medical Exception - This means the physician or health care professional must obtain a medical exception from Aetna, in order for the medication to be eligible for coverage. Medical Exception criteria apply to Formulary Excluded drugs for members enrolled in or covered by closed benefits plans, and also apply to Step-Therapy drugs in cases where a member's physician believes it is medically necessary for the member to use a step-therapy drug in the first instance without a trial of the prerequisite alternative drug(s).
*Information regarding Aetna's Preferred Drug List, Formulary Exclusions list, Precertification and Step-Therapy lists is available on our website. In addition, members should refer to their plan documents and may call the toll-free telephone number on their ID card for information regarding their benefits. Health care professionals also may obtain information by calling the Pharmacy Management Precertification Unit at 1-800-414-2386, or they can register to use our password-protected provider website. Visit www.aetna.com, select "Doctors & Hospitals" and choose "Physician Self-Service." Once registration is completed, health care professionals may use our online Precertification/medical exception email request form.
The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas (for example, step-therapy does not apply to fully insured New Jersey members).
Many medications on the Preferred Drug List are subject to manufacturer rebate arrangements between Aetna and the manufacturer of those medications. If the member's prescription benefits plan has a deductible or copay levels based on a percentage of Aetna's contracted rate with the participating pharmacy, the contracted rate does not include or reflect any manufacturer rebate arrangements between Aetna and the medication manufacturer. In prescription plans with a deductible or copayment or coinsurance tiers, use of drugs from the Preferred Drug List generally will result in lower costs to members. However, where the prescription plan utilizes a deductible or copayments or coinsurance calculated on a percentage basis, there could be some circumstances in which a preferred drug would cost the member more than a nonpreferred drug because (1) the negotiated pharmacy payment rate for the preferred drug may be more than the negotiated pharmacy payment rate for the nonpreferred drug, and (2) rebates received by Aetna from drug manufacturers are not reflected in the cost of a prescription drug obtained by a member. The Preferred Drug List is subject to change.
In evaluating clinically and therapeutically similar drugs for selection for the Preferred Drug List, Aetna reviews the costs of drugs and takes into account rebates negotiated between Aetna and drug manufacturers. Consequently, a drug may be included on the Preferred Drug list that is more expensive than a nonpreferred alternative before any rebates Aetna may receive from a drug manufacturer are taken into account. In addition, certain drugs may be chosen for "preferred" status because of their clinical or therapeutic advantages or level of acceptance among physicians even though they cost more than nonpreferred alternatives. The net cost to a self-funded plan sponsor for covered prescriptions will vary based on (1) the terms of Aetna's arrangements with participating pharmacies; (2) the amount of the member's copayment, coinsurance or deductible obligation under the terms of the plan; and (3) the percentage, if any, of rebates to which the plan sponsor is entitled under its agreement with Aetna. As a result, a self-funded plan sponsor's actual claim expense per prescription for a particular preferred drug may in some circumstances be higher than for a nonpreferred alternative.
For members in Texas, additions to the 2006 Preferred Drug List will be effective no later than January 1, 2006. In accordance with state law, fully insured members in Texas who are receiving coverage for medications that are removed from the Preferred Drug List during the plan year will continue to have those medications covered at the same benefit level until their plan's renewal date.
This definition of precertification is not the same as the definition used by Texas law. Our use of the term "precertification" relates to the prior authorization of your services by Aetna, based on our decision of whether the service is medically necessary. Precertification is not a guarantee of payment or "verification" as defined by Texas law.
California HMO members enrolled in a closed formulary benefits plan who are receiving coverage for medications that are moved to the Formulary Exclusions List, and California HMO members who are receiving coverage for medications added to the Precertification or Step-Therapy lists, will continue to have those medications covered, for as long as the treating physician continues prescribing them. This coverage, in accordance with state law, is only provided when the drug is appropriately prescribed and is considered safe and effective for treating the member's medical condition.
Nothing in this section shall preclude the prescribing health care professional from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to prohibit generic drug substitutions.
Place of Service:
The above policy is based on the following references:
- Goldman: Cecil Textbook of Medicine, 21st ed. 2000 W.B. Saunders pg 1342.
- Rakel: Conn's Current Therapy 2000, 52nd edition.
- The Medical Letter, Vol. 42 (Issue 1070) January 24, 2000: 10.
- 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.
- 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.
- Derman RJ. An overview of the noncontraceptive benefits and risks of oral contraception. Int J Fertil 1992;37 Suppl 1:19-26
- Stergachis A. Epidemiology of the noncontraceptive effects of oral contraceptives. Am J Obstet Gynecol 1992;167:1165-70.
- Weisberg E. Prescribing oral contraceptives. Drugs 1995; 49 (2): 224-31.
- Shaw JC. Antiandrogen therapy in dermatology. Int J Dermatol 1996; 35 (11): 770-778.
- Ruggiero RJ. Contraception. In: Young LY, Koda-Kimble MA, eds. Applied Therapeutics: The Clinical Use of Drugs, 6th edition. Vancouver: Applied Therapeutics, Inc, 1995.
- Darney PD. OC practice guidelines: minimizing side effects. Int J Fertil 1997; 42 (Suppl 1):158-169.
- USP DI® Drug Information For The Health Care Professional - 26th Ed. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2006 .
- AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2006.
- Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. 2006.
- PDR® Electronic Library, Thomson Micromedex, Greenwood Village, Colorado (Edition expires 2006).
- 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).
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.
January 1, 2006
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