ModifiedColorado Rocky Mountain Health PlansPolicy 2026D0129F

Omvoh (mirikizumab-mrkz) — prior authorization and medical necessity for ulcerative colitis and Crohn's disease

Medical policy governing prior authorization and medical necessity criteria for Omvoh (mirikizumab-mrkz) for treatment of moderately to severely active ulcerative colitis and Crohn's disease for UnitedHealthcare Commercial, Individual Exchange, and Community Plan members. Affects prescribing providers, pharmacies (self-administered vs medical benefit), and prior authorization reviewers.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOmvoh (mirikizumab-mrkz) coverage for inflammatory bowel disease

Policy CodePolicy 2026D0129F

Change TypeRevised coverage criteria and example lists

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization confirming three IV induction doses and that the patient is not receiving Omvoh in combination with another systemic targeted immunomodulator for the same indication.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria to replace the requirement that the patient not receive Omvoh in combination with another targeted immunomodulator with a clarified prohibition against Omvoh combined with another systemic targeted immunomodulator for the same indication.

Updated and revised example lists of systemic targeted immunomodulators that patients must not be receiving in combination with Omvoh and lists of previously tried agents for both UC and CD.

Added Application section indicating the policy applies to UnitedHealthcare Commercial and Individual Exchange benefit plans.

3authorization issued for induction

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65%clinical response (UC-1, 12w)

24%clinical remission (UC-1, 12w)

Coverage Criteria for Omvoh (mirikizumab-mrkz)

inv-01: COVERAGE CRITERIA

Covered when ALL of the following are met:

ALL of the following

diagnosis: Diagnosis of moderately to severely active ulcerative colitis
dosing: Omvoh is to be administered as three intravenous induction doses in accordance with FDA labeled dosing for ulcerative colitis3 IV induction doses
Authorization issued for 3 induction doses
concomitant_therapy: Patient is not receiving Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication
Examples listed in policy (e.g., adalimumab, vedolizumab, upadacitinib, golimumab, risankizumab, guselkumab, tofacitinib, ustekinumab, ozanimod)

inv-02: COVERAGE CRITERIA (Community Plan)

Covered when ALL of the following are met (Community Plan):

ALL of the following

diagnosis: Diagnosis of moderately to severely active ulcerative colitis
prior_treatment: Either prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine) OR prior treatment with a systemic targeted immunomodulator FDA-approved for ulcerative colitis
Examples of agents listed in policy
dosing: Omvoh is to be administered as three intravenous induction doses per FDA labeled dosing3 IV induction doses
Authorization issued for 3 induction doses

inv-03: COVERAGE CRITERIA

Covered when ALL of the following are met:

ALL of the following

diagnosis: Diagnosis of moderately to severely active Crohn's disease
prior_treatment: Either history of failure to conventional therapies at up to maximally indicated doses (corticosteroids, 6-mercaptopurine, azathioprine, methotrexate) unless contraindicated OR prior treatment with an FDA-approved systemic targeted immunomodulator for Crohn's disease
Examples of agents listed in policy
dosing: Omvoh is to be administered as three intravenous induction doses in accordance with FDA labeled dosing for Crohn's disease3 IV induction doses
Authorization issued for 3 induction doses

inv-04: Initial and maintenance coverage criteria (trial-aligned)

Covered when ALL of the following are met (summary of trial-based eligibility and policy revisions):

Indication: Adult patient with moderately to severely active ulcerative colitis or Crohn's disease as defined by trial criteria (UC: mMS 5–9 with endoscopy subscore 2–3; CD: CDAI ≥ 220 and SES‑CD thresholds).see thresholds

Supported by UC-1/UC-2 and CD-1 trials

Prior therapies: Patient has inadequate response, loss of response, or intolerance to conventional therapies and/or prior biologic/JAKi therapies as appropriate for the indication (per policy examples and trial populations).document prior failures/intolerance

Policy examples of previously tried systemic targeted immunomodulators were revised (see policy history).

Concomitant therapy: Patient is on stable concomitant aminosalicylates or immunomodulators as allowed by trials, and corticosteroid tapering is required for those on corticosteroids who achieve response prior to maintenance as described in trials.

Use of Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication is excluded. The policy explicitly states the patient must not be receiving Omvoh concurrently with another systemic targeted immunomodulator (examples listed in policy) and authorization is contingent on meeting this requirement.

The policy clarifies the combination-therapy prohibition: Omvoh must not be used in combination with another systemic targeted immunomodulator for the same indication. The revision updated and standardized example lists of systemic targeted immunomodulators to illustrate agents subject to this exclusion.

