Subject: Orilissa PA 2634-A P01-2026

Drug

ORILISSA  (elagolix)

Policy:

Indications

FDA-approved Indications

Orilissa is indicated for the management of moderate to severe pain associated with endometriosis.

Limitations of Use

Limit the duration of use based on the dose and coexisting condition.

Coverage Criteria

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 of the following criteria are met:

·        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.

·        The patient meets ONE of the following:

§  If the patient has not previously received treatment with an elagolix-containing product (e.g., Oriahnn, Orilissa) or a relugolix-containing product (e.g., Myfembree), the patient will receive 150 mg once daily of the requested drug OR 200 mg twice daily of the requested drug.

§  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)

·        2634-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.      Orilissa [package insert]. North Chicago, IL: AbbVie Inc.; June 2023.

2.     Lupaneta Pack [package insert]. North Chicago, IL: AbbVie Inc.; August 2023.

3.     Lupron Depot [package insert]. North Chicago, IL: AbbVie Inc.; September 2025.

4.     Myfembree [package insert]. Marlborough, MA: Sumitomo Pharma America, Inc.; August 2025.

5.     Oriahnn [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; September 2025.

8.     Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed November 17, 2025.

9.     Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/17/2025).

10.  Schrager S, Falleroni J, Edgoose J. Evaluation and Treatment of Endometriosis. Am Fam Physician. 2013;87(2):107-113.

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, 2026