CurrentMass General Brigham Health PlanPolicy N/A

Omvoh (mirikizumab-mrkz) coverage and prior authorization

Defines prior authorization, coverage criteria, limits, and benefit routing for Omvoh (mirikizumab-mrkz) for members of Mass General Brigham Health Plan (commercial/Exchange/MassHealth UPPL) for intravenous (medical benefit) and subcutaneous (pharmacy benefit) formulations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOmvoh (mirikizumab-mrkz) coverage and prior authorization

Policy CodePolicy N/A

Change TypeMaterial clinical and coverage updates

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization showing trial and failure, intolerance, or contraindication to one conventional therapy (or documentation that disease severity warrants biologic first-line); indicate IV versus SC formulation for correct benefit routing.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for the supplemental indication of Crohn's disease.

Updated initial approval length for Omvoh SC to 24 months and Omvoh IV initial approvals for 12 weeks with no reauthorizations.

Removed requirement for specialist prescriber and modified prior biologic step-through requirements per recent updates.

2 formulationsbenefit routing: IV medical / SC pharmacy

12 weeksinitial approval length for Omvoh IV

24 months

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Coverage Criteria for Omvoh (mirikizumab-mrkz)

Initial Therapy (Ulcerative Colitis)

Authorization may be granted when ALL of the following are met for moderately to severely active ulcerative colitis:

Ulcerative Colitis Initial: 1. Diagnosis of moderately to severely active ulcerative colitis; 2. Member has had trial and failure, intolerance, or contraindication to ONE of the following conventional therapies: aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine), 6-mercaptopurine, azathioprine, OR corticosteroids (e.g., prednisone); OR 3. Disease severity warrants systemic biologic as first-line therapy.N/A

Conventional therapy list must include one agent as specified.

Initial Therapy (Crohn's Disease)

Authorization may be granted when ALL of the following are met for moderately to severely active Crohn's disease:

Crohn's Disease Initial: 1. Diagnosis of moderately to severely active Crohn's disease; 2. Member has had trial and failure, intolerance, or contraindication to ONE of the following conventional therapies: 6-mercaptopurine, azathioprine, corticosteroids (e.g., prednisone), OR methotrexate; OR 3. Disease severity warrants systemic biologic as first-line therapy.N/A

Supplemental indication for Crohn's disease added per review history.

Continuation of Therapy

Requests for reauthorization will be approved when ALL of the following are met:

Continuation: 1. Documentation is submitted supporting improvement in the member’s condition as evidenced by low disease activity or improvement in signs and symptoms of the condition; 2. For subcutaneous (SC) Omvoh, initial and reauthorization approvals may be granted for up to 24 months with documentation of clinical response; 3. Omvoh intravenous (IV) initial approvals are limited to 12 weeks and reauthorizations for IV will not be granted.N/A

See Limitations for approval durations and quantity limits.

Omvoh administered intravenously (Omvoh IV) is limited to initial approvals only. Per policy limitations, reauthorizations will not be granted for Omvoh IV; initial approvals for the IV formulation are granted for 12 weeks only.

Use of Omvoh is not authorized when the diagnosis-specific coverage criteria are not met. Authorization requires either continuation of therapy for members already receiving the drug within the plan’s 90-day new-to-plan allowance or meeting the initial-therapy criteria for the indicated diagnosis. Additionally, for initial therapy the member must have trial and failure, intolerance, or contraindication to ONE listed conventional therapy for the condition (for example, aminosalicylates, 6-mercaptopurine, azathioprine, corticosteroids, or methotrexate where specified), unless disease severity warrants a systemic biologic as first-line; if these conventional therapy requirements are unmet and disease severity does not justify first-line biologic use, the request is not authorized.

Product Packaging, Codes and Quantity Limits

Product packaging / quantity-limited itemsNDC

Omvoh 100 mg/mL autoinjector	UC pack: 2 autoinjectors per 28 days quantity limit description
Omvoh 200 mg/2 mL autoinjector	CD pack: autoinjector included in CD pack quantity limit
Omvoh 100 mg/mL prefilled syringe	prefilled syringe packaging and quantity limit
Omvoh 200 mg/2 mL prefilled syringe	prefilled syringe packaging and quantity limit

Product packaging / quantity-limited items (benefit routing note)mixed

Omvoh IV	Available on Medical Benefit only (specialty pharmacy designated)
Omvoh SC	Available on Pharmacy Benefit only (specialty pharmacy designated)

inv-07: Quantity limits — Omvoh

Quantity limit (autoinjectors)2 autoinjectors per 28 days

Quantity limit (prefilled syringes)2 prefilled syringes per 28 days

Applies to UC packOmvoh 100 mg/mL autoinjector — UC pack: 2 autoinjectors per 28 days

Applies to CD packOmvoh 100 mg/mL + 200 mg/2 mL autoinjectors or prefilled syringes — 2 autoinjectors or 2 prefilled syringes per 28 days

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior authorization and benefit routing

Prior authorization is required for Omvoh. The intravenous (IV) formulation is billed via the medical benefit and the subcutaneous (SC) formulation is billed via the pharmacy benefit. This product is designated specialty and must be dispensed through a contracted specialty pharmacy.

Omvoh IV is available on Medical Benefit Only; Omvoh SC is available on Pharmacy Benefit Only.
This medication has been designated specialty and must be filled at a contracted specialty pharmacy.

Step Therapy

Step therapy / conventional therapy requirement

For both moderately to severely active ulcerative colitis and Crohn's disease, the member must have had trial and failure, intolerance, or contraindication to ONE conventional therapy from the listed agents unless disease severity warrants a systemic biologic as first-line therapy.

Ulcerative colitis conventional options include: aminosalicylates (eg, mesalamine, olsalazine, sulfasalazine), 6-mercaptopurine, azathioprine, or corticosteroids (eg, prednisone).

Definitions and Indications

inv-13: Moderately to severely active ulcerative colitis and Crohn's disease in adults

Indication (summary)Moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease in adults (Omvoh indication)

Initial therapy requirementDiagnosis of moderately to severely active disease and trial and failure, intolerance, or contraindication to ONE conventional therapy (eg, aminosalicylate, 6‑mercaptopurine, azathioprine, corticosteroids, methotrexate for Crohn's) unless disease severity warrants biologic first-line

Continuation / reauthorizationReauthorization requires documentation of clinical improvement (low disease activity or improved signs/symptoms); note Omvoh IV has no reauthorizations while Omvoh SC may be reauthorized

Formulation & benefit routing notePolicy distinguishes IV (medical benefit) vs SC (pharmacy benefit) formulations with different approval durations

Background on Omvoh (mirikizumab-mrkz)

Omvoh (mirikizumab-mrkz) is an interleukin-23 (IL-23) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in adults. The policy applies prior authorization, formulary routing, and utilization limits consistent with its indications and supporting prescribing information.

Policy Revision History

2025-05-14material_changeLatest

Added coverage criteria for the supplemental indication of Crohn's disease and aligned Crohn's criteria with ulcerative colitis allowing approval when conventional therapy trial/failure or disease severity warrants biologic as first-line.

2025-07-01administrative_change

Clarified approval durations: initial approvals for Omvoh IV granted for 12 weeks with no reauthorizations; Omvoh SC initial and reauthorization approvals granted for 24 months.

2024-09-11