CurrentCareSourcePolicy N/A

Omvoh (mirikizumab-mrkz) intravenous for ulcerative colitis — Prior Authorization / Induction Criteria

Policy governs prior authorization and medical-benefit coverage criteria for Omvoh IV induction therapy in adults with moderate to severe ulcerative colitis for CareSource members; applies to prescribers and providers requesting coverage.

Policy Summary

PayerCareSource

PolicyOmvoh (mirikizumab-mrkz) intravenous for ulcerative colitis — Prior Authorization / Induction Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and ensure prescription by or consultation with a gastroenterologist for three IV induction doses (300 mg at Weeks 0, 4, and 8) when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3IV induction doses approved (Weeks 0, 4, 8)

200 mgrecommended maintenance subcutaneous dose

3 monthsinitial approval duration

18minimum patient age (years)

Concurrent biologic/targetedexplicitly not recommended for concurrent use

Coverage Criteria for Omvoh (mirikizumab-mrkz)

Initial Induction Criteria

Approve three IV induction doses (300 mg at Weeks 0, 4, and 8) when ALL of the following are met

FDA-Approved Indication - Induction: Patient is >= 18 years of age; AND the medication will be used as induction therapy; AND patient meets ONE of the following: (i) patient has tried one systemic therapy; OR (ii) patient meets BOTH: (a) patient has pouchitis; AND (b) patient has tried an antibiotic, probiotic, corticosteroid enema, or mesalamine enema; AND the medication is prescribed by or in consultation with a gastroenterologist.

Examples of systemic therapies include 6-mercaptopurine, azathioprine, cyclosporine, tacrolimus, or systemic corticosteroids. A trial of a mesalamine product does not count as a systemic therapy. A trial of one biologic other than the requested medication counts as a trial of one systemic agent. Examples of antibiotics include metronidazole and ciprofloxacin; examples of corticosteroid enemas include hydrocortisone enema.

Do not approve requests for Omvoh (mirikizumab-mrkz) IV when it is being used concurrently with another biologic or with a targeted synthetic oral small molecule for an inflammatory condition. Combination therapy is generally not recommended due to a potentially higher rate of adverse events and lack of controlled clinical data supporting additive efficacy.

Coverage of Omvoh intravenous is not recommended for circumstances not specifically listed in the Recommended Authorization Criteria. Criteria will be updated as new published data become available; requests that fall outside those criteria should not be approved.

Policy Summary

PayerCareSource

PolicyOmvoh (mirikizumab-mrkz) intravenous for ulcerative colitis — Prior Authorization / Induction Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and ensure prescription by or consultation with a gastroenterologist for three IV induction doses (300 mg at Weeks 0, 4, and 8) when criteria are met.

SourceLink

On This Page

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Provider Requirements and Authorization Workflow

Prior Authorization

Prior authorization required for induction

Prior authorization is recommended for medical-benefit coverage of Omvoh IV. Approvals are provided for three months to allow completion of induction (three IV doses). Approve three 300 mg IV induction doses administered at Weeks 0, 4, and 8 when the patient meets the age and indication criteria and the medication is prescribed by or in consultation with a gastroenterologist.

Approve 300 mg IV infusions at Weeks 0, 4, and 8 (three doses total).
Initial approvals are provided for three months to allow completion of the three-dose induction.

Step Therapy

Therapy history requirement

For the FDA‑approved ulcerative colitis indication, the patient must be at least 18 years of age and meet the prior‑therapy criteria described in the criteria: a trial of one systemic therapy or a trial of one biologic other than the requested medication counts as a systemic therapy trial; a trial of a mesalamine product does not count as a systemic therapy.

Patient is ≥ 18 years of age.
Patient has tried one systemic therapy OR meets the pouchitis pathway (has pouchitis and tried an antibiotic, probiotic, corticosteroid enema, or mesalamine enema).
Examples of systemic therapies include 6‑mercaptopurine, azathioprine, cyclosporine, tacrolimus, or systemic corticosteroids.

Documentation Required

Prior authorization and prescriber requirement

Initial authorization requires Omvoh IV to be prescribed by or in consultation with a gastroenterologist because of the specialized skills required for evaluation and monitoring. All initial approvals are provided for three months.

Prescription must be by or in consultation with a physician who specializes in the condition treated (gastroenterologist).
Approvals are issued for a three‑month duration to permit completion of induction dosing.

Denial Risk

Concurrent use exclusion — deny if combined with another biologic/targeted small molecule

Requests where Omvoh is used concurrently with another biologic or with a targeted synthetic oral small molecule for an inflammatory condition are not recommended for approval and may be denied.

Combination therapy with another biologic or a targeted synthetic oral small molecule is generally not recommended due to higher adverse event risk and lack of supporting controlled data.
This exclusion does not apply to conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine).

OpenPayer

Omvoh (mirikizumab-mrkz) intravenous for ulcerative colitis — Prior Authorization / Induction Criteria

Coverage Criteria for Omvoh (mirikizumab-mrkz)

Provider Requirements and Authorization Workflow

Background

Dosing Definitions