ANNOVERA (segesterone acetate/ethinyl estradiol)

ANNOVERA (segesterone acetate/ethinyl estradiol)

SELF ADMINISTRATION

Indications for Prior Authorization:

• Indicated for use by females of reproductive potential to prevent pregnancy

• Limitations: not adequately evaluated in females with a BMI >29 kg/m²

Patients must meet the following criteria for the indication(s) above:

• Prescribed for prevention of pregnancy, AND

• Trial and failure of two formulary contraceptive alternatives, unless contraindicated or adverse effects are experienced, AND

• Trial and failure of Nuvaring®, AND

• Patient does not have a contraindication to treatment:

  • High risk of arterial or venous thrombotic diseases

  • 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 any of the components of Annovera™

  • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

Dosing:

• Insert 1 Annovera™ ring and leave in place for 3 weeks, followed by a 1-week system-free interval

• One Annovera™ system provides contraception for 13 cycles

Approval:

• 1 year (Max: 1 ring per year)