OMVOH (mirikizumab-mrkz)

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

2. 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

2. 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.