CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Omvoh (mirikizumab) coverage for ulcerative colitis and Crohn's disease

Defines 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) coverage for ulcerative colitis and Crohn's disease

Policy CodePolicy N/A

Change TypeHCPCS addedscope clarification

Effective DateMay 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization with documentation of disease severity, TB screening, baseline labs, and prior biologic therapy history.

SourceLink

POLICY UPDATE CHANGES

Explicit HCPCS code J2267 for mirikizumab-mrkz was added to the policy.

Separate medical (IV) and pharmacy (SC) scopes with different duration and renewal rules were specified.

12 weeksSingle-course IV induction duration

6 monthsInitial SC coverage duration

J2267HCPCS code assigned

Weeks 0,4,8Induction IV dosing

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Coverage Criteria for Omvoh (mirikizumab)

General prerequisites

Covered when ALL of the following are met for any indication:

General prerequisites: Submission of the member's chart/medical record documenting medical necessity; pretreatment TB screening (unless exempt due to prior biologic/tsDMARD use); no clinically important active infection; no live vaccines during therapy; physician-assessed baseline disease severity using an objective measure; baseline liver enzymes and bilirubin obtained; will not be used concomitantly with other injectable biologic response modifiers or specified oral non-biologic agents.

From policy general requirements.

Initial therapy — Ulcerative Colitis

Authorization for moderately to severely active ulcerative colitis when ALL of the following are met:

UC initial: Member is 18 years of age or older; prescribed by or in consultation with a gastroenterologist; documented moderate to severe 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 step therapy requirements.

Initial therapy — Crohn's Disease

Authorization for moderately to severely active Crohn's disease when ALL of the following are met:

CD initial: Prescribed by, or in consultation with, a gastroenterologist; documented moderate to severe 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 step therapy requirements.

Continuation therapy — Ulcerative Colitis

Continuation/renewal for UC — 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 from the drug (examples: anaphylaxis or other serious allergic reactions, severe infections, jaundice or other evidence of significant liver injury); and member is using the medication for moderate to severe active ulcerative colitis and has achieved or maintained remission OR achieved/maintained a positive clinical response as evidenced by improvement in at least one clinical sign/symptom or objective marker (stool frequency, rectal bleeding, urgency, C-reactive protein, fecal calprotectin, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or improvement on a disease activity scoring tool such as UCEIS or Mayo) from baseline.

UC renewal requires objective or symptomatic improvement.

Continuation therapy — Crohn's Disease

Continuation/renewal for CD — Authorization of 6 months may be granted for IV Omvoh when ALL of the following are met:

CD continuation: Member continues to meet all initial authorization criteria; absence of unacceptable toxicity from the drug (examples: anaphylaxis or other serious allergic reactions, severe infections, jaundice or other evidence of significant liver injury); and member is using the medication for moderate to severely active Crohn's disease and has achieved or maintained remission OR achieved/maintained a positive clinical response as evidenced by improvement in signs and symptoms or objective measures from baseline (abdominal pain or tenderness, diarrhea, body weight, abdominal mass, or hematocrit).

CD renewal requires objective or symptomatic improvement.

Omvoh must not be used concomitantly with other injectable biologic response modifiers (for example, TNF-inhibitors such as adalimumab, etanercept, infliximab, golimumab, or interleukin inhibitors such as secukinumab, ustekinumab, guselkumab, tildrakizumab, risankizumab) or with specified oral non-biologic agents (for example, apremilast, tofacitinib, baricitinib, upadacitinib, etrasimod).

This restriction is part of the policy's general prerequisites and is intended to avoid overlapping immunomodulation and increased risk of serious infection; documentation in the medical record confirming the absence of concomitant prohibited agents is required for authorization.

Intravenous (IV) Omvoh is covered as a single induction course only: coverage is provided once for a 12-week induction (three IV doses) and may not be renewed. This reflects the medical-scope dosing and renewal limitation for IV administration.

