CurrentBlue Cross Blue Shield - IowaPolicy N/A

Omvoh (mirikizumab) — Medical Necessity and Authorization Criteria

Covers medical necessity and authorization criteria for Omvoh (mirikizumab-mrkz) when used to treat moderately to severely active ulcerative colitis or Crohn's disease in adults; applies to Wellmark/Blue Cross and Blue Shield membership decisions and prescribers in Iowa's plan network.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyOmvoh (mirikizumab) — Medical Necessity and Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionInitial approval requires documented failure or intolerance to at least two preferred products or current insured use with positive therapeutic outcome; prescribe in consultation with a gastroenterologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

2 preferredrequired failures

TB screeningpre-initiation testing

J2267current HCPCS

Coverage Criteria for Omvoh (mirikizumab)

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Initial: Ulcerative Colitis

Covered for moderately to severely active ulcerative colitis in adults when at least ONE of the following is met

UC initial approval: Member has had an inadequate response to treatment or intolerable adverse event with at least TWO of the preferred products (Adalimumab-aacf, Entyvio, Rinvoq, Skyrizi, Otulfi (Ustekinumab-aauz), Velsipity, Tremfya, and Xeljanz/Xeljanz XR) OR member is currently receiving treatment with the requested product through insurance (samples or manufacturer patient assistance programs excluded) and is experiencing a positive therapeutic outcome.at least 2 preferred product failures OR current insured benefit with positive outcome

Must also meet Preferred Drug Plan Design when applicable.

Initial: Crohn's Disease

Covered for moderately to severely active Crohn's disease in adults when at least ONE of the following is met

CD initial approval: Member has had an inadequate response to treatment or intolerable adverse event with at least TWO of the preferred products (Adalimumab-aacf, Entyvio, Rinvoq, Skyrizi, Tremfya, and Otulfi (Ustekinumab-aauz)) OR member is currently receiving treatment with the requested product through insurance (samples or manufacturer patient assistance programs excluded) and is experiencing a positive therapeutic outcome.at least 2 preferred product failures OR current insured benefit with positive outcome

Must also meet Preferred Drug Plan Design when applicable.

Continuation Therapy

Continuation of therapy may be authorized for 12 months when the member achieves or maintains remission or demonstrates a positive clinical response

Continuation: Authorization for 12 months may be granted for members using the medication who achieve or maintain remission OR who achieve/maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms (examples include stool frequency, rectal bleeding, CRP, fecal calprotectin, endoscopic appearance, CDAI or Mayo/UCEIS scores, abdominal pain, diarrhea, body weight, hematocrit).improvement from baseline in listed clinical measures

Continuation requests require submission of chart notes or medical record documentation supporting response or remission.

Dose-specific coverage limits

Coverage subject to dosing and quantity limits as follows:

Ulcerative Colitis dosing: Induction: 300 mg IV at weeks 0, 4, and 8; Maintenance: 2 x 100 mg pens/prefilled syringes per 28 days.

Quantity limits per policy.

Crohn's Disease dosing: Induction: 900 mg IV at weeks 0, 4, and 8; Maintenance: 300 mg per 28 days (packaged as 1 carton containing 200 mg and 100 mg single‑dose prefilled pens/syringes as specified).

Quantity limits per policy; approvals may be subject to dosing limits consistent with FDA labeling and accepted compendia.

Do not administer Omvoh (mirikizumab) concomitantly with any other biologic or targeted synthetic drug for the same indication. Prior to initiation, obtain documented TB screening within 12 months for members who are naive to biologic or targeted synthetic therapies; acceptable tests include a tuberculosis skin test (PPD), an interferon‑release assay (IGRA), or chest x‑ray. If TB screening is positive, pursue further evaluation to exclude active disease. Do not give Omvoh to members with active TB. If latent TB is identified, start appropriate TB treatment before initiating Omvoh.

Approvals for Omvoh may be limited to dosing that is consistent with FDA‑approved labeling and accepted compendia or evidence‑based practice guidelines. Doses outside these limits are not eligible for approval; see the quantity limits section for specific induction and maintenance dosing for ulcerative colitis and Crohn's disease.

Omvoh is considered not medically necessary for members who do not meet the coverage criteria described in this policy, including required prior therapy, prescriber specialty requirements, TB screening, and dosing/quantity limits.

The HCPCS code C9168 for mirikizumab‑mrkz was cancelled effective 7/1/2024 and is not valid for billing after that date; use the current code J2267 for reporting mirikizumab services effective 7/1/2024.

Prior Authorization, Step Therapy, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Omvoh. Initial approvals require that the member meets the plan's preferred drug design and documents inadequate response or intolerance to preferred products, or documents current receipt of the requested non-preferred product through insurance with a positive therapeutic outcome. Prescriptions for initial approvals must be by or in consultation with a gastroenterologist for the relevant indications.

Preferred products include: Adalimumab-aacf, Enbrel, Entyvio, Cosentyx, Otezla, Rinvoq, Skyrizi, Otulfi (Ustekinumab-aauz), Tremfya, Velsipity, Xeljanz/Xeljanz XR
Initial approval requires failure or intolerance to at least TWO preferred products for the indication unless exceptions apply
Members currently receiving the non-preferred drug via insurance and demonstrating positive therapeutic outcome may qualify without meeting step requirements

Billing Rule

Dosing and Quantity Limits May Apply

Approvals may include dosing and quantity limits aligned with FDA labeling, accepted compendia, and evidence-based guidelines. Specific induction and maintenance quantity limits are defined for each indication and will be enforced during authorization.

Ulcerative Colitis: Induction — 300 mg IV at weeks 0, 4, and 8; Maintenance — 2 x 100 mg pens/PFS per 28 days
Crohn's Disease: Induction — 900 mg IV at weeks 0, 4, and 8; Maintenance — 300 mg (specified pen/syringe presentation) per 28 days
Approvals may limit dose and frequency to those in the FDA label, compendia, or guidelines

Denial Risk

Denial Risk for Out‑of‑Limit Dosing

Requests for doses or quantities that exceed FDA-approved labeling, accepted compendia, or evidence-based practice guidelines may be denied as not medically necessary. Authorization decisions will reference labeling, compendia, and clinical guidelines when evaluating dosing beyond standard limits.

Doses outside FDA label or guideline-supported ranges are subject to denial
Operational denial risk if documentation does not support medical necessity for higher-than-recommended dosing

Step Therapy

Step Therapy to Preferred Products

Step therapy requires trial of preferred biologic/targeted agents prior to non-preferred products for applicable indications. The policy requires inadequate response or intolerable adverse events to at least TWO preferred products before approval of non-preferred agents, unless the member meets an exception (e.g., clinical contraindication to all preferred products, current positive response to the non-preferred agent under insurance).

Step therapy: failure/intolerance to ≥2 preferred products for the indication is required prior to non-preferred product approval
Exceptions: documented contraindication to all preferred products, or current insured use of the non-preferred drug with demonstrated positive clinical outcome
Members accessing the requested drug as samples or via manufacturer assistance must still meet initial approval criteria

OpenPayer

Omvoh (mirikizumab) — Medical Necessity and Authorization Criteria

Coverage Criteria for Omvoh (mirikizumab)

Product Coding, Dosing, and Quantity Limits

Prior Authorization, Step Therapy, and Documentation

Definitions and Background

J2267	Injection, mirikizumab-mrkz, mg (effective 7/1/2024)
C9168	Injection, mirikizumab-mrkz, mg (cancelled 7/1/2024)