CurrentUnitedHealthcarePolicy 2025 P 2320-3

Omvoh (mirikizumab-mrkz) prior authorization / medical necessity

Defines UnitedHealthcare prior authorization and medical necessity requirements for subcutaneous Omvoh for adults with moderately to severely active ulcerative colitis or Crohn's disease; applies to providers seeking coverage under UnitedHealthcare medical/pharmacy benefits.

Policy Summary

PayerUnitedHealthcare

PolicyOmvoh (mirikizumab-mrkz) prior authorization / medical necessity

Policy CodePolicy 2025 P 2320-3

Change TypeAdded coverage criteria for Crohn's diseasewording clarifications

Effective DateMay 1, 2025

Next Review Date

Key ActionSubmit prior authorization for maintenance dosing of subcutaneous Omvoh and include documentation of diagnosis and prior therapy/date and duration when claiming established use.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Crohn's disease.

Reworded criteria for established therapy through a medical prior authorization for clarity.

Updated background and references and examples with no change to clinical intent.

12 monthsAuthorization duration

AdultsIndicated population

SubcutaneousFormulation

P&T 1/2024,1/2025,3/2025P&T history

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Coverage Criteria for Omvoh (mirikizumab-mrkz)

Reauthorization - Ulcerative Colitis

Covered when ALL of the following are met:

Ulcerative colitis reauthorization: (1) Documentation of positive clinical response to Omvoh therapy; AND (2) Patient is not receiving Omvoh in combination with another targeted immunomodulator.

Authorization will be issued for 12 months.

Initial Authorization - Crohn's Disease

Covered when ALL of the following are met for moderately to severely active Crohn's disease:

Crohn's disease initial maintenance: (1) Diagnosis of moderately to severely active Crohn's disease; AND (2) One of the following: (a) Patient has been established on therapy with Omvoh under an active UnitedHealthcare medical benefit prior authorization for moderately to severely active Crohn's disease; OR (b) Both of the following: (i) Patient is currently on Omvoh therapy for moderately to severely active Crohn's disease as documented by claims history or submission of medical records (document date and duration of therapy); AND (ii) Patient has not received a manufacturer supplied sample at no cost in the prescriber's office, or any form of assistance from an Eli Lilly sponsored program as a means to establish current use; AND (3) Patient is not receiving Omvoh in combination with another targeted immunomodulator; AND (4) Prescribed by or in consultation with a gastroenterologist.

Authorization will be issued for 12 months.

Reauthorization - Crohn's Disease

Covered when ALL of the following are met:

Crohn's disease reauthorization: (1) Documentation of positive clinical response to Omvoh therapy; AND (2) Patient is not receiving Omvoh in combination with another targeted immunomodulator.

Authorization will be issued for 12 months.

The intravenous formulation of Omvoh is typically billed and covered under the medical benefit. For details on inpatient or infusion-center administration, billing, and any separate coverage rules, refer to the UnitedHealthcare Drug Policy for Omvoh.

Omvoh must not be used in combination with other targeted immunomodulators. Concomitant use with agents such as adalimumab, certolizumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, risankizumab, ustekinumab, tofacitinib, or similar targeted immunomodulators would not meet coverage criteria and may lead to denial of the request.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization required for maintenance dosing of subcutaneous Omvoh for moderately to severely active ulcerative colitis or Crohn's disease.

Prior authorization is required for maintenance dosing of subcutaneous Omvoh for moderately to severely active ulcerative colitis or Crohn's disease.
Authorization will be issued for 12 months (where applicable).

Billing Rule

Additional Utilization Controls

Supply limits and benefit-specific rules may apply; IV infusion coverage is under the medical benefit per separate drug policy.

Drug Definition

Omvoh (mirikizumab-mrkz) — Key definition

Generic namemirikizumab-mrkz

Brand nameOmvoh

Mechanism of actionInterleukin-23 antagonist

IndicationsModerately to severely active ulcerative colitis (adults); moderately to severely active Crohn's disease (adults)

Formulation covered by this programSubcutaneous formulation (authorization program applies to subcutaneous only)

Background

Omvoh (mirikizumab-mrkz) is an interleukin-23 antagonist indicated for adults with moderately to severely active ulcerative colitis and Crohn's disease. This policy applies to the subcutaneous formulation for maintenance dosing and aligns prior authorization to documented clinical response and medication history.

Policy Revision History

2025-05-01effective_dateLatest

Policy effective date for this version of the Omvoh prior authorization/medical necessity criteria.

2025-03material_change

Added coverage criteria for Crohn's disease (new criteria section mirroring ulcerative colitis criteria).

2025-03clarification

Reworded criteria for established therapy through a medical prior authorization for clarity; no change to clinical intent.

Policy Summary

PayerUnitedHealthcare

PolicyOmvoh (mirikizumab-mrkz) prior authorization / medical necessity

Policy CodePolicy 2025 P 2320-3

Change TypeAdded coverage criteria for Crohn's diseasewording clarifications

Effective DateMay 1, 2025

Next Review Date

Key ActionSubmit prior authorization for maintenance dosing of subcutaneous Omvoh and include documentation of diagnosis and prior therapy/date and duration when claiming established use.

SourceLink

On This Page

Supply limits may be in place.

The intravenous infusion of Omvoh is typically covered under the medical benefit — refer to the UnitedHealthcare Drug Policy for Omvoh.

Documentation Required

Required Documentation for Established Therapy

For patients claimed as current users, submit documentation of date and duration of prior Omvoh therapy (claims history or medical records). If the patient was established on therapy via a manufacturer-supplied sample or Eli Lilly assistance program, the patient must meet initial authorization criteria as if new to therapy.

Document date and duration of prior Omvoh therapy (claims history or medical record).
If patient was established on therapy via a manufacturer-supplied sample at no cost in the prescriber's office or any Eli Lilly sponsored assistance program, initial authorization criteria for new patients apply.

Denial Risk

Triggers for Denial

Requests may be denied if the patient is receiving Omvoh in combination with another targeted immunomodulator or if required documentation of prior therapy (date and duration) is not provided. Examples of targeted immunomodulators that preclude approval when used concomitantly include adalimumab, certolizumab (Cimzia), etanercept (Enbrel), vedolizumab (Entyvio), baricitinib (Olumiant), abatacept (Orencia), upadacitinib (Rinvoq), golimumab (Simponi), risankizumab (Skyrizi), ustekinumab, tofacitinib (Xeljanz/Xeljanz XR), and ozanimod (Zeposia).

Requests may be denied if Omvoh is used in combination with another targeted immunomodulator (see examples).
Requests may be denied if documentation does not include date and duration of prior Omvoh therapy for patients claimed as current users.

2025-03reference_update

Updated background and references (including package insert reference dated January 2025).

2024-01program_creation

Initial creation and implementation of the Prior Authorization/Medical Necessity program for Omvoh.