CurrentCignaPolicy PSM011

Omvoh Intravenous Preferred Specialty Management Policy for Individual and Family Plans

Defines prior authorization, step therapy (preferred vs non-preferred) and exception criteria for Omvoh IV for inflammatory bowel disease (Crohn's disease and ulcerative colitis) for Cigna Individual and Family Plans.

Policy Summary

PayerCigna

PolicyOmvoh Intravenous Preferred Specialty Management Policy for Individual and Family Plans

Policy CodePolicy PSM011

Change TypeMaterial updates to preferred/non-preferred designations and product list

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization and document a trial of one Step 1 preferred agent (or state current Omvoh induction) when requesting Omvoh IV for Crohn's disease induction.

SourceLink

POLICY UPDATE CHANGES

Omvoh intravenous is listed as a Step 2 Non-Preferred product directed to one Step 1 agent for Crohn's disease and ulcerative colitis.

Tremfya IV was added as a Step 1 Preferred product and note clarified that Tremfya subcutaneous also counts as a trial.

A trial of multiple adalimumab or ustekinumab products counts as one preferred product; examples of ustekinumab and infliximab products were expanded.

Individual & FamilyPlan scope

Step 2Omvoh classification

3 dosesInduction approval

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Coverage Criteria for Omvoh (mirikizumab-mrkz) IV

Non-Preferred Product Exception — Crohn's Disease Induction

Approve Omvoh IV for induction (three doses) when ALL of the following are met:

Crohn's Disease - Induction: Patient meets the standard Inflammatory Conditions - Omvoh Intravenous Prior Authorization Policy criteria.

Refer to the standard prior authorization policy for baseline medical necessity.

AND

a) Trial of a preferred agent: Patient has tried at least one of the following preferred agents: an adalimumab product, Skyrizi intravenous, Tremfya intravenous, an ustekinumab intravenous product, Entyvio (vedolizumab) intravenous, or an infliximab intravenous product. (A trial of multiple products within the same biologic group counts as ONE trial; certain subcutaneous formulations such as Simponi SC, Entyvio SC, Skyrizi SC, ustekinumab SC, Tremfya SC, or Zymfentra may also count toward this trial.)
Examples of products are listed in policy; multiple products in same class count as one trial.
b) Ongoing Omvoh induction: According to the prescriber, the patient has already started on or is currently undergoing induction therapy with Omvoh intravenous.
Prescriber attestation of ongoing induction is acceptable per policy.

Any request for Omvoh intravenous that does not meet the stated Non-Preferred Product Exception Criteria is considered not medically necessary and will not be approved under this policy.

Requests for Omvoh IV that fail to meet the Non-Preferred Product Exception Criteria, or that lack the appropriate prior authorization or covered diagnosis/procedure codes, will be handled per policy and considered not medically necessary when criteria are not met. When coverage is available and medically necessary, dosing, frequency, duration, and site of care must be reasonable and supported by evidence; note that receipt of sample product does not satisfy coverage criteria.

Coding and Dosing Details

Referenced drug NDC notesNDC

NDCs (examples referenced)

NDCs for certain products were removed from Preferred lists (e.g., Humira NDCs starting 00074; Hyrimoz NDCs starting 61314) — document references but exact codes not listed in policy text.

Induction dosing approval count

Induction dosing approvedThree doses (approve for three doses for induction)

Applicable scenarioCrohn's Disease - Induction Therapy

Approval conditionRequires meeting standard Inflammatory Conditions - Omvoh Intravenous Prior Authorization Policy criteria

Provider Actions, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Omvoh IV requires prior authorization and step therapy when clinically appropriate. Approval of Omvoh IV as a Step 2 Non-Preferred product requires documentation that the patient meets the applicable Prior Authorization Policy criteria.

Prior authorization required per the standard Inflammatory Conditions - Omvoh Intravenous Prior Authorization Policy.
Omvoh IV is Step 2 Non-Preferred and is directed to ONE Step 1 Preferred agent; trials of Step 1 agent(s) required when clinically appropriate.

Step Therapy

Step Therapy / Step 2 Non-Preferred

Omvoh IV is Step 2 Non-Preferred and approval generally requires a prior trial of one Step 1 Preferred agent (directed to ONE Step 1 agent) unless an exception applies. A trial of more than one product within the same preferred class (e.g., multiple adalimumab products) counts as one Preferred Product trial for purposes of step therapy.

Step 1 Preferred agents include listed adalimumab products, Skyrizi IV, Ustekinumab IV products, Tremfya IV, Infliximab IV products (Avsola, Inflectra), and Entyvio IV.

Definitions and Product Classification

Preferred Product

Preferred Step 1 agents (Crohn's Disease)Adalimumab products; Skyrizi IV; Ustekinumab IV products; Tremfya IV; Infliximab IV products; Entyvio IV

Preferred Step 1 agents (Ulcerative Colitis)Adalimumab products; Skyrizi IV; Ustekinumab IV products; Tremfya IV; Infliximab IV products; Entyvio IV

Notes on counting trialsA trial of more than one adalimumab or ustekinumab product counts as ONE Preferred Product

Non-Preferred Product Exception Criteria

Primary exception pathwayApprove Omvoh IV as non-preferred if patient meets standard Omvoh IV prior authorization criteria and has tried at least one Step 1 preferred agent (adalimumab product, Skyrizi IV, Tremfya IV, ustekinumab IV product, Entyvio IV, or an infliximab IV product).

Alternative exception pathway

Background

Omvoh (mirikizumab-mrkz) intravenous is an anti‑inflammatory biologic indicated in inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis. Multiple biologic agents are available for these conditions (for example, adalimumab products, ustekinumab IV products, Tremfya IV, infliximab IV products, Entyvio IV, and Skyrizi IV), and this policy positions Omvoh IV as a Step 2 Non‑Preferred product that requires prior authorization and, when clinically appropriate, a trial of a Step 1 Preferred agent before approval for induction therapy. When approved under the non‑preferred exception for induction, Omvoh IV is authorized for three doses.