CurrentAdvanced HealthPolicy N/A

Orilissa Drug Use Criteria

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This policy governs prior authorization for Orilissa used to manage moderate to severe endometriosis-associated pain in adult women. It establishes required prior therapies, hepatic-function criteria, treatment-duration limits, renewal requirements, and denial conditions.

Policy Summary

PayerAdvanced Health

PolicyOrilissa Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewFeb 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing the covered indication, required first- and second-line treatment history, treatment-duration eligibility, and hepatic function.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age

3 moStep-therapy trial

24 mo150 mg maximum

6 mo200 mg maximum

Normal/A

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CurrentAdvanced HealthPolicy N/A

Orilissa Drug Use Criteria

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Sign up for all advancedhealth policy alerts

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Policy Summary

PayerAdvanced Health

PolicyOrilissa Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewFeb 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing the covered indication, required first- and second-line treatment history, treatment-duration eligibility, and hepatic function.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age

3 moStep-therapy trial

24 mo150 mg maximum

6 mo200 mg maximum

Normal/A

Standard hepatic status

C excludedSevere impairment

Coverage Criteria

Initial Therapy Criteria

Covered for initial therapy when all applicable criteria are met:

Initial therapy

Covered indication
- Indication and age: The request is for management of moderate to severe pain associated with endometriosis in a woman older than 18 years.>18 years
  Off-label use is not a covered OHP benefit.
First-line therapy qualification
- Adequate trial and failure: The member tried and failed an adequate trial of at least one preferred first-line endometriosis therapy for at least 3 months, including a combined hormonal contraceptive or a progestin administered orally, by depot injection, or intrauterine.At least 3 months
- Qualifying exception: The member has documented intolerance, an FDA-labeled contraindication, or hypersensitivity to the preferred first-line therapy options.
Second-line therapy qualification
- Adequate trial and failure: The member tried and failed an adequate trial of at least one preferred second-line endometriosis therapy for at least 3 months, including Synarel (nafarelin) or Lupron Depot (leuprolide).At least 3 months
Treatment-duration eligibility
- Cumulative limits not exceeded: The member has not received 24 or more cumulative months of Orilissa 150 mg once daily, Oriahnn, or Myfembree, and has not received 6 or more cumulative months of Orilissa 200 mg twice daily.24 months for 150 mg daily regimen; 6 months for 200 mg twice-daily regimen
  Count previous treatment exposure and fills.
Hepatic-function eligibility
- Normal or mild hepatic impairment
  - Liver function: The member has normal liver function or mild hepatic impairment (Child-Pugh class A), supported by liver-function laboratory data.Normal or Child-Pugh class A
    Approve Orilissa 150 mg once daily for up to 12 months or 200 mg twice daily for up to 6 months.
- Moderate hepatic impairment
  - Liver function: The member has moderate hepatic impairment (Child-Pugh class B), supported by liver-function laboratory data.Child-Pugh class B
    Approve Orilissa 150 mg once daily for up to 6 months only. Orilissa 200 mg twice daily is not recommended.

Continuation and Renewal Therapy

Covered for continuation and renewal therapy when all applicable criteria are met:

Continuation and renewal therapy

Maximum course not reached
- Applicable cumulative limit remains available
  - Orilissa 200 mg twice daily: The member has not completed a 6-month cumulative course of Orilissa 200 mg twice daily.Less than 6 cumulative months
  - Orilissa 150 mg once daily with moderate hepatic impairment: The member has not completed a 6-month cumulative course of Orilissa 150 mg once daily while having moderate hepatic impairment (Child-Pugh class B).Less than 6 cumulative months

Coverage is excluded for members with hypersensitivity to elagolix or any formulation component, pregnancy, known osteoporosis, severe hepatic impairment (Child-Turcotte-Pugh class C), or concomitant use of OATP1B1 drugs known or expected to significantly increase elagolix plasma concentrations.

