ModifiedColorado Rocky Mountain Health PlansPolicy 2025 P 1425-3

Omvoh™ (mirikizumab-mrkz) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Prior authorization/notification requirements for the subcutaneous formulation of Omvoh (mirikizumab-mrkz) for treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults for UnitedHealthcare Commercial Plans; includes initial authorization, reauthorization, and additional clinical rules.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOmvoh™ (mirikizumab-mrkz) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1425-3

Change TypeAdded Crohn's disease coverage criteria; annual review

Effective DateMay 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for the subcutaneous formulation of Omvoh per this program; authorization will be issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Crohn's disease.

Annual review with no change to clinical criteria; updated examples and reference.

Updated background and reference to package insert (January 2025).

2Covered Indications

12 moAuthorization Duration

subcutaneousFormulation Covered

Coverage Summary

Omvoh (mirikizumab-mrkz) is indicated for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease in adults. This policy applies to the subcutaneous formulation of Omvoh. The payer/scope for this program is UnitedHealthcare Commercial and the coverage stance is covered_with_criteria. Reference: Omvoh [package insert], Eli Lilly; January 2025.

Omvoh - Key Policy Facts

Policy number2025 P 1425-3

Effective date2025-05-01

Last review2025-03-01

Covered Indications2 (ulcerative colitis; Crohn's disease)

Authorization Duration12 months

Formulation CoveredSubcutaneous formulation

Initial Therapy Criteria

Initial Authorization - Ulcerative Colitis (maintenance dosing)

Omvoh will be approved based on both of the following criteria:

ALL of the following

Diagnosis of moderately to severely active ulcerative colitis
Patient is not receiving Omvoh in combination with another targeted immunomodulator
Examples of targeted immunomodulators: 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)

Initial Authorization - Crohn's Disease (maintenance dosing)

Omvoh will be approved based on both of the following criteria:

ALL of the following

Continuation / Reauthorization Criteria

Reauthorization - Ulcerative Colitis

Omvoh will be approved based on both of the following criteria:

ALL of the following

Documentation of positive clinical response to Omvoh therapy
Patient is not receiving Omvoh in combination with another targeted immunomodulator
Examples listed as in initial authorization

Reauthorization - Crohn's Disease

Omvoh will be approved based on both of the following criteria:

ALL of the following

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required for subcutaneous Omvoh

Prior authorization/notification is required for the subcutaneous formulation of Omvoh per this program; authorization will be issued for 12 months.

Documentation Required

Document clinical response for reauthorization

For reauthorization, providers must document positive clinical response to Omvoh therapy.

Background & Clinical References

Omvoh (mirikizumab-mrkz) is an interleukin-23 (IL-23) antagonist. It is approved for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease in adults. This program specifically covers the subcutaneous formulation of Omvoh. Reference: Omvoh [package insert], Eli Lilly; January 2025.

Reference: Omvoh [package insert], Eli Lilly; January 2025.

Revision History

2025-03material_change

Added coverage criteria for Crohn's disease.

2025-01annual_review

Annual review with no change to clinical criteria; updated examples and reference.

2025-01background_update

Updated background and reference to package insert (January 2025).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOmvoh™ (mirikizumab-mrkz) - Prior Authorization/Notification - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1425-3

Change TypeAdded Crohn's disease coverage criteria; annual review

Effective DateMay 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for the subcutaneous formulation of Omvoh per this program; authorization will be issued for 12 months.

SourceLink

On This Page

Diagnosis of moderately to severely active Crohn's disease

Patient is not receiving Omvoh in combination with another targeted immunomodulator

Examples include adalimumab, certolizumab (Cimzia), etanercept (Enbrel), baricitinib (Olumiant), abatacept (Orencia), upadacitinib (Rinvoq), golimumab (Simponi), risankizumab (Skyrizi), ustekinumab, tofacitinib (Xeljanz)

Documentation of positive clinical response to Omvoh therapy

Patient is not receiving Omvoh in combination with another targeted immunomodulator

Examples listed as in initial authorization for Crohn's disease

Denial Risk

Concomitant targeted immunomodulator exclusion

Claims may be denied if patient is receiving Omvoh in combination with another targeted immunomodulator as listed.

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)

Billing Rule

IV formulation medical benefit

The intravenous infusion formulation is typically covered under the medical benefit; refer to the UnitedHealthcare Drug Policy for Omvoh for medical-benefit billing.

Prior Authorization

Automated approvals permitted

UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated processes varies by program.

References to ICD-10 diagnosis codes for automated approvalsICD-10

No codes listed