ModifiedColorado Rocky Mountain Health PlansPolicy CS2026D00129J

Omvoh (mirikizumab-mrkz) medical benefit drug policy

Governs medical benefit coverage and authorization requirements for Omvoh (mirikizumab-mrkz) for treatment of moderate to severely active ulcerative colitis and Crohn's disease for Colorado Rocky Mountain Health Plans members; includes applicable coding and clinical justification. Pharmacy benefit note: self-administered subcutaneous product is routed to pharmacy benefit.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOmvoh (mirikizumab-mrkz) medical benefit drug policy

Policy CodePolicy CS2026D00129J

Change TypeRevised coverage criteria and updated example agent lists

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization documenting diagnosis, prior targeted therapy trials (drug names, dates, duration), and confirm patient is not receiving Omvoh with another systemic targeted immunomodulator for the same indication.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria; replaced criterion requiring 'the patient is not receiving Omvoh in combination with another targeted immunomodulator' with 'the patient is not receiving Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication'.

Revised lists of examples of systemic targeted immunomodulators the patient must not be receiving in combination with Omvoh for UC and CD—added and removed specific agents.

Revised list of systemic targeted immunomodulators with which the patient has been previously treated (agents added/removed).

3IV induction doses authorized

65%UC clinical response at 12 wks

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24%UC clinical remission at 12 wks

66%Remission maintained at 1 yr

Coverage Criteria for Omvoh (mirikizumab-mrkz)

Ulcerative Colitis (UC) — Initial Coverage

Covered when ALL of the following are met:

UC Coverage prerequisites: Diagnosis of moderately to severely active ulcerative colitis

Prior therapy requirement: Patient has had prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine) OR patient has been previously treated with a systemic targeted immunomodulator FDA-approved for the treatment of ulcerative colitis (examples provided in policy)

Examples: adalimumab, Entyvio (vedolizumab), Rinvoq (upadacitinib), Simponi (golimumab), Skyrizi (risankizumab), Tremfya (guselkumab), Xeljanz/Xeljanz XR (tofacitinib), ustekinumab, Zeposia (ozanimod)

Targeted agent failures: History of failure, contraindication, or intolerance to two targeted immunomodulators FDA-approved for the treatment of ulcerative colitis (document drug, date, and duration of trial)2 agents

Dosing and combination: Omvoh is to be administered as three intravenous induction doses per FDA-labeled dosing; patient is not receiving Omvoh in combination with another systemic targeted immunomodulator for the same indication3 induction doses authorized

Prescribed by or in consultation with a gastroenterologist; authorization will be issued for 3 induction doses

Crohn's Disease (CD) — Initial Coverage

Covered when ALL of the following are met:

CD Coverage prerequisites: Diagnosis of moderately to severely active Crohn's disease

Prior conventional therapy requirement: History of failure to one of the following conventional therapies at up to maximally indicated doses unless contraindicated: corticosteroids (e.g., prednisone, methylprednisolone, budesonide), 6-mercaptopurine, azathioprine, methotrexate

Prior targeted therapy option: OR patient has been previously treated with a systemic targeted immunomodulator FDA-approved for the treatment of Crohn's disease (examples provided in policy)

Examples: adalimumab, Cimzia (certolizumab), Entyvio (vedolizumab), Omvoh (mirikizumab-mrkz), Rinvoq (upadacitinib), Skyrizi (risankizumab), Tremfya (guselkumab), ustekinumab

Targeted agent failures: History of failure, contraindication, or intolerance to two targeted immunomodulators FDA-approved for the treatment of Crohn's disease (document drug, date, and duration of trial)

Coverage criteria (summary)

Covered when ALL of the following are met (summary of clinical/administrative requirements reflected in document excerpt):

Indication: Patient has moderately to severely active ulcerative colitis or moderately to severely active Crohn's disease as defined by clinical trial criteriasee clinical_context thresholds

Supported by UC-1/UC-2 and CD-1 trial populations

Therapy intent and regimen: Use consistent with induction and maintenance regimens evaluated in trials (intravenous induction leading to Week 12 response; maintenance dosing every 4 weeks up to 52 weeks as applicable)induction response at Week 12 for maintenance randomization

UC and CD trial designs described in policy

Combination therapy restriction: Patient is not receiving Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication

Patient requests for Omvoh will be denied if the patient is receiving Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication. This concurrent combination prohibition applies to agents listed as examples in the policy (see policy examples) and is enforced when determining medical necessity for IV-administered Omvoh.

The policy language has been revised to explicitly prohibit concurrent use of Omvoh with another systemic targeted immunomodulator for treatment of the same indication. Examples of agents were updated in the revision; for UC the examples now include additions such as Entyvio (vedolizumab), Tremfya (guselkumab), and Zeposia (ozanimod) and other agents were removed or modified. For CD the example lists were likewise updated. When evaluating requests, reviewers should apply the revised phrasing — the prohibition targets concurrent use of another systemic targeted immunomodulator being used to treat the same diagnosis.

