Subject: Myfembree PA 4752-A P01-2025

Drug

MYFEMBREE  (Relugolix/estradiol/norethindrone acetate)

Policy:

Indications

FDA-approved Indications

Heavy Menstrual Bleeding Associated with Uterine Leiomyomas

Myfembree is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

Moderate to Severe Pain Associated with Endometriosis

Myfembree is indicated for the management of moderate to severe pain associated with endometriosis in premenopausal women.

Limitations of Use

Use of Myfembree should be limited to 24 months due to the risk of continued bone loss that may not be reversible.

Coverage Criteria

Heavy Menstrual Bleeding Associated with Uterine Leiomyomas (Fibroids)

Authorization may be granted when the requested drug is being prescribed for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) when ALL the following criteria is met:

• The patient is premenopausal.
• If the patient has previously received treatment with an elagolix-containing product (e.g., Oriahnn, Orilissa) or a relugolix-containing product (e.g., Myfembree), the patient must not have already received ANY of the following:
  • Greater than or equal to 24 cumulative months of treatment with elagolix-containing products (e.g., Oriahnn, Orilissa) and/or relugolix-containing products (e.g., Myfembree).
  • Greater than or equal to 6 months of treatment with Orilissa 200 mg twice daily.

Moderate to Severe Pain Associated with Endometriosis

Authorization may be granted when the requested drug is being prescribed for the management of moderate to severe pain associated with endometriosis when ALL the following criteria are met:

• The patient is premenopausal.
• The patient has NOT received the maximum recommended treatment course of 12 months of Lupron Depot or Lupaneta Pack OR 6 months of Synarel or Zoladex.
• If the patient has previously received treatment with an elagolix-containing product (e.g., Oriahnn, Orilissa) or a relugolix-containing product (e.g., Myfembree), the patient must not have already received ANY of the following:
  • Greater than or equal to 24 cumulative months of treatment with elagolix-containing products (e.g., Oriahnn, Orilissa) and/or relugolix-containing products (e.g., Myfembree).
  • Greater than or equal to 6 months of treatment with Orilissa 200 mg twice daily.

Duration of Approval (DOA)

• 4752-A: Total additive duration: 24 months (see chart)

Cumulative months of prior treatment with an   elagolix- and/or relugolix-containing product	Duration of Approval (in months)
No prior treatment	12
≤ 12	12
13	11
14	10
15	9
16	8
17	7
18	6
19	5
20	4
21	3
22	2
23	1

Place of Service:

Outpatient

The above policy is based on the following references:

1. Myfembree [package insert]. Marlborough, MA: Sumitomo Pharma America, Inc.; July 2024.
2. Lupaneta Pack [package insert]. North Chicago, IL: AbbVie Inc.; June 2015.
3. Lupron Depot [package insert]. North Chicago, IL: AbbVie Inc.; October 2023.
4. Oriahnn [package insert]. North Chicago, IL: AbbVie Inc.; June 2023.
5. Orilissa [package insert]. North Chicago, IL: AbbVie Inc.; June 2023.
6. Synarel [package insert]. New York, NY: Pfizer Inc.; January 2023.
7. Zoladex 3.6 mg [package insert]. Deerfield, IL: TerSera Therapeutics LLC; March 2023.
8. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed November 29, 2024.
9. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/29/2024).
10. Schrager S, Falleroni J, Edgoose J. Evaluation and treatment of endometriosis. Am Fam Physician. 2013;87(2):107.
11. Management of endometriosis. Practice Bulletin No. 114. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2010;116:223-236.
12. Edi R, Cheng T. Endometriosis: Evaluation and Treatment. Am Fam Physician. 2022;106(4):397-404.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 06, 2025