CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Omvoh (mirikizumab-mrkz) — Intravenous and Subcutaneous

Policy governing medical and pharmacy coverage, dosing, and authorization criteria for intravenous and subcutaneous Omvoh for treatment of moderately to severely active ulcerative colitis and Crohn's disease for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOmvoh (mirikizumab-mrkz) — Intravenous and Subcutaneous

Policy CodePolicy N/A

Change TypeScope and coding additions

Effective Date05/01/2024

Next Review Date01/22/2025

Key ActionSubmit prior authorization with member chart documenting medical necessity, prior biologic trials, TB screening, baseline liver tests, and gastroenterology consult when required.

SourceLink

POLICY UPDATE CHANGES

Specifies separate Medical Scope (IV) and Pharmacy Scope (SC) coverage rules and durations.

Lists HCPCS J-code J2267 for mirikizumab-mrkz (1 mg).

3IV induction doses (weeks 0, 4, 8) for UC

900 mgCD IV induction per infusion

J2267HCPCS listed

6 monthsSC coverage initial period

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Omvoh (mirikizumab-mrkz)

inv-01: Initial Approval — General

Covered when ALL of the following are met:

General requirements: Submission of the member's chart or medical record documenting medical necessity; member is free of any clinically important active infection (including localized infections); pretreatment tuberculosis screening with a TB skin test or an interferon gamma release assay (eg, QFT-GIT, T‑SPOT.TB) (note: members who have received another biologic or targeted synthetic DMARD are exempt from TB screening requirements); member will not receive live vaccines during therapy; baseline liver enzymes and bilirubin have been obtained prior to initiating therapy; physician has assessed baseline disease severity using an objective measure/tool; Omvoh will not be used concomitantly with another injectable biologic response modifier (eg, TNF‑inhibitors) or specified oral non‑biologic agents (eg, apremilast, tofacitinib, baricitinib, upadacitinib, etrasimod).

From general criteria

inv-02: Initial Approval — Ulcerative Colitis

Authorization may be granted when ALL of the following are met:

UC initial: Member is ≥18 years; medication is prescribed by or in consultation with a gastroenterologist; documented moderately to severely active ulcerative colitis; inadequate response, intolerance, or contraindication to at least a 3‑month trial of infliximab IV or adalimumab at maximum tolerated doses; inadequate response, intolerance, or contraindication to at least a 6‑month trial of ustekinumab biosimilar at maximum tolerated doses.

UC‑specific prior therapy requirements

inv-03: Initial Approval — Crohn's Disease

Authorization may be granted when ALL of the following are met:

CD initial: Prescribed by or in consultation with a gastroenterologist; documented moderately to severely active Crohn's disease; inadequate response, intolerance, or contraindication to at least a 3‑month trial of infliximab IV or adalimumab at maximum tolerated doses; inadequate response, intolerance, or contraindication to at least a 6‑month trial of ustekinumab biosimilar at maximum tolerated doses.

CD‑specific prior therapy requirements

inv-04: Continuation Therapy — Ulcerative Colitis

Authorization of 6 months may be granted when ALL of the following are met:

UC continuation: Member continues to meet all initial authorization criteria; absence of unacceptable toxicity (examples include anaphylaxis or other serious allergic reactions, severe infections, jaundice or other evidence of significant liver injury); member has achieved or maintained remission OR demonstrated a positive clinical response as evidenced by improvement from baseline in stool frequency, rectal bleeding, C‑reactive protein (CRP), urgency, fecal calprotectin, disease activity scoring tools (eg, UCEIS, Mayo score), or mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound.

6‑month reauthorization criteria

inv-05: Continuation Therapy — Crohn's Disease

Authorization of 6 months may be granted when ALL of the following are met for IV Omvoh:

CD continuation (IV Omvoh): Member continues to meet all initial authorization criteria; absence of unacceptable toxicity (eg, anaphylaxis, severe infections, jaundice or other evidence of significant liver injury); member has achieved or maintained remission OR demonstrated a positive clinical response as evidenced by improvement from baseline in abdominal tenderness/pain, diarrhea, body weight, abdominal mass, hematocrit, or disease activity scoring tools (eg, CDAI).

