ModifiedUnitedHealthcarePolicy 2026D0129F

Omvoh (mirikizumab-mrkz) — Coverage Criteria for Ulcerative Colitis and Crohn's Disease

Defines UnitedHealthcare Commercial and Individual Exchange coverage and medical necessity criteria for Omvoh (mirikizumab-mrkz) when used for moderately to severely active ulcerative colitis or Crohn's disease; applies to plan members subject to each benefit plan's terms.

Policy Summary

PayerUnitedHealthcare

PolicyOmvoh (mirikizumab-mrkz) — Coverage Criteria for Ulcerative Colitis and Crohn's Disease

Policy CodePolicy 2026D0129F

Change TypeRevised coverage criteriaupdated examples and application

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for initiation; authorization will be issued for three IV induction doses when medical necessity criteria are met.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria to clarify combination therapy restriction to 'the patient is not receiving Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication'.

Updated examples of systemic targeted immunomodulators not to be used in combination with Omvoh for ulcerative colitis and Crohn's disease (added vedolizumab, guselkumab, ozanimod in UC; added vedolizumab and guselkumab in CD; removed several older examples).

Application section indicating this policy applies to UnitedHealthcare Commercial and Individual Exchange benefit plans.

3induction IV doses authorized

J2267HCPCS code

Moderately to severely active

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Coverage and Medical Necessity Criteria

Initial therapy — Ulcerative Colitis

Covered when ALL of the following are met

UC Initial Induction: Diagnosis of moderately to severely active ulcerative colitis

UC Induction Route: Omvoh is to be administered as three intravenous induction doses3 IV doses

Authorization will be issued for 3 induction doses

UC Dosing: Omvoh induction dosing is in accordance with the United States Food and Drug Administration (FDA) labeled dosing for UCFDA labeled dosing

UC Concomitant Therapy: Patient is not receiving Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication

Examples of systemic targeted immunomodulators listed in policy (e.g., adalimumab, vedolizumab, upadacitinib, golimumab, risankizumab, guselkumab, tofacitinib, ustekinumab, ozanimod)

Initial therapy — Crohn's Disease

Covered when ALL of the following are met

CD Diagnosis: Diagnosis of moderately to severely active Crohn's disease

CD Induction Route: Omvoh is to be administered as three intravenous induction doses3 IV doses

Authorization will be issued for 3 induction doses

CD Dosing: Omvoh induction dosing is in accordance with the United States Food and Drug Administration (FDA) labeled dosing for CDFDA labeled dosing

CD Prior Therapy: Either history of failure to one of the following conventional therapies at up to maximally indicated doses unless contraindicated (corticosteroids, 6-mercaptopurine, azathioprine, methotrexate) OR prior treatment with a systemic targeted immunomodulator FDA‑approved for Crohn's disease

Community Plan — UC coverage

Community Plan — Covered when ALL of the following are met

Diagnosis of moderately to severely active ulcerative colitis

Prior Therapy or Biologic: Patient has had prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine) OR has been previously treated with a systemic targeted immunomodulator FDA‑approved for the treatment of ulcerative colitis

Examples of prior targeted immunomodulators listed in policy

Administration and Prescriber: Omvoh administered as three IV induction doses per FDA labeled dosing and prescribed by or in consultation with a gastroenterologist3 IV doses

Authorization will be issued for 3 induction doses

Initial therapy coverage criteria

Covered when ALL of the following are met (initial therapy for adults):

Indication: Diagnosis of moderately to severely active ulcerative colitis or moderately to severely active Crohn's disease in an adult

Supported by FDA indication and trial populations.

Prior therapy/failure: History of inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate), and/or biologic therapy as applicable

Reflects populations enrolled in UC-1/UC-2 and CD-1.

Combination therapy restriction: Patient is not receiving Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication

Policy revised to specify 'systemic targeted immunomodulator' and updated example list.

Maintenance therapy coverage criteria

Covered for continuation/maintenance when ALL of the following are met:

Response to induction: Patient achieved clinical response during induction (e.g., Week 12 response in UC) to qualify for maintenance therapy as per trial design

UC-2 enrolled Week 12 responders; maintenance efficacy demonstrated in trial.

Ongoing disease management: Continued use at maintenance dosing (e.g., 200 mg SC every 4 weeks in UC‑2) with documentation of continued clinical benefit (clinical remission or steroid‑free remission as applicable)

Maintenance dosing/regimen per trials; corticosteroid tapering required for those on steroids at baseline who responded.

Patient use of Omvoh in combination with another systemic targeted immunomodulator for the same indication is not allowed. This policy requires that, for coverage of Omvoh in ulcerative colitis, the patient is not receiving Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication. Examples of agents listed in the policy include biologics and targeted therapies such as adalimumab, vedolizumab, upadacitinib, golimumab, risankizumab, guselkumab, tofacitinib, ustekinumab, and ozanimod. Authorization for induction will be issued for 3 intravenous induction doses when the remaining medical necessity criteria are met.

