Cigna: Omvoh IV Induction Dosing & GI Prescriber Requirement (Mar 2026)

Cigna’s March 2026 update authorizes Omvoh IV as a three-dose induction series for adults with Crohn’s disease (900 mg IV at Weeks 0, 4, 8) and ulcerative colitis (300 mg IV at Weeks 0, 4, 8) and requires prescription by or in consultation with a gastroenterologist. The policy aligns with FDA-labeled induction dosing and documents manufacturer-recommended transitions to subcutaneous maintenance (Crohn’s: 300 mg SC at Week 12 then q4w; UC: 200 mg SC at Week 12 then q4w). Concurrent use of Omvoh IV with another biologic or a targeted synthetic oral small molecule for inflammatory conditions is explicitly not covered; conventional synthetic DMARDs are allowed. Guideline references (ACG/AGA 2024–2025) are cited to place Omvoh among recommended advanced therapies for moderate–severe IBD.

This revision establishes coverage parameters for Omvoh intravenous specifically for induction treatment in adults with Crohn's disease and ulcerative colitis and codifies the FDA-aligned induction dosing and prescriber requirements. The policy specifies approval of a three-dose IV induction series for each indication (900 mg for Crohn's disease; 300 mg for ulcerative colitis) and requires that the medication be prescribed by or in consultation with a gastroenterologist. These elements are presented as the core FDA-approved indications and dosing under the OVERVIEW and FDA-Approved Indications sections.

The document also clarifies maintenance expectations following IV induction by referencing the manufacturer-recommended subcutaneous maintenance dosing: Omvoh 300 mg SC at Week 12 and then every 4 weeks for Crohn's disease, and Omvoh 200 mg SC at Week 12 and then every 4 weeks for ulcerative colitis. While the IV approval language is limited to induction, the policy text explicitly describes the recommended maintenance regimens following induction therapy.

Coverage is limited to adult patients (age ≥ 18) for induction therapy in the two FDA-labeled inflammatory bowel disease indications: Crohn's disease and ulcerative colitis. For Crohn's disease the policy authorizes three IV infusions of at Weeks 0, 4, and 8; for ulcerative colitis it authorizes three IV infusions of at the same schedule. In both indications approval is conditional on (A) adult age, (B) use for induction therapy, and (C) prescription by or in consultation with a gastroenterologist.

Following the IV induction course, the policy documents the recommended maintenance regimens as described in the OVERVIEW section. For Crohn's disease, maintenance is identified as Omvoh 300 mg SC at Week 12 (4 weeks after the last induction dose) then every 4 weeks. For ulcerative colitis, maintenance is identified as Omvoh 200 mg SC at Week 12 then every 4 weeks. These maintenance doses are presented as the manufacturer-recommended transition after the IV induction sequence.

Although the FDA-Approved Indications block focuses on authorization of the three IV induction doses, the inclusion of maintenance dosing in the policy text provides clarity on the intended treatment continuum following induction with the IV product.

The policy explicitly defines a Conditions Not Covered category that disallows use of Omvoh intravenous in combination with another biologic or with a targeted synthetic oral small molecule drug for inflammatory conditions. The policy rationale states combination therapy is generally not recommended due to higher adverse event rates and lack of controlled clinical data supporting additive efficacy. The exclusion does not extend to conventional synthetic DMARDs — the policy notes that agents such as methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine are not excluded from concurrent use.

This restriction is presented as a categorical not medically necessary determination for concurrent use with other advanced immunomodulators, and the policy indicates the list of examples will be maintained in an Appendix that may be updated as new evidence becomes available.

The policy situates Omvoh within contemporary guideline recommendations for moderate to severe inflammatory bowel disease. It cites the 2025 American College of Gastroenterology (ACG) and American Gastroenterological Association (AGA) guidance for Crohn's disease, which endorse upfront use of advanced therapies (including IL-23 inhibitors) rather than step-up therapy. For ulcerative colitis the policy references the 2024 AGA and 2025 ACG guidelines that allow systemic corticosteroids or advanced therapies for induction and recommend introducing steroid-sparing agents for maintenance when steroids are used.

These guideline references provide clinical context for the policy's coverage decisions by acknowledging IL-23 inhibitors (the mechanism class for Omvoh) as among the recommended advanced therapies for induction and maintenance in moderate to severe disease according to the cited societies.

OpenPayer

March 2026 Revision: Induction Dosing and Gastroenterologist Prescriber Requirement

Indication-Specific Induction Eligibility and Dosing

Documented Maintenance Regimens Following IV Induction

Explicit Exclusion: No Concurrent Biologic or Targeted Synthetic Combination Therapy

Guideline Context: Placement of `Omvoh` Among Advanced Therapies for IBD