6‑month reauthorization criteria for CD (IV induction)

inv-06: Scope and duration

Scope rules: Medical Scope (IV): Coverage for IV Omvoh is provided once for 12 weeks (3 IV doses at Weeks 0, 4, and 8) and may not be renewed. For members meeting criteria, subcutaneous Omvoh (200 mg for UC; 300 mg for CD) may be approved every 4 weeks thereafter for 4 months for Medicaid and Commercial. Pharmacy Scope (SC): Coverage for subcutaneous Omvoh is provided for 6 months and may be renewed for additional 6‑month periods. Quantity limits (Pharmacy Scope): UC maintenance — 2 pens per 28 days (200 mg total); CD maintenance — 1 carton per 28 days (one 200 mg and one 100 mg pen per carton).

Payer‑specific scope and duration rules

The policy separates coverage by setting. Under the Medical Scope, IV Omvoh (intravenous) is covered as a one-time induction course of 12 weeks (three IV doses) and may not be renewed. For members meeting criteria, the payer will transition to subcutaneous therapy: SC Omvoh 200 mg for ulcerative colitis or SC Omvoh 300 mg for Crohn's disease administered every 4 weeks thereafter for 4 months for Medicaid and Commercial members. Under the Pharmacy Scope, SC Omvoh is covered for an initial period of 6 months and may be renewed for additional 6-month periods.

Renewal of the IV induction course is not permitted. The policy explicitly states that IV Omvoh is provided once for 12 weeks (3 IV doses) and may not be renewed, so ongoing or repeat IV induction beyond this single 12-week course will be denied under the Medical Scope.

Billing Codes and Quantity Limits

HCPCSHCPCSCovered

J2267

Injection, mirikizumab-mrkz, 1 mg

NDCNDCCovered

0002-7575-01	NDC for induction (ulcerative colitis and Crohn's disease)
0002-8011-27	NDC for ulcerative colitis maintenance
0002-8870-27	NDC for ulcerative colitis maintenance
0002-7717-11	NDC for Crohn's disease maintenance
0002-7722-11	NDC for Crohn's disease maintenance

Quantity limits (Pharmacy Scope)

Ulcerative colitis (Pharmacy - SC)2 pens per 28 days (Omvoh 100 mg/mL pens) — total 200 mg per 28 days

Crohn's disease (Pharmacy - SC)1 carton per 28 days (contains one 200 mg/2 mL pen and one 100 mg/mL pen) — combined per-carton supply

ScopePharmacy Scope: subcutaneous product quantity limits apply as specified above

Required Provider Actions and Documentation

Prior Authorization

Prior authorization required for initial therapy

Prior authorization is required for Omvoh (mirikizumab-mrkz). Initial approval criteria include member age and prescribing requirements, documentation of moderate to severe disease, specialist prescribing/consultation when specified, and prior inadequate response/intolerance/contraindication to specified biologics (see indication-specific criteria).

Policy lists J2267 as the HCPCS code for prior authorization requests.

Step Therapy

Required prior biologic trials before authorization

For both ulcerative colitis and Crohn's disease, the member must have had inadequate response, intolerance, or a contraindication to at least a 3-month trial of infliximab IV or adalimumab at maximum tolerated doses and to at least a 6-month trial of ustekinumab biosimilar at maximum tolerated doses before authorization may be granted.

UC: "Member has had an inadequate response, intolerance, Or contraindication to at least a 3month trial of infliximab IV or adalimumab..." and "...at least a 6 month trial of ustekinumab biosimilar" (chunk 8).

Dosing Definitions and Administration

Induction and maintenance dosing

Ulcerative colitis — IV induction300 mg IV infusion at Weeks 0, 4, and 8 (administered over at least 30 minutes)

Ulcerative colitis — SC maintenance200 mg subcutaneous (given as two consecutive 100 mg injections) at Week 12, then every 4 weeks

Crohn's disease — IV induction900 mg IV infusion at Weeks 0, 4, and 8 (administered over at least 90 minutes)

Crohn's disease — SC maintenance300 mg subcutaneous (given as two consecutive injections of 100 mg and 200 mg in any order) at Week 12, then every 4 weeks

Background on Omvoh (mirikizumab-mrkz)

Omvoh (mirikizumab-mrkz) is an interleukin-targeting biologic available in both intravenous and subcutaneous formulations for treatment of moderately to severely active inflammatory bowel disease. The policy defines an IV induction pathway consisting of a single 12-week course (three IV doses) to initiate therapy, followed by specified SC maintenance dosing regimens depending on disease and payer coverage. Baseline screening and documentation requirements still apply prior to initiating therapy.

Policy Revision History

05/01/2024policy_effective

Policy effective date established for Omvoh (mirikizumab-mrkz).

02/08/2024policy_review

Policy underwent review on 02/08/2024 (listed among review dates).

07/17/2024policy_review

Policy underwent review on 07/17/2024 (listed among review dates).