CurrentCignaPolicy N/A

Orilissa (elagolix) — Drug Quantity Management / Coverage Criteria

Defines drug quantity limits and exception criteria for Orilissa (elagolix) for Cigna-administered health benefit plans, including retail and home delivery dispensing limits and conditions for overrides.

Policy Summary

PayerCigna

PolicyOrilissa (elagolix) drug quantity management and coverage criteria

Policy CodePolicy N/A

Change TypeMaterial updates and clarifications to quantity limit overrides

Effective DateN/A

Next Review DateMay 29, 2024

Key ActionTo request the 365-per-365-days override for 150 mg dosing, submit documentation showing continuation of therapy and acceptable hepatic function.

SourceLink

POLICY UPDATE CHANGES

Override criteria were updated to approve 365 tablets per 365 days for a total of 24 months of therapy at retail and home delivery if the patient meets the existing criteria; previously overrides approved 30 tablets per dispensing at retail or 90 tablets per dispensing at home delivery for 24 months.

Policy clarified that there are no overrides to the 'Per Rx' limits and that overrides apply to the 'Per Days' limit.

Orilissa 200 mg tablets: clarified there are no overrides to the 'Per Rx' or 'Per Days' limits.

180150 mg retail/home per 365 days

360200 mg retail/home per 365 days

24 moOverride max duration (150 mg)

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Coverage Criteria

inv-01: Orilissa 150 mg 'Per Rx' Limit

Covered when the following per-prescription limit applies:

Per Rx limits for Orilissa 150 mg: Orilissa 150 mg tablets per‑prescription limit: no overrides recommended.Per Rx limits in effect

Per Rx limits remain in effect; there are no overrides to the 'Per Rx' limit for Orilissa 150 mg.

inv-02: Orilissa 150 mg 'Per Days' Limit Override

Approve an increased per‑days quantity only when ALL of the following criteria are met:

Approve 365 tablets per 365 days for continuation up to 24 months

A: Hepatic function: Patient has normal liver function OR mild hepatic impairment (Child‑Pugh A).
Either normal liver function or Child‑Pugh A suffices.
B: Therapy status: The request is for continuation of therapy.
Continuation of therapy is required for this per‑days override.

inv-03: Orilissa 200 mg 'Per Rx' and 'Per Days' Limits

Covered when the following per‑prescription and per‑days limits apply:

Per Rx and Per Days for 200 mg: Orilissa 200 mg tablets per‑prescription and per‑365‑days limits: no overrides recommended.Per Rx and Per Days limits in effect

200 mg dosing has no exceptions; there are no overrides to the 'Per Rx' or 'Per Days' limits for Orilissa 200 mg.

Any exceptions to the quantity limits listed above are considered medically necessary only when the specific criteria in this policy are met. The Drug Quantity Management program is applied at the point of service to prevent stockpiling, misuse, or overuse while allowing a sufficient supply of Orilissa; if the program rule is not met, coverage will be determined by the criteria in this policy and approvals are provided for the durations noted herein.

Any other exception to the quantity limits listed above that does not meet the explicit criteria detailed in this policy is considered not medically necessary and will be denied.

Quantity Limits (per 365 days / per dispensing)

Orilissa 150 mg — Document maximum

ProductOrilissa 150 mg tablets

Document-level maximum (per 365 days)180 tablets per 365 days

Unittablets

Orilissa 200 mg — Document maximum

ProductOrilissa 200 mg tablets

Document-level maximum (per 365 days)360 tablets per 365 days

Unittablets

Coding Guidance

Coding guidancemixed

affected codes

Document references that providers must use most appropriate codes; no specific CPT/ICD-10 codes listed in this policy.

Maximum therapy duration by dose

150 mg dosing (normal liver function)150 mg once daily (QD) — up to 24 months

200 mg dosing200 mg twice daily (BID) — up to 6 months (dyspareunia)

150 mg dosing (moderate hepatic impairment)150 mg QD — up to 6 months (Child-Pugh Class B)

Provider Actions & Requirements

Prior Authorization

Drug Quantity Management requirement

Drug Quantity Management: This Drug Quantity Management program applies at the point of service (POS). It is intended to prevent stockpiling, misuse, and/or overuse while providing a sufficient quantity of Orilissa. If the Drug Quantity Management rule is not met at POS for the requested medication, coverage will be determined by the criteria in this policy. All approvals are provided for the duration specified in the Criteria.

Applies at point of service (POS) — quantity limits enforced at POS.
If POS rule not met, adjudication will follow the coverage criteria in this policy.