Requests that fail to meet the policy's diagnosis or dosing requirements, or that involve concurrent systemic targeted immunomodulator therapy for the same indication, do not meet medical necessity. Specifically, the policy requires a documented diagnosis of moderately to severely active ulcerative colitis or Crohn's disease and that induction be given as three intravenous induction doses per FDA‑labeled dosing; concurrent use with another systemic targeted immunomodulator for the same indication would render the request non‑compliant.

Operationally, prior authorization reviewers should apply the combination‑therapy prohibition and revised prior‑treatment lists when adjudicating requests. Scenarios where the combination‑therapy exclusion or prior‑therapy requirements are not satisfied may be managed per the policy (e.g., denial or request for additional documentation confirming absence of concurrent systemic targeted immunomodulator use and documented prior therapies).

Coding and Disease Activity Thresholds

Covered HCPCSHCPCSCovered

J2267

Injection, mirikizumab-mrkz, 1 mg.

Applicable ICD-10 Codes - Crohn's disease (partial list)ICD-10

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.
K50.111	Crohn's disease of large intestine with rectal bleeding.
K50.112	Crohn's disease of large intestine with intestinal obstruction.
K50.113	Crohn's disease of large intestine with fistula.

1–10 of 13

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Applicable ICD-10 Codes - Ulcerative colitis (partial list)ICD-10

K51.00	Ulcerative (chronic) pancolitis without complications.
K51.011	Ulcerative (chronic) pancolitis with rectal bleeding.
K51.013	Ulcerative (chronic) pancolitis with fistula.
K51.014	Ulcerative (chronic) pancolitis with abscess.
K51.20	Ulcerative (chronic) proctitis without complications.
K51.311	Ulcerative (chronic) recto sigmoiditis with rectal bleeding.
K51.319	Ulcerative (chronic) recto sigmoiditis with unspecified complications.
K51.50	Left sided colitis without complications.
K51.90	Ulcerative colitis, unspecified, without complications.

Other applicable ICD-10ICD-10

K52.1

Toxic gastroenteritis and colitis.

Drug codes (referenced)NDC

NDC	Not specified in this document; see Omvoh package insert

inv-14: Disease activity score thresholds — UC and CD numeric thresholds (mMS, CDAI, SES-CD)

Ulcerative colitis (mMS)Modified Mayo score (mMS) 5–9 at baseline with centrally read endoscopy subscore of 2 or 3 (study UC‑1); median mMS = 7

Crohn's disease (CDAI)Crohn's Disease Activity Index (CDAI) ≥ 220 defines moderate‑to‑severe CD (study CD‑1)

Crohn's disease (SES‑CD) — ileal‑colonicSES‑CD ≥ 7 (centrally read) for ileal‑colonic disease (study CD‑1)

Crohn's disease (SES‑CD) — isolated ilealSES‑CD ≥ 4 for isolated ileal disease (study CD‑1)

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for Omvoh (mirikizumab-mrkz). Authorization will be issued for three induction doses when criteria are met. Confirm benefit routing per member plan (pharmacy benefit for self-administered subcutaneous Omvoh unless the member's benefit specifies otherwise).

Authorization issued for 3 induction (IV) doses
Self‑administered subcutaneous Omvoh is generally obtained under the pharmacy benefit unless the member's plan specifies otherwise

Denial Risk

Combination‑Therapy Exclusion / Denial Risk

Requests may be denied if the patient is receiving Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication. Examples of systemic targeted immunomodulators include adalimumab, vedolizumab (Entyvio), upadacitinib (Rinvoq), golimumab (Simponi), risankizumab (Skyrizi), guselkumab (Tremfya), tofacitinib (Xeljanz/Xeljanz XR), ustekinumab, and ozanimod (Zeposia).

Background and Context

Omvoh (mirikizumab‑mrkz) is a humanized IgG4 monoclonal antibody that selectively binds the p19 subunit of interleukin‑23 (IL‑23), inhibiting IL‑23 receptor interaction and modulating mucosal inflammatory T‑cell and innate immune subsets relevant to inflammatory bowel disease. In clinical trials, induction was studied as three intravenous infusions followed by subcutaneous maintenance; trial eligibility used disease activity thresholds such as the modified Mayo score for ulcerative colitis and CDAI/SES‑CD for Crohn's disease.

