CurrentCignaPolicy PSM011

Omvoh Intravenous Preferred Specialty Management Policy for Individual and Family Plans

Defines coverage, prior authorization, and non-preferred product exception criteria for Omvoh intravenous for inflammatory bowel diseases (Crohn's disease and ulcerative colitis) under Cigna Individual and Family Plans.

Policy Summary

PayerCigna

PolicyOmvoh Intravenous Preferred Specialty Management Policy for Individual and Family Plans

Policy CodePolicy PSM011

Change TypeNew policyStep 1 product list updated

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization and document a trial of one Step 1 Preferred gastroenterology agent (or evidence of current induction with Omvoh) before approval.

SourceLink

POLICY UPDATE CHANGES

New policy created for Omvoh Intravenous Preferred Specialty Management for Individual and Family Plans.

Tremfya IV was added as a Step 1 Preferred product and subcutaneous Tremfya now counts toward a preferred-product trial.

Policy title and applicability updated to apply to Individual and Family Plans only; removed Employer Plans language.

Step 2Placement

3Induction doses

Multi→1Trial counting

IFPPlan scope

Coverage Criteria for Omvoh Intravenous

Induction Therapy (Crohn's Disease and Ulcerative Colitis)

Omvoh intravenous is considered medically necessary when the Non-Preferred Product Exception Criteria are met for induction therapy.

Induction approval for Crohn's Disease

Criterion i: Patient meets the standard Inflammatory Conditions - Omvoh Intravenous Prior Authorization Policy criteria
Criterion ii
- ii.a Trial of Preferred Product: Patient has tried one of an adalimumab product, Skyrizi intravenous, Tremfya intravenous, ustekinumab intravenous product, Entyvio intravenous, or an infliximab intravenous product
  A trial of multiple products within a class counts as one product; subcutaneous formulations of listed agents can count

Policy Summary

PayerCigna

PolicyOmvoh Intravenous Preferred Specialty Management Policy for Individual and Family Plans

Policy CodePolicy PSM011

Change TypeNew policyStep 1 product list updated

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization and document a trial of one Step 1 Preferred gastroenterology agent (or evidence of current induction with Omvoh) before approval.

SourceLink

On This Page

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ii.b Current induction with Omvoh: According to the prescriber, the patient has already started on or is currently undergoing induction therapy with Omvoh intravenous

Induction approval for Ulcerative Colitis

Criterion i: Patient meets the standard Inflammatory Conditions - Omvoh Intravenous Prior Authorization Policy criteria
Criterion ii
- ii.a Trial of Preferred Product: Patient has tried one of an adalimumab product, Skyrizi intravenous, ustekinumab intravenous product, Tremfya intravenous, Entyvio intravenous, or an infliximab intravenous product
  A trial of multiple products within a class counts as one product; subcutaneous formulations of listed agents can count
- ii.b Current induction with Omvoh: According to the prescriber, the patient has already started on or is currently undergoing induction therapy with Omvoh intravenous

Any exception other than the stated Non-Preferred Product Exception Criteria for Omvoh intravenous is considered not medically necessary.

Requests for Omvoh intravenous that do not meet the Non-Preferred Product Exception Criteria are considered not medically necessary.

Coding, Dose, and Related Identifiers

Preferred product identifiers and examplesNDC

NDCs starting with 82009

adalimumab-ryvk preferred NDCs

Induction dose count

Induction dose countApprove for three doses for induction when the Non-Preferred Product Exception Criteria are met

Indication contextsApplies to induction therapy for Crohn's disease and ulcerative colitis

Approval condition (general)Requires meeting the standard Inflammatory Conditions - Omvoh Intravenous Prior Authorization Policy criteria

Provider Actions, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for Omvoh intravenous per the standard Inflammatory Conditions prior authorization policies. Requests must meet the applicable prior authorization criteria and any approval limitations in those policies.

Prior authorization required for Omvoh intravenous effective 2026-01-01
Approvals limited to criteria in the applicable Prior Authorization Policy and Coverage Policy PSM011

Step Therapy

Step Therapy Requirement

Omvoh intravenous is a Step 2 Non-Preferred product and requires documentation of a trial and inadequate response or intolerance to ONE Step 1 Preferred gastroenterology agent prior to approval. Examples of Step 1 Preferred agents include adalimumab products (e.g., Cyltezo, Simlandi), Skyrizi IV, ustekinumab IV products (e.g., Selarsdi IV, Yesintek IV), Tremfya IV, infliximab IV products (Avsola, Inflectra), and Entyvio IV. A trial of more than one adalimumab product counts as one Preferred Product; likewise for ustekinumab products.

Step therapy: Trial of ONE Step 1 Preferred gastroenterology agent required before Omvoh IV (Step 2) will be approved
Examples of Step 1 agents: Adalimumab products, Skyrizi IV, Ustekinumab IV products, Tremfya IV, Infliximab IV products, Entyvio IV
A trial of multiple products within the same biologic class (adalimumab or ustekinumab) counts as one Preferred Product

Documentation Required

Coding and Billing Documentation

When submitting claims or prior authorization requests, providers must use the most appropriate and covered diagnosis and procedure codes effective on the date of service. Services billed without covered codes under the applicable Coverage Policy may be denied.

Use current, appropriate CPT/HCPCS/NDC/ICD-10 codes as of the date of service
Claims or services billed without covered codes under the applicable Coverage Policy may be impacted or denied

Denial Risk

Non-Preferred Product Exception Denial

Requests for Omvoh intravenous that do not meet the Non-Preferred Product Exception Criteria will be considered not medically necessary and may be denied. Ensure documentation supports why Step 1 Preferred agents are not appropriate when requesting an exception.

Non-Preferred Product Exception Denial: Requests not meeting the exception criteria = not medically necessary
Provide clinical justification and documentation if requesting an exception to Step Therapy

Background

Omvoh (mirikizumab-mrkz) administered intravenously is positioned in this policy as a non-preferred product that may be approved only when the specified exception criteria are met. The policy addresses use for inflammatory bowel disease induction (Crohn’s disease and ulcerative colitis) and limits induction approval to the conditions and dosing outlined in the Non-Preferred Product Exception Criteria.

Definitions

Induction Therapy

DefinitionInduction Therapy: initial treatment phase to induce clinical response in inflammatory bowel disease patients starting Omvoh intravenous

Typical approval quantityThree doses approved for induction when exception criteria are met

Exception pathwayPatient may be approved for induction if currently undergoing induction with Omvoh per prescriber statement

Alternative requirementOr patient has tried one Step 1 preferred agent (examples listed in policy) prior to approval