CurrentCignaPolicy IP0662

Omvoh Intravenous Prior Authorization Policy

Cigna coverage policy specifying prior authorization, clinical criteria, dosing, and coding for Omvoh IV (mirikizumab-mrkz) for induction treatment of Crohn's disease and ulcerative colitis in adults; includes not-covered circumstances and appendix of related biologics and oral targeted therapies.

Policy Summary

PayerCigna

PolicyDrug Coverage Policy — Omvoh Intravenous Prior Authorization Policy

Policy CodePolicy IP0662

Change TypeRevisions (criteria and administrative edits)

Effective DateMar 15, 2026

Next Review Date

Key ActionPrior Authorization is required; submit documentation of age, indication (induction), and gastroenterologist prescribing/consultation to support a 3-month approval.

SourceLink

POLICY UPDATE CHANGES

Policy created as new on 11/01/2024 and subsequently revised multiple times including adding Crohn's disease and other editorial/criteria updates through 03/15/2026.

Most recent selected revision dated 03/15/2026 removed specific initial therapy options for Crohn's Disease.

Annual Revision 03/01/2026: No criteria changes noted (administrative).

2Covered Indications (induction)

3 monthsInitial approval duration

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Primary billing code

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Cigna coverage policy specifying prior authorization, clinical criteria, dosing, and coding for Omvoh IV (mirikizumab-mrkz) for induction treatment of Crohn's disease and ulcerative colitis in adults; includes not-covered circumstances and appendix of related biologics and oral targeted therapies. Subject: Omvoh (mirikizumab-mrkz) intravenous prior authorization. Status: CURRENT. Effective / Last review date: 2026-03-15.

FDA-Approved Indications - Crohn's Disease (Induction)

Approve three doses for induction if the patient meets ALL of the following (A, B, and C):

ALL of the following

Patient is ≥ 18 years of age
The medication will be used as induction therapy
The medication is prescribed by or in consultation with a gastroenterologist

FDA-Approved Indications - Ulcerative Colitis (Induction)

Approve three doses for induction if the patient meets ALL of the following (A, B, and C):

ALL of the following

Patient is ≥ 18 years of age
The medication will be used as induction therapy
The medication is prescribed by or in consultation with a gastroenterologist

Dosing / Duration (Induction)

Dosing - Crohn's Disease (Induction)

Dosing for approved Crohn's disease induction:

ALL of the following

IV induction dosing: Approve 900 mg as an intravenous infusion administered at Weeks 0, 4, and 8
Approval provided for three months to allow three doses
Maintenance note: Following IV induction, maintenance dosing is Omvoh 300 mg SC at Week 12 then every 4 weeks (per prescribing information)
Maintenance SC is mentioned but this policy's PA is for IV induction

Dosing - Ulcerative Colitis (Induction)

Dosing for approved ulcerative colitis induction:

ALL of the following

Not Medically Necessary / Exclusions

Not Medically Necessary / Conditions Not Covered

Omvoh intravenous for any other use is considered not medically necessary, including but not limited to:

Examples of not covered uses

Concurrent use with another biologic for an inflammatory condition
Concurrent use with a targeted synthetic oral small molecule drug for an inflammatory condition
Any use not meeting the above FDA-approved induction criteria
Combination biologic/targeted synthetic therapy is generally not recommended due to higher adverse events and lack of controlled data
Does NOT exclude conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) in combination

Applicable Codes

Covered J-code for mirikizumabHCPCSCovered

J2267

Injection, mirikizumab-mrkz, 1 mg

When billing, providers must use the most appropriate codes as of the service date; claims without covered codes under this policy will be denied as not covered.

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required for benefit coverage of Omvoh IV. Approval is recommended for patients who meet the policy Criteria and Dosing. All approvals are provided for three months to allow the patient to receive three induction doses.

J2267

Documentation Required

Specialist prescriber documentation

Initial approval requires Omvoh IV to be prescribed by or in consultation with a physician who specializes in the condition being treated (gastroenterologist). Documentation should include the patient's age, the indication as induction therapy, and evidence of specialist involvement.

Clinical Evidence & References

Evidence sources include: FDA prescribing information — Omvoh IV infusion, SC injection; Eli Lilly; April 2024.

