CurrentCignaPolicy IP0663

Omvoh Subcutaneous Prior Authorization Policy

Defines prior authorization, clinical criteria, and coverage limits for Omvoh subcutaneous for Crohn's disease and ulcerative colitis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOmvoh Subcutaneous Prior Authorization Policy

Policy CodePolicy IP0663

Change TypeNew indication addedprior therapy requirements updated

Effective DateMar 15, 2026

Next Review Date

Key ActionObtain prior authorization and document specialist prescribing or consultation (gastroenterologist); initial approvals are for 6 months and continuation approvals for 1 year.

SourceLink

POLICY UPDATE CHANGES

Crohn's disease was added as a newly approved condition to the policy.

For Crohn's initial therapy, prior options requiring systemic corticosteroid or conventional systemic therapy were removed.

For Ulcerative Colitis initial therapy, prior approval options requiring prior therapies (e.g., pouchitis treatment options) were removed in an earlier revision.

Omvoh subcutaneous requires prescribing by or in consultation with a specialist (gastroenterologist) due to specialized evaluation and monitoring requirements.

2FDA-indicated conditions covered (CD, UC)

6 moInitial approval duration

1 yrContinuation approval duration

Policy Summary

PayerCigna

PolicyOmvoh Subcutaneous Prior Authorization Policy

Policy CodePolicy IP0663

Change TypeNew indication addedprior therapy requirements updated

Effective DateMar 15, 2026

Next Review Date

Key ActionObtain prior authorization and document specialist prescribing or consultation (gastroenterologist); initial approvals are for 6 months and continuation approvals for 1 year.

SourceLink

On This Page

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Coverage Criteria for Omvoh (mirikizumab) subcutaneous

Crohn's Disease (FDA-Approved Indications)

Approve for Crohn's disease if ONE of the following is met:

Crohn's disease - Initial or Ongoing: A) Initial Therapy: Approve for 6 months if ALL of (i) patient is > 18 years of age; AND (ii) according to the prescriber, the patient will receive induction dosing with Omvoh intravenous within 3 months of initiating therapy with Omvoh subcutaneous; AND (iii) the medication is prescribed by or in consultation with a gastroenterologist. OR B) Patient is Currently Receiving Omvoh Subcutaneous: Approve for 1 year if BOTH of (i) patient has been established on therapy for at least 6 months; AND (ii) patient meets at least ONE of: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include fecal markers such as fecal calprotectin, serum markers such as C-reactive protein, imaging, endoscopic assessment, or reduced corticosteroid dose); OR (b) compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool).see text

A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy.

Ulcerative Colitis (FDA-Approved Indications)

Approve for Ulcerative Colitis if ONE of the following is met:

Ulcerative Colitis - Initial or Ongoing: A) Initial Therapy: Approve for 6 months if ALL of (i) patient is ≥ 18 years of age; AND (ii) according to the prescriber, the patient will receive three induction doses with Omvoh intravenous within 3 months of initiating therapy with Omvoh subcutaneous; AND (iii) the medication is prescribed by or in consultation with a gastroenterologist. OR B) Patient is Currently Receiving Omvoh Subcutaneous: Approve for 1 year if BOTH of (i) patient has been established on the requested drug for at least 6 months; AND (ii) patient meets at least ONE of: (a) when assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include fecal markers such as fecal calprotectin, serum markers such as C-reactive protein, endoscopic assessment, and/or reduced corticosteroid dose); OR (b) compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, or decreased rectal bleeding).see text

A patient who has received < 6 months of therapy or who is restarting therapy with the requested drug is reviewed under Initial Therapy.

Requests for Omvoh (mirikizumab) subcutaneous used concurrently with another biologic or a targeted synthetic oral small molecule drug for an inflammatory condition are considered not medically necessary. Combination therapy is not recommended because available evidence does not demonstrate additive benefit and concurrent use may increase the risk of adverse events.

Omvoh subcutaneous must not be administered in combination with another biologic or a targeted synthetic oral small molecule therapy for the treatment of inflammatory conditions. This policy excludes combination regimens due to a lack of controlled clinical data supporting added efficacy and a potentially higher rate of adverse events. Note that this exclusion does not apply to concomitant use of conventional synthetic disease‑modifying antirheumatic drugs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine).

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Omvoh subcutaneous. Initial approvals are for 6 months. Continuation (patients currently receiving Omvoh subcutaneous who meet continuation criteria) are approved for 1 year. Because of the specialized skills required for evaluation and diagnosis of patients treated with Omvoh subcutaneous as well as the monitoring required for adverse events and long-term efficacy, approval requires Omvoh subcutaneous to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior authorization required
Initial approval duration: 6 months
Continuation approval duration: 1 year
Approvals in months: 1 month = 30 days
Prescriber requirement: prescribed by or in consultation with a specialty physician

Note

Preferred Product Requirement for Certain Lines of Business

This product requires the use of preferred products before approval for certain lines of business. For Individual and Family Plans, refer to the Inflammatory Conditions Preferred Specialty Management Policy (PSM002) for additional preferred product criteria requirements and exceptions.

Background on Omvoh (mirikizumab)

Omvoh (mirikizumab) is a monoclonal antibody targeting the p19 subunit of interleukin‑23 (IL‑23). It is indicated for maintenance treatment of moderate to severe Crohn’s disease and ulcerative colitis in adults and is available as an intravenous formulation for induction followed by subcutaneous maintenance dosing every 4 weeks. For safety and efficacy considerations, concurrent use with other biologics or targeted synthetic oral small molecule therapies for inflammatory conditions is considered not medically necessary.

Definitions and Dosing Notes

Induction with IV formulation — Omvoh dosing schedule

Induction IV dosing scheduleOmvoh IV infusion given at Weeks 0, 4, and 8 for induction

Transition to maintenanceAfter IV induction, switch to Omvoh subcutaneous for maintenance dosing

Maintenance dosing intervalOmvoh subcutaneous administered once every 4 weeks

Indications for IV inductionIV formulation indicated as induction therapy for both Crohn's disease and ulcerative colitis

Patient populationAdults with moderate to severe active Crohn's disease or ulcerative colitis