WHA

Brand Estradiol Transdermal Systems

Indications for Prior Authorization

Minivelle (estradiol transdermal system)
  • For diagnosis of Moderate to Severe Vasomotor Symptoms
    Indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

  • For diagnosis of Prevention of Postmenopausal Osteoporosis
    Indicated for the prevention of postmenopausal osteoporosis.

    Limitation of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.

  • Gender Dysphoria

Menostar (estradiol transdermal system)
  • For diagnosis of Prevention of Postmenopausal Osteoporosis
    Indicated for the prevention of postmenopausal osteoporosis.

    Limitation of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.

  • Gender Dysphoria

Alora (estradiol transdermal system)
  • For diagnosis of Moderate to Severe Vasomotor Symptoms
    Indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

  • For diagnosis of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy
    Indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

    Limitation of Use: When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.

  • For diagnosis of Hypoestrogenism
    Indicated for the treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.

  • For diagnosis of Prevention of Postmenopausal Osteoporosis
    Indicated for the prevention of postmenopausal osteoporosis.

    Limitation of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, only consider therapy for women at significant risk of osteoporosis. First consider the use of non-estrogen medications.

  • Gender Dysphoria

Vivelle-Dot (estradiol transdermal system)
  • For diagnosis of Moderate to Severe Vasomotor Symptoms
    Indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

  • For diagnosis of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy
    Indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.

    Limitations of Use: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.

  • For diagnosis of Hypoestrogenism
    Indicated for the treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

  • For diagnosis of Prevention of Postmenopausal Osteoporosis
    Indicated for the prevention of postmenopausal osteoporosis.

    Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.

  • Gender Dysphoria

Criteria

Minivelle, Menostar, Alora, Vivelle-Dot

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • Trial and failure of a minimum 28-day supply or intolerance to generic estradiol patch
Minivelle, Menostar, Alora, Vivelle-Dot

Approval Length: N/A - Requests for gender transition or gender dysphoria should not be approved. Deny as a benefit exclusion.

Non Formulary

Length of Approval: N/A - Requests for non-approvable diagnoses should not be approved
For diagnosis of Gender Dysphoria/Gender Incongruence (off-label)

  • Requests for coverage for diagnoses of gender transition or gender dysphoria are not authorized and will not be approved

  • Guideline ID
    GL-448214

  • Formulary
    Custom

  • Effective date
    Jan 1, 2026

  • P&T approval date
    Nov 20, 2025

P & T Revisions

2025-12-05, 2025-07-17, 2024-07-18, 2023-07-20, 2022-07-22, 2022-02-01, 2021-06-18, 2020-09-02

  1. Minivelle Prescribing Information. Noven Pharmaceuticals Inc. Miami, FL. February 2024.
  2. Menostar Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ. December 2023.
  3. Alora Prescribing Information. Allergan USA, Inc. Madison, NJ. March 2020.
  4. Vivelle-Dot Prescribing Information. Sandoz Inc. Princeton, NJ. November 2023.
  • 2025-12-05: Add Gender Dysphoria Exclusion Criteria
  • 2025-07-17: 2025 annual review: no criteria changes.
  • 2024-07-18: 2024 annual review: no criteria changes, removed obsolete Alora 0.05 mg patch, background updates.
  • 2023-07-20: Annual review - updated trial duration from 30 to 28 days.
  • 2022-07-22: Annual review: no criteria changes.
  • 2022-02-01: Renamed guideline. Added Vivelle-Dot as a target to align with coding.
  • 2021-06-18: Annual Review
  • 2020-09-02: New Program