Currentsierra health and lifePolicy 2025D0129E

Omvoh (Mirikizumab-Mrkz) Medical Benefit Drug Policy

Defines UnitedHealthcare medical benefit coverage criteria, applicable codes, clinical indications (moderately to severely active ulcerative colitis and Crohn's disease in adults), dosing form (three IV induction doses) and benefit considerations including pharmacy vs medical benefit routing and prior authorization for induction doses.

Policy Summary

Payersierra health and life

PolicyOmvoh (Mirikizumab-Mrkz) Medical Benefit Drug Policy

Policy CodePolicy 2025D0129E

Change TypeAdded language on benefit routing for self-administered subcutaneous product; archived prior version

Effective DateOct 1, 2025

Next Review Date

Key ActionPrior authorization review is required for 3 IV induction doses; ensure prescribed by or in consultation with a gastroenterologist and follow benefit routing guidance for self‑administered subcutaneous Omvoh.

POLICY UPDATE CHANGES

Added language clarifying Omvoh for self-administered subcutaneous injection is obtained under the pharmacy benefit unless specified in the member's benefit plan; exception for certain UnitedHealthcare of California plans allowing medical benefit routing.

2Covered Indications

3Induction Doses Authorized

1HCPCS codes listed

Coverage Summary

Defines UnitedHealthcare medical benefit coverage criteria for Omvoh (mirikizumab-mrkz) (Policy Number: 2025D0129E, Effective Date: October 1, 2025). Applicable clinical indications are moderately to severely active ulcerative colitis and Crohn's disease in adults. Initial/induction therapy is administered as three intravenous induction doses (authorization issued for 3 induction doses). Benefit considerations note that self-administered subcutaneous Omvoh is obtained under the pharmacy benefit unless the member's benefit plan specifies otherwise, with an exception for certain UnitedHealthcare of California delegated provider groups where self-administered Omvoh may be obtained under the medical benefit. Prior authorization review is required for induction doses and criteria-based authorization is consistent with the policy.

Initial Therapy Criteria — Ulcerative Colitis (Induction)

Proven Indication - Ulcerative Colitis (initial authorization for induction)

Omvoh is proven for the treatment of ulcerative colitis when ALL of the following criteria are met:

ALL of the following

Diagnosis of moderately to severely active ulcerative colitis
Omvoh is to be administered as three intravenous induction doses
Omvoh induction dosing is in accordance with the United States Food and Drug Administration (FDA) labeled dosing for UC
Patient is not receiving Omvoh in combination with another targeted immunomodulator (examples: Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), Stelara (ustekinumab), Skyrizi (risankizumab))
Authorization will be issued for 3 induction doses

Continuation / Maintenance Criteria — Ulcerative Colitis

Medically Necessary - Ulcerative Colitis (maintenance/continued therapy authorization)

Omvoh is medically necessary for the treatment of ulcerative colitis when ALL of the following criteria are met:

ALL of the following

Diagnosis of moderately to severely active ulcerative colitis
ONE of the following
- Patient has had prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine)
- Patient has been previously treated with a targeted immunomodulator FDA-approved for the treatment of ulcerative colitis (examples: adalimumab, infliximab, Entyvio (vedolizumab), Rinvoq (upadacitinib), Simponi (golimumab), Skyrizi (risankizumab-rzaa), Stelara (ustekinumab), Xeljanz (tofacitinib))
Omvoh is to be administered as three intravenous induction doses
Omvoh induction dosing is in accordance with the U.S FDA labeled dosing for UC
Patient is not receiving Omvoh in combination with another targeted immunomodulator (examples listed above)
Prescribed by or in consultation with a gastroenterologist
Authorization will be issued for 3 induction doses

Initial Therapy Criteria — Crohn's Disease (Induction)

Proven Indication - Crohn's Disease (initial authorization for induction)

Omvoh is proven for the treatment of Crohn's disease when ALL of the following criteria are met:

ALL of the following

Diagnosis of moderately to severely active Crohn's disease
Omvoh is to be administered as three intravenous induction doses
Omvoh induction dosing is in accordance with the United States Food and Drug Administration (FDA) labeled dosing for CD
Patient is not receiving Omvoh in combination with another targeted immunomodulator (examples: adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Olumiant (baricitinib), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Skyrizi (risankizumab-rzaa), Stelara (ustekinumab), Xeljanz (tofacitinib))
Authorization will be issued for 3 induction doses

Continuation / Maintenance Criteria — Crohn's Disease

Medically Necessary - Crohn's Disease (maintenance/continued therapy authorization)

Omvoh is medically necessary for the treatment of Crohn's disease when ALL of the following criteria are met:

ALL of the following

Diagnosis of moderately to severely active Crohn's disease
ONE of the following
- History of failure to one of the following conventional therapies at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced: Corticosteroids (e.g., prednisone, methylprednisolone, budesonide); 6-mercaptopurine (Purinethol); Azathioprine (Imuran); Methotrexate (Rheumatrex, Trexall)
- Patient has been previously treated with a targeted immunomodulator FDA-approved for the treatment of Crohn's disease (examples: adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Olumiant (baricitinib), Orencia (abatacept), Rinvoq (upadacitinib), Simponi (golimumab), Skyrizi (risankizumab-rzaa), Stelara (ustekinumab), Xeljanz (tofacitinib))
Omvoh is to be administered as three intravenous induction doses
Omvoh induction dosing is in accordance with the United States Food and Drug Administration (FDA) labeled dosing for CD
Patient is not receiving Omvoh in combination with another targeted immunomodulator (examples listed above)
Prescribed by or in consultation with a gastroenterologist
Authorization will be issued for 3 induction doses