Billing Rule

Provider submission & billing

Providers must submit prior authorization requests and any continuation requests in accordance with the coverage criteria in this policy. Requests should include documentation of diagnosis, prior treatment history, laboratory or clinical data supporting liver function status (if applicable), and evidence of continuation of therapy when requesting the 365 tablets per 365 days override for 150 mg dosing. Use applicable billing and NDC codes on claims; coverage will be determined by whether submitted requests meet the policy criteria.

Continuation of Therapy Criteria

inv-14: Continuation of Therapy

Continuation of therapy is required as part of override approval for 150 mg per‑days quantity increases.

Continuation requirement: Request must be for continuation of therapy to qualify for the 365 tablets per 365 days override for Orilissa 150 mg dosing.

Continuation of therapy is one of the two required conditions (the other is acceptable hepatic function) for approval of the per‑days override; approval under this override permits up to 24 months of therapy.

Definitions

Hepatic impairment categories (Child-Pugh) and dosing implications

Hepatic categories referencedNormal liver function; Mild hepatic impairment (Child-Pugh A); Moderate hepatic impairment (Child-Pugh B)

Dosing implication — normal/mildNormal liver function or Child-Pugh A supports 150 mg QD up to 24 months for eligible patients

Dosing implication — moderateChild-Pugh B (moderate) limits 150 mg QD to up to 6 months; 200 mg BID not recommended

Background

Orilissa (elagolix) is an oral gonadotropin‑releasing hormone (GnRH) receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis. Dosing and duration recommendations in the manufacturer labeling and referenced in this policy vary by dose and hepatic function: 150 mg once daily (QD) may be used for up to 24 months in patients with normal liver function or mild hepatic impairment (Child‑Pugh A); 200 mg twice daily (BID) dosing is limited to shorter durations (e.g., up to 6 months for dyspareunia); and dosing/duration should be reduced for patients with moderate hepatic impairment (Child‑Pugh B). This policy’s quantity limits and any allowable overrides are tied to these clinical dosing and hepatic function considerations.

Policy Summary

PayerCigna

PolicyOrilissa (elagolix) drug quantity management and coverage criteria

Policy CodePolicy N/A

Change TypeMaterial updates and clarifications to quantity limit overrides

Effective DateN/A

Next Review DateMay 29, 2024

Key ActionTo request the 365-per-365-days override for 150 mg dosing, submit documentation showing continuation of therapy and acceptable hepatic function.

SourceLink

On This Page

Orilissa 150 mg — Per-dispensing retail limit

ProductOrilissa 150 mg tablets — retail (per dispensing)

Per-dispensing limit30 tablets per Rx (retail)

Also applies to home delivery?See separate home delivery limit

Orilissa 150 mg — Per-dispensing home delivery limit

ProductOrilissa 150 mg tablets — home delivery (per dispensing)

Per-dispensing home delivery limit90 tablets per Rx (home delivery)

NoteHome delivery maximum per 365 days is 180 tablets (document) unless override criteria met

Orilissa 200 mg — Per-dispensing retail limit

ProductOrilissa 200 mg tablets — retail (per dispensing)

Per-dispensing limit60 tablets per Rx (retail)

Also applies to home delivery?See separate home delivery limit

Orilissa 200 mg — Per-dispensing home delivery limit

ProductOrilissa 200 mg tablets — home delivery (per dispensing)

Per-dispensing home delivery limit180 tablets per Rx (home delivery)

NoteHome delivery maximum per 365 days is 360 tablets (document)

Submit requests per the coverage criteria in this policy.
Include documentation of liver function (normal or Child-Pugh A) when applicable.
For 150 mg dosing override to 365 tablets/365 days, continuation of therapy documentation is required.
Bill using the most appropriate procedure and drug codes; claims lacking covered codes will be denied.

Prior Authorization

Continuation requirement

Continuation requirement: For approval of the Orilissa 150 mg tablets limit of 365 tablets per 365 days (24 months approval), the request must be for continuation of therapy and the patient must meet liver function criteria (normal liver function or mild hepatic impairment, Child‑Pugh A).

Continuation of therapy documentation is required for the 365 tablets per 365 days override for 150 mg dosing.
Patient must have normal liver function or mild hepatic impairment (Child‑Pugh A).

Denial Risk

Point-of-service rule fallback

Point-of-service fallback: If the Drug Quantity Management rule is not met at POS, adjudicators will determine coverage based on the criteria in this policy. Providers should ensure claims and prior authorization requests contain the necessary documentation to support coverage under those criteria.

If POS quantity limit denies at point of sale, submit supporting documentation for medical review per policy criteria.
Claims without required documentation or appropriate covered codes may be denied.