ModifiedCignaPolicy N/A

Prior Authorization Policy – Inflammatory Conditions: Omvoh (mirikizumab-mrkz) Subcutaneous

Defines Cigna prior authorization requirements and coverage criteria for Omvoh subcutaneous injection for Crohn's disease and ulcerative colitis in adults; applies to prescription benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyPrior Authorization Policy – Omvoh subcutaneous (mirikizumab-mrkz)

Policy CodePolicy N/A

Change TypeMaterial clinical changes (added CDrevised UC criteriaclarified combination therapy exclusion)

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionSubmit prior authorization supporting documentation showing patient meets age, induction IV dosing, and initial therapy prerequisites for approval.

SourceLink

POLICY UPDATE CHANGES

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

Ulcerative colitis initial therapy criteria were revised to remove certain approval options (trial of one systemic therapy; pouchitis options).

Conditions Not Covered: clarified that concurrent use with a biologic or targeted synthetic oral small molecule drug is not allowed.

2FDA-approved disease indications (CD, UC)

6 monthsInitial therapy approval duration

1 yearContinuation therapy approval duration

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Coverage Criteria for Omvoh (mirikizumab-mrkz) Subcutaneous

Crohn's Disease

Covered when ONE of the following is met (Initial Therapy OR Currently Receiving Omvoh SC):

Crohn's Disease: Initial Therapy (A): Approve for 6 months if ALL of i-iv are met

i. Patient is > 18 years of age; ii. According to the prescriber, the patient will receive induction dosing with Omvoh IV within 3 months of initiating Omvoh SC; iii. Patient meets ONE of: a) patient has tried or is currently taking corticosteroids, or corticosteroids are contraindicated (examples: prednisone, methylprednisolone); OR b) patient has tried one other conventional systemic therapy for Crohn's disease (examples: azathioprine, 6-mercaptopurine, methotrexate); OR c) patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR d) patient had ileocolonic resection; iv. Medication is prescribed by or in consultation with a gastroenterologist.

Crohn's Disease: Continuing Therapy (B): Approve for 1 year if BOTH i-ii are met

i. Patient has been established on therapy for at least 6 months (patients with <6 months or restarting reviewed under Initial Therapy); ii. Patient meets at least ONE of: a) when assessed by at least one objective measure (e.g., fecal markers such as fecal lactoferrin or fecal calprotectin, serum markers such as C-reactive protein, imaging, endoscopy, or reduced steroid dose) the patient experienced a beneficial clinical response from baseline; OR b) compared with baseline, the patient experienced improvement in at least one symptom (decreased pain, fatigue, stool frequency, and/or blood in stool).

Ulcerative Colitis

Covered when ONE of the following is met (Initial Therapy OR Currently Receiving Omvoh SC):

Ulcerative Colitis: Initial Therapy (A): Approve for 6 months if ALL of i-iii are met

i. Patient is ≥ 18 years of age; ii. According to the prescriber, the patient will receive three induction doses with Omvoh IV within 3 months of initiating Omvoh SC; iii. Medication is prescribed by or in consultation with a gastroenterologist.

Ulcerative Colitis: Continuing Therapy (B): Approve for 1 year if BOTH i-ii are met

i. Patient has been established on the requested drug for at least 6 months (patients with <6 months or restarting reviewed under Initial Therapy); ii. Patient meets at least ONE of: a) when assessed by at least one objective measure (e.g., fecal calprotectin, C-reactive protein, endoscopy, or reduced steroid dose) the patient experienced a beneficial clinical response from baseline; OR b) compared with baseline, the patient experienced improvement in at least one symptom (decreased pain, fatigue, stool frequency, and/or decreased rectal bleeding).

Concurrent administration of Omvoh (mirikizumab) subcutaneous with another biologic agent or with a targeted synthetic oral small molecule drug for an inflammatory condition is considered not medically necessary. Combination therapy is generally not recommended because of a potentially higher rate of adverse events and a lack of controlled clinical data demonstrating additive efficacy. Conventional synthetic disease‑modifying antirheumatic drugs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) are not excluded from use with Omvoh.

The appendix provides example agents, mechanisms, and indications to inform prior authorization decisions but is not an all‑inclusive list of indications. For definitive FDA‑approved indications, dosing, and safety information, refer to each agent’s prescribing information.

Administration of Omvoh subcutaneous in combination with another biologic or a targeted synthetic oral small molecule drug is considered not medically necessary and may result in denial of coverage when requested for combination use.

Provider Actions, Prior Authorization, and Denial Criteria

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Approvals for initial therapy are typically for 6 months; approvals for ongoing therapy are for 1 year (when continuation criteria met). Approval requires the medication be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., gastroenterologist for Crohn's disease). When approval durations are given in months, 1 month = 30 days.

Initial therapy approval duration: 6 months (see FDA‑Approved Indications — Initial Therapy).
Continuation therapy approval duration: 1 year when continuation criteria are met (patient established on therapy ≥ 6 months and demonstrates response).
Prescriber specialty requirement: medication must be prescribed by or in consultation with a specialist in the treated condition (e.g., gastroenterologist for Crohn's disease).

Denial Risk

Denial Risk — Combination Therapy

Conditions Not Covered / Denial Risk. Use of Omvoh subcutaneous in combination with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is considered not medically necessary and may be denied. Conventional synthetic DMARDs (e.g., methotrexate) are not excluded when used concomitantly.

Definitions and Key Terms

Omvoh IV induction

DefinitionOmvoh IV induction: IV infusion administered at Weeks 0, 4, and 8 as the induction regimen prior to switching to subcutaneous maintenance.

PurposeProvides induction of remission for Crohn's disease and ulcerative colitis prior to SC maintenance dosing.

Timing relative to SC therapyIV induction is given at Weeks 0, 4, and 8, followed by Omvoh subcutaneous once every 4 weeks for maintenance.

Required window for initial SC authorizationPrescriber must state patient will receive induction dosing with Omvoh IV within 3 months of initiating Omvoh SC (per initial therapy prerequisites).

Age population referencedInduction regimen described for adults with moderate to severe Crohn's disease or ulcerative colitis (≥18 years).

Abbreviations

Background

Omvoh (mirikizumab) is a monoclonal antibody that targets the p19 subunit of interleukin‑23. It is indicated for maintenance treatment of moderate to severe Crohn’s disease and ulcerative colitis in adults; an intravenous induction regimen is used prior to subcutaneous maintenance dosing. Refer to the product prescribing information and the appendix for detailed dosing and indication summaries.