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)
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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
- Patient has had a previous interventional therapy to reduce bleeding [B]
- 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
- Patient has had surgical ablation to prevent recurrence
- 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
- Oriahnn Prescribing Information. AbbVie Inc. North Chicago, IL. June 2023.
- Myfembree Prescribing Information. Myovant Sciences, Inc. Brisbane, CA. April 2024.
- 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.
- 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.
- 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.
- Stewart EA. Uterine Fibroids (Leiomyomas): Treatment Overview. UpToDate. Available by subscription at: https://www.uptodate.com. Accessed July 14, 2022.
- 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.
- 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.
End Notes
- Results of UF-EXTEND and LIBERTY Extension demonstrated that up to 12 months of elagolix or relugolix with addback therapy provided sustained efficacy in reducing menstrual blood loss with no new or unexpected adverse effects compared with results of the preceding 6-month UF-1, UF-2, LIBERTY 1, and LIBERTY 2 studies. [4, 7]
- Alternatives to surgery include oral contraceptives, progestins, tranexamic acid, and a variety of interventional therapies (e.g., uterine-artery embolization and magnetic resonance–guided focused ultrasonography) [3, 5-6]
- Use of Oriahnn and Myfembree should be limited to 24 months due to the risk of continued bone loss, which may not be reversible. [1, 2]
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
HEALTHY LIVING