CurrentCignaPolicy N/A

Inflammatory Conditions - Omvoh Subcutaneous Prior Authorization Policy

Prior authorization policy for Omvoh subcutaneous injection for Crohn's disease and ulcerative colitis in adults, specifying initial and continuation criteria, prescribing provider requirements, and non-covered uses (notably combination therapy with other biologics or targeted synthetic oral small molecules). Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Omvoh Subcutaneous Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial updates to indications and initial therapy criteria

Effective Date

Next Review Date

Key ActionObtain prior authorization and document age, planned/completed IV induction within 3 months, prior therapy trials or contraindications, and objective response or symptom improvement; ensure prescribing specialist involvement.

POLICY UPDATE CHANGES

Crohn's disease indication was added to the policy.

Ulcerative Colitis initial therapy options were revised to remove several approval options (trial of one systemic therapy; pouchitis options).

Conditions Not Covered language changed regarding combination therapy listing.

Clarified that mesalamine does not count as a systemic agent for Crohn's disease trials.

2Covered Indications (CD, UC)

1Non-covered: concurrent biologic/targeted synthetic

Initial approval months

Coverage Summary

This prior authorization policy covers Omvoh (mirikizumab-mrkz) subcutaneous injection for adults with inflammatory bowel disease under Cigna-administered health benefit plans. Omvoh is FDA‑approved for maintenance treatment of moderate to severe Crohn's disease and ulcerative colitis in adults. Induction is given with an intravenous (IV) formulation (dosing at Weeks 0, 4, and 8) followed by subcutaneous (SC) maintenance once every 4 weeks. The policy applies to Cigna-administered plans and requires prior authorization with criteria for initial and continuation therapy.

Policy quick facts

Non-covered use categories1

Initial approval duration (months)6

Continuation threshold>= 6 months established on therapy

IV induction timingIV induction within 3 months of initiating SC

Medical Necessity Criteria

Crohn's Disease - FDA-Approved Indication

Approve for the duration noted if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is > 18 years of age
- According to the prescriber, the patient will receive induction dosing with Omvoh intravenous within 3 months of initiating therapy with Omvoh subcutaneous
  Approval duration: 6 months
- ONE of
  - a: Patient has tried or is currently taking corticosteroids, or corticosteroids are contraindicated in this patient
    Examples of corticosteroids: prednisone or methylprednisolone

Conditions Not Covered (Not Medically Necessary)

Omvoh subcutaneous is considered not medically necessary for ANY other use(s) including the following:

Concurrent use with another biologic for an inflammatory condition is not covered

Concurrent use with a targeted synthetic oral small molecule drug used for an inflammatory condition is not covered

This does NOT exclude use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine)

Note: The policy's excluded concurrent combination therapies do NOT exclude conventional synthetic DMARDs. Conventional synthetic agents (for example, methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) are permitted in combination with Omvoh. Also, per the definitions and policy notes, a trial of mesalamine does NOT count as a systemic agent for Crohn's disease when assessing prior therapy requirements.

Coding

Drug / productNDCCovered

mirikizumab-mrkz (Omvoh) SC

Omvoh (mirikizumab-mrkz) subcutaneous injection - covered per criteria

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for prescription benefit coverage of Omvoh subcutaneous. Approvals are provided for specified durations: 6 months for initial therapy and 1 year for continuation (as described in the policy).

Initial therapy approvals: 6 months
Continuation (established on therapy) approvals: 1 year

Documentation Required

Document induction and response

Document the patient’s age and that intravenous induction dosing is planned or was completed within 3 months of initiating Omvoh subcutaneous per the indication. For initial therapy, document trials of prior therapies or contraindications (e.g., corticosteroid trial or contraindication, or trial of one conventional systemic therapy unless exceptions apply). For continuation, document objective measures of response or symptom improvement versus baseline. Ensure the medication is prescribed by or in consultation with a gastroenterologist (specialist).

Background & Definitions

Background: Omvoh is a monoclonal antibody that targets the p19 subunit of interleukin‑23 (IL‑23). It is indicated for maintenance therapy in adults with moderate to severe Crohn's disease and ulcerative colitis; an IV formulation is used for induction dosing followed by SC maintenance. Clinical practice guidelines for moderate to severe Crohn's disease and ulcerative colitis recommend advanced therapies, including IL‑23 inhibitors, among options for induction and maintenance of remission.

