Pharmacy Prior Authorization Criteria

Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), Myfembree (relugolix, estradiol, and norethindrone acetate)

Indications for Prior Authorization

Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules)

• For diagnosis of Heavy Menstrual Bleeding Associated With Uterine Leiomyomas (Fibroids)
  Indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

  Limitations of Use: Use should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.

Myfembree (relugolix, estradiol, and norethindrone acetate)

• For diagnosis of Heavy Menstrual Bleeding Associated With Uterine Leiomyomas (Fibroids)
  Indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

  Limitations of Use: Use should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.

• For diagnosis of Pain Associated With Endometriosis
  Indicated for the management of moderate to severe pain associated with endometriosis in premenopausal women.

  Limitations of Use: Use should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.

Criteria

Oriahnn, Myfembree

Prior Authorization (Initial Authorization)

Length of Approval: 12 month(s) [A]
For diagnosis of Heavy Menstrual Bleeding Associated With Uterine Leiomyomas (Fibroids)

• Diagnosis of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
AND
• Patient is premenopausal
AND
• One of the following: [3, 5-6]
• History of inadequate control of bleeding following a trial of at least 3 months, or history of intolerance or contraindication to one of the following:
• Combination (estrogen/progestin) contraceptive
• Progestins
• Tranexamic acid
OR
• Patient has had a previous interventional therapy to reduce bleeding [B]
AND
• Treatment duration of therapy has not exceeded a total of 24 months [C]

Oriahnn, Myfembree

Prior Authorization (Reauthorization)

Length of Approval: 12 months(s) [A]
For diagnosis of Heavy Menstrual Bleeding Associated With Uterine Leiomyomas (Fibroids)

• Patient has improvement in bleeding associated with uterine leiomyomas (fibroids) (e.g., significant/sustained reduction in menstrual blood loss per cycle, improved quality of life, etc.)
AND
• Treatment duration of therapy has not exceeded a total of 24 months [C]

Myfembree

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Pain Associated With Endometriosis

• Diagnosis of moderate to severe pain associated with endometriosis
AND
• Patient is premenopausal
AND
• ONE of the following:
• History of inadequate pain control response following a trial of 30 days, or history of intolerance or contraindication to one of the following:
• Danazol
• Combination (estrogen/progestin) contraceptive
• Progestins
OR
• Patient has had surgical ablation to prevent recurrence
AND
• Treatment duration of Myfembree has not exceeded a total of 24 months [C, 2]

Myfembree

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Pain Associated With Endometriosis

• Patient has improvement in pain associated with endometriosis (e.g., improvement in dysmenorrhea and nonmenstrual pelvic pain)
AND
• Treatment duration of Myfembree has not exceeded a total of 24 months [C, 2]

P & T Revisions

2024-07-12, 2023-07-31, 2022-10-07, 2022-08-22, 2021-07-28, 2020-07-29

References

1. Oriahnn Prescribing Information. AbbVie Inc. North Chicago, IL. June 2023.
2. Myfembree Prescribing Information. Myovant Sciences, Inc. Brisbane, CA. April 2024.
3. Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. N Engl J Med. 2020;382(4): 328-340.
4. Simon JA, Al-Hendy A, Archer DF, et al. Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas. Obstet Gynecol. 2020;135(6):1313-1326.
5. De La Cruz MS, Buchanan EM. Uterine Fibroids: Diagnosis and Treatment. Am Fam Physician. 2017 Jan 15;95 (2): 100-107. Available by subscription at: https://www.aafp.org/afp/2017/0115/p100.html. Accessed June 8, 2021.
6. Stewart EA. Uterine Fibroids (Leiomyomas): Treatment Overview. UpToDate. Available by subscription at: https://www.uptodate.com. Accessed July 14, 2022.
7. Al-Hendy A, Lukes AS, Poindexter A, et al. LIBERTY: Long-term Extension Study Demonstrating One-year Efficacy and Safety of Relugolix Combination Therapy in Women with Symptomatic Uterine Fibroids. ASRM Scientific Congress & Expo. October 2020. Available at: https://asrm.confex.com/asrm/2020/meetingapp.cgi/Paper/7846. Accessed July 27, 2021.
8. Nezhat, C., Vang, N. et al. Optimal Management of Endometriosis and Pain. Obstetrics & Gynecology: October 2019 - Vol. 134, Issue 4, p 834-839. Available at https://journals.lww.com/greenjournal/pages/articleviewer.aspx?year=2019&issue=10000&article=00025&type=Fulltext. Accessed September 10, 2022.

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Revision History

• 2024-07-12: 2024 annual review. Background updates.
• 2023-07-31: 2023 UM Annual Review. Updated references
• 2022-10-07: Guideline Update
• 2022-08-22: Annual review: no criteria changes.
• 2021-07-28: Add new drug Myfembree. Background updates.
• 2020-07-29: New program

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