Last Review Date: 02/04/2025

Date of Origin: 12/07/2023

Dates Reviewed: 12/2023, 06/2024, 02/2025

1. Length of Authorization

• Initial coverage will be provided for 11 weeks (for 3 intravenous doses) as induction and may be renewed annually thereafter for subcutaneous maintenance.

2. Dosing Limits

Max Units (per dose and over time) [HCPCS Unit]:

Crohn’s Disease

• Induction dose: 900 billable units at Week 0, 4, & 8
• Maintenance: 300 billable units at Week 12 and every 4 weeks thereafter

Ulcerative Colitis

• Induction dose: 300 billable units at Week 0, 4, & 8
• Maintenance: 200 billable units at Week 12 and every 4 weeks thereafter

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Patient is up to date with all age-appropriate vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND
• Baseline liver enzymes and bilirubin levels have been obtained prior to initiating therapy; AND

Universal Criteria ¹

• Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for the presence of TB during treatment; AND
• Patient does not have an active infection, including clinically important localized infections; AND
• Patient will not receive live vaccines during therapy; AND
• Patient is not on concurrent treatment with another biologic therapy or targeted synthetic therapy; AND

Crohn’s Disease (CD) † ^1,15-17

• Documented moderate to severe active disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate, etc.); OR
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of a TNF modifier such as adalimumab, certolizumab, or infliximab; OR
  • Patient has evidence of high-risk disease for which corticosteroids or immunomodulators are inadequate and biologic therapy is necessary; OR
  • Patient is already established on a biologic or targeted synthetic therapy for the treatment of CD

Ulcerative Colitis (UC) † ^1,8,9,22

• Documented moderate to severe active disease; AND
  • Documented failure or ineffective response to a minimum 3-month trial of conventional therapy [aminosalicylates, corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate, etc.)] at maximum tolerated doses, unless there is a contraindication or intolerance to use; OR
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of a TNF modifier such as adalimumab, golimumab, or infliximab; OR
  • Patient is already established on a biologic or targeted synthetic therapy for the treatment of UC

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and indication-specific criteria as identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: serious hypersensitivity reactions (including anaphylaxis), severe infections, hepatotoxicity, drug-induced liver injury, etc.; AND

Crohn’s Disease (CD) ^18-20

• Patient is to start maintenance therapy and has received three 900 mg intravenous induction doses at weeks 0, 4 and 8.; AND
  • Patient has shown a beneficial disease response and/or no worsening of disease with an absence of unacceptable toxicity to the intravenous doses; OR
• Patient requires continuation of maintenance therapy; AND
  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight regain, hematocrit, presence of extra intestinal complications, use of anti-diarrheal drugs, tapering or discontinuation of corticosteroid therapy, improvement in biomarker levels [i.e., fecal calprotectin or serum C-reactive protein (CRP)] and/or an improvement on a disease activity scoring tool (e.g., Harvey-Bradshaw Index score, etc.)

Ulcerative Colitis (UC) ^3-6,21

• Patient is to start maintenance therapy and has received three 300 mg intravenous induction doses at weeks 0, 4 and 8.; AND
  • Patient has shown a beneficial disease response and/or no worsening of disease with an absence of unacceptable toxicity to the intravenous doses; OR
• Patient requires continuation of maintenance therapy; AND
  • Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, endoscopic activity, tapering or discontinuation of corticosteroid therapy, normalization of C-reactive protein (CRP) or fecal calprotectin (FC), and/or an improvement on a disease activity scoring tool

5. Dosage/Administration ¹

   Indication	Dose
   Crohn’s Disease	Induction: Administer 900 mg intravenously at Week 0, Week 4, and Week 8. Maintenance: Administer 300 mg subcutaneously (given as two consecutive injections of 100 mg and 200 mg in any order) at Week 12 and every 4 weeks thereafter. Patients may self-inject the maintenance dose after training in subcutaneous injection technique. **NOTE: The 200 mg/2 mL prefilled pen and prefilled syringe are only for maintenance treatment of Crohn’s disease.
   Ulcerative Colitis	Induction: Administer 300 mg intravenously at Week 0, Week 4, and Week 8. Maintenance: Administer 200 mg subcutaneously (given as two consecutive injections of 100 mg each) at Week 12 and every 4 weeks thereafter. Patients may self-inject the maintenance dose after training in subcutaneous injection technique.

