Cigna’s Entyvio (vedolizumab) policy clarifies indications, dosing options, and approval durations for adults with moderately to severely active Crohn’s disease and ulcerative colitis, effective 2026-03-15. Initial therapy approvals are limited to 6 months (patient ≥18 and GI prescriber/consult), while patients already on Entyvio for ≥6 months may receive renewals up to 1 year when objective improvement or symptom benefit is documented. Authorized dosing includes standard IV induction (300 mg at Weeks 0, 2, 6) with maintenance no more frequently than every 8 weeks, an alternative 0/2 week induction, and switching to 108 mg SC every 2 weeks at Week 6 or any responding IV visit; established patients may escalate IV dosing to every 4 weeks if needed. The policy aligns with recent ACG/AGA guidance endorsing Entyvio as an upfront advanced therapy option and emphasizes steroid-sparing maintenance and documentation requirements for continued approvals.
2026-03-15 Revision: Indications, Duration, and Dosing Clarified
This revision (Effective Date: 2026-03-15) retains Entyvio (vedolizumab) indications for adults with moderately to severely active Crohn's disease and ulcerative colitis and clarifies dosing and approval durations tied to initial versus established therapy. The policy explicitly codifies initial therapy approval periods (6 months) and renewal criteria for patients currently receiving Entyvio (1 year) for both Crohn's disease and ulcerative colitis when specific conditions are met.
The document also emphasizes permitted dosing options: standard IV induction at Weeks 0, 2, and 6 with maintenance every 8 weeks, an alternative IV induction at Weeks 0 and 2, and allowance for switching to subcutaneous Entyvio at Week 6 or any scheduled IV infusion in responding patients. For established patients, the policy permits maintenance approvals up to annual reviews and allows up-titration to IV dosing as frequently as every 4 weeks in certain circumstances.
Approval Pathways: Initial Therapy vs. Established Patients
The policy separates criteria for Initial Therapy and for patients Currently Receiving Entyvio (IV or SC). For initial therapy in both Crohn's disease and ulcerative colitis, approval is for 6 months provided the patient is ≥ 18 years of age and the medication is prescribed by or in consultation with a gastroenterologist. Patients restarting or already established on Entyvio for at least 6 months are eligible for up to 1 year of approval if they meet specified response criteria.
For established patients, the policy requires evidence of benefit either by at least one objective measure (examples listed include fecal calprotectin, fecal lactoferrin, C-reactive protein, MRE/CTE, endoscopy, or corticosteroid dose reduction) or by patient symptom improvement (e.g., decreased pain, fatigue, stool frequency, bleeding). The distinction between initial and ongoing therapy governs both duration of approval and the documentation expected for renewal.
Dosing Regimens and IV-to-SC Switching Details
The policy delineates specific IV dosing regimens as allowable under FDA-Approved Indications. Initial dosing options include 300 mg IV at Weeks 0, 2, and 6 with subsequent maintenance no more frequently than every 8 weeks, or an alternative induction of 300 mg IV at Week 0 and 2. For patients currently receiving Entyvio (IV or SC), the policy permits dosing up to 300 mg IV as frequently as every 4 weeks when indicated.
The overview further notes the recommended maintenance dose for subcutaneous Entyvio is 108 mg SC every 2 weeks and documents that switching from IV to SC may occur at Week 6 or at any scheduled IV infusion for patients with clinical response or remission. The policy references trial-extension data supporting dosing-interval shortening to recapture response in patients who lose clinical benefit.
Guideline Context Supporting Entyvio Use in CD and UC
The policy references contemporary guideline support for use of Entyvio in both disease states. For Crohn's disease, the American College of Gastroenterology (ACG) [2025] and the American Gastroenterological Association (AGA) [2025] recommend upfront use of advanced therapies (including TNF inhibitors, Entyvio, IL-23 inhibitors, IL-12/23 inhibitors, and upadacitinib) rather than strict step-up after corticosteroid or immunomodulator failure.
For Ulcerative colitis, the AGA (2024) and ACG (2025) guidelines endorse systemic corticosteroids or advanced therapies for induction in moderate to severe disease and list Entyvio among recommended advanced therapies alongside TNF inhibitors, IL-23 inhibitors, IL-12/23 inhibitors, S1P receptor modulators, and JAK inhibitors. The policy notes guideline emphasis on steroid-sparing maintenance and continuity of effective induction agents into maintenance.
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