Definitions and Scoring Instruments

inv-24: Omvoh (mirikizumab-mrkz) — drug definition and target

Generic name / brandmirikizumab‑mrkz (Omvoh)

Drug classHumanized IgG4 monoclonal antibody

TargetBinds selectively to the p19 subunit of human interleukin‑23 (IL‑23), inhibiting interaction with the IL‑23 receptor

inv-25: modified Mayo score (mMS) — definition and note on UC‑1 baseline

Score range0–9 total modified Mayo score (mMS)

ComponentsThree subscores (each 0–3): stool frequency, rectal bleeding, and centrally read endoscopy subscore

Trial baseline requirement (UC‑1)

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOmvoh (mirikizumab-mrkz) coverage for inflammatory bowel disease

Policy CodePolicy 2026D0129F

Change TypeRevised coverage criteria and example lists

Effective DateMay 1, 2026

Next Review DateN/A

SourceLink

On This Page

specialist: Prescribed by or in consultation with a gastroenterologist

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

Examples listed in policy

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

Examples listed in policy

specialist: Prescribed by or in consultation with a gastroenterologist

stable doses per trial

Reflects trial requirements for concomitant therapy and steroid tapering.

Combination therapy exclusion: Patient is not receiving Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication.N/A

Policy language revised to clarify systemic targeted immunomodulator exclusion and example lists were updated.

Denial risk if combined with another systemic targeted immunomodulator for the same indication
Examples: adalimumab; Entyvio (vedolizumab); Rinvoq (upadacitinib); Simponi (golimumab); Skyrizi (risankizumab); Tremfya (guselkumab); Xeljanz/Xeljanz XR (tofacitinib); ustekinumab; Zeposia (ozanimod)

Documentation Required

Documentation Required for Prior Authorization

Required documentation must be submitted with the prior authorization request to support the medical necessity of Omvoh.

Documentation of the diagnosis (moderately to severely active ulcerative colitis or Crohn's disease)
Planned administration as three intravenous induction doses consistent with FDA‑labeled dosing
Clinical records supporting prior therapies tried, response status, loss of response, or intolerance (see step‑therapy requirements below)
Prescribing clinician specialty or documentation of consultation with a gastroenterologist when required

Documentation Required

Clinical Evidence Required

Clinical evidence must demonstrate disease activity and prior treatment history as applicable.

For ulcerative colitis: baseline disease activity documented by modified Mayo score (mMS) and centrally read endoscopy subscore when available
For Crohn's disease: baseline CDAI and Simple Endoscopic Score for Crohn's disease (SES‑CD) where applicable (e.g., CDAI ≥ 220 and SES‑CD thresholds per study definitions)
Documentation of prior biologic or JAK inhibitor exposure, inadequate response, loss of response, or intolerance as applicable
Clinical notes, endoscopy reports, and prior medication records to substantiate response/failure

Step Therapy

Step Therapy / Prior Failure Requirements

Step‑therapy and prior‑failure requirements differ by indication and plan (Community Plan vs Commercial/Exchange) and must be confirmed before approval.

Ulcerative colitis (Commercial/Exchange): confirm prior inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, and/or prior biologic/JAKi as specified by the coverage criteria when applicable
Ulcerative colitis (Community Plan): evidence of prior or concurrent inadequate response to oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine) OR prior treatment with an FDA‑approved systemic targeted immunomodulator for UC
Crohn's disease: history of failure to conventional therapies at maximally indicated doses (corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate) unless contraindicated, OR prior treatment with an FDA‑approved systemic targeted immunomodulator for CD

Denial Risk

Prior‑Treatment Confirmation and Denial Conditions

Confirm that prior‑treatment criteria are met and that the patient is not concurrently receiving a disallowed combination therapy; requests failing these requirements may be denied.

Verify prior therapies and documented inadequate response, loss of response, or intolerance per indication
Verify absence of concurrent systemic targeted immunomodulator for the same indication
Prescriptions or administration records showing overlapping therapy may trigger denial

Subjects enrolled in UC‑1 had mMS 5–9 with median mMS = 7

inv-26: Modified Mayo score (mMS) — components and baseline eligibility

mMS components detailEach subscore scored 0 (normal) to 3 (most severe): stool frequency, rectal bleeding, and endoscopic findings (centrally read)

Endoscopy subscores specifiedEndoscopy subscore 2: marked erythema, absent vascular pattern, friability, erosions; subscore 3: spontaneous bleeding and ulceration

Baseline eligibility for UC trialsBaseline requirement included a centrally read endoscopy subscore of 2 or 3 in addition to total mMS 5–9

inv-27: CDAI and SES-CD — definitions used for Crohn's disease severity and trial thresholds

CDAI definition useCrohn's Disease Activity Index (CDAI) used to assess baseline disease activity; trial defined moderate‑to‑severe CD as CDAI ≥ 220

SES‑CD roleSimple Endoscopic Score for Crohn's disease (SES‑CD) used with CDAI to define baseline severity

SES‑CD thresholds by locationSES‑CD ≥ 7 (centrally read) for ileal‑colonic disease; SES‑CD ≥ 4 for isolated ileal disease

Baseline medians in CD‑1Median CDAI = 329 and median SES‑CD = 12 at baseline in study CD‑1