CurrentCignaPolicy PSM019

Omvoh Intravenous Preferred Specialty Management Policy: Legacy Prescription Drug Lists

Defines prior authorization and non-preferred product exception criteria for Omvoh intravenous for inflammatory bowel diseases (Crohn's disease and ulcerative colitis) under Cigna legacy prescription drug lists.

Policy Summary

PayerCigna

PolicyOmvoh Intravenous Preferred Specialty Management Policy: Legacy Prescription Drug Lists

Policy CodePolicy PSM019

Change TypeMaterial revisions and additions (preferred product updatesstep therapy changes)

Effective Date03/15/2025

Next Review DateN/A

Key ActionObtain prior authorization and document a trial of one Step 1 Preferred agent (or attest the patient has already started Omvoh induction) to qualify for Omvoh IV coverage.

SourceLink

POLICY UPDATE CHANGES

New policy: Criteria for Legacy Drug List Plans was previously located within Inflammatory Conditions - Omvoh Intravenous Preferred Specialty Management Policy (PSM011).

Hyrimoz NDCs starting with 61314 were removed from the Preferred Products; prior trial of these NDCs still counts toward adalimumab product trial.

Tremfya IV was added as a Step 1 Preferred product for Ulcerative Colitis and note clarifies subcutaneous Tremfya also counts.

Omvoh intravenous was added as a Step 2 Non-Preferred Product directed to one Step 1 agent for Crohn's Disease.

PSM019Coverage Policy Number

Step 1Preferred therapy tier

Step 2Non-Preferred tier for Omvoh

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Induction approval duration for Omvoh

Coverage Criteria for Omvoh Intravenous

Induction Therapy (Crohn's Disease and Ulcerative Colitis)

Omvoh intravenous is considered medically necessary when the following exception criteria are met for induction therapy:

Overall: Approve for three doses for induction if ALL of the following are met3 doses

Criterion 1A(i): Patient meets the standard Inflammatory Conditions - Omvoh Intravenous Prior Authorization Policy criteria

Criterion 1A(ii): Patient meets ONE of the following

Option a: Patient has tried one of: an adalimumab product, Skyrizi intravenous, Stelara intravenous, Entyvio intravenous, or an infliximab intravenous product (Note: examples of adalimumab and infliximab products are provided in policy; trials of multiple formulations of the same molecule count as one product; certain subcutaneous formulations also count)

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

If 1A(i) met but 1A(ii) not met: A request for a Preferred Product may be reviewed using the respective standard Inflammatory Conditions Prior Authorization Policy criteria (examples include Humira [NDCs starting with 00074], select adalimumab biosimilars, Skyrizi IV, Stelara IV, Tremfya IV [for UC], Avsola, Inflectra, or Entyvio IV)

Any exception requests not meeting the specified Non-Preferred Product Exception Criteria are considered not medically necessary. This policy requires that Omvoh (mirikizumab-mrkz) intravenous meet the stated exception criteria before approval; exceptions outside those criteria will be denied as not medically necessary.

Requests for Omvoh intravenous that do not meet the standard Prior Authorization Policy criteria and the required trial of preferred products (or a prescriber attestation that the patient has already started induction with Omvoh IV) are considered not medically necessary. Per the program, Omvoh is a Step 2 Non-Preferred product directed to one Step 1 preferred agent, and approval requires meeting both the standard prior authorization requirements and the Non-Preferred Product Exception Criteria unless the prescriber documents current induction with Omvoh.

Coding and Dosing Information

NDC references and examplesNDC

NDCs starting with 00074	Humira (adalimumab) specific NDC range referenced as preferred
NDCs starting with 61314	Hyrimoz NDCs — removed from Preferred Products per revision

Induction doses allowed

Induction doses allowedApprove for three doses for induction

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Omvoh intravenous requires prior authorization and must meet the standard Inflammatory Conditions - Omvoh Intravenous Prior Authorization criteria. Approval of a Non‑Preferred product also requires that the patient meet the Non‑Preferred Product Exception Criteria specified in this policy. Receipt of sample product does not satisfy prior authorization requirements.

