Subject: Myfembree PA Policy 4752-A 01-2023

Drug

MYFEMBREE  (relugolix/estradiol/norethindrone acetate)

Policy:

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
The requested drug will be covered with prior authorization when the following criteria are met:
•   The requested drug is being prescribed for the management of
     heavy menstrual bleeding associated with uterine leiomyomas
     (fibroids) in a premenopausal patient
OR
•   The requested drug is being prescribed for the management of
     moderate to severe pain associated with endometriosis in a
     premenopausal patient
     AND
     º   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
AND
•   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 has not already received ANY
     of the following: A) 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), B)
     Greater than or equal to 6 months of treatment with Orilissa 200
     mg twice daily

Duration of Approval Limits apply.
Total additive duration: 24 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Lupaneta Pack [package insert]. North Chicago, IL: AbbVie Inc.; June 2015.
2. Lupron Depot [package insert]. North Chicago, IL: AbbVie Inc.; July 2022.
3. Myfembree [package insert]. Brisbane, CA: Myovant Sciences, Inc.; September 2022.
4. Oriahnn [package insert]. North Chicago, IL: AbbVie Inc.; August 2021.
5. Orilissa [package insert]. North Chicago, IL: AbbVie Inc.; February 2021.
6. Synarel [package insert]. New York, NY: Pfizer Inc.; April 2022.
7. Zoladex [package insert]. Deerfield, IL: TerSera Therapeutics LLC; December 2020.
8. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed November 22, 202
9. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed November 22, 2022.
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 15, 2023