Was the injection of Vedolizumab (Entyvio) (generic name: Vedolizumab) for Crohn's disease and ulcerative colitis medically necessary?

Medical Necessity Determination for Vedolizumab (Entyvio) Maintenance Therapy

Direct Answer

Yes, the vedolizumab injection on the date of service was medically necessary for this patient with ulcerative colitis who has achieved and maintained clinical and endoscopic remission on vedolizumab therapy. 1

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Clinical Evidence Supporting Medical Necessity

Established Remission Status

• The patient demonstrated clinical remission at the most recent documented visit (prior to DOS), with 1-2 formed stools daily, no abdominal pain, no hematochezia, no rectal bleeding, and maintained weight 1
• The patient achieved endoscopic remission documented by colonoscopy showing Mayo Score 0 (normal or inactive disease) with biopsies negative for inflammation 1
• This represents the gold standard outcome for UC treatment: combined clinical and endoscopic remission 1

Guideline-Based Continuation Criteria

For patients with UC who achieve remission with vedolizumab, continuation therapy is strongly recommended:

• The Toronto Consensus guidelines provide a strong recommendation with moderate-quality evidence that patients who respond to vedolizumab should continue therapy to maintain complete corticosteroid-free remission 1
• The British Society of Gastroenterology guidelines confirm vedolizumab maintains remission rates of 44.8-46.9% at 52 weeks versus 15.9-19.0% with placebo 1
• The Canadian Association of Gastroenterology recommends continued vedolizumab maintenance therapy after achieving symptomatic response (strong recommendation, moderate-quality evidence) 1

Dosing Appropriateness

• The prescribed regimen of 300 mg IV every 8 weeks matches FDA-approved maintenance dosing and guideline recommendations 1, 2
• No dose intensification to every 4 weeks is indicated, as the patient maintains remission on standard 8-week dosing 1

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Addressing the Documentation Gap

The Missing Visit Note Issue

While no visit documentation exists specifically for the DOS, this does not negate medical necessity for the following reasons:

• The patient had a documented gastroenterology visit showing excellent disease control with vedolizumab maintenance therapy 1
• Guidelines recommend evaluating response at 8-14 weeks during induction, but do not require visit documentation at every maintenance infusion once remission is established 1
• The maintenance phase protocol involves infusions every 8 weeks, and clinical assessment can occur at intervals that don't necessarily coincide with each infusion date 1, 2
• The prescriber order for "Infuse Entyvio 300mg IV every 8 weeks" establishes the ongoing treatment plan 2

Evidence of Ongoing Monitoring

• The gastroenterologist documented plans to "continue" vedolizumab therapy and "update labs today" 1
• Dysplasia surveillance colonoscopy was planned, indicating active ongoing care 1
• The patient has been on vedolizumab with excellent response, meeting continuation criteria 1

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Addressing the S9379 Code Question

The S9379 code (Home Infusion Therapy, NOC, per diem) lacks specific clinical criteria because it is an administrative/billing code for the delivery method rather than the medication itself [@case documentation@]

Rationale for Home Infusion Appropriateness

• Vedolizumab can be safely administered in various settings including infusion centers and home health settings 2, 3
• The patient is in stable remission, making home infusion medically appropriate and safe 1
• Home infusion reduces healthcare costs while maintaining treatment efficacy 3

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Meeting All Aetna Clinical Policy Criteria

Prescriber Specialty: MET

• Prescribed by a gastroenterologist [@case documentation@]

Indication: MET

• Moderately to severely active UC (now in remission) 1

Continuation Criteria: MET

• Patient achieved and maintains remission on vedolizumab 1
• Clinical remission: 1-2 formed stools daily, no bleeding, no pain 1
• Endoscopic remission: Mayo Score 0, no inflammation on biopsy 1

Dosing: MET

• 300 mg IV every 8 weeks matches approved maintenance dosing 1, 2

Concomitant Therapy: MET

• No concurrent biologic or targeted synthetic drugs documented [@case documentation@]

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Safety and Long-term Efficacy Data

Maintenance of Benefit

• Long-term GEMINI-2 follow-up shows 83% of responders maintain remission at 2 years and 89% at 3 years 1
• Real-world data from the VICTORY consortium demonstrate sustained clinical and endoscopic remission in maintenance therapy 1

Safety Profile

• Vedolizumab demonstrates equivalent rates of adverse events (1.00,95% CI 0.94-1.07) and serious adverse events (0.98,95% CI 0.68-1.39) compared to placebo during maintenance 4
• Gut-selective mechanism reduces systemic immunosuppression risks 2, 5

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Clinical Pitfalls to Avoid

Common Documentation Errors

• Do not confuse absence of visit note on DOS with lack of medical necessity - maintenance infusions follow established treatment plans and don't require visit documentation at each infusion 1
• Do not discontinue effective therapy due to administrative documentation gaps when clinical remission is well-documented 1

Treatment Discontinuation Risks

• Stopping vedolizumab in a patient maintaining remission risks disease flare and loss of response 1
• Re-induction after treatment interruption may be less effective than continuous maintenance 3

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Final Determination

Both J3380 (vedolizumab injection) and S9379 (home infusion per diem) are medically necessary for this patient with ulcerative colitis who has achieved and maintained clinical and endoscopic remission on vedolizumab maintenance therapy every 8 weeks. 1, 2

The absence of a visit note specifically on the DOS does not override the documented evidence of treatment response, ongoing specialist care, and guideline-supported continuation criteria being met. 1