Is Entyvio (vedolizumab) 300mg intravenous infusion at weeks 0, 2, 6, and then every 8 weeks for a year medically necessary for the treatment of lymphocytic colitis?

Medical Necessity Determination for Vedolizumab (Entyvio) in Lymphocytic Colitis

Primary Recommendation

Vedolizumab (Entyvio) for lymphocytic colitis is NOT medically necessary based on current evidence-based guidelines, as lymphocytic colitis is explicitly listed as an indication with insufficient evidence in the Aetna coverage policy, and no major gastroenterology society guidelines support its use for this condition. 1

Rationale Based on Coverage Criteria

Aetna Policy Exclusion

• The Aetna Clinical Policy Bulletin #0885 explicitly states that vedolizumab is considered "insufficient evidence, or unproven" for lymphocytic colitis, listing it specifically among indications where effectiveness has not been established 1
• The policy only considers vedolizumab medically necessary for: Crohn's disease, ulcerative colitis, immune checkpoint inhibitor-related toxicity, and acute graft versus host disease—lymphocytic colitis is notably absent from this list 1

Guideline Evidence Gap

• The British Society of Gastroenterology 2019 and 2025 guidelines address vedolizumab exclusively for ulcerative colitis and Crohn's disease, with no mention of microscopic colitis subtypes including lymphocytic colitis 2
• The Toronto Consensus Guidelines (2015) similarly restrict vedolizumab recommendations to ulcerative colitis only, providing strong recommendations with moderate-quality evidence for UC but no guidance for lymphocytic colitis 2
• The AGA Clinical Practice Update on immune checkpoint inhibitor colitis discusses vedolizumab use but only in the context of ICI-related enterocolitis, not primary lymphocytic colitis 2

Limited Research Evidence

Case Series Data

• The only available evidence is a 2019 international case series of 11 patients with refractory microscopic colitis (5 lymphocytic colitis, 6 collagenous colitis) treated with vedolizumab 1
• Clinical remission occurred in only 5/11 patients (45%) after three infusions, with only 2/5 lymphocytic colitis patients achieving remission 1
• All patients in this series were highly refractory, having failed budesonide and at least one anti-TNF agent (10/11 patients), representing a much more severe disease course than the current case 1

Comparison to Established Indications

• In ulcerative colitis, vedolizumab demonstrates response rates of 47.1% at week 6 and clinical remission rates of 41.8-44.8% at week 52 in large randomized controlled trials 3
• The evidence base for UC includes multiple phase III trials with hundreds of patients, whereas lymphocytic colitis has only a single case series of 11 patients 3, 1

Clinical Context of This Case

Disease Severity Assessment

• The patient has documented lymphocytic colitis on biopsy (1/6/2025) but colonoscopy shows "normal mucosa in the whole colon" with only congestion and edema, not ulceration or severe inflammation [@case documentation]
• The patient has tried budesonide (Entocort), mesalamine, cholestyramine, and Colestid, with variable responses but no documentation of complete treatment failure with all standard therapies [@case documentation]
• The GI note from 9/10/2025 states the patient "has been having regular formed bowel movements without associated bleeding" and "initially was seeing a great response with the mesalamine," suggesting some therapeutic success with conventional therapy [@case documentation]

Standard Treatment Algorithm Not Exhausted

• First-line therapy for lymphocytic colitis is budesonide, which the patient received [@7@]
• The patient showed initial response to mesalamine but developed recurrent symptoms, and bile acid sequestrants (cholestyramine, Colestid) were not well tolerated [@case documentation]
• No documentation indicates trial of immunomodulators (azathioprine, methotrexate) or anti-TNF agents, which have been reported effective in small cohort studies for refractory microscopic colitis 1

Alternative Approaches

Evidence-Based Options for Refractory Lymphocytic Colitis

• Anti-TNF agents (infliximab, adalimumab) have been reported effective in small cohort studies for budesonide-refractory microscopic colitis and should be considered before vedolizumab 1
• Immunomodulators including azathioprine and methotrexate have documented use in refractory microscopic colitis 1
• Optimization of bile acid sequestrant therapy (different formulations, dosing adjustments) may be warranted given intolerance rather than inefficacy [@case documentation]

Clinical Trial Consideration

• Given the lack of established efficacy data, vedolizumab use in lymphocytic colitis would be considered investigational/experimental per the plan's exclusion criteria [@case documentation]
• The patient might be appropriate for enrollment in a clinical trial evaluating vedolizumab for microscopic colitis if available

Common Pitfalls to Avoid

• Do not extrapolate efficacy data from ulcerative colitis to lymphocytic colitis—these are distinct disease entities with different pathophysiology, and vedolizumab's gut-selective mechanism may not address the specific inflammatory pathways in microscopic colitis 2, 1
• Do not approve based solely on physician request without guideline support—the plan language requires medical necessity determination based on established evidence, and experimental/investigational treatments are explicitly excluded [@case documentation]
• Do not overlook that the single case series showed only 40% response rate in lymphocytic colitis patients (2/5), which is substantially lower than established therapies for approved indications 1

Final Determination

The request for vedolizumab (J3380) for lymphocytic colitis (K52.832) should be DENIED as not medically necessary. The indication is explicitly excluded from the Aetna coverage policy as having insufficient evidence, no major gastroenterology guidelines support its use for this condition, and only a single small case series with modest efficacy exists. The patient should be considered for alternative evidence-based therapies including anti-TNF agents or immunomodulators before pursuing an investigational treatment. [@7@, @case documentation]