ETHINYL ESTRADIOL/ LEVONORGESTREL TAB
Clinical Criteria Summary
Criteria for Monophasic Oral Contraceptive Pills
- 20 mcg Ethinyl Estradiol (EE) Combinations: Drospirenone 3 mg; Levonorgestrel 0.1 mg; Norethindrone 1 mg. Regimen: 21 active pills; 7 inert pills.
- 30 mcg EE Combinations: Desogestrel 0.15 mg; Drospirenone 3 mg; Levonorgestrel 0.15 mg; Norethindrone 1.5 mg; Norethindrone 1 mg; Norgestimate 0.25 mg. Regimen: 21 active pills; 7 inert pills.
- 35 mcg EE Combinations: Levonorgestrel 0.05/0.075/0.125 mg; Norethindrone 0.5/0.75/1 mg; Norgestimate 0.18/0.215/0.25 mg. Regimen: 21 active pills; 7 inert pills.
Criteria for Triphasic Oral Contraceptive Pills
- Contains varying doses of levonorgestrel, norethindrone, or norgestimate across the cycle.
- Regimen: 21 active pills; 7 inert pills.
Criteria for Extended Cycle Oral Contraceptive Pills
- Levonorgestrel 0.15 mg with 30 mcg EE.
- Regimen: 84 active pills; 7 inert pills.
Criteria for Progestin-Only Oral Contraceptive Pills
- Norethindrone 0.35 mg.
- Regimen: Active pill daily continuously; no inert pills.
Criteria for Vaginal Ring
- Etonogestrel 15 mcg EE/day.
- Regimen: 1 ring inserted for 3 weeks, 1 week off.
Criteria for Transdermal Patch
- Norelgestromin 150 mcg/day with 35 mcg EE/day.
- Regimen: 1 patch weekly for 3 weeks, 1 week off.
Criteria for Injectable Contraceptives
- Intramuscular (IM): Medroxyprogesterone acetate 150 mg. Regimen: 1 injection Q3 months (13 weeks).
- Subcutaneous (SQ): Medroxyprogesterone acetate 104 mg. Regimen: 1 injection Q3 months (12 to 14 weeks).
Criteria for Emergency Contraception
- Levonorgestrel 1.5 mg or Ulipristal 30 mg.
- Regimen: 1 pill x1.
General Class-Wide Clinical Criteria & Formulary Guidance
- Highly effective in preventing pregnancy when used as directed, without significant differences between formulations.
- Combination agents differ mainly in strength of estrogen, type and strength of progestin, regimen, and route of administration.
- Nuisance side effects may be managed by adjusting the estrogen/progestin content or ratio.
- Progestin-only products may be considered for patients with contraindications to estrogen or a desire to avoid estrogen.
- Non-oral hormonal contraceptives (medroxyprogesterone depot injection, vaginal ring, transdermal patch, contraceptive implant) may be useful for patients with compliance issues who do not require daily dosing.
Prerequisites for 12-Month Dispensing of Contraceptive Agents
- Patient must be stable on the product for at least 3 months.
- Contraceptive must be on the Consolidated Mail Outpatient Pharmacy (CMOP) greater than 90-day supply list.
- Patient must accept the copay burden, if applicable.
Guidance for Self-Administration of Subcutaneous Depot Medroxyprogesterone Acetate (DMPA-SQ)
- Although package labeling states the product is intended for healthcare professional administration, self-administration is a safe and effective alternative.
- Self-administration may be offered in the context of shared decision making per CDC U.S. Selected Practice Recommendations.