Guidelines referenced — ACG 2025 and AGA 2024/2025 clinical practice guidelines for Crohn's disease and ulcerative colitis.

Background

Background: Omvoh IV (mirikizumab-mrkz) is a monoclonal antibody against the IL-23 p19 subunit indicated for induction treatment of moderate to severe Crohn's disease and ulcerative colitis in adults. Induction regimens differ by indication — 900 mg IV at Weeks 0, 4, and 8 for Crohn's disease and 300 mg IV at Weeks 0, 4, and 8 for ulcerative colitis — with subsequent subcutaneous maintenance per prescribing information. This prior authorization policy covers the IV induction regimen only.

Definition

TermInduction therapy

DefinitionInitial treatment regimen intended to induce remission; for Omvoh IV defined as three IV infusions at Weeks 0, 4, and 8 per indication-specific dosing.

Typical course for CD900 mg IV at Weeks 0, 4, and 8 (three infusions)

Typical course for UC300 mg IV at Weeks 0, 4, and 8 (three infusions)

Revision History

11/01/2024policy_created

Policy created as new (New policy).

03/15/2025policy_revised

Crohn's disease added to the policy as a newly approved condition.

04/01/2025policy_revised

Preferred product note edits: removed certain Prescription Drug Lists from the 'Note' and Omvoh moved to a preferred product for those lists.

Policy Summary

PayerCigna

PolicyDrug Coverage Policy — Omvoh Intravenous Prior Authorization Policy

Policy CodePolicy IP0662

Change TypeRevisions (criteria and administrative edits)

Effective DateMar 15, 2026

Next Review Date

Key ActionPrior Authorization is required; submit documentation of age, indication (induction), and gastroenterologist prescribing/consultation to support a 3-month approval.

SourceLink

On This Page

IV induction dosing: Approve 300 mg as an intravenous infusion administered at Weeks 0, 4, and 8
Approval provided for three months to allow three doses
Maintenance note: Following IV induction, maintenance dosing is Omvoh 200 mg SC at Week 12 then every 4 weeks (per prescribing information)
Maintenance SC is mentioned but this policy's PA is for IV induction

Quick facts — approval & dosing

Initial approval duration3 months

Age requirementPatient is ≥ 18 years

Covered indications (induction)Crohn's disease; Ulcerative colitis (2)

Crohn's disease induction dosing900 mg IV at Weeks 0, 4, and 8

Ulcerative colitis induction dosing300 mg IV at Weeks 0, 4, and 8

Definition - Induction therapy: Initial treatment regimen intended to induce remission; for Omvoh IV defined as three IV infusions at Weeks 0, 4, and 8 per indication-specific dosing.

Provider Actions - Prescriber requirement: Omvoh IV must be prescribed by or in consultation with a physician who specializes in the condition being treated (gastroenterologist); specialist involvement is required for initial approval and documentation of age, indication (induction), and specialist involvement should be provided.

Note: Combination biologic/targeted synthetic therapy is generally not recommended and requests for Omvoh IV in combination with another biologic or targeted synthetic oral small molecule for an inflammatory condition are considered not medically necessary and may be denied.

Step Therapy

Preferred product requirement for Individual and Family Plans

This product requires use of preferred products before approval for Individual and Family Plans per the Inflammatory Conditions - Omvoh Intravenous Preferred Specialty Management Policy (PSM011). Refer to PSM011 for additional preferred product criteria and exceptions; the preferred-product requirement applies specifically to Individual and Family Plans.

PSM011

Denial Risk

Combination therapy exclusion

Requests for Omvoh IV in combination with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition are considered not medically necessary and may be denied.

Billing Rule

Dosing/billing alignment

When billing, providers must use the most appropriate codes as of the service date. Claims submitted without covered code(s) under this policy will be denied as not covered. Use the covered J-code for mirikizumab when applicable.

J2267

09/01/2025policy_revised

Ulcerative Colitis: For initial therapy, removed specific options of approval related to prior therapies (e.g., tried one systemic therapy; pouchitis with specified treatments).

03/01/2026annual_revision

Annual Revision: No criteria changes; Appendix updated to add Otezla XR (apremilast extended-release tablets).

03/15/2026policy_revisedLatest

Selected Revision: For Crohn's Disease initial therapy, several options of approval were removed (removal of specified initial therapy options).