Orilissa is covered only for the FDA-approved indication of managing moderate to severe pain associated with endometriosis in a woman older than 18 years. Use outside this indication, including off-label use, is not covered.

Treatment Duration Requirements

First-line therapy trial

Required minimum trialAt least 3 months

Second-line therapy trial

Required minimum trialAt least 3 months

Orilissa 150 mg once-daily maximum duration

Cumulative treatment limit24 months with Orilissa 150 mg once daily

Orilissa 200 mg twice-daily maximum duration

Cumulative treatment limit

Authorization, Documentation, and Denial Risks

Prior Authorization

Initial Authorization Required

Prior authorization is required for Orilissa. For an initial request, approve only when all applicable criteria are documented, including the covered diagnosis and age, required first- and second-line treatment history or qualifying exceptions, cumulative treatment limits, and liver-function status. Approval is regimen- and hepatic-function-specific: normal or mild hepatic impairment supports 150 mg once daily for up to 12 months or 200 mg twice daily for up to 6 months; moderate hepatic impairment supports 150 mg once daily for up to 6 months only.

Document management of moderate to severe endometriosis-associated pain in a woman older than 18 years.
Provide LFT laboratory data supporting normal liver function or Child-Pugh Class A or B hepatic impairment.
For Child-Pugh Class B, do not approve Orilissa 200 mg twice daily.

Prior Authorization

Renewal Authorization Required

Renewal authorization requires documentation that the member has not reached the applicable cumulative treatment limit, has experienced improvement in endometriosis-related pain while on therapy, and has normal liver function or mild hepatic impairment. Approve only within the regimen-specific cumulative maximum, including previous fills.

Medication Background

Orilissa (elagolix) is a short-acting, nonpeptide gonadotropin-releasing hormone antagonist used to manage moderate to severe pain associated with endometriosis. It suppresses pituitary and ovarian hormone function in a dose-dependent manner, reducing dysmenorrhea and nonmenstrual pelvic pain. Hormone concentrations rapidly return toward prior levels after treatment is discontinued.

Definitions and Duration Rules

Hepatic impairment categories

Child-Pugh class AMild hepatic impairment

Child-Pugh class BModerate hepatic impairment

Child-Pugh class CSevere hepatic impairment

Cumulative treatment duration

Prior fillsPrevious fills count toward the applicable cumulative treatment limit

Orilissa regimenTreatment duration includes prior treatment with the specified Orilissa regimen

Related productsOriahnn and Myfembree count toward the 24-month limit associated with Orilissa 150 mg once daily

Initial Orilissa Authorization

Orilissa Renewal

Orilissa renewal is allowed only when all of the following are met:

Orilissa renewal

Applicable maximum course not reached
- Orilissa 200 mg twice daily: The member has not received a 6-month cumulative course of Orilissa 200 mg twice daily.Less than 6 cumulative months
- Orilissa 150 mg once daily with moderate hepatic impairment: The member has not received a 6-month cumulative course of Orilissa 150 mg once daily while having moderate hepatic impairment (Child-Pugh class B).Less than 6 cumulative months

Required Prior Therapies

Step	Preferred therapy	Required trial/failure
1	At least one preferred first-line endometriosis therapy: a combined hormonal contraceptive or a progestin administered orally, by depot injection, or intrauterine.	Try and fail for at least 3 months. A documented intolerance, FDA-labeled contraindication, or hypersensitivity may substitute for the trial.

Step	Preferred therapy	Required trial/failure
2	At least one preferred second-line endometriosis therapy, including Synarel (nafarelin) or Lupron Depot (leuprolide).	Try and fail for at least 3 months.

Maximum Treatment Duration

Orilissa 150 mg

Maximum treatment duration24 months

Orilissa 200 mg

Maximum treatment duration6 months

Policy Summary

PayerAdvanced Health

PolicyOrilissa Drug Use Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewFeb 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing the covered indication, required first- and second-line treatment history, treatment-duration eligibility, and hepatic function.

