Subject: Oriahnn PA Policy 3960-A UDR 01-2024

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

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 of the following criteria are 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 has not 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)
•     3960-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]. Brisbane, CA: Myovant Sciences, Inc.; August 2023.
2. Oriahnn [package insert]. North Chicago, IL: AbbVie Inc.; June 2023.
3. Orilissa [package insert]. North Chicago, IL: AbbVie Inc.; June 2023.
4. Lexicomp Online, Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed December 06, 2023.
5. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 12/06/2023).

 

 

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 16, 2024