Omvoh (mirikizumab-mrkz) coverage for UC and CD
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This policy governs medical and pharmacy benefit coverage and prior authorization requirements for Omvoh (mirikizumab-mrkz) for treatment of moderately to severely active ulcerative colitis and Crohn's disease for UnitedHealthcare Commercial and Individual Exchange plans.
Revised coverage criteria to clarify combination therapy restriction to 'the patient is not receiving Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication'.
Updated lists of example systemic targeted immunomodulators that must not be used in combination with Omvoh for UC and CD and updated lists of prior targeted agents.
Application section added to indicate policy applies to UnitedHealthcare Commercial and Individual Exchange benefit plans.
Coverage Criteria for Omvoh (mirikizumab-mrkz)
Ulcerative Colitis — Induction
Covered when ALL of the following are met:
Applies to Commercial and Individual Exchange plans unless benefit documents specify otherwise
Crohn's Disease — Induction
Covered when ALL of the following are met:
For Community Plan, also require prior inadequate response to conventional therapies or prior targeted immunomodulator per Community Plan text
Community Plan — Prior therapy requirement
For the Community Plan, coverage requires either:
Applies to Ulcerative Colitis and Crohn's Disease under Community Plan policy text
Initial and maintenance therapy coverage criteria
Covered when ALL of the following are met (reflecting trial populations and revised policy language):
Based on UC-1/UC-2 and CD-1 trial entry definitions
Refer to UC-1/UC-2 and CD-1 for studied populations
Reflects UC-1/UC-2 trial requirements
Revised coverage criterion; examples of systemic targeted immunomodulators added/removed in policy history
Use of Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication is not allowed. This restriction applies to concurrent systemic targeted immunomodulators administered for the same disease (ulcerative colitis or Crohn's disease) and is a condition of medical necessity and authorization for Omvoh.
Examples of systemic targeted immunomodulators with which Omvoh must not be combined are listed in the policy text and include, for ulcerative colitis and Crohn's disease, agents such as adalimumab, vedolizumab (Entyvio), upadacitinib (Rinvoq), risankizumab (Skyrizi), guselkumab (Tremfya), tofacitinib (Xeljanz/Xeljanz XR), ustekinumab, and others as enumerated in the coverage criteria. The policy history documents that example lists were revised on 05/01/2026, with additions (e.g., vedolizumab, guselkumab, ozanimod) and removals or replacements of other named agents; prior targeted agents relevant to prior‑therapy determinations were likewise updated.
FDA approval of Omvoh is informational only and does not by itself establish coverage. Coverage is determined through a separate medical necessity review consistent with the applicable UnitedHealthcare plan; the policy states that FDA approval alone is not a basis for coverage and that a plan‑specific medical necessity determination is required.
Coding and Diagnostic Codes
| J2267 | Injection, mirikizumab-mrkz, 1 mg. |
| 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. |
| N/A | No explicit CPT/HCPCS/ICD-10/NDC codes listed in this document excerpt. |
Provider Actions, Authorization, and Documentation
Prior authorization for 3 induction doses
Prior authorization is required for Omvoh; when criteria are met authorization will be issued for three induction doses administered as IV infusions consistent with FDA‑labeled dosing.
- HCPCS code listed: J2267 (see coding) — use for prior auth submission as appropriate
Confirm coverage criteria and combination‑therapy restriction
Confirm the patient meets all coverage criteria before requesting authorization, including diagnosis of moderately to severely active UC or CD, required prior treatment history (when applicable), and that Omvoh will not be administered in combination with another systemic targeted immunomodulator for the same indication.
- Authorization must verify absence of concurrent systemic targeted immunomodulator for the same indication (policy lists examples).
- Prescriber should be a gastroenterologist or consult one as required by the criteria.
Document prior inadequate response or prior targeted therapy (Community Plan & CD)
For Community Plan members and for Crohn’s disease under the general criteria, document prior inadequate response to conventional therapies (corticosteroids, 6‑mercaptopurine, azathioprine, or methotrexate) OR prior treatment with an FDA‑approved systemic targeted immunomodulator for the indication.
- Conventional therapies include prednisone, methylprednisolone, budesonide, 6‑mercaptopurine, azathioprine, and methotrexate.
- Prior targeted agents examples are listed in the policy (e.g., adalimumab, vedolizumab, upadacitinib, ustekinumab, others).
Prior treatment history expected (informational)
Policy expectations (informational): prior inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, and/or biologic therapy or JAK inhibitors were part of the studied populations and are referenced as prior treatment requirements for authorization.
- UC trials allowed stable aminosalicylates, immunomodulators, and corticosteroids with defined tapering; CD trial populations included patients with prior loss of response/inadequate response to biologics.
- Document prior agents tried and outcomes (failure, intolerance, or loss of response).
Required prescriber clinical documentation
Include prescriber documentation of the diagnosis, statement that Omvoh will be administered as three IV induction doses per FDA labeling, and whether the patient has previously received targeted immunomodulators (or other prior therapies as applicable).
- If Community Plan, indicate prior or concurrent inadequate response to corticosteroids/immunosuppressants or prior targeted immunomodulator exposure as specified.
- Indicate prescriber specialty or consultation (prescribed by or in consultation with a gastroenterologist where required).
Clinical documentation to support medical necessity
Support medical necessity with baseline disease activity and prior treatment history: for UC include modified Mayo score (mMS) and endoscopy subscore (baseline mMS 5–9 with endoscopy subscore 2–3); for CD include CDAI and SES‑CD (CDAI ≥220 and SES‑CD thresholds) and documentation of prior biologic/JAKi exposure and concomitant therapies/steroid taper plan as applicable.
- Document baseline mMS, CDAI, and SES‑CD values where available.
- Document prior biologic or JAK inhibitor exposure, outcomes, and any concomitant UC/CD therapies with stability or taper plans.
Denial risk: combination therapy or non‑authorized induction dosing
Requests may be denied if Omvoh is prescribed concurrently with another systemic targeted immunomodulator for the same indication or if induction dosing exceeds the authorized three IV induction doses consistent with FDA‑labeled dosing.
- Policy lists example systemic targeted immunomodulators that must not be used in combination with Omvoh; updated examples are in the policy history.
- Authorization is issued for three induction IV doses — exceeding this induction regimen may lead to denial.
Combination therapy restriction — verify no concurrent systemic targeted immunomodulator
Use of Omvoh in combination with another systemic targeted immunomodulator for treatment of the same indication may trigger denial under the revised coverage criterion; verify no concurrent systemic targeted immunomodulator for the same indication before approval.
- Policy revision clarifies the prohibition applies to 'systemic targeted immunomodulator for treatment of the same indication' and updates example agent lists.
- Ensure prior authorization documentation confirms compliance with this restriction.
Background and Definitions
Omvoh (mirikizumab‑mrkz) is a humanized IgG4 monoclonal antibody that selectively binds the p19 subunit of interleukin‑23 (IL‑23), inhibiting IL‑23 interaction with its receptor and downstream mucosal inflammatory pathways. Clinical development included randomized controlled trials in ulcerative colitis (UC‑1 and UC‑2) and Crohn's disease (CD‑1) evaluating intravenous induction and maintenance dosing; UC induction trials enrolled patients with baseline modified Mayo scores typically in the 5–9 range, and CD trials used CDAI and SES‑CD thresholds for entry. Authorization in the policy is aligned to the studied IV induction regimen (three induction doses) and to the indication for moderately to severely active UC and CD.
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