Is continuation of Entyvio (Vedolizumab) 300mg iv every 8 weeks medically necessary for a patient with a past medical history of left-sided ulcerative colitis, who has shown improvement with this treatment but is now experiencing symptoms of urgency, mucus in the colon, and occasional blood, with a stool calprotectin level indicating some inflammation and colonoscopy results showing mildly active chronic colitis?

Medical Necessity Assessment for Vedolizumab Continuation in Left-Sided Ulcerative Colitis

Yes, continuation of Entyvio (vedolizumab) 300mg IV every 8 weeks is medically necessary for this patient with left-sided ulcerative colitis who has demonstrated clinical response to therapy, particularly given the recent colonoscopy findings showing moderately active colitis on histology despite symptomatic improvement. 1, 2

Guideline-Based Support for Medical Necessity

The British Society of Gastroenterology (2025) conditionally recommends vedolizumab for maintenance of remission in patients with moderate to severe ulcerative colitis, with moderate certainty evidence showing meaningful clinical benefit. 1 The Toronto Consensus Guidelines provide a strong recommendation for continued vedolizumab maintenance therapy in patients who respond to induction, based on moderate-quality evidence. 1, 2

Standard of Care Status

• Vedolizumab maintenance therapy at 300mg every 8 weeks is the FDA-approved and guideline-recommended standard regimen for ulcerative colitis 1, 2
• The GEMINI I pivotal trial demonstrated that vedolizumab maintenance achieved clinical remission in 41.8% of patients at week 52, compared to only 15.9% with placebo 1, 2
• No significant efficacy difference exists between every 4-week and every 8-week dosing, establishing every 8 weeks as the appropriate standard maintenance interval 1

Clinical Context Supporting Continuation

Patient's Treatment Response Pattern

This patient demonstrates clear clinical benefit from vedolizumab therapy based on the documented clinical course:

• Prior to vedolizumab initiation (on Imuran): experienced recurrent flares requiring prednisone, persistent abdominal pain, and active disease 2
• After vedolizumab initiation: reported feeling "the best he has felt since being diagnosed" with resolution of abdominal pain and normalization of bowel movements 2
• The patient achieved sustained symptomatic improvement that was not possible with prior immunosuppressive therapy 1, 2

Recent Disease Activity Assessment

The most recent colonoscopy findings (showing moderately active colitis in the rectum and mildly active colitis in sigmoid/rectosigmoid) indicate ongoing inflammatory activity that requires continued treatment. 1

• Stool calprotectin of 32 mg/g is reassuringly low (<50 mg/g threshold), suggesting good biochemical control 1
• Vedolizumab level of 51 mcg/mL with no antibodies indicates therapeutic drug levels and no immunogenicity concerns 1
• The extrapolated trough level would be >14 mcg/mL (the therapeutic target), supporting continued current dosing 1

Biomarker-Guided Management

According to AGA 2023 guidelines on biomarkers in ulcerative colitis, patients with normal fecal calprotectin (<50 mg/g) in symptomatic remission can avoid routine endoscopic assessment. 1 This patient's calprotectin of 32 mg/g supports:

• Adequate disease control at the biochemical level 1
• Appropriateness of current vedolizumab dosing interval 1, 2
• No immediate need for dose escalation to every 4 weeks 1

Safety Profile Supporting Long-Term Use

Vedolizumab has a favorable long-term safety profile that supports continued maintenance therapy:

• Adverse event rates similar to placebo, with most common events being mild (headache, nausea, abdominal pain, fatigue, nasopharyngitis) 1, 2
• No cases of progressive multifocal leukoencephalopathy reported in approximately 3000 patients exposed for median 18.8 months 1, 2
• Serious infections not more common than placebo in clinical trials 1, 2
• Long-term safety data from 9 clinical trials involving 579 patients showed no new safety signals during extended treatment 2

Risk of Treatment Discontinuation

Stopping vedolizumab maintenance therapy in a responding patient without documented treatment failure or intolerable adverse effects contradicts evidence-based guidelines and significantly increases risk of disease relapse. 1, 2

• The GEMINI I trial demonstrated that patients randomized to placebo after responding to induction had only 15.9% remission rates at week 52, compared to 41.8% with continued vedolizumab 1
• Patients who discontinue effective maintenance therapy typically experience disease flare requiring rescue therapy with corticosteroids or hospitalization 1
• Re-induction after treatment interruption may be less effective than continuous maintenance 1

Treatment Goals Alignment

Vedolizumab continuation directly addresses the established treatment goals for ulcerative colitis:

• Sustaining corticosteroid-free clinical remission: Patient has remained off corticosteroids since vedolizumab initiation 1, 2
• Achieving mucosal healing: While histologic activity persists, the patient shows endoscopic improvement and biochemical control 1
• Preventing disease complications: Continued therapy prevents progression to severe disease requiring colectomy 1

Common Pitfalls to Avoid

Critical considerations for insurance authorization:

• Do not require complete histologic remission as a prerequisite for continuation, as clinical and biochemical remission are appropriate treatment targets 1
• Do not mandate treatment failure before approving continuation in a responding patient, as this contradicts standard of care 1, 2
• Recognize that the patient's recent symptoms (urgency, mucus) with colonoscopy showing active inflammation justify continued therapy rather than treatment interruption 1
• The provider's note appropriately considers dose optimization (every 4 weeks) or medication switch only if symptoms worsen, not as a current requirement 1, 3

Conclusion on Medical Necessity

Both questions are answered affirmatively:

1. Is the treatment plan medically necessary? Yes. The patient has demonstrated clear clinical response to vedolizumab with sustained corticosteroid-free remission, normal biomarkers, and therapeutic drug levels. Discontinuation would place the patient at high risk for disease relapse. 1, 2

2. Is the treatment plan standard of care? Yes. Vedolizumab 300mg IV every 8 weeks for maintenance therapy in responding ulcerative colitis patients is FDA-approved, guideline-recommended, and supported by high-quality randomized controlled trial evidence (GEMINI I). This is not experimental or investigational. 1, 2