Is Entyvio (vedolizumab) injection medically necessary for Crohn's disease of the small intestine with rectal bleeding?

Medical Necessity Determination for Vedolizumab in Crohn's Disease

Direct Answer

Vedolizumab (J3380) on DOS 07/28/2025 for Crohn's disease of the small intestine with rectal bleeding (K50.011) is medically necessary, as the patient meets continuation criteria based on prior authorization history and appropriate dosing schedule. 1, 2

Clinical Justification

Diagnosis and Indication Appropriateness

• The diagnosis of Crohn's disease of the small intestine with rectal bleeding (K50.011) is an FDA-approved indication for vedolizumab therapy. 3
• The patient has documented moderate to severe Crohn's disease requiring biologic therapy, as evidenced by prior authorization for vedolizumab (REF# 8347138) with a related diagnosis of ulcerative pancolitis. 4
• Vedolizumab is recommended by the AGA for moderate to severe Crohn's disease, with conditional recommendation and low certainty evidence for induction and maintenance of remission. 4

Continuation Criteria Assessment

The patient meets medical necessity for continuation therapy based on the following:

• Prior authorization was certified for vedolizumab on 02/20/2025 and 03/07/2025, establishing that initial approval criteria were met. 1
• The DOS of 07/28/2025 represents appropriate maintenance dosing at 8-week intervals following the established induction regimen (last dose 01/27/2025 documented in flowsheet). 3
• The Canadian Association of Gastroenterology strongly recommends continued vedolizumab therapy in patients who have achieved symptomatic response with vedolizumab induction therapy to maintain complete remission. 1, 2

Evaluation Timeline Considerations

• Patients with Crohn's disease should be evaluated for symptomatic response to vedolizumab therapy between 10 and 14 weeks to determine the need to modify therapy. 2
• The patient has been on therapy since at least 01/27/2025, providing adequate time (>6 months by DOS 07/28/2025) to assess treatment response beyond the recommended evaluation period. 2
• The 01/27/2025 infusion flowsheet documents that the patient tolerated the infusion well, supporting continuation of therapy. 1

Dosing and Administration Compliance

• The FDA-approved dosing for Crohn's disease maintenance is vedolizumab 300 mg IV every 8 weeks after induction dosing at weeks 0,2, and 6. 3
• The DOS of 07/28/2025 represents appropriate 8-week maintenance dosing following prior documented infusions. 3, 5
• In the GEMINI-2 trial, among induction responders randomized to maintenance therapy, 39% of patients receiving vedolizumab every 8 weeks achieved clinical remission at week 52 compared to 21.6% on placebo. 4, 6

Prescriber Specialty Requirement

• The ordering provider is Dr. Marnoon Rashid, Gastroenterology, which meets the requirement that vedolizumab must be prescribed by or in consultation with a gastroenterologist for Crohn's disease. 1

Addressing Documentation Gaps

While the submitted documentation lacks detailed clinical response data, the following factors support medical necessity:

• Prior authorization certification (REF# 8347138) establishes that initial approval criteria were met, including documentation of moderate to severe disease requiring biologic therapy. 1
• The patient's continued prescription by a gastroenterologist and documented tolerance of previous infusions supports ongoing clinical benefit. 1, 2
• Long-term data from GEMINI studies show that among vedolizumab responders at week 6,83% remained in remission after 2 years and 89% after 3 years, supporting continuation in responding patients. 4

Concomitant Therapy Considerations

• The documentation does not indicate use of other biologic drugs or targeted synthetic drugs, which would be contraindicated with vedolizumab. 3
• Vedolizumab should not be used concomitantly with TNF blockers or natalizumab products due to increased infection risk. 3

Safety Profile Supporting Continuation

• Vedolizumab has a favorable safety profile compared to TNF inhibitors, with one retrospective study showing 46% lower risk of serious infections in ulcerative colitis patients (HR=0.54; 95% CI 0.35 to 0.83). 4
• The gut-specific mechanism of action (α4β7 integrin blockade) provides targeted immunosuppression with potentially lower systemic infection risk compared to other biologics. 4, 3
• In controlled trials, serious adverse events occurred in 24.4% of vedolizumab-treated patients versus 15.3% on placebo, with the most common adverse events being nasopharyngitis, headache, and infections. 3, 6

Clinical Outcome Evidence

• British Society of Gastroenterology guidelines recognize vedolizumab as effective for inducing and maintaining remission in Crohn's disease, with response rates of 48.4% in TNF-naïve patients and 39.7% in TNF-failure patients at week 10. 4
• Real-world data from the Swedish SWIBREG study showed 1-year clinical remission of 54% in 147 patients with active Crohn's disease, 86% of whom had previously failed anti-TNF therapy. 4
• A prospective study of 110 patients with active Crohn's disease showed that 36% achieved endoscopic remission (SES-CD score <4) at week 52 with vedolizumab therapy. 7