6. Billing Code/Availability Information

HCPCS Code:

• J2267* – Injection, mirikizumab-mrkz, 1 mg; 1 billable unit = 1 mg

(*Note: CMS generally creates codes for products themselves, without specifying a route of administration in the code descriptor, as there might be multiple routes of administration for the same product. Drugs that fall under this category should be billed with either the JA modifier for the intravenous infusion of the drug or billed with the JB modifier for subcutaneous injection of the drug.)

NDC(s):

7. References

1. Omvoh [package insert]. Indianapolis, IN; Eli Lilly and Company; January 2025. Accessed January 2025.
2. D’Haens G, Kobayashi T, Morris N, et al. OP26 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. Journal of Crohn's and Colitis, Volume 16, Issue Supplement_1, January 2022, Pages i028–i029, https://doi.org/10.1093/ecco-jcc/jjab232.025.
3. Lewis JD, Chuai S, Nessel L, et al. Use of the Non-invasive Components of the Mayo Score to Assess Clinical Response in Ulcerative Colitis. Inflamm Bowel Dis. 2008 Dec; 14(12): 1660–1666. doi:  10.1002/ibd.20520.
4. Paine ER. Colonoscopic evaluation in ulcerative colitis. Gastroenterol Rep (Oxf). 2014 Aug; 2(3): 161–168.
5. Walsh AJ, Bryant RV, Travis SPL. Current best practice for disease activity assessment in IBD. Nature Reviews Gastroenterology & Hepatology 13, 567–579 (2016) doi:10.1038/nrgastro.2016.128
6. Kornbluth, A, Sachar, DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23.
7. A. S. Cheifetz, M. T. Abreu, W. Afif, et al. A Comprehensive Literature Review and Expert Consensus Statement on Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease. Am J Gastroenterol 2021  Accession Number: 34388143 DOI: 10.14309/ajg.0000000000001396.3
8. Raine T, Bonovas S, Burisch J, et al. ECCO Guidelines on therapeutics in ulcerative colitis: medical treatment. J Crohns Colitis. 2022 Jan 28. 16 (1):2-17. Doi: 10.1093/ecco-jcc/jjab178.
9. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2020;158(5):1450-1461. doi:10.1053/j.gastro.2020.01.006.
10. National Institute for Health and Care Excellence. NICE 2019. Ulcerative colitis: management. Published 03 May 2019. NICE guideline [NG130]. https://www.nice.org.uk/guidance/ng130.
11. Dignass A, Lindsay JO, Sturm A, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohns Colitis. 2012 Dec;6(10):991-1030.
12. Harbord M, Eliakim R, Bettenworth D, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017 Jan 28. doi: 10.1093/ecco-jcc/jjx009.
13. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019 Mar;114(3):384-413.
14. Ferrante M, D'Haens G, Jairath V, et al; VIVID Study Group. 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. Lancet. 2024 Dec 14;404(10470):2423-2436. doi: 10.1016/S0140-6736(24)01762-8. Epub 2024 Nov 21. PMID: 39581202.
15. Lichtenstein GR, Loftus EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27v.
16. 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 Jun;160(7):2496-2508. doi: 10.1053/j.gastro.2021.04.022. PMID: 34051983; PMCID: PMC8988893.
17. Gordon H, Minozzi S, Kopylov U, et al. ECCO Guidelines on Therapeutics in Crohn’s Disease: Medical Treatment, Journal of Crohn's and Colitis, 2024;  https://doi.org/10.1093/ecco-jcc/jjae091.
18. National Institute for Health and Care Excellence. NICE 2019. Crohn’s Disease: Management. Published 03 May 2019. Clinical Guideline [NG129]. https://www.nice.org.uk/guidance/ng129/resources/crohns-disease-management-pdf-66141667282885.
19. Ranasinghe IR, Tian C, Hsu R. Crohn Disease. [Updated 2024 Feb 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024.  https://www.ncbi.nlm.nih.gov/books/NBK436021/. Accessed January 17, 2025.
20. Ananthakrishnan AN, Alder J, Chachu KA, et al. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Crohn’s Disease. Gastroenterology. 2023 Dec;165(6):1367-1399. doi: 10.1053/j.gastro.2023.09.029. PMID: 37981354.
21. Singh S, Ananthakrishnan AN, Nguyen NH, et al. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis. Gastroenterology. 2023 Mar;164(3):344-372. doi: 10.1053/j.gastro.2022.12.007. PMID: 36822736.
22. Singh S, Loftus EV Jr, Limketkai BN, et al. AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2024 Dec;167(7):1307-1343. doi: 10.1053/j.gastro.2024.10.001. PMID: 39572132.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A