CurrentCignaPolicy IP0196

Gonadotropin-Releasing Hormone Antagonists - Orilissa

This policy governs prior authorization and coverage criteria for Orilissa (elagolix) for management of moderate to severe pain associated with endometriosis for members of Cigna health benefit plans.

Policy Summary

PayerCigna

PolicyGonadotropin-Releasing Hormone Antagonists - Orilissa

Policy CodePolicy IP0196

Change TypeRevised — name and initial authorization duration updated

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document required step-therapy trial or exception; approvals for initial therapy are for 6 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Updated policy name from 'Elagolix' to 'Gonadotropin-Releasing Hormone Antagonists - Orilissa' and changed initial therapy authorization duration from 12 months to 6 months for treatment of endometriosis.

150 mg QDRecommended dose (no coexisting conditions)

200 mg BIDRecommended dose (coexisting dyspareunia)

150 mg QDModerate hepatic impairment

6 monthsInitial authorization duration

Not coveredNon-endometriosis use

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Coverage Criteria for Orilissa (elagolix)

FDA-Approved Indication - Endometriosis

Approve for 6 months if the patient meets ONE of the following (A or B):

A) Initial Therapy

ALL of the following
- A contraceptive (e.g., combination oral contraceptives, levonorgestrel-releasing intrauterine systems such as Mirena or Liletta, or a depo‑medroxyprogesterone injection).
- An oral progesterone (e.g., norethindrone tablets).
Exception: An exception to the trial requirement may be made if the patient previously used a gonadotropin‑releasing hormone agonist (e.g., leuprolide depot) or Myfembree (relugolix/estradiol/norethindrone).

B) Continuing Therapy: Patient is currently receiving Orilissa.current use

If met, approve for 6 months.

Orilissa (elagolix) for any indication other than treatment of endometriosis is not medically necessary and is not covered under this policy.

Use of Orilissa for indications other than management of endometriosis is explicitly considered not medically necessary and therefore not eligible for coverage.

Coding, Duration, and Dose Guidance

Coding guidancemixed

N/A	Policy references that claims must be billed with the most appropriate codes; document does not list specific CPT/ICD codes.

Authorization duration for initial therapy

Authorization duration (initial therapy)6 months (approvals provided for the duration noted; months = 30 days)

Applicable indicationTreatment of moderate to severe pain associated with endometriosis

Approval conditionApprove for 6 months if patient meets initial therapy trial requirements or is currently receiving Orilissa

Prescriber Requirements, Prior Authorization, and Billing Rules

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is recommended for prescription benefit coverage of Orilissa. All approvals are provided for the duration noted by the policy. In cases where the approval is authorized in months, 1 month = 30 days. Orilissa must be prescribed by a physician who has consulted with or who specializes in the condition due to the specialized skills required for evaluation, diagnosis, and monitoring for adverse events and long‑term efficacy.

Approvals provided for specified durations: 6 months for FDA‑approved indication when criteria met

Step Therapy

Step Therapy Requirement

Step therapy requirement — For initial therapy, patient must have tried ONE of the specified contraceptive or progesterone therapies, unless contraindicated. An exception to the step requirement may be made if the patient previously used a gonadotropin‑releasing hormone agonist (e.g., leuprolide depot) or Myfembree (relugolix/estradiol/norethindrone) for endometriosis.

Required trial options (need ONE unless contraindicated): combination oral contraceptives, levonorgestrel‑releasing intrauterine system (e.g., Mirena, Liletta), depo‑medroxyprogesterone injection, OR an oral progesterone (e.g., norethindrone tablets)

Definitions

Endometriosis — definition and clinical summary

DefinitionEndometriosis: tissues similar to the uterine lining migrate outside the uterus, commonly in the pelvic cavity (peritoneum, uterosacral ligaments, rectovaginal septum) and may attach to reproductive organs such as ovaries and fallopian tubes

EpidemiologyImpacts up to 10% of reproductive-age patients in the US

Clinical manifestationsOften presents with pelvic pain and can involve sites between the bladder, uterus, vagina, and rectum; less commonly found on intestines, colon, appendix or rectum

Relevance to policyPolicy covers Orilissa for management of moderate to severe pain associated with endometriosis when criteria are met

Orilissa (elagolix) — drug description and dosing summary

Drug class and indication

Background

Endometriosis is a condition in which tissue similar to the lining of the uterus migrates outside the uterus, commonly within the pelvic cavity, and is associated with chronic pelvic pain and other symptoms that can substantially affect quality of life. It is estimated to affect up to 10% of reproductive-age patients in the United States. Orilissa is an oral gonadotropin-releasing hormone receptor antagonist indicated for management of moderate to severe pain related to endometriosis; its use is limited in duration because of anti‑estrogenic effects and potential for loss of bone mineral density.

Revision Details

2025-07-15annual_reviewLatest

Annual revision noting no criteria changes.

2024-08-01policy_update

Policy name changed from 'Elagolix' to 'Gonadotropin-Releasing Hormone Antagonists - Orilissa' and initial therapy authorization duration for endometriosis updated from 12 months to 6 months.

Policy Summary

PayerCigna

PolicyGonadotropin-Releasing Hormone Antagonists - Orilissa

Policy CodePolicy IP0196

Change TypeRevised — name and initial authorization duration updated

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document required step-therapy trial or exception; approvals for initial therapy are for 6 months when criteria are met.

SourceLink

On This Page

Exception: prior use of a GnRH agonist (e.g., Lupron Depot) or Myfembree meets step requirement

Documentation Required

Prescriber and Duration Documentation

Prescriber and duration documentation — Orilissa approvals require that the medication be prescribed by a physician who has consulted with or specializes in endometriosis. Document indication (endometriosis), whether this is initial therapy or continuation, the trial of required prior therapy (or noted exception), and the requested duration. Follow dosing limits: 150 mg once daily up to 24 months (no coexisting conditions); 200 mg twice daily up to 6 months (patients with coexisting dyspareunia). For moderate hepatic impairment (Child‑Pugh B): 150 mg QD for up to 6 months; 200 mg BID not recommended. Orilissa is contraindicated in severe hepatic impairment.

Document prescribing physician specialty/consultation
Document prior therapy tried or exception
Document requested duration consistent with policy dosing limits

Billing Rule

Coding and Billing Compliance

Coding and billing compliance — Claims submitted without a covered diagnosis or without adherence to coding guidance will be denied. When billing, providers must use the most appropriate diagnosis and procedure codes as of the date of service. Receipt of sample product does not satisfy criteria requirements for coverage.

Claims lacking covered diagnosis/procedure codes or required documentation will be denied
Use most appropriate codes current on date of submission
Samples do not satisfy prior‑therapy or other criteria

Orilissa (elagolix): oral gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for management of moderate to severe pain associated with endometriosis

Recommended dosing — no coexisting conditions150 mg once daily (QD) up to 24 months

Recommended dosing — coexisting dyspareunia200 mg twice daily (BID) up to 6 months

Hepatic impairment guidanceIn moderate hepatic impairment (Child-Pugh B): 150 mg QD up to 6 months; 200 mg BID is not recommended; contraindicated in severe hepatic impairment

Limitation of useDuration limited due to anti-estrogenic effects including decrease in bone mineral density