Last Review Date: 06/04/2024

Date of Origin: 12/07/2023

Dates Reviewed: 12/2023, 06/2024

1. Length of Authorization

• Coverage will be provided for 9 weeks (for 3 intravenous doses) initially as induction and may be renewed annually thereafter for subcutaneous maintenance.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Omvoh 300 mg/15 mL single-dose vial for intravenous infusion: 1 vial at Weeks 0, 4 & 8 (3 vials total)
• Omvoh 100 mg/mL solution in a single-dose prefilled pen for subcutaneous injection: 2 pens starting on week 12 and every 4 weeks thereafter
• Omvoh 100 mg/mL solution in a single-dose prefilled syringe for subcutaneous injection: 2 syringes starting on week 12 and every 4 weeks thereafter

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

• 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 IL-inhibitor, TNF-inhibitor, biologic response modifier or other non-biologic immunomodulating agent (e.g., apremilast, tofacitinib, baricitinib, upadacitinib, abrocitinib, deucravacitinib, etc.); AND

Ulcerative Colitis † ^1,8-10,13

• 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 on previous therapy with of a TNF modifier such as adalimumab, golimumab, or infliximab

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

4. Renewal Criteria ^1,3-5,8

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
  • 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, and/or endoscopic activity, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g., an improvement on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score or the Mayo Score].

5. Dosage/Administration ¹

   Indication	Dose
   Ulcerative Colitis	Induction: Administer 300 mg intravenously at Week 0, Week 4, and Week 8. Maintenance: Administer 200mg (given as two consecutive injections of 100 mg each) subcutaneously 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(s):

• J3590 – Unclassified biologics (Discontinue use on 07/01/2024)
• C9168 – Injection, mirikizumab-mrkz, 1 mg; 1 billable unit = 1 mg (Discontinue use on 07/01/2024)
• J2267* – Injection, mirikizumab-mrkz, 1 mg; 1 billable unit = 1 mg (Effective 07/01/2024)

(*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):

• Omvoh carton containing one 300 mg/15 mL single-dose vial for intravenous infusion: 00002-7575-xx
• Omvoh carton containing two 100 mg/mL single-dose prefilled pens for subcutaneous injection: 00002-8011-xx
• Omvoh carton containing two 100 mg/mL single-dose prefilled syringes for subcutaneous injection: 00002-8870-xx

7. References

1. Omvoh [package insert]. Indianapolis, IN; Eli Lilly and Company; April 2024. Accessed May 2024.
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.
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.

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