ESTRADIOL/ NORETHINDRONE FILM,CONT REL
Clinical Criteria Summary
Document 338: Contraceptive Agents Hormonal on VA National Formulary
Criteria for Combination Hormonal Contraceptive Pills
- Desogestrel/Ethinyl Estradiol (and other Monophasic pills with 20 mcg EE)
- Indication/Use: Highly effective in preventing pregnancy when used as directed.
- Regimen: 21 active pills; 7 inert pills.
- Monophasic pills with 30 mcg EE (includes Drospirenone/Ethinyl Estradiol, Norethindrone/Ethinyl Estradiol)
- Regimen: 21 active pills; 7 inert pills.
- Monophasic pills with 35 mcg EE (includes Norethindrone/Ethinyl Estradiol, Norgestimate/Ethinyl Estradiol)
- Regimen: 21 active pills; 7 inert pills.
- Extended Cycle Pills (Levonorgestrel/Ethinyl Estradiol 30 mcg)
- Regimen: 84 active pills; 7 inert pills.
- Management of nuisance side effects: Adjust estrogen/progestin content or ratio.
Criteria for Progestin-Only Pills
- Indication/Use: Considered in patients with contraindications to estrogen or a desire to avoid estrogen.
- Drug: Norethindrone 0.35 mg (Camila, Errin, Heather, Micronor, Incassia, Jencycla, Nor-QD, Eluryng)
- Regimen: Active pill daily continuously; no inert pills.
Criteria for Non-Oral Hormonal Contraceptives
- Indication/Use: Useful for patients with compliance issues that do not require daily dosing.
- Vaginal Ring (EE 15 mcg/day + Etonogestrel)
- Regimen: 1 ring inserted for 3 wks, 1 wk off.
- Transdermal Patch (EE 35 mcg + Norelgestromin 150 mcg/day)
- Regimen: 1 patch used for 3 wks, 1 wk off.
- Injection (Medroxyprogesterone acetate 150 mg IM or 104 mg SQ)
- Regimen: 1 injection Q3 mos (13 wks or 12 to 14 wks).
- Note: Self-administration of SQ DMPA is a safe and effective alternative; may be offered in the context of shared decision making.
Criteria for Emergency Contraception
- Levonorgestrel 1.5 mg (Aftera, My Choice, My Way, Plan B One-Step, Next Choice, Opcicon, Take Action)
- Regimen: 1 pill x1.
- Ulipristal 30 mg (ella)
- Regimen: 1 pill x1.
Criteria for Long-Acting Reversible Contraceptives (IUDs & Implants)
- Levonorgestrel IUD (52 mg, 19.5 mg, 13.5 mg)
- Duration: Up to 8 yrs, up to 5 yrs, or up to 3 yrs respectively.
- Non-hormonal Copper IUD (Paragard)
- Duration: Up to 10 yrs.
- Etonogestrel Implant (Nexplanon)
- Duration: Up to 5 yrs.
Formulary & Dispensing Criteria
- All contraceptives are listed on the National Formulary as generic components to allow substitution of the least expensive equivalent product.
- 12-month dispensing prerequisites: 1) Stable on product for at least 3 mos; 2) Contraceptive is on CMOP greater than 90-day supply list; and 3) Patient accepts copay burden, if applicable.
Document 560: Menopausal Therapies in VA Table
Criteria for Systemic Hormonal Menopausal Medications
- Bazedoxifene/Conjugated Estrogens (DUAVEE): Alternative to progestin for patients with a uterus.
- Systemic Estrogen Preparations: Effective in treating vasomotor symptoms. Use the lowest effective dose of estrogen. Choice of product should consider patient symptoms, risk-benefit profile, and patient preference. Transdermal estrogen may have lower risk of thrombosis.
- Progestins (when used with systemic estrogen): Should be prescribed to all patients with an intact uterus receiving systemic estrogen therapy to reduce the risk of endometrial hyperplasia and cancer.
Criteria for Genitourinary Symptoms of Menopause (GSM) Medications
- Estradiol Ring (ESTRING): PA-F; subject to PBM Criteria for Use; classified as low dose vaginal estrogen.
- Ospemifene (OSPHENA): Oral option indicated for vaginal dryness and dyspareunia.
Criteria for Systemic Nonhormonal Medications
- Fezolinetant (VEOZAH): Subject to PBM Criteria for Use.
- Elinzanetant (LYNKUET): Pending PBM review.
- Testosterone Topical Gel: Indicated off-label for HSDD; use 1% testosterone gel tubes 50 mg (should last ~5–10 days); subject to PBM Clinical Guidance.
- Gabapentin: Useful for nocturnal symptoms.