Subject: Oriahnn PA Policy 3960-A 01-2022

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 200mg twice daily

Duration of Approval Limits apply.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Myfembree [package insert]. Brisbane, CA: Myovant Sciences, Inc.; May 2021.
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.; 2021; Accessed November 23, 2021.
5. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed November 23, 2021

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 12, 2022