OMVOH (mirikizumab-mrkz)

Office Administration - Intravenous (IV) infusion

Self-Administration – Subcutaneous (SC) injection

Diagnosis considered for coverage:
  • Ulcerative Colitis (UC): Indicated for the treatment of moderately to severely active ulcerative colitis in adults.
Coverage Criteria:
  1. Omvoh IV
  • Diagnosis of moderately to severely active ulcerative colitis, AND
  • One of the following:
    • 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:
    • 6-mercaptopurine
    • Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
    • Azathioprine
    • Corticosteroids (e.g., prednisone), AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*:
      • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz, or Brand Adalimumab-adaz
      • Simponi (golimumab)
      • Skyrizi (risankizumab-rzaa) 
      • Stelara (ustekinumab)
      • Rinvoq (upadacitinib)
      • Xeljanz/XR (tofacitinib/ER), OR
    • For continuation of prior therapy, defined as no more than a 45-day gap in therapy, AND
    • Will be administered as an intravenous induction dose
  1. Omvoh SC
  • 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
Reauthorization Criteria:
  1. Omvoh SC
  • Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following:
    • 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
Coverage Duration:
  1. Omvoh IV
  • Initial: 3 months
  1. Omvoh SC
  • Initial: 6 months
  • Reauthorization: 12 months
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • * Includes attestation that the patient has failed to respond to the TNF inhibitor mechanism of action in the past and should not be made to try a second TNF inhibitor. In this case, only a single step through a preferred agent is required.
Policy Updates:
  • 02/20/2024 – New policy approved by P&T.
  • 10/01/2024 – Addition of Skyrizi as an additional trial option for UC indication.
References:
  1. Omvoh prescribing information. Eli Lilly & Co. Indianapolis, IN. October 2023.
  2. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413.
  3. 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.

Last review date: September 30, 2024

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