CurrentUnitedHealthcarePolicy 2025 P 1425-3

Omvoh (mirikizumab-mrkz) prior authorization

Prior authorization and notification requirements for subcutaneous Omvoh (mirikizumab-mrkz) for treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults; applies to UnitedHealthcare members subject to state and plan benefits.

Policy Summary

PayerUnitedHealthcare

PolicyOmvoh (mirikizumab-mrkz) prior authorization

Policy CodePolicy 2025 P 1425-3

Change TypeMaterial: added Crohn's disease criteria

Effective DateMay 1, 2025

Next Review Date

Key ActionInitial authorization requires diagnosis of moderately to severely active ulcerative colitis or Crohn's disease and no concomitant targeted immunomodulator.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Crohn's disease.

Updated background and reference; annual review with no change to clinical criteria noted earlier in 1/2025.

12 monthsauthorization duration

1program number

1/2024,1/2025,3/2025P&T approval dates

Jan 2025package insert

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

inv-01: Initial Therapy — Ulcerative Colitis — Covered when ALL of the following are met

Covered when ALL of the following are met

ref

inv-02: Initial Therapy — Crohn's Disease — Covered when ALL of the following are met

Covered when ALL of the following are met

ref

inv-03: Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Reauthorization: Documentation of positive clinical response to Omvoh therapy

AND patient is not receiving Omvoh in combination with another targeted immunomodulator

Use of Omvoh in combination with another targeted immunomodulator is excluded from coverage and will not be approved. Examples of prohibited concomitant agents include, but are not limited to: adalimumab; certolizumab (Cimzia); etanercept (Enbrel); vedolizumab (Entyvio); baricitinib (Olumiant); abatacept (Orencia); upadacitinib (Rinvoq); golimumab (Simponi); risankizumab (Skyrizi); ustekinumab; guselkumab (Tremfya); tofacitinib (Xeljanz/Xeljanz XR); and ozanimod (Zeposia).

Initial Therapy (Maintenance Dosing) Requirements

inv-11: Initial Therapy (Maintenance Dosing) — Initial authorization for maintenance dosing requires diagnosis and no concomitant targeted immunomodulator.

Initial authorization for maintenance dosing requires diagnosis and absence of concomitant targeted immunomodulator.

Initial therapy nodes: Diagnosis of moderately to severely active ulcerative colitis or Crohn's disease

Concomitant therapy exclusion: Patient is not receiving Omvoh in combination with another targeted immunomodulator (examples listed)

Examples listed in policy

Reauthorization / Continuation Criteria

inv-12: Reauthorization — Reauthorization requires documented positive clinical response and absence of concomitant targeted immunomodulator use.

Reauthorization requires documented positive clinical response and absence of concomitant targeted immunomodulator use.

Reauthorization nodes: Documentation of positive clinical response to Omvoh therapy

Concomitant therapy exclusion: Patient is not receiving Omvoh in combination with another targeted immunomodulator (examples listed)

Examples listed in policy

Provider Actions, Documentation, and Program-level Notes

Prior Authorization

Initial authorization – diagnosis and concomitant therapy restriction

Initial authorization for maintenance dosing requires documentation of a diagnosis of moderately to severely active ulcerative colitis. Approval is contingent on meeting the specified diagnosis criterion and other program requirements.

Diagnosis: moderately to severely active ulcerative colitis
Applies to initial maintenance dosing

Prior Authorization

Initial authorization – diagnosis and concomitant therapy restriction

Initial authorization for maintenance dosing requires documentation of a diagnosis of moderately to severely active Crohn's disease. Approval is contingent on meeting the specified diagnosis criterion and other program requirements.

Diagnosis: moderately to severely active Crohn's disease
Applies to initial maintenance dosing

Documentation Required

Reauthorization clinical response

Reauthorization requires documentation of positive clinical response to Omvoh therapy. Provide clinical notes or objective measures demonstrating improvement on therapy.

Documentation of positive clinical response required for continuation
Examples: symptom improvement, endoscopic findings, or physician assessment

Denial Risk

Concomitant targeted immunomodulator exclusion

Coverage may be denied if the patient is receiving Omvoh in combination with another targeted immunomodulator. Confirm the patient is not on concurrent targeted biologic or JAK inhibitor therapy prior to approval.

Concurrent targeted immunomodulators include (but are not limited to): adalimumab, certolizumab (Cimzia), etanercept (Enbrel), vedolizumab (Entyvio), baricitinib (Olumiant), abatacept (Orencia), upadacitinib (Rinvoq), golimumab (Simponi), risankizumab (Skyrizi), ustekinumab, guselkumab (Tremfya), tofacitinib (Xeljanz/Xeljanz XR), ozanimod (Zeposia)
Concurrent use may constitute a denial risk

Note

Program-level automation and step considerations

Other utilization management programs or prior-therapy requirements may apply per plan. UnitedHealthcare may use automated approval processes based on prior claim/medication history, diagnosis codes (ICD-10), and claim logic. Intravenous infusion coverage and supply limits may be governed by benefit design and the UnitedHealthcare Omvoh drug policy.

Automated approval/reapproval may use claims, medication history, and ICD-10 diagnosis codes
IV infusion typically billed to medical benefit per UnitedHealthcare Omvoh policy
Supply limits may apply

Program-level note	Details
Other utilization management programs or prior therapy requirements may apply
UnitedHealthcare may approve initial and re-authorization based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic; use of automated approval and re-approval processes varies by program and therapeutic class.

Site of Care / Benefit Considerations

Billing Rule

Site-of-care / billing: IV infusion billed to medical benefit (hospital outpatient)

The intravenous (IV) infusion formulation of Omvoh is typically billed and covered under the medical benefit (hospital outpatient); refer to the UnitedHealthcare medical policy for Omvoh IV formulation for specific billing and site-of-care rules.

Confirm medical benefit coverage and billing instructions per the UnitedHealthcare Omvoh medical policy when administering IV infusions in the hospital outpatient setting.

Policy Summary

PayerUnitedHealthcare

PolicyOmvoh (mirikizumab-mrkz) prior authorization

Policy CodePolicy 2025 P 1425-3

Change TypeMaterial: added Crohn's disease criteria

Effective DateMay 1, 2025

Next Review Date

Key ActionInitial authorization requires diagnosis of moderately to severely active ulcerative colitis or Crohn's disease and no concomitant targeted immunomodulator.

SourceLink

On This Page

OpenPayer

Omvoh (mirikizumab-mrkz) prior authorization

Coverage Criteria for Omvoh (mirikizumab-mrkz)

Initial Therapy (Maintenance Dosing) Requirements

Reauthorization / Continuation Criteria

Provider Actions, Documentation, and Program-level Notes

Drug Definition and Key Identifiers

Background and Clinical Overview

Step Therapy and Related Utilization Management

Quantity Limits and Supply Controls

Site of Care / Benefit Considerations