CurrentUnitedHealthcarePolicy N/A

Orilissa (elagolix) prior authorization and medical necessity

Defines UnitedHealthcare Pharmacy prior authorization, medical necessity, and reauthorization criteria for Orilissa (elagolix) for management of moderate to severe endometriosis pain and who may prescribe it.

Policy Summary

PayerUnitedHealthcare

PolicyOrilissa (elagolix) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

Key ActionObtain prior authorization and document diagnosis and required prior trials or contraindications before initiating Orilissa.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

150 mg dailyapproved dosing option with criteria

200 mg bidapproved dosing option with criteria and 6-month limit

24 momax duration (150 mg)

6 momax duration (200 mg)

2 failedanalgesic trial requirement

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Coverage Criteria for Orilissa (elagolix)

inv-01: Initial Therapy - Orilissa 150 mg

Covered when ALL of the following are met

Initial authorization criteria for Orilissa 150 mg: (1) Diagnosis of moderate to severe pain associated with endometriosis; (2) Failure after a three-month trial, contraindication, or intolerance of two analgesics (e.g., ibuprofen, meloxicam, naproxen); (3) Failure after a three-month trial, contraindication, or intolerance to either hormonal contraceptives or a progestin (e.g., norethindrone); (4) Prescribed by or in consultation with an Obstetrics/Gynecologist (OB/GYN) or a reproductive endocrinologist.

Authorization duration per policy; see reauthorization and duration limits.

inv-02: Initial Therapy - Orilissa 200 mg

Covered when ALL of the following are met

Initial authorization criteria for Orilissa 200 mg: (1) Diagnosis of moderate to severe pain associated with endometriosis; (2) Failure after a three-month trial, contraindication, or intolerance of two analgesics (e.g., ibuprofen, meloxicam, naproxen); (3) Failure after a three-month trial, contraindication, or intolerance to either hormonal contraceptives or a progestin (e.g., norethindrone); (4) Prescribed by or in consultation with an Obstetrics/Gynecologist (OB/GYN) or a reproductive endocrinologist.

Authorization will be issued for 6 months; maximum treatment duration 6 months for 200 mg twice daily.

inv-03: Reauthorization - Orilissa 150 mg

Covered when ALL of the following are met

Reauthorization criteria for Orilissa 150 mg: (1) Documentation of positive clinical response to therapy; (2) Impact to bone mineral density has been considered; (3) Treatment duration has not exceeded a total of 24 months.

Authorization will be issued for 12 months up to a maximum treatment duration of 24 months.

Treatment durations that exceed the labeled maximums are excluded from authorization. Specifically, Orilissa 150 mg once daily is limited to a maximum total treatment duration of 24 months. Requests that would result in cumulative therapy beyond this 24-month limit are not eligible for approval.

Use of Orilissa beyond the labeled maximum treatment durations or without the required prior trials, prescriber consultation, or documentation is not covered. For example, Orilissa 200 mg twice daily is limited to a maximum treatment duration of 6 months, and approvals require documentation of failed/intolerant/contraindicated trials of two analgesics and trial/intolerance/contraindication to hormonal contraceptives or a progestin, plus prescription by or consultation with an OB/GYN or reproductive endocrinologist. Similarly, continuation of Orilissa 150 mg requires documentation of clinical benefit, consideration of bone mineral density, and that total treatment has not exceeded the 24-month maximum.

Initial Therapy Requirements

inv-13: Initial Therapy — Initial coverage requires specified diagnoses, prior trials, and prescriber qualifications

Initial coverage requires specified diagnoses, prior trials, and prescriber qualifications

Initial therapy nodes: Diagnosis of moderate to severe pain associated with endometriosis; failure after a three-month trial, contraindication, or intolerance of two analgesics (e.g., ibuprofen, meloxicam, naproxen); failure after a three-month trial, contraindication, or intolerance to either hormonal contraceptives or a progestin (e.g., norethindrone); prescribed by or in consultation with an OB/GYN or reproductive endocrinologist; state-specific exceptions may reduce the required analgesic trial to 30 days for CT, KY, and MS.

