Subject: Oriahnn PA Policy 3960-A 01-2023

Drug

ORIAHNN  (elagolix/estradiol/norethindrone acetate)

Policy:

FDA-APPROVED INDICATIONS
Oriahnn is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

Limitation of Use:
Use of Oriahnn should be limited to 24 months due to the risk of continued bone loss, which 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
     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 cumulative duration: 24 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Myfembree [package insert]. Brisbane, CA: Myovant Sciences, Inc.; September 2022.
2. Oriahnn [package insert]. North Chicago, IL: AbbVie Inc.; August 2021.
3. Orilissa [package insert]. North Chicago, IL: AbbVie Inc.; February 2021.
4. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed November 22, 2022.
5. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed November 22, 2022.

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