PRASTERONE INSERT,VAG
Clinical Criteria Summary
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.
Document 784: Prasterone INTRAROSA Criteria Oct 2025
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.