Self-administered subcutaneous formulations of Omvoh are routed to and managed under the pharmacy benefit. This medical benefit policy governs IV administration of Omvoh (including the three-dose IV induction regimen) and does not apply to the pharmacy-managed, self-administered product.

FDA approval and prescribing information for Omvoh are provided for informational purposes only. FDA approval alone is not a basis for coverage; coverage decisions are made according to this policy and applicable plan or contractual provisions.

Applicable Coding and Diagnostic Codes

Applicable HCPCSHCPCS

J2267

Injection, mirikizumab-mrkz, 1 mg.

Applicable ICD-10 Diagnosis Codes (selected excerpts)ICD-10

K50.00	Crohn's disease of small intestine without complications.
K50.011	Crohn's disease of small intestine with rectal bleeding.
K50.012	Crohn's disease of small intestine with intestinal obstruction.
K50.013	Crohn's disease of small intestine with fistula.
K50.014	Crohn's disease of small intestine with abscess.
K50.018	Crohn's disease of small intestine with other complication.
K50.019	Crohn's disease of small intestine with unspecified complications.
K50.10	Crohn's disease of large intestine without complications.
K51.00	Ulcerative (chronic) pancolitis without complications.
K51.011	Ulcerative (chronic) pancolitis with rectal bleeding.

1–10 of 15

1/2

Affected billing codesmixed

affected codes

Placeholder in document indicating policy-level affected billing codes (specific CPT/HCPCS codes not listed in this excerpt).

inv-11: CDAI — numeric threshold used in CD trial documentation

CDAI threshold (trial definition)CDAI ≥ 220

Clinical baseline medianMedian CDAI at baseline: 329

Use in documentationCDAI ≥ 220 may be used to document moderately to severely active Crohn's disease for medical necessity

inv-12: SES-CD (ileal-colonic) — numeric threshold used in CD trial documentation

SES-CD threshold (ileal-colonic)SES-CD ≥ 7 (centrally read)

Baseline median SES-CDMedian SES-CD at baseline: 12

Provider Requirements, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for Omvoh induction (three IV doses) per FDA-labeled dosing. Requests that do not document a diagnosis of moderately to severely active ulcerative colitis or Crohn's disease will be at risk for denial.

Authorization will be issued for 3 induction doses
Prescribed by or in consultation with a gastroenterologist
Omvoh induction dosing must follow FDA-labeled dosing for the indication

Denial Risk

Requests may be denied if documentation does not show moderately to severely active disease or if required prior treatment trials are missing. Denials can also occur if the member is receiving Omvoh in combination with another systemic targeted immunomodulator for the same indication.

Lack of documented diagnosis of moderately to severely active UC or CD may result in denial

Background on Omvoh and Clinical Evidence

Omvoh (mirikizumab-mrkz) is a humanized IgG4 monoclonal antibody that selectively binds the p19 subunit of interleukin-23, inhibiting IL-23 receptor interaction and downstream pro-inflammatory signaling. It was developed and studied for treatment of moderately to severely active ulcerative colitis and Crohn's disease; the IV induction regimen authorized by this medical benefit policy follows the trial and FDA-labeled induction dosing of three IV doses prior to maintenance treatment.

Definitions and Trial Measures

inv-24: mirikizumab mechanism — IL-23 p19 inhibitor

Mechanism of actionMirikizumab selectively binds the p19 subunit of human IL-23 and inhibits its interaction with the IL-23 receptor (IL-23 p19 inhibitor)

Molecule classHumanized IgG4 monoclonal antibody

Pathophysiology relevanceTargets IL-23 involved in mucosal inflammation by affecting T cell and innate immune cell subsets

inv-25: mMS — modified Mayo score definition (0-9 composite used to assess UC disease activity)

DefinitionModified Mayo score (mMS) is a 0–9 composite of three subscores: stool frequency, rectal bleeding, and centrally read endoscopy (each 0–3)

Score rangeTotal mMS ranges from 0 (least active) to 9 (most severe)

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOmvoh (mirikizumab-mrkz) medical benefit drug policy

Policy CodePolicy CS2026D00129J

Change TypeRevised coverage criteria and updated example agent lists

Effective DateMay 1, 2026

Next Review DateN/A

SourceLink

On This Page

Prescribed by or in consultation with a gastroenterologist; authorization will be issued for 3 induction doses

Revised explicit prohibition language and updated example agent lists

Prior targeted therapy considerations: Policy requires documentation of prior exposure to systemic targeted immunomodulators where applicable; examples of prior agents were updated in the revisionN/A

Lists of prior agents added/removed in revision

Role in endpointsSES-CD used to define endoscopic response/remission in CD trial assessments

inv-13: SES-CD (isolated ileal) — numeric threshold used in CD trial documentation

