WHA

Omvoh (mirikizumab-mrkz)

Indications for Prior Authorization

Omvoh (mirikizumab-mrkz) IV & SC
  • For diagnosis of Crohn’s disease (CD)
    Indicated for the treatment of moderately to severely active Crohn’s disease in adults.

  • For diagnosis of Ulcerative Colitis (UC)
    Indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Criteria

Omvoh IV

Prior Authorization

Length of Approval: 3 Month(s)
For diagnosis of Crohn’s disease (CD)

  • Diagnosis of moderately to severely active Crohn’s disease (CD)
    • AND
  • One of the following [2, 3]:
    • Frequent diarrhea and abdominal pain
    • At least 10% weight loss
    • Complications such as obstruction, fever, abdominal mass
    • Abnormal lab values (e.g., C-reactive protein [CRP])
    • CD Activity Index (CDAI) greater than 220
    AND
  • Prescribed by or in consultation with a gastroenterologist
    • AND
  • Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies [2, 3]:
    • 6-mercaptopurine
    • Azathioprine
    • Corticosteroids (e.g., prednisone)
    • Methotrexate
    AND
  • Will be administered as an intravenous induction dose
Omvoh SC

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Crohn’s disease (CD)

  • Diagnosis of moderately to severely active Crohn’s disease (CD)
    • AND
  • Will be used as a maintenance dose following the intravenous induction doses
    • AND
  • Prescribed by or in consultation with a gastroenterologist
Omvoh IV

Prior Authorization

Length of Approval: 3 Month(s)
For diagnosis of Ulcerative Colitis (UC)

  • Diagnosis of moderately to severely active ulcerative colitis
    • AND
  • One of the following [4, 5]:
    • Greater than 6 stools per day
    • Frequent blood in the stools
    • Frequent urgency
    • Presence of ulcers
    • Abnormal lab values (e.g., hemoglobin, erythrocyte sedimentation rate, C-reactive protein)
    • Dependent on, or refractory to, corticosteroids
    AND
  • Prescribed by or in consultation with a gastroenterologist
    • AND
  • Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies [4, 5]:
    • 6-mercaptopurine
    • Azathioprine
    • Corticosteroids (e.g., prednisone)
    • Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
    AND
  • Will be administered as an intravenous induction dose
Omvoh SC

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Ulcerative Colitis (UC)

  • Diagnosis of moderately to severely active ulcerative colitis
    • AND
  • Will be used as a maintenance dose following the intravenous induction doses
    • AND
  • Prescribed by or in consultation with a gastroenterologist
Omvoh SC

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of CD & UC

  • Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1-5]:
    • Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
    • Reversal of high fecal output state

  • Guideline ID
    GL-164210

  • Formulary
    Premium

  • Effective date
    Apr 1, 2025

  • P&T approval date
    Jan 17, 2024

P & T Revisions

2025-02-09, 2024-12-11, 2024-09-08, 2024-07-30, 2024-06-24, 2024-06-05, 2024-05-30, 2024-04-24, 2024-03-07, 2024-04-26, 2024-01-03

  1. Omvoh prescribing information. Eli Lilly & Co. Indianapolis, IN. January 2025.
  2. Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG clinical guideline: management of Crohn's disease in adults. Am J Gastroenterol. 2018;113:481-517.
  3. Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021;160(7):2496-2508.
  4. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413.
  5. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterol. 2020;158:1450-1461.
  • 2025-02-09: Addition of CD criteria; annual review - no criteria changes for UC
  • 2024-12-11: Removed step through TIMS agents
  • 2024-09-08: Removed bypass verbiage for UC
  • 2024-07-30: Addition of Skyrizi as an additional trial option for UC indication.
  • 2024-06-24: Added new 100mg/ml prefilled syringe to existing Omvoh SC criteria; updated background table to specify BI manufacturer for adalimumab-adbm
  • 2024-06-05: Added new 100mg/ml prefilled syringe to existing Omvoh SC criteria.
  • 2024-05-30: Updated background table to include CalPERS formulary; no criteria changes
  • 2024-04-24: Updated verbiage in the step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
  • 2024-03-07: Updated verbiage in the step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
  • 2024-04-26: New program
  • 2024-01-03: New program