VA Criteria for Use Formulary Advisor Reference
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PRASTERONE INSERT,VAG

Generic Name
PRASTERONE INSERT
Brand Names
INTRAROSA
Drug Class
HORMONES/SYNTHETICS/MODIFIERS,OTHER
Formulary Status
Prior Auth Required Formulary with prior authorization
Copay Tier
3
Last Updated
December 1, 2025

Clinical Criteria Summary

Document 560: Menopausal Therapies in VA Table

⇄ This criteria document covers 36 drugs across 8 drug classes.
See all drugs in this document
  • BAZEDOXIFENE/ ESTROGENS TAB,ORAL
  • CITALOPRAM TAB
  • DESVENLAFAXINE TAB,SA
  • DROSPIRENONE/ ESTRADIOL TAB
  • ESCITALOPRAM TAB,ORAL
  • ESTRADIOL CREAM,VAG
  • ESTRADIOL GEL,TOP
  • ESTRADIOL GEL,TRANSDERMAL
  • ESTRADIOL INSERT,VAG
  • ESTRADIOL PATCH
  • ESTRADIOL RING,VAG
  • ESTRADIOL RING,VAG
  • ESTRADIOL SPRAY,TOP
  • ESTRADIOL TAB
  • ESTRADIOL TAB,VAG
  • … and 21 more

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.

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.

Source Documents

Document 560: Menopausal Therapies in VA Table Document 784: Prasterone INTRAROSA Criteria Oct 2025