Subcutaneous (SC) Omvoh is covered under the pharmacy scope for an initial period of 6 months and may be renewed for additional 6-month periods per the pharmacy renewal rules. For some members (Medicaid and Commercial), SC dosing may be approved as ongoing every 4 weeks after induction when criteria are met; ensure pharmacy versus medical billing alignment when transitioning from IV to SC.

All coverage beyond the specified periods (e.g., continuing IV beyond the one-time 12-week course or continuing SC beyond covered renewal intervals without meeting continuation criteria) may be considered not covered unless the member meets the policy's renewal/continuation criteria and required documentation (including objective evidence of response and absence of unacceptable toxicity) is submitted.

Billing and Coding

HCPCSHCPCS

J2267

Injection, mirikizumab-mrkz, 1 mg

NDCNDC

0002-7575-01	Omvoh induction NDC for UC and CD
0002-8011-27	Omvoh UC maintenance NDC
0002-8870-27	Omvoh UC maintenance NDC
0002-7717-11	Omvoh CD maintenance NDC
0002-7722-11	Omvoh CD maintenance NDC

Induction dosing schedule — IV doses at Weeks 0, 4, and 8

Ulcerative colitis (IV induction)300 mg IV administered by infusion over ≥30 minutes at Weeks 0, 4, and 8 (one‑time 12‑week course of 3 IV doses)

Crohn's disease (IV induction)900 mg IV administered by infusion over ≥90 minutes at Weeks 0, 4, and 8 (one‑time 12‑week course of 3 IV doses)

ScheduleAll IV induction doses given at Weeks 0, 4, and 8

Course durationInduction course defined as a single 12‑week course consisting of three IV doses

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage. Submit a completed prior authorization request with supporting documentation demonstrating medical necessity for the requested indication.

Effective Date: 2024-05-01
Payer: Neighborhood Health Plan of Rhode Island

Step Therapy

Step Therapy Requirements

Step therapy must be met before approval. For ulcerative colitis and Crohn's disease, the member must have experienced inadequate response, intolerance, or have a contraindication to the specified prior therapies before Omvoh (or the requested agent) will be authorized.

Ulcerative colitis: inadequate response/intolerance/contraindication to a ≥3 month trial of infliximab IV or adalimumab at maximum tolerated doses; AND inadequate response/intolerance/contraindication to a ≥6 month trial of ustekinumab biosimilar at maximum tolerated doses.
Crohn's disease: inadequate response/intolerance/contraindication to a ≥3 month trial of infliximab IV or adalimumab at maximum tolerated doses; AND inadequate response/intolerance/contraindication to a ≥6 month trial of ustekinumab biosimilar at maximum tolerated doses.

Background

Omvoh (mirikizumab-mrkz) is a monoclonal antibody available in both intravenous (IV) induction and subcutaneous (SC) maintenance formulations for treatment of moderately to severely active ulcerative colitis and Crohn's disease. The IV formulation is administered as the induction course at specified dosing intervals, and the SC formulation is used for ongoing maintenance dosing every 4 weeks.

Before initiating therapy, baseline requirements include tuberculosis screening (unless exempt), assessment of baseline disease severity using an objective tool, and baseline liver enzymes and bilirubin. Live vaccines should not be given during treatment, and the drug must not be used concomitantly with other injectable biologic response modifiers or specified oral non-biologic agents.

Definitions and Dosing Terms

IV induction — Induction dosing summary

UC IV induction dose300 mg IV infusion over at least 30 minutes at Weeks 0, 4, and 8

CD IV induction dose900 mg IV infusion over at least 90 minutes at Weeks 0, 4, and 8

Administration noteInduction is delivered as three IV infusions at the specified weeks (single 12‑week course)

SC maintenance — Maintenance dosing summary

UC SC maintenance dose200 mg SC (two consecutive 100 mg injections) given at Week 12, then every 4 weeks

CD SC maintenance dose300 mg SC (two consecutive injections: one 100 mg and one 200 mg in any order) given at Week 12, then every 4 weeks