CurrentCignaPolicy N/A

Gonadotropin-Releasing Hormone Antagonists - Orilissa Drug Quantity Management Policy - Per Rx and Per Days

Defines per-prescription and per-days quantity limits for Orilissa (elagolix) for Cigna-administered health benefit plans and the criteria for medically necessary exceptions; applies to dispensing at retail and home delivery.

Policy Summary

PayerCigna

PolicyOrilissa (elagolix) drug quantity management — per Rx and per days limits

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateMay 2, 2025

Next Review DateMay 2, 2025

Key ActionSubmit prior authorization when requesting quantities that exceed per‑Rx or per‑days limits and include documentation of liver function and continuation status.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30150 mg retail per Rx

180150 mg annual

60200 mg retail per Rx

360200 mg annual

24 mo150 mg continuation max

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Coverage Criteria for Orilissa (elagolix)

Orilissa 150 mg 'Per Days' Limit Exception

Exceptions to quantity limits for Orilissa 150 mg per-days limit

Approve 365 tablets per 365 days for up to 24 months

A - hepatic status: Patient has normal liver function OR mild hepatic impairment (Child-Pugh A)
either condition qualifies
B - therapy status: Request is for continuation of therapy
continuation required

Non-overridden limits

No overrides for 150 mg 'Per Rx': No overrides recommended for the 150 mg per-Rx limit30 tablets per Rx (retail)

Per Rx limit remains enforced

No overrides for 200 mg: No overrides recommended for 200 mg per-Rx or per-days limits60 tablets per Rx (retail); 360 per 365 days

No exceptions provided

Exceptions to the numeric quantity limits for Orilissa are limited to the specific criteria listed in this policy. Any other exception is considered not medically necessary.

Requests that do not meet the listed exception criteria will not be approved. This includes requests that exceed the per‑prescription or per‑365‑day quantity limits without satisfying the policy’s qualifying conditions (for example, lack of documented normal liver function or mild hepatic impairment (Child‑Pugh A) and lack of documentation that the request is for continuation of therapy). Such overrides are not medically necessary.

Provider Actions, Authorization, and Documentation

Prior Authorization

Quantity Limit Override Requires Exception Criteria

Quantity limit overrides require that the request meet the policy's exception criteria. Requests that exceed the per-Rx or per-days quantity limits for Orilissa (elagolix) must be supported by the clinical criteria described in the policy (see Criteria section). If the Drug Quantity Management rule is not met at point of service, an exception may only be approved when the documented clinical rationale satisfies the applicable exception criteria (e.g., continuation of therapy with required hepatic function status for 150 mg tablets).

Applies to per-Rx and per-365-day limits
See Criteria: continuation-of-therapy and hepatic function requirements for 150 mg tablets

Documentation Required

Provider Action — Follow Benefit Plan Terms

Providers must follow the terms of the applicable benefit plan when submitting coverage requests. Coverage determinations depend on plan language and may vary by client; refer to the member's benefit plan document for final coverage rules.

Cigna companies may provide utilization review only for some clients — plan documents govern final decisions
Submit requests with supporting documentation tied to the applicable benefit plan terms

Documentation Required

Provider Action — Documentation and Billing Guidance

When requesting authorization, include relevant clinical documentation to support medical necessity and any exception to quantity limits. Document indication, prior therapy, response to therapy, current hepatic function status (where relevant), and whether the request is for continuation of therapy.

Include liver function documentation for patients on Orilissa 150 mg when seeking a 365/365 approval
Indicate if request is continuation of therapy and duration of prior treatment

Denial Risk

If Quantity Management Rule Not Met at Point of Service

If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the criteria in the policy. For Orilissa 150 mg tablets, approval of 365 tablets per 365 days (24 months) is possible only when the patient meets BOTH: (A) normal liver function or mild hepatic impairment (Child-Pugh A), and (B) the request is for continuation of therapy. No overrides are recommended for Orilissa 150 mg per-Rx limits or for Orilissa 200 mg per-Rx or per-days limits outside the stated criteria.

Approvals provided for the duration noted in criteria (e.g., 24 months for qualifying 150 mg continuation requests)
No overrides recommended for 150 mg per-Rx limit or for 200 mg per-Rx and per-days limits

Background

Orilissa (elagolix) is an oral gonadotropin‑releasing hormone (GnRH) receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis. Recommended dosing varies by hepatic status and indication: 150 mg once daily may be used for up to 24 months in patients with normal liver function or mild hepatic impairment (Child‑Pugh A), while higher‑dose regimens (e.g., 200 mg twice daily) have shorter recommended durations and are limited in hepatic impairment. Continuation approvals under this policy are contingent on documented liver function and evidence the request is for ongoing therapy.

Definitions and Hepatic Function

Normal liver function (definition and relevance)

DefinitionNormal liver function — clinical assessment per prescriber; relevant because duration of therapy differs by hepatic status

Associated dosing (normal function)150 mg once daily (QD) up to 24 months; 200 mg twice daily (BID) up to 6 months for dyspareunia

Relevance to exceptionsNormal liver function qualifies under continuation criteria for approving increased per‑days quantity (365 tablets per 365 days for up to 24 months)

Moderate hepatic impairment (Child‑Pugh B)

DefinitionModerate hepatic impairment — Child‑Pugh Class B

Dosing restriction200 mg BID is not recommended in moderate hepatic impairment

Duration limit150 mg QD limited to up to 6 months in moderate hepatic impairment

Quantity Limits for Orilissa

Orilissa 150 mg — per‑prescription dispensing limits

Retail per‑Rx limit (150 mg)30 tablets per Rx (retail)

Home delivery per‑Rx limit (150 mg)90 tablets per Rx (home delivery)

NotePer‑Rx limits are enforced; exceptions require meeting specified criteria

Orilissa 150 mg — annual quantity limit and exception

Annual quantity limit (150 mg)180 tablets per 365 days

Continuation exceptionQualifying continuation therapy may allow approval up to 365 tablets per 365 days for up to 24 months when criteria met

EnforcementAny other exception is considered not medically necessary

Orilissa 200 mg — per‑prescription dispensing limits

Retail per‑Rx limit (200 mg)60 tablets per Rx (retail)

Home delivery per‑Rx limit (200 mg)180 tablets per Rx (home delivery)

NotePer‑Rx limits are enforced; no overrides recommended

Orilissa 200 mg — annual quantity limit and exception status

Annual quantity limit (200 mg)360 tablets per 365 days

ExceptionsNo overrides recommended for 200 mg per‑Rx or per‑days limits

NoteAny request exceeding limits without meeting listed criteria is not medically necessary