ModifiedCignaPolicy IP0662

Omvoh Intravenous Prior Authorization Policy

Defines prior authorization, coverage criteria, dosing, and coding for Omvoh intravenous induction therapy for adults with moderate to severe Crohn's disease or ulcerative colitis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOmvoh Intravenous Prior Authorization Policy

Policy CodePolicy IP0662

Change TypeMaterial revisions — added Crohn's, narrowed UC options, preferred-product placement

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization for Omvoh IV and document that the patient meets the indication-specific criteria and three-dose induction dosing.

SourceLink

POLICY UPDATE CHANGES

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

Ulcerative colitis initial therapy approval options were narrowed by removing specified prior-therapy options.

Omvoh intravenous moved to a preferred product for certain employer prescription drug lists and direction to specific PSM019 content was removed.

2FDA-approved indications (CD, UC)

3-dose3-dose induction

3 monthsApproval duration

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Coverage Criteria for Omvoh (mirikizumab-mrkz) IV

Billing and Codes

Considered Medically Necessary HCPCS CodesHCPCSCovered

J2267

Injection, mirikizumab-mrkz, 1 mg

Drug list (no billing codes provided)mixed

No codes listed

Age

Minimum age>= 18 years

Applies toAdults with Crohn's disease or ulcerative colitis being considered for induction therapy

Source policy notePatient must be >= 18 years as part of indication-specific criteria for induction

Prior Authorization, Prescribing, and Billing Actions

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Omvoh IV. Approval is recommended for those who meet the Criteria and Dosing for the listed indication. Extended approvals are allowed if the patient continues to meet the Criteria and Dosing. Requests for doses outside of the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (i.e., Medical Director or Pharmacist).

All approvals are provided for three months (adequate duration for the patient to receive three doses).
Initial approval requires Omvoh IV to be prescribed by or in consultation with a physician who specializes in the condition being treated (specialist prescribing or consultation required).
Refer to the Inflammatory Conditions - Omvoh Intravenous Preferred Specialty Management Policy (PSM011) for preferred product requirements and exceptions.

Documentation Required

Specialist Prescribing and Approval Length

Requests for doses outside the dosing documented in this policy will be reviewed by a clinician on a case-by-case basis. Receipt of sample product does not satisfy any criteria requirements for coverage.

FDA-approved induction dosing for Crohn's Disease: 900 mg IV at Weeks 0, 4, and 8 (approve three doses when criteria met).
FDA-approved induction dosing for Ulcerative Colitis: 300 mg IV at Weeks 0, 4, and 8 (approve three doses when criteria met).
All approvals are issued for three months; continuation requires meeting ongoing criteria.

Note

Appendix: Biologic and Oral Therapies (Informational)

Appendix: This policy includes an informational listing of biologic and oral therapies (agents, formulations, mechanisms, and example indications). This list is not all-inclusive; refer to prescribing information for FDA-approved indications.

Biologic agents (examples from appendix): Cosentyx (secukinumab) – IL-17A inhibitor; Taltz (ixekizumab) – IL-17A inhibitor; Bimzelx (bimekizumab) – IL-17A/17F inhibitor; Ilumya (tildrakizumab) – IL-23 inhibitor; Skyrizi (risankizumab) – IL-23 inhibitor; Tremfya (guselkumab) – IL-23 inhibitor; Entyvio (vedolizumab) – integrin receptor antagonist.
Oral therapies/targeted synthetic agents (examples from appendix): Otezla (apremilast) – PDE4 inhibitor; Cibinqo (abrocitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), Xeljanz (tofacitinib) – JAK pathway inhibitors; Sotyktu (deucravacitinib) – TYK2 inhibitor; Zeposia (ozanimod), Velsipity (etrasimod) – S1P receptor modulators.
*Not an all-inclusive list; see Appendix and prescribing information for additional agents, formulations, mechanisms, and example indications.

Denial Risk

Coding-based Denial Risk

Claims submitted for services that are not accompanied by covered diagnosis or procedure codes under the applicable Coverage Policy will be denied as not covered.

Ensure billing uses the most appropriate codes as of the date of service.
Claims without covered diagnosis or procedure codes referenced in this Coverage Policy will be denied.

Documentation Required

Provider Actions

Provider actions: When submitting prior authorization requests include documentation that demonstrates the patient meets the indication-specific criteria (age, induction vs continuation intent, prior therapy trials or contraindications, presence of fistulas or prior surgery when applicable) and the specialist prescribing or consult note. For dose or regimen requests outside policy-specified dosing, include rationale and supporting clinical documentation for clinical review.

For Crohn's Disease induction approval include: patient age ≥ 18; intent for induction therapy; evidence of prior systemic corticosteroid use or contraindication, or trial of another conventional systemic therapy, or presence of enterocutaneous/rectovaginal fistulas, or history of ileocolonic resection; and gastroenterologist prescribing or consult note.
For Ulcerative Colitis induction approval include: patient age ≥ 18; intent for induction therapy; and gastroenterologist prescribing or consult note.
Include prior medication history (biologics, conventional systemic agents) and any contraindications to therapies; a biosimilar of the requested biologic does not count as a trial of another biologic for exception to step requirements.

Background on Omvoh (mirikizumab-mrkz)

Omvoh (mirikizumab‑mrkz) is a monoclonal antibody that targets the p19 subunit of interleukin‑23 (IL‑23 p19), inhibiting the IL‑23 signaling pathway involved in inflammatory bowel disease. It is indicated for induction treatment of moderate to severe Crohn's disease and ulcerative colitis in adults. Induction dosing is delivered as a three‑dose IV regimen (Crohn's disease: 900 mg IV at Weeks 0, 4, and 8; ulcerative colitis: 300 mg IV at Weeks 0, 4, and 8), with maintenance therapy administered subcutaneously after induction per the prescribing information.

Dosing Regimens and Abbreviations

Induction regimen — Crohn's disease / Ulcerative colitis

Crohn's disease induction regimen900 mg IV at Weeks 0, 4, and 8

Induction dose formIntravenous (IV) infusion

Authorization implicationPolicy approves three IV induction doses when criteria met

Induction regimen — Ulcerative colitis

Ulcerative colitis induction regimen300 mg IV at Weeks 0, 4, and 8

Maintenance transition (post-induction)See maintenance dosing: transition to SC injections at Week 12

Dosing context