Applies to Omvoh intravenous (Step 2 Non‑Preferred product).
Requests must reference the Inflammatory Conditions - Omvoh Intravenous Prior Authorization policy.

Denial Risk

Denial Triggers for Omvoh

Requests that do not meet the Non‑Preferred Product Exception Criteria — including required prior trials of one Step 1 Preferred agent when clinically appropriate — will be denied. If the patient has already started or is currently undergoing induction therapy with Omvoh intravenous, document this in the request. Any other exception not meeting the criteria is considered not medically necessary and will be denied.

Definitions and Terms

Induction Therapy — definition of initial course of therapy

DefinitionInitial course of therapy for disease control; policy permits an induction course of three doses for Omvoh intravenous when criteria are met

Condition for approvalPatient must meet the standard Inflammatory Conditions - Omvoh Intravenous prior authorization criteria and the Non-Preferred Product Exception Criteria (including required prior trial of preferred agents or prescriber attestation of ongoing induction)

Examples of acceptable prior trials (UC)Adalimumab product OR Skyrizi IV OR Stelara IV OR Tremfya IV OR Entyvio IV OR an infliximab IV product; trials of multiple formulations of the same molecule count as one product

Background

Omvoh (mirikizumab-mrkz) intravenous is a biologic therapy used for inflammatory bowel diseases including Crohn’s disease and ulcerative colitis. It is placed on a Step 2 Non-Preferred tier within the gastroenterology specialty management framework and therefore generally requires a prior trial of a Step 1 Preferred agent (for example, adalimumab products, Skyrizi IV, Stelara IV, infliximab IV products, Entyvio IV, and for ulcerative colitis also Tremfya IV) or documentation that the patient has already begun induction with Omvoh. When medically necessary and covered, 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.

Policy Summary

PayerCigna

PolicyOmvoh Intravenous Preferred Specialty Management Policy: Legacy Prescription Drug Lists

Policy CodePolicy PSM019

Change TypeMaterial revisions and additions (preferred product updatesstep therapy changes)

Effective Date03/15/2025

Next Review DateN/A

Key ActionObtain prior authorization and document a trial of one Step 1 Preferred agent (or attest the patient has already started Omvoh induction) to qualify for Omvoh IV coverage.

SourceLink

On This Page

Denial will occur if the required trial of ONE Step 1 Preferred agent is not documented when directed by the Step therapy requirements.
Denial will occur if the Non‑Preferred Product Exception Criteria (induction/continuation criteria) are not satisfied.
Receipt of sample product alone is not acceptable documentation and may trigger denial.

Documentation Required

Required Documentation

Documentation must demonstrate that the standard Prior Authorization Policy criteria for Inflammatory Conditions - Omvoh Intravenous are met and must support any claimed prior trials of Preferred products or prior/current use of Omvoh for induction. Include relevant clinical records such as diagnosis, prior medication trials (drug name, dates, dosage, and reason for discontinuation if applicable), treatment start dates, and prescriber attestation of ongoing induction therapy when applicable.

Clinical diagnosis and indication (Crohn's disease or ulcerative colitis).
Evidence of trial(s) of ONE Step 1 Preferred agent when required (agent name, start/stop dates, reason for failure/intolerance).
If claiming current induction with Omvoh, provide prescriber statement confirming induction therapy has begun and dates of administered doses.
Relevant prior authorization approval details for Preferred agents, if applicable.

Step Therapy

Step Therapy Requirement

Omvoh intravenous is a Step 2 Non‑Preferred product directed to ONE Step 1 Preferred agent; a prior trial of a Preferred agent is required prior to approval except where the Non‑Preferred Product Exception Criteria explicitly allow approval (for example, documented ongoing induction with Omvoh).

Step 1 Preferred agents include adalimumab products (Humira and biosimilars), Skyrizi IV, Stelara IV, Tremfya IV (where listed), infliximab IV products (Avsola, Inflectra), and Entyvio IV.
Step 2 Non‑Preferred: Omvoh intravenous — prior trial of ONE Step 1 agent is required unless exception criteria are met.