SourceLink

On This Page

Orilissa 150 mg once daily with normal or mild hepatic impairment: The member has not completed a 24-month cumulative course of Orilissa 150 mg once daily while having normal liver function or mild hepatic impairment (Child-Pugh class A).Less than 24 cumulative months

Clinical response

Improvement in pain: The member has experienced improvement in pain related to endometriosis while receiving therapy.Documented improvement
If there is no improvement, change the treatment plan to optimize response.

Hepatic function

Eligible hepatic function: The member has normal liver function or mild hepatic impairment (Child-Pugh class A).Normal or Child-Pugh class A
Renewal is not recommended for moderate or severe hepatic impairment (Child-Pugh class B or C).

Remaining cumulative allowance

Requested regimen remains within limit: The requested regimen remains within 24 cumulative months for Orilissa 150 mg once daily or 6 cumulative months for Orilissa 200 mg twice daily, including previous fills.150 mg once daily: 24 cumulative months; 200 mg twice daily: 6 cumulative months

6 months with Orilissa 200 mg twice daily

Orilissa 150 mg once daily: up to 24 cumulative months.
Orilissa 200 mg twice daily: up to 6 cumulative months.
Renewal is not recommended for moderate or severe hepatic impairment (Child-Pugh Class B or C).

Step Therapy

First-Line Step Therapy Required

Before initial approval, the member must have tried and failed an adequate trial of at least one preferred first-line endometriosis treatment for at least 3 months, unless a documented intolerance, FDA-labeled contraindication, or hypersensitivity applies.

Preferred first-line options include combined hormonal contraceptives or progestins used orally, by depot injection, or intrauterine.

Step Therapy

Second-Line Step Therapy Required

Before initial approval, the member must have tried and failed an adequate trial of at least one preferred second-line endometriosis treatment for at least 3 months.

Preferred second-line options include Synarel (nafarelin) or Lupron Depot (leuprolide).
The required second-line trial must be documented in the request.

Documentation Required

Liver Function Documentation

Provide laboratory and clinical documentation of hepatic function. Initial approval depends on normal liver function or mild hepatic impairment (Child-Pugh Class A), while Child-Pugh Class B permits only a limited 150 mg once-daily regimen.

Include LFT laboratory data supporting the reported hepatic status.
For Child-Pugh Class A or normal liver function: 150 mg once daily up to 12 months or 200 mg twice daily up to 6 months.
For Child-Pugh Class B: 150 mg once daily up to 6 months only.

Documentation Required

Diagnosis, Indication, and Age Documentation

Document that the request is for management of moderate to severe pain associated with endometriosis in a woman older than 18 years. Requests outside this diagnosis, pain severity, or age requirement do not meet criteria.

The requested product is not FDA-approved for other indications.
Off-label medication use is not a covered benefit on OHP.

Documentation Required

First-Line Treatment History

Document an adequate first-line treatment trial of at least 3 months and failure before initial approval, unless the member has a documented intolerance, FDA-labeled contraindication, or hypersensitivity to the preferred first-line options.

Acceptable first-line options include combined hormonal contraceptives or progestins: oral, depot injection, or intrauterine.

Documentation Required

Second-Line Treatment History

Document an adequate trial of at least one preferred second-line treatment for at least 3 months and failure before initial approval.

Preferred options include Synarel (nafarelin) or Lupron Depot (leuprolide).
The second-line requirement applies unless the policy provides no alternative exception.

Documentation Required

Cumulative Treatment History

Document all prior exposure and cumulative treatment duration for Orilissa, Oriahnn, and Myfembree, including previous fills. Cumulative exposure determines whether the member remains eligible for initial or renewal authorization.

Deny after at least 24 cumulative months of Orilissa 150 mg once daily, Oriahnn, or Myfembree.
Deny after at least 6 cumulative months of Orilissa 200 mg twice daily.

