Pharmacy Prior Authorization Criteria

Brand Estradiol Transdermal Systems

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.

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.

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.

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.

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

2024-07-18, 2023-07-20, 2022-07-22, 2022-02-01, 2021-06-18, 2020-09-02

Minivelle Prescribing Information. Noven Pharmaceuticals Inc. Miami, FL. February 2024.
Menostar Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ. December 2023.
Alora Prescribing Information. Allergan USA, Inc. Madison, NJ. March 2020.
Vivelle-Dot Prescribing Information. Sandoz Inc. Princeton, NJ. November 2023.

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