SES-CD threshold (isolated ileal)SES-CD ≥ 4 (centrally read)

ContextThreshold applied for subjects with isolated ileal Crohn's disease to meet 'moderately to severely active' definition

Use in endpointsSES-CD contributed to coprimary and secondary endoscopic outcome assessments

inv-14: Urgency NRS weekly average — baseline subgroup threshold reported

Baseline subgroup threshold>= 3 (Urgency NRS weekly average)

Scale describedUrgency NRS is a 0–10 patient-reported scale; weekly averages used to categorize urgency severity

Reported outcomePatients with baseline weekly average ≥3 showed greater improvement to weekly averages of 0–1 on mirikizumab vs placebo at Week 40

Concurrent use with another systemic targeted immunomodulator for the same indication is a denial risk

Documentation Required

Document Prior Targeted Immunomodulator Trials

Document the specific targeted immunomodulators tried (drug name), start and stop dates, and duration of each trial, with evidence of failure, contraindication, or intolerance. For prior targeted immunomodulator trials, include drug names, dates, and duration of therapy.

Provide drug name(s), dates (start and stop), and duration of each prior targeted immunomodulator trial
Include documentation of failure, contraindication, or intolerance for each prior agent

Step Therapy

Step Therapy Requirement for UC and CD

For Ulcerative Colitis and Crohn's Disease, patients must have moderately to severely active disease and meet step therapy requirements: prior inadequate response to conventional therapies and documented failure, contraindication, or intolerance to two targeted immunomodulators FDA‑approved for the respective indication.

UC: prior or concurrent inadequate response to oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine) or prior treatment with a systemic targeted immunomodulator for UC (examples include adalimumab, Entyvio (vedolizumab), Rinvoq (upadacitinib), Simponi (golimumab), Skyrizi (risankizumab), Tremfya (guselkumab), Xeljanz/Xeljanz XR (tofacitinib), ustekinumab, Zeposia (ozanimod))
CD: prior inadequate response to conventional therapies (e.g., corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate) or prior treatment with a systemic targeted immunomodulator for CD (examples include adalimumab, Cimzia (certolizumab), Entyvio (vedolizumab), Rinvoq (upadacitinib), Skyrizi (risankizumab), Tremfya (guselkumab), ustekinumab)
History of failure, contraindication, or intolerance to two targeted immunomodulators FDA‑approved for the treatment of UC or CD must be documented (include drug, dates, duration)

Documentation Required

Disease Severity Documentation

Disease severity must be documented. For Crohn's disease, disease activity thresholds used in clinical trials included CDAI ≥ 220 and SES‑CD ≥ 7 for ileal‑colonic disease or SES‑CD ≥ 4 for isolated ileal disease. Provide CDAI and/or endoscopic scores or other objective evidence supporting moderately to severely active disease.

Document Crohn's Disease Activity Index (CDAI) and Simple Endoscopic Score for Crohn's disease (SES‑CD) when available (e.g., CDAI ≥ 220; SES‑CD ≥ 7 for ileal‑colonic disease or ≥ 4 for isolated ileal disease)
For UC, provide objective evidence of moderately to severely active disease (endoscopic, clinical indices, or physician documentation)

Use in trialmMS used to assess disease activity and eligibility in UC-1 with baseline mMS 5–9

inv-26: Endoscopic remission — normalization of endoscopic mucosa defined as Mayo endoscopic subscore of 0

Endoscopic remission definitionNormalization of endoscopic mucosa defined as Mayo endoscopic subscore of 0

Trial outcomeEndoscopic remission at Week 40 observed more with mirikizumab vs placebo (22% vs 14%)

Assessment methodEndoscopic subscore centrally read as part of Mayo endoscopic scoring

inv-27: Urgency Numeric Rating Scale (NRS) — patient-reported 0–10 scale used to assess bowel urgency; weekly averages interpretation

Scale descriptionUrgency Numeric Rating Scale (NRS) is a patient-reported 0–10 scale assessing bowel urgency

Interpretation of weekly averagesWeekly average scores of 0–1 indicate low urgency; subgroup with baseline ≥3 analyzed separately

Reported improvementSubjects with baseline weekly average ≥3 treated with mirikizumab more likely to reach weekly averages of 0–1 compared to placebo

inv-28: Trial definition of moderately to severely active Crohn's disease — CDAI ≥ 220 and SES-CD thresholds

Trial definition (CD)Moderately to severely active Crohn's disease defined as CDAI ≥ 220 AND SES-CD ≥ 7 for ileal-colonic disease or ≥ 4 for isolated ileal disease

Baseline valuesMedian baseline CDAI 329 and SES-CD 12 in CD-1 population

Use for medical necessityThese thresholds were used to define the eligible CD trial population and may support documentation of disease severity for coverage