Skip to main content

Mirikizumab-mrkz (Omvoh™)

Commercial Medical Policy
Version Date: February 2025

Restricted Product(s):

  • mirikizumab-mrkz (Omvoh™) intravenous infusion for administration by a healthcare professional

FDA Approved Use:

  • For the treatment of moderately to severely active Crohn’s disease in adults
  • For the treatment of moderately to severely active ulcerative colitis in adults

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

  1. The patient has a diagnosis of moderately to severely active Crohn’s disease (CD); AND
    1. The patient is 18 years of age or older; AND
    2. ONE of the following:
      1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate) used in the treatment of CD for at least 3-months [medical record documentation required]; OR
      2. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of CD [medical record documentation required]; OR
      3. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD [medical record documentation required]; AND
    3. ONE of the following:
      1. The patient has tried and had an inadequate response to ONE of the following agents used in the treatment of CD for at least 3-months: an adalimumab product, ustekinumab (Stelara®), risankizumab-rzaa (Skyrizi®), vedolizumab (Entyvio®), upadacitinib (Rinvoq®) [medical record documentation required]; OR
      2. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to ONE of the following agents used in the treatment of CD: an adalimumab product, ustekinumab (Stelara®), risankizumab-rzaa (Skyrizi®), vedolizumab (Entyvio®), upadacitinib (Rinvoq®) [medical record documentation required]; OR
      3. The patient has an FDA labeled contraindication to ALL of the following agents used in the treatment of CD: an adalimumab product, ustekinumab (Stelara®), risankizumab-rzaa (Skyrizi®), vedolizumab (Entyvio®), upadacitinib (Rinvoq®) [medical record documentation required]; OR
      4. BOTH of the following:
        1. The prescriber has provided information indicating why ALL of the following agents for treatment of CD are not clinically appropriate for the patient: an adalimumab product, ustekinumab (Stelara®), risankizumab-rzaa (Skyrizi®), vedolizumab (Entyvio®), upadacitinib (Rinvoq®) [medical record documentation required]; AND
        2. The prescriber has provided a complete list of previously tried agents for the requested indication [medical record documentation required]; AND
    4. The request is for initiation of Omvoh (mirikizumab) therapy, and an initial intravenous infusion of Omvoh (mirikizumab) will be administered; AND
    5. The patient will NOT be treated with the 100 mg and 200 mg dose subcutaneous injections; OR
  2. The patient has a diagnosis of moderately to severely active ulcerative colitis (UC); AND
    1. The patient is 18 years of age or older; AND
    2. ONE of the following:
      1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) used in the treatment of UC for at least 3-months [medical record documentation required]; OR
      2. The patient has severely active ulcerative colitis [medical record documentation required]; OR
      3. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of UC [medical record documentation required]; OR
      4. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC [medical record documentation required]; AND
    3. ONE of the following:
      1. The patient has tried and had an inadequate response to ONE of the following agents used in the treatment of UC for at least 3-months: an adalimumab product, ustekinumab (Stelara®), risankizumab-rzaa (Skyrizi®), guselkumab (Tremfya®), vedolizumab (Entyvio®), upadacitinib (Rinvoq®), tofacitinib (Xeljanz®/Xeljanz XR®) [medical record documentation required]; OR
      2. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to ONE of the following agents used in the treatment of UC: an adalimumab product, ustekinumab (Stelara®), risankizumab-rzaa (Skyrizi®), guselkumab (Tremfya®), vedolizumab (Entyvio®), upadacitinib (Rinvoq®), tofacitinib (Xeljanz®/Xeljanz XR®) [medical record documentation required]; OR
      3. The patient has an FDA labeled contraindication to ALL of the following agents used in the treatment of UC: an adalimumab product, ustekinumab (Stelara®), risankizumab-rzaa (Skyrizi®), guselkumab (Tremfya®), vedolizumab (Entyvio®), upadacitinib (Rinvoq®), tofacitinib (Xeljanz®/Xeljanz XR®) [medical record documentation required]; OR
      4. BOTH of the following:
        1. The prescriber has provided information indicating why ALL of the following agents for treatment of UC are not clinically appropriate for the patient: an adalimumab product, ustekinumab (Stelara®), risankizumab-rzaa (Skyrizi®), guselkumab (Tremfya®), vedolizumab (Entyvio®), upadacitinib (Rinvoq®), tofacitinib (Xeljanz®/Xeljanz XR®) [medical record documentation required]; AND
        2. The prescriber has provided a complete list of previously tried agents for the requested indication [medical record documentation required]; AND
    4. The request is for initiation of Omvoh (mirikizumab) therapy, and an initial intravenous infusion of Omvoh (mirikizumab) will be administered; AND
    5. The patient will NOT be treated with the 100 mg dose subcutaneous injection; AND
  3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist for CD, UC) or has consulted with a specialist in the area of the patient’s diagnosis; AND
  4. The patient will NOT be using mirikizumab-mrkz (Omvoh™) in combination with another biologic immunomodulator agent or Zeposia®; AND
  5. The patient does NOT have any FDA labeled contraindications to mirikizumab-mrkz (Omvoh™); AND
  6. The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB; AND
  7. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).

Duration of Approval:  Crohn’s disease or ulcerative colitis induction (IV): 90 days

FDA Label Reference   

Medication  IndicationDosing  HCPCS  Maximum Units*

mirikizumab-mrkz (Omvoh™)

intravenous (IV) infusion

CD in patients ≥ 18 years oldInduction: 900 mg IV at week 0, week 4, and week 8

 

J2267

CD: 2,700

 

UC: 900

UC in patients ≥ 18 years oldInduction: 300 mg IV at week 0, week 4, and week 8

*Maximum units allowed for duration of approval 

References:

all information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

February 2025: Criteria change: Added newly approved indication for moderately to severely active Crohn’s disease in adults with associated criteria, and added associated dosing to FDA label reference table.

January 2025: Criteria change: Changed trial and failure requirements from two biologic immunomodulator products to ONE biologic immunomodulator product, added Tremfya and Entyvio as options within trial and failure requirements, and removed Simponi as an option within trial and failure requirements.

July 2024: Criteria change: Changed trial and failure requirements from three biologic immunomodulator products to two biologic immunomodulator products, and added Skyrizi and Simponi as options within trial and failure requirements. Adjusted duration of approval from 56 days to 90 days to allow time to schedule all induction doses after authorization approval.

July 2024: Coding change: Added HCPCS code J2267 to dosing reference table effective 7/1/2024; deleted C9168, J3490, and J3590 termed 6/30/2024.

April 2024: Coding change: Added HCPCS code for C9168 to dosing reference table effective 4/1/2024; deleted C9399 termed 3/31/2024.

November 2023: Original medical policy criteria issued.

Disclosures:

BLUE CROSS®, BLUE SHIELD® and the Cross and Shield Symbols are registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. Blue Cross NC is an independent licensee of the Blue Cross and Blue Shield Association. All other marks are the property of their respective owners.

Blue Cross and Blue Shield of North Carolina does not discriminate on the basis of race, color, national origin, sex, age or disability in its health programs and activities. Learn more about our non-discrimination policy and no-cost services available to you.

Information in other languages: Español   中文   Tiếng Việt   한국어   Français   العَرَبِيَّة   Hmoob   ру́сский   Tagalog   ગુજરાતી   ភាសាខ្មែរ   Deutsch   हिन्दी   ລາວ   日本語

© 2025 Blue Cross and Blue Shield of North Carolina. ®, SM Marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. All other marks and names are property of their respective owners. Blue Cross and Blue Shield of North Carolina is an independent licensee of the Blue Cross and Blue Shield Association.