Pharmacy Prior Authorization Criteria

Orilissa (elagolix)

Indications for Prior Authorization

Orilissa (elagolix)

• For diagnosis of Endometriosis
  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.

Criteria

Orilissa 150 mg

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of moderate to severe pain associated with endometriosis
AND
• One of the following: [2, 3]
• History of inadequate pain control response following a trial of at least 3 months, or history of intolerance or contraindication to one of the following:
• Danazol
• Combination (estrogen/progesterone) oral contraceptive
• Progestins
OR
• Patient has had surgical ablation to prevent recurrence

Orilissa 150 mg

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

• Patient has improvement in pain associated with endometriosis (e.g., improvement in dysmenorrhea and nonmenstrual pelvic pain)
AND
• Treatment duration of Orilissa has not exceeded a total of 24 months [1]

Orilissa 200 mg*

*NOTE: Orilissa 200 mg is used for a maximum of 6 months.

Prior Authorization

Length of Approval: 6 Month(s)

• Diagnosis of moderate to severe pain associated with endometriosis
AND
• One of the following: [2, 3]
• History of inadequate pain control response following a trial of at least 3 months, or history of intolerance or contraindication to one of the following:
• Danazol
• Combination (estrogen/progesterone) oral contraceptive
• Progestins
OR
• Patient has had surgical ablation to prevent recurrence

P & T Revisions

2024-07-30, 2023-08-02, 2022-08-03, 2021-07-24, 2020-06-22

References

1. Orilissa prescribing information. AbbVie Inc. North Chicago, IL. June 2023.
2. Taylor H, Giudice L, Lessey B, et al. Treatment of endometriosis-associated pain with Elagolix, an oral GnRH Antagonist. N Engl J Med 2017; 377:28-40.
3. Armstrong C. ACOG Updates Guideline on Diagnosis and Treatment of Endometriosis. Am Fam Physician. 2011 Jan 1;83 (1): 84-85. Available by subscription at: https://www.aafp.org/afp/2011/0101/p84.html. Accessed July 30, 2024.

---

Revision History

• 2024-07-30: Annual review: No criteria changes.
• 2023-08-02: Annual review: No criteria changes. Updated references and background.
• 2022-08-03: Annual review: No criteria changes.
• 2021-07-24: Updated references section.
• 2020-06-22: Updated references.

---