Entyvio denials in California external review
In the California DMHC record, independent physician reviewers decided 27 published external-review cases involving Entyvioand overturned the plan’s denial in 96.3%. That is a historical result among cases that reached this program, not a forecast for an individual appeal.
By condition
| Condition | Decisions | Overturned |
|---|---|---|
| Ulcerative Colitis | 12 | 100% |
What the reviewers wrote
Where the denial was overturned
Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Entyvio infusions. Entyvio is effective for the treatment of moderate to severe ulcerative colitis. Researchers report that vedolizumab, an anti-adhesion therapy, is approved for treating ulcerative colitis by the U.S. Food and Drug Administration (FDA). The American Gastroenterological Association (AGA) and American College of Gastroenterology (ACG) guidelines support Entyvio as the primary therapy for moderate to severe ulcerative colitis. Researchers report that in a randomized controlled trial involving patients with moderately to severely active ulcerative colitis, vedolizumab was superior to adalimumab with respect to achievement of clinical remission and endoscopic improvement.
Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Entyvio (vedolizumab) 300 mg injection at weeks zero, two, and six, followed by 300 mg every four weeks. Findings: The physician reviewer found that Entyvio has a different mechanism of action than anti-tumor necrosis factor (TNF) medications and other immunosuppressants and is effective for the treatment of moderate-to-severe ulcerative colitis. The American College of Gastroenterology (ACG) guidelines on the treatment of ulcerative colitis support the use of Entyvio in patients with moderate-to-severe ulcerative colitis.
Where the denial was upheld
Findings: The physician reviewer found that the parent of a patient has requested authorization and coverage for Entyvio. First-line treatments for induction of remission in pediatric Crohn’s disease patients include medications such as prednisone or budesonide. FDA-approved treatments for pediatric Crohn’s disease include infliximab and adalimumab. Vedolizumab is not FDA-approved in pediatric Crohn’s disease and is not considered in pediatric patients unless they have failed prior treatments. According to the records, this patient has not failed treatments such as steroids, immunomodulators, or biologics. Given these findings, the requested Entyvio is not medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested medication is not medically necessary for the treatment of the patient's medical condition.
Figures and quotations on this page come from 42,749 published decisions in the California DMHC Independent Medical Review dataset. These are California external-review outcomes. Other state and federal programs have different eligibility rules, processes, and current availability; the rates here do not transfer to those programs or predict an individual result. Excerpts are quoted verbatim from the public record and describe this treatment generally, not any individual case.
Why plans deny Entyvio — and what reviewed cases show
Entyvio (vedolizumab) is FDA-approved for: moderately to severely active ulcerative colitis (adults); moderately to severely active Crohn's disease (adults). An on-label indication can be important evidence when a denial frames the requested use as unproven or cosmetic.
Step therapy — “fail a TNF blocker first”
Entyvio is gut-selective, which is often exactly why a gastroenterologist chooses it — infection history, malignancy history, age, or prior systemic-agent problems. Formularies still commonly demand TNF-blocker failure first. The denial ignores the selection rationale; the appeal puts it back on the record.
Site-of-care and infusion restrictions
Plans push infusions from hospital outpatient departments to cheaper infusion sites or home infusion, and deny claims at the “wrong” site. This is a cost decision with legitimate patient-safety considerations on both sides — prescriber documentation of why a monitored setting matters for you is what wins the exception.
Continuation denied on plan change
IBD remission on vedolizumab is hard-won. A new plan's formulary preferring different biologics doesn't change your clinical history — continuity of care is the argument, and interrupting a working biologic regimen is the risk the plan must justify.
A step-therapy exception with the prescriber's statement — prior failures, infection or malignancy history, or other reasons a TNF blocker is inappropriate — is the standard path, and plans must decide it on short mandatory deadlines.
Evidence cited in overturned Entyvio decisions
- Lead with why gut-selectivity was chosen: the clinical reasons a systemic immunosuppressant is inappropriate for you are the strongest possible exception rationale.
- Document prior biologic and conventional-therapy history completely — including adverse effects, not just failures.
- For stable patients, frame the denial as un-approving working therapy and demand the clinical justification.
- Both Entyvio indications are adult Crohn's disease and ulcerative colitis — on-label, not experimental.
The published California record contains 27 external-review decisions involving Entyvio; 96.3% were overturned. This historical rate does not predict another case. For the full class-wide picture — step therapy, biosimilar switching, dose caps, and the record for every IBD biologic — see the Crohn’s & colitis biologic appeal guide.
These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Entyvio, then check the rights and deadlines that apply to your plan.
SOURCE: CALIFORNIA DMHC INDEPENDENT MEDICAL REVIEW OUTCOMES (CHHS OPEN DATA