ESTRADIOL/ NORETHINDRONE TAB

Generic Name: ESTRADIOL/ NORETHINDRONE TAB
Brand Names: ABIGALE, ABIGALE LO, ACTIVELLA, ESTRADIOL-NORETHINDRONE ACETAT, MIMVEY
Drug Class: HORMONES/SYNTHETICS/MODIFIERS,OTHER
Formulary Status: Non-Formulary Requires prior authorization
Copay Tier: 2
Last Updated: December 1, 2025

Clinical Criteria Summary

⇄ This criteria document covers 42 drugs across 5 drug classes.

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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.

Contains varying doses of levonorgestrel, norethindrone, or norgestimate across the cycle.
Regimen: 21 active pills; 7 inert pills.

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).

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.

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.

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.

⇄ This criteria document covers 36 drugs across 8 drug classes.

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Bazedoxifene/Estrogens: Bazedoxifene is an alternative to progestin for patients with a uterus.
General Systemic Estrogen Therapy:
All systemic estrogen preparations are effective in treating vasomotor symptoms.
Transdermal estrogen may have lower risk of thrombosis.
The lowest effective dose of estrogen should be used.
Choice of product should consider patient symptoms, risk-benefit profile, and patient preference.
A progestin should be prescribed to all patients with an intact uterus receiving systemic estrogen therapy to reduce the risk of endometrial hyperplasia and cancer.

Prasterone (DHEA): PA-F (Prior Authorization, Facility Level) applies; PBM Criteria for Use available. Classified as low dose vaginal estrogen.
Estradiol vaginal ring (Estring): Not to be confused with FEMRING.

Ospemifene: Oral option indicated for vaginal dryness and dyspareunia.
Fezolinetant: PBM Criteria for Use available.
Citalopram, Escitalopram, Paroxetine, Desvenlafaxine, Venlafaxine, Gabapentin, Oxybutynin: PBM Criteria for Use available; all marked as off-label use.