PRASTERONE INSERT,VAG
Clinical Criteria Summary
Document 560
Systemic Hormonal Menopausal Therapy (Oral Estrogen Combinations)
- Dosing Criteria: 0.45 mg conjugated equine estrogens/20 mg bazedoxifene daily
- Clinical Use Criteria: Bazedoxifene is an alternative to progestin for patients with a uterus
- Systemic Estrogen Formulary Requirements:
- Prescribe the lowest effective dose of estrogen
- Product selection should consider patient symptoms, risk-benefit profile, and patient preference
- A progestin (or bazedoxifene alternative) must be prescribed for all patients with an intact uterus receiving systemic estrogen to reduce endometrial hyperplasia and cancer risk
Document 784
Exclusion Criteria
- Undiagnosed abnormal genital bleeding
- Inclusion Criteria (All must be met)
- Moderate to severe dyspareunia and/or vaginal dryness as a symptom of vulvar or vaginal atrophy due to menopause
- Intolerance, inadequate response, or unable to use vaginal estrogen
Additional Inclusion Criteria
- For patients with known or suspected history of breast cancer: Use a multidisciplinary, shared decision-making approach considering potential unknown risk and benefit.