See dosing-specific entries for authorization duration and maximum treatment limits (150 mg: 24 months; 200 mg twice daily: 6 months).

Reauthorization and Continuation Criteria

Prior Authorization

Prior Authorization and Documentation Requirements

Prior authorization is required for continued use. Submit documentation demonstrating ongoing clinical benefit and that total cumulative treatment duration does not exceed the indicated maximums. Failure to provide required documentation may result in denial of reauthorization.

Prior authorization required for continuation of therapy
Submit clinical notes documenting positive clinical response to therapy
Indicate cumulative treatment duration to ensure maximum durations are not exceeded

Reauthorization and Continuation Criteria

Reauthorization will be issued when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to therapy.
Impact to bone mineral density has been considered.
Treatment duration has not exceeded a total of 24 months for Orilissa 150 mg once daily, or 6 months total for Orilissa 200 mg twice daily.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior authorization required for initiation

Prior authorization is required for Orilissa (elagolix). Initial approval for both 150 mg and 200 mg dosing requires a diagnosis of moderate to severe pain associated with endometriosis and that all listed prior trial and prescriber criteria are met.

Diagnosis of moderate to severe pain associated with endometriosis
Meet the prior trial and prescriber criteria specified for the selected dosing regimen

Step Therapy

Required prior trials before initiation

Before initiating Orilissa, document failure, contraindication, or intolerance to two analgesics after a three-month trial and failure, contraindication, or intolerance to a three-month trial of hormonal contraceptives or a progestin. State-specific exceptions (CT, KY, MS) allow a 30-day analgesic trial.

Failure after a three-month trial of two analgesics (e.g., ibuprofen, meloxicam, naproxen) — inadequate pain relief, contraindication, or intolerance
Failure after a three-month trial of hormonal contraceptives or a progestin (e.g., norethindrone) — or documented contraindication/intolerance
For Connecticut, Kentucky, and Mississippi, the analgesic trial requirement may be 30 days

Denial Risk

Denial triggers for missing requirements

Claims may be denied if required documentation is not provided or if the patient has not met the mandated trial requirements (analgesics and hormonal therapy) or does not have the required diagnosis of moderate to severe endometriosis-associated pain.

Lack of documentation of diagnosis of moderate to severe pain associated with endometriosis
Absence of documented failed/contraindicated/intolerant trials of two analgesics
Absence of documented failed/contraindicated/intolerant trial of hormonal contraceptives or a progestin

Step Therapy / Prior Trial Details

Step	Requirement	Notes
1	Failure after a three-month trial (inadequate pain relief), contraindication, or intolerance of two analgesics (e.g., ibuprofen, meloxicam, naproxen)	For CT, KY, MS business the required analgesic trial may be 30 days instead of three months; state mandates may apply.
2	Failure after a three-month trial, contraindication, or intolerance to hormonal contraceptives or a progestin (e.g., norethindrone)	Applies to initial authorization for both 150 mg and 200 mg dosing regimens.
3	Prescribed by or in consultation with an OB/GYN or reproductive endocrinologist	Documentation of consultation or prescription by these specialists is required per initial therapy criteria.

Key Definitions and Dosing

Orilissa 150 mg

DosingOrilissa 150 mg — once daily

Maximum total treatment duration24 months

Reauthorization requirementsDocumentation of positive clinical response; consideration of bone mineral density impact; authorization issued for 12 months up to cumulative 24 months

Orilissa 200 mg

DosingOrilissa 200 mg — twice daily

Authorization durationInitial authorization will be issued for 6 months

Maximum total treatment duration6 months

Initial coverage requirementsDiagnosis of moderate to severe endometriosis-associated pain and failure/intolerance/contraindication to two analgesics and to hormonal contraceptives or a progestin; prescribed by or in consultation with an OB/GYN or reproductive endocrinologist

OpenPayer

Orilissa (elagolix) prior authorization and medical necessity

Coverage Criteria for Orilissa (elagolix)

Initial Therapy Requirements

Reauthorization and Continuation Criteria

Provider Actions, Authorization & Documentation

Step Therapy / Prior Trial Details

Key Definitions and Dosing

Background

Site of Care / Program Notes