Definitions

Objective measures examples

Revision History

11/14/2023clarified

Clarified that a trial of a mesalamine product does not count as a systemic agent for Crohn's disease. (non-material)

12/04/2024added

**MATERIAL CHANGE:** Crohn's disease indication was added to the policy.

09/11/2024revised

**MATERIAL CHANGE:** Conditions Not Covered language changed regarding combination therapy listing (Concurrent use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug).

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Omvoh Subcutaneous Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial updates to indications and initial therapy criteria

Effective Date

Next Review Date

On This Page

b: Patient has tried one other conventional systemic therapy for Crohn's disease

Examples include azathioprine, 6-mercaptopurine, or methotrexate; mesalamine does NOT count as a systemic agent

c: Patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas

d: Patient had ileocolonic resection (to reduce the chance of Crohn's disease recurrence)

The medication is prescribed by or in consultation with a gastroenterologist

B) Current Receiving Omvoh Subcutaneous

Patient has been established on therapy for at least 6 months
Approval duration: 1 year
ONE of
- a: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (prior to initiating Omvoh)
  Examples: fecal markers (fecal lactoferrin, fecal calprotectin), serum markers (CRP), imaging (MRE, CTE), endoscopic assessment, and/or reduced dose of corticosteroids
- b: Compared with baseline, patient experienced an improvement in at least one symptom (decreased pain, fatigue, stool frequency, and/or blood in stool)

title": "Crohn's Disease - FDA-Approved Indication"}

Note: The JSON above is a single string representing the top-level CriteriaNode structure for the Crohn's Disease group. It preserves the AND/OR logic, required elements, and notes/approval durations as specified in the source.

Ulcerative Colitis - FDA-Approved Indication

Approve for the duration noted if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of age
- According to the prescriber, the patient will receive three induction doses with Omvoh intravenous within 3 months of initiating therapy with Omvoh subcutaneous
  Approval duration: 6 months
- The medication is prescribed by or in consultation with a gastroenterologist
B) Current Receiving Omvoh Subcutaneous
- Patient has been established on the requested drug for at least 6 months
  Approval duration: 1 year
- ONE of
  - a: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline
    Examples: fecal markers (e.g., fecal calprotectin), serum markers (CRP), endoscopic assessment, and/or reduced dose of corticosteroids
  - b: Compared with baseline, patient experienced an improvement in at least one symptom (decreased pain, fatigue, stool frequency, and/or decreased rectal bleeding)

Note: The JSON above is a single string representing the top-level CriteriaNode structure for the Ulcerative Colitis group. It preserves the AND/OR logic, required elements, and notes/approval durations as specified in the source.

Prescriber Requirement

Omvoh subcutaneous must be prescribed by or in consultation with a physician who specializes in the condition being treated (gastroenterologist for CD/UC)

Examples of objective evidence: fecal markers (fecal lactoferrin, fecal calprotectin), serum markers (CRP), imaging (MRE, CTE), endoscopic assessment, and/or reduced corticosteroid dose
Examples of symptom improvement: decreased pain, fatigue, stool frequency, and/or blood in stool (or decreased rectal bleeding for UC)
Examples of prior therapies: corticosteroids (e.g., prednisone, methylprednisolone) or one conventional systemic therapy (e.g., azathioprine, 6-mercaptopurine, methotrexate)

Denial Risk

Concurrent therapy exclusion

Claims will be considered not medically necessary if Omvoh is administered concurrently with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition. Conventional synthetic DMARDs (for example methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) are not excluded and may be used in combination.

Concurrent use with another biologic for an inflammatory condition is not covered
Concurrent use with a targeted synthetic oral small molecule drug for an inflammatory condition is not covered
Conventional synthetic DMARDs are allowed (not excluded)

01/22/2025revisedLatest

**MATERIAL CHANGE:** Ulcerative Colitis initial therapy options were revised to remove several approval options (removed trial of one systemic therapy and pouchitis-related options).