ETHINYL ESTRADIOL/ SEGESTERONE RING,VAG

Clinical Criteria Summary

• Prevention of pregnancy in females of reproductive potential
• Not adequately studied in females with a body mass index (BMI) greater than 29 kg/m²

• High risk of arterial or venous thrombotic disease
• Current or history of breast cancer or other estrogen- or progestin-sensitive cancer
• Liver tumors, acute hepatitis, or severe (decompensated) cirrhosis
• Undiagnosed abnormal uterine bleeding
• Hypersensitivity to ingredients
• Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

• Risk of venous thromboembolic events (VTE) and arterial events (e.g., stroke, myocardial infarction)
• Liver enzyme elevations
• Hypertension
• Potential for gall bladder disease
• Abnormal uterine bleeding
• Depression
• Toxic shock syndrome (TSS)
• Vaginal and cervical erosion and/or ulceration
• Risk of vaginal infection with prolonged use

• Patient-inserted into vagina; must remain continuously for 3 weeks (21 days) followed by a 1-week (7-day) ring-free interval
• Reusable ring stored in provided case during the ring-free interval
• Provides contraception for 13 cycles (1 year)
• Must be cleaned with mild soap and water before storage and prior to re-insertion

• Pregnancy: No indication for use
• Lactation: Hormones and metabolites are found in human milk and may reduce milk production; alternative contraception recommended for breastfeeding females
• Does not protect against sexually transmitted infections including HIV
• Oil-based (including silicone-based) vaginal lubricants and medications will alter the vaginal system/exposure and should not be used
• Compatible with water-based vaginal lubricants/creams and male condoms

• Considered when a 12-month product is preferred due to clinical or patient-specific needs (e.g., extended travel or deployment, limited or no access to refrigeration, history of or potential difficulties with obtaining timely refills)
• Not studied for indications other than pregnancy prevention or dosing regimens outside the product label

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

See all drugs in this document

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.