Background

Mirikizumab-mrkz (e.g., Omvoh) is an interleukin-23 antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. It is the first and only interleukin-23p19 antagonist approved for the treatment of UC in adults. This humanized IgG4 monoclonal antibody selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor, which is involved in mucosal inflammation and affects the differentiation, expansion, and survival of T cell subsets, and innate immune cell subsets, representing sources of pro-inflammatory cytokines. Research in animal models has shown that pharmacologic inhibition of IL-23p19 can ameliorate intestinal inflammation. (Dubinsky, 2022).

Caution is advised when administering mirikizumab to individuals with a history of chronic or recurrent infections. Prior to initiating therapy, all potential drug recipients should be evaluated for tuberculosis (TB) infections. Mirikizumab should not be administered in individuals with active TB infection. Individuals with latent TB should initiate treatment before receiving mirikizumab. (D'Haens, 2022).

Policy (Criteria)

Coverage of these drugs is provided when the criteria below is met and for non-preferred products there has been a trial and failure of preferred therapy (if applicable).

Mirikizumab intravenous may be considered MEDICALLY NECESSARY for the following condition(s):

Ulcerative Colitis (UC)

1. Diagnosis of moderately to severely active ulcerative colitis
2. 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

3. Trial and failure, contraindication, or intolerance to treatment with at least one of the following:

• Corticosteroid
• Purinethol (6-mercaptopurine)
• Imuran (azathioprine)
• Aminosalicylates (e.g., mesalamine [Asacol, Pentasa, Rowasa], olsalazine [Dipentum], sulfasalazine [Azulfidine, Sulfazine])

4. Prescribed by or in consultation with a gastroenterologist
5. Will be administered as an intravenous induction dose

Authorization duration: 6 months

Crohn’s disease (CD)

1. Diagnosis of moderately to severely active Crohn’s disease (CD)
2. One of the following:

• 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

3. Trial and failure, contraindication, or intolerance to treatment with at least one immunomodulator or corticosteroid (e.g., Purinethol [6-mercaptopurine], Imuran [azathioprine], Sandimmune [cyclosporine A], Prograf [tacrolimus], MTX [methotrexate])
4. Prescribed by or in consultation with a gastroenterologist
5. Will be administered as an intravenous induction dose

Authorization duration: 3 months

References

1. ACIP(2025) Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention www.cdc.gov/acip/index.html
2. D’Haens G, Kobayashi T, Morris N et al.(2022) Efficacy and safety of mirikizumab as induction therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-1 study [DDW abstract 884]. Gastroenterology. 2022;162(suppl 1)
3. Dubinsky MC, Irving PM, Li X et al.(2022) Efficacy and safety of mirikizumab as maintenance therapy in patients with moderately to severely active ulcerative colitis: results from the phase 3 LUCENT-2 study [DDW abstract 867e]. Gastroenterology. 2022;162(suppl 1).
4. Ferrante M, d'Haens G, Jairath V, et. al.(2024) Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. The Lancet. 2024 Dec 14;404(10470):2423-36.
5. Omvoh [package insert]. Indianapolis, IN: Eli Lilly and Company; January 2025
6. Omvoh(2023) package insert Indianapolis, IN: Eli Lilly and Company; 2023.
7. Sandborn WJ, Ferrante M, Bhandari BR, et al.(2020) Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology. 2020;158(3):537-549.e10. doi:10.1053/j.gastro.2019.08.043
8. Sands BE, Peyrin-Biroulet L, Kierkus J, et. al.(2022) Crohn's Disease Gastroenterology. 2022 Feb 1;162(2):495-508.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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