Provider Actions and Billing Rules

Prior Authorization

Prior authorization required for induction doses

Prior authorization review is required for induction dosing. Authorization will be issued for 3 induction doses. Prior authorization must be consistent with the policy criteria, including appropriate diagnosis, documentation of prior therapy failures or prior targeted immunomodulator exposure where required, and that induction dosing is administered as three intravenous induction doses. Affected HCPCS code: J2267 (Injection, mirikizumab-mrkz, 1 mg).

Affected code: J2267
Authorization issued for 3 induction doses
Prior authorization review consistent with policy criteria: diagnosis, prior therapy failures or prior targeted immunomodulator exposure, and dosing as 3 IV induction doses

Documentation Required

Specialist prescription or consultation required

Prescribed by or in consultation with a gastroenterologist is required for medically necessary authorization for both ulcerative colitis and Crohn's disease indications.

Billing Rule

Benefit routing for self-administered subcutaneous product

Self‑administered subcutaneous Omvoh is obtained under the pharmacy benefit unless the member's benefit plan specifies otherwise. Exception: for members enrolled in UnitedHealthcare of California plans with a delegated provider group conducting the prior authorization review, self‑administered Omvoh may be obtained under the medical benefit.

Applicable Codes

HCPCS - Injectable drug codeHCPCS

J2267

Injection, mirikizumab-mrkz, 1 mg

ICD-10 - Crohn's disease diagnosis codes referencedICD-10

K50.00	Crohn's disease of small intestine without complications
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

1–10 of 28

1/3

ICD-10 - Ulcerative colitis diagnosis codes referencedICD-10

K51.00	Ulcerative (chronic) pancolitis without complications
K51.011	Ulcerative (chronic) pancolitis with rectal bleeding
K51.012	Ulcerative (chronic) pancolitis with intestinal obstruction
K51.013	Ulcerative (chronic) pancolitis with fistula
K51.014	Ulcerative (chronic) pancolitis with abscess
K51.018	Ulcerative (chronic) pancolitis with other complication
K51.019	Ulcerative (chronic) pancolitis with unspecified complications
K51.20	Ulcerative (chronic) proctitis without complications
K51.211	Ulcerative (chronic) proctitis with rectal bleeding
K51.212	Ulcerative (chronic) proctitis with intestinal obstruction

1–10 of 49

1/5

Clinical Evidence

24%UC‑1 clinical remission at Week 12 (mirikizumab) vs 15% placebo

65%UC‑1 clinical response at Week 12 (mirikizumab) vs 43% placebo

22%UC‑2 endoscopic remission at Week 40 (mirikizumab) vs 14% placebo

34%CD‑1 clinical remission at Week 12 (mirikizumab) vs 23% placebo

10%CD‑1 endoscopic remission at Week 12 (mirikizumab) vs 4% placebo

Clinical development included randomized, double-blind, placebo-controlled induction and maintenance trials for ulcerative colitis (UC-1 induction and UC-2 maintenance) and a randomized study in Crohn's disease (CD-1). In these trials induction therapy was given intravenously and responders continued on subcutaneous maintenance. Key efficacy results include the UC-1/UC-2 and CD-1 findings summarized in the policy evidence section (e.g., clinical remission and response outcomes at Week 12 and Week 40/52) and are reflected as evidence summaries in the policy.

Background and Definitions

Omvoh (mirikizumab-mrkz) is a humanized IgG4 monoclonal antibody that selectively binds the p19 subunit of IL-23, inhibiting interaction with the IL-23 receptor. It is indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults. Clinical dosing in trials and per the policy uses an intravenous induction regimen followed by subcutaneous maintenance administration.

Term	Definition
Induction dosing	Administration as three intravenous doses (per FDA labeled dosing) for initial treatment.
Targeted immunomodulator	Biologic or small molecule agents listed in policy examples (e.g., adalimumab, infliximab, vedolizumab, tofacitinib, upadacitinib, risankizumab, ustekinumab, golimumab, certolizumab, etanercept, abatacept, baricitinib).

Revision History

2025-10-01policy_effective_date

Policy effective date published as October 1, 2025.

2025-10-01material_change_addedLatest

Added language clarifying Omvoh for self-administered subcutaneous injection is obtained under the pharmacy benefit unless otherwise specified in the member's benefit plan; exception for members enrolled in UnitedHealthcare of California plans with a delegated provider group conducting the prior authorization review allowing the self-administered Omvoh to be obtained under the medical benefit.

archived_previous_version

Archived previous policy version 2025D0129D.

Policy Summary

Payersierra health and life

PolicyOmvoh (Mirikizumab-Mrkz) Medical Benefit Drug Policy

Policy CodePolicy 2025D0129E

Change TypeAdded language on benefit routing for self-administered subcutaneous product; archived prior version

Effective DateOct 1, 2025

Next Review Date

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