For Crohn's disease coverage, the policy excludes combination use: the patient must not be receiving Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication. The Crohn's criteria explicitly list examples of systemic targeted immunomodulators (e.g., adalimumab, certolizumab, vedolizumab, upadacitinib, risankizumab, guselkumab, ustekinumab) that should not be used concurrently. The revised policy language clarifies the prohibition applies to other systemic targeted immunomodulators given for the same condition and aligns prior-authorization adjudication with this restriction.

Requests will not meet medical necessity when they lack a documented diagnosis of moderately to severely active ulcerative colitis or Crohn's disease, when the intended induction regimen does not follow the FDA-labeled schedule of three intravenous induction doses, or when Omvoh is being combined with another systemic targeted immunomodulator for the same indication. Documentation should support the diagnosis, the planned IV induction dosing, and that the patient is not receiving a prohibited concomitant systemic targeted immunomodulator.

FDA approval of Omvoh is provided for informational context only and does not by itself establish coverage. Coverage decisions require that therapy meet the policy's medical necessity criteria and any applicable member benefit terms; FDA approval alone is not a basis for coverage under this policy.

Billing Codes and Clinical Code References

Applicable HCPCSHCPCSCovered

J2267

Injection, mirikizumab-mrkz, 1 mg.

Crohn's disease ICD-10 codes (partial list)ICD-10

K50.011	Crohn's disease of small intestine with rectal bleeding.
K50.012	Crohn's disease of small intestine with intestinal obstruction.
K50.013	Crohn's disease of small intestine with fistula.
K50.014	Crohn's disease of small intestine with abscess.
K50.018	Crohn's disease of small intestine with other complication.
K50.019	Crohn's disease of small intestine with unspecified complications.
K50.10	Crohn's disease of large intestine without complications.
K50.111	Crohn's disease of large intestine with rectal bleeding.
K50.112	Crohn's disease of large intestine with intestinal obstruction.
K50.113	Crohn's disease of large intestine with fistula.

1–10 of 13

1/2

Ulcerative colitis ICD-10 codes (partial list)ICD-10

K51.00	Ulcerative (chronic) pancolitis without complications.
K51.011	Ulcerative (chronic) pancolitis with rectal bleeding.
K51.013	Ulcerative (chronic) pancolitis with fistula.
K51.014	Ulcerative (chronic) pancolitis with abscess.
K51.20	Ulcerative (chronic) proctitis without complications.
K51.311	Ulcerative (chronic) recto sigmoiditis with rectal bleeding.
K51.30	Ulcerative (chronic) recto sigmoiditis without complications.
K51.50	Left sided colitis without complications.
K51.90	Ulcerative colitis, unspecified, without complications.

Other applicable ICD-10ICD-10

K52.1

Toxic gastroenteritis and colitis

Prior authorization / affected codesmixed

affected codes

Policy references prior authorization and affected billing codes but specific CPT/HCPCS/NDC codes not provided in this document section.

modified Mayo score (mMS) — thresholds

mMS induction eligibilityModified Mayo score (mMS) 5–9 (subjects in UC-1 had baseline mMS 5 to 9)

Severe disease definitionSevere disease defined as mMS 7–9 (58% had mMS 7–9 in UC-1)

Scale rangemMS ranges from 0 to 9

Disease activity entry thresholds

UC entry thresholdmMS 5–9 with centrally read endoscopy subscore of 2 or 3

CD CDAI threshold

Prior Authorization, Documentation, and Actionable Provider Guidance

Prior Authorization

Prior Authorization Required

Prior authorization required for initiation. Authorization will be issued for three induction doses when medical necessity criteria are met.

Authorization = 3 induction doses (IV at Week 0, 4, 8 per FDA labeling)
Prescriber = required to be or consult with a gastroenterologist for certain plans

Documentation Required

Required Clinical Documentation

Documentation must support the diagnosis and clinical severity and include objective disease activity measures, prior therapy history, and a dosing plan. Include medication reconciliation showing the member is not receiving Omvoh in combination with another systemic targeted immunomodulator for the same indication.

Ulcerative colitis: diagnosis of moderately to severely active disease with modified Mayo score (mMS) and endoscopic subscore as appropriate

Background and Drug Overview

Omvoh (mirikizumab-mrkz) is a humanized IgG4 monoclonal antibody that selectively binds the p19 subunit of the interleukin-23 (IL-23) cytokine, inhibiting interaction with the IL-23 receptor and modulating mucosal inflammation. Clinical development included an intravenous induction program and subsequent maintenance evaluation for ulcerative colitis; Omvoh is indicated for moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease in adults.

Definitions and Clinical Scoring

Omvoh (mirikizumab-mrkz)

Drug classHumanized IgG4 monoclonal antibody targeting the p19 subunit of IL‑23

MechanismBinds IL‑23 p19 subunit and inhibits interaction with IL‑23 receptor

Inflammation roleModulates mucosal inflammation via effects on T‑cell and innate immune subsets

modified Mayo score (mMS) — definition and components

ComponentsThree subscores: stool frequency, rectal bleeding, and centrally read endoscopy subscore

Subscore scoringEach subscore scored 0 (normal) to 3 (most severe)

Purpose