CurrentAvMedPolicy N/A

Omvoh (mirikizumab-mrkz) prior authorization

Pharmacy prior authorization and step-edit form and criteria for Omvoh (mirikizumab-mrkz) for Ulcerative Colitis and Crohn's Disease, covering pharmacy and medical benefit use (IV induction billed under medical benefit). Includes dosing, NDCs, and clinical trial-of-therapy requirements for approval.

Policy Summary

PayerAvMed

PolicyOmvoh (mirikizumab-mrkz) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the prior authorization/step-edit request form and provide supporting documentation (labs, diagnostics, chart notes, pharmacy paid claims) or request may be denied.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage criteria or policy content.

2Indications listed

90 daysEstablished therapy requirement

900 mgIV induction Crohn's loading dose

Coverage Summary

Scope: This prior authorization/step-edit form covers Omvoh (mirikizumab-mrkz) for both Ulcerative Colitis and Crohn's Disease under pharmacy and medical benefits. Pharmacy prior authorization applies to ongoing subcutaneous maintenance dosing, while IV induction dosing must be billed under the medical benefit using NDC 00002-7575-01 and HCPCS J2267. The form includes dosing for induction and maintenance, applicable NDCs/HCPCS, and required trials of prior therapies and documentation to support authorization.

Crohn's Disease - Medical Benefit One-time Induction (IV)

Induction (IV): IV loading doses administered at Week 0, Week 4, and Week 8 — 300 mg per infusion for Ulcerative Colitis (one 300 mg vial) and 900 mg total (three 300 mg vials) for Crohn's Disease, administered by intravenous infusion over the specified minimum infusion time.

Maintenance (SubQ): Ongoing subcutaneous maintenance dosing beginning at Week 12 — 200 mg every 4 weeks (given as two consecutive 100 mg injections) for Ulcerative Colitis; 300 mg every 4 weeks (given as two consecutive injections: 100 mg and 200 mg in any order) for Crohn's Disease.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prescriber must complete and sign the prior authorization/step-edit request form and provide supporting documentation (labs, diagnostics, chart notes, pharmacy paid claims) or request may be denied.

Documentation Required

Specialty pharmacy / claims verification

Previous therapies will be verified through pharmacy paid claims or submitted chart notes; samples do not meet step edit/preauthorization criteria.

Billing Rule

IV induction billed under medical benefit

Omvoh IV induction for Crohn's Disease and Ulcerative Colitis must be billed under the medical benefit using NDC 00002-7575-01 and HCPCS code J2267.

NDC: 00002-7575-01
HCPCS: J2267

Documentation Required

Administration site information required for medical induction

For medical benefit induction, provide the location/site of drug administration and the NPI or DEA number of the administering location.

Step Therapy

Step/failure requirements

Members must have trial/failure or intolerance/contraindication to prior steroids, DMARDs, and biologics per the criteria (including required preferred biologic failures) before approval.

Trial/failure of budesonide or high‑dose steroids unless contraindicated
Trial/failure of at least one DMARD (e.g., 5‑ASA agents, oral mesalamine) unless contraindicated
Trial/failure of prior biologic(s) per the preferrred biologic failure requirements

Denial Risk

Concomitant biologic therapy not permitted

Use of concomitant therapy with more than one biologic immunomodulator prescribed for the same or different indications is considered experimental/investigational and will not be permitted.

Applicable Codes

Pharmacy NDCs - SubcutaneousNDCCovered

00002-8011-27	Omvoh 100 mg/mL prefilled pen (UC maintenance 200 mg dose supplied as two 100 mg injections)
00002-8870-27	Omvoh 100 mg/mL prefilled syringe (UC maintenance)
0002-7717-11	Omvoh 200 mg/2 mL + 100 mg/mL prefilled pen (CD maintenance 300 mg dose: 100 mg + 200 mg)
0002-7722-11	Omvoh 200 mg/2 mL + 100 mg/mL prefilled syringe (CD maintenance)

Medical Benefit NDC / J-code - IV InductionmixedCovered

00002-7575-01	Omvoh (J2267) IV 300 mg/15 mL vial; 1 vial = 300 billable units (UC induction); 3 vials = 900 mg (CD induction)
J2267	HCPCS J-code associated with Omvoh IV formulation

Background

Background and purpose: This prior authorization form is used to request approval for Omvoh (mirikizumab-mrkz) and documents dosing for induction and maintenance in Ulcerative Colitis and Crohn's Disease, verifies billing requirements, and lists required prior therapy trials and supporting documentation.

Dosing — Ulcerative Colitis: Induction IV is 300 mg per infusion administered over at least 30 minutes at Week 0, Week 4, and Week 8 (NDC: 00002-7575-01; J-code: J2267). Maintenance SubQ is 200 mg at Week 12 and every 4 weeks thereafter (given as two consecutive 100 mg injections; NDCs: 00002-8011-27 and 00002-8870-27).

Dosing — Crohn's Disease: Induction IV is a total 900 mg loading regimen (three 300 mg vials; NDC: 00002-7575-01) administered by intravenous infusion at Week 0, Week 4, and Week 8 (infusion duration per form). Maintenance SubQ is 300 mg at Week 12 and every 4 weeks thereafter (two consecutive injections: 100 mg + 200 mg; NDCs: 0002-7717-11 and 0002-7722-11).

Billing note: Omvoh IV induction (loading dose) for both Crohn's Disease and Ulcerative Colitis must be billed under the medical benefit using NDC 00002-7575-01 and HCPCS J2267.

Required trials and documentation: All listed criteria and trial/failure requirements must be met for approval. The form requires documentation (labs, diagnostics, chart notes, pharmacy paid claims) to support each checked criterion; previous therapies will be verified via pharmacy paid claims or chart notes and samples do not meet step-edit/preauthorization criteria.

Additional procedural notes: Prescriber must complete and sign the prior authorization/step-edit request form; for medical-benefit induction, the location/site of drug administration and the NPI or DEA number of the administering location must be supplied. One-time medical induction approvals are time-limited (up to two months for up to three IV infusion doses) and member must meet maintenance authorization criteria.

Definitions

Induction (IV): IV loading doses administered at Week 0, Week 4, and Week 8 — 900 mg for Crohn's Disease (three 300 mg vials) and 300 mg per infusion for Ulcerative Colitis.

Maintenance (SubQ): Ongoing subcutaneous maintenance dosing — 200 mg every 4 weeks for Ulcerative Colitis; 300 mg every 4 weeks for Crohn's Disease, starting at Week 12.