Documentation Required

Renewal Response Documentation

For renewal, document that endometriosis-related pain improved while the member was receiving therapy. The response must be demonstrated before continued authorization.

Document the clinical response and relevant pain-related findings in the renewal request.

Denial Risk

Denial Risk: Indication or Age Not Met

Deny requests that are not for moderate to severe endometriosis-associated pain in a woman older than 18 years. Off-label use is not a covered benefit on OHP.

Noncovered situations include an unapproved indication, insufficient pain severity, or age 18 years or younger.

Denial Risk

Denial Risk: First-Line Requirement Not Met

Deny when the member has not tried and failed at least one preferred first-line endometriosis therapy for at least 3 months and has no documented intolerance, FDA-labeled contraindication, or hypersensitivity.

A qualifying first-line option includes combined hormonal contraceptives or progestins used orally, by depot injection, or intrauterine.

Denial Risk

Denial Risk: Second-Line Requirement Not Met

Deny when the member has not tried and failed at least one preferred second-line endometriosis therapy for at least 3 months. The request does not meet criteria without documented Synarel or Lupron Depot trial and failure.

The second-line step-therapy requirement is subject to prior authorization.

Denial Risk

Denial Risk: Maximum Treatment Duration Exceeded

Deny when the applicable cumulative treatment limit has been reached or exceeded, including prior fills and qualifying exposure to related products.

Orilissa 150 mg once daily, Oriahnn, or Myfembree: maximum 24 cumulative months.
Orilissa 200 mg twice daily: maximum 6 cumulative months.

Denial Risk

Hepatic Impairment Exclusion

Apply hepatic-function restrictions to both initial and renewal requests. Treatment is not recommended with severe hepatic impairment (Child-Pugh Class C); moderate impairment (Child-Pugh Class B) has regimen-specific limitations and is not eligible for renewal.

Child-Pugh Class B initial approval: Orilissa 150 mg once daily for up to 6 months only.
Orilissa 200 mg twice daily is not recommended with Child-Pugh Class B impairment.
Renewal is denied for moderate or severe hepatic impairment (Child-Pugh Class B or C).

Denial Risk

Contraindications and Interacting Medications

Do not authorize Orilissa when a listed contraindication or clinically significant interacting medication is present.

Hypersensitivity to elagolix or any formulation component.
Pregnancy or known osteoporosis.
Severe hepatic impairment (Child-Turcotte-Pugh Class C).
Concomitant use of an OATP1B1 inhibitor known or expected to significantly increase elagolix plasma concentrations.

Denial Risk

Denial Risk: No Clinical Improvement

Deny renewal when the member has not demonstrated improvement in endometriosis-related pain while on therapy. The treatment plan should be changed to optimize the member's response.

Document improvement in endometriosis-related pain before requesting continued authorization.

Orilissa 150 mg once daily with normal or mild hepatic impairment: The member has not received a 24-month cumulative course of Orilissa 150 mg once daily while having normal liver function or mild hepatic impairment (Child-Pugh class A).Less than 24 cumulative months

Clinical response

Improvement in endometriosis-related pain: The member has experienced improvement in pain related to endometriosis while on therapy.Documented improvement
If there is no improvement, deny renewal and recommend changing the treatment plan to optimize response.

Hepatic-function requirement

Normal or mild hepatic impairment: The member has normal liver function or mild hepatic impairment (Child-Pugh class A).Normal or Child-Pugh class A
Renewal is not recommended for moderate or severe hepatic impairment (Child-Pugh class B or C).

Cumulative allowance for requested regimen

Remaining treatment duration: The requested regimen remains within 24 cumulative months for Orilissa 150 mg once daily or 6 cumulative months for Orilissa 200 mg twice daily, including previous fills.150 mg once daily: up to 24 cumulative months; 200 mg twice daily: up to 6 cumulative months