ESTRADIOL/ LEVONORGESTREL PATCH
Clinical Criteria Summary
Document 338: Contraceptive Agents Hormonal on VA National Formulary
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.
Document 560: Menopausal Therapies in VA Table
Criteria for Systemic Hormonal Menopausal Medications
- 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.
Criteria for Genitourinary Symptoms of Menopause (GSM) Medications
- 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.
Criteria for Systemic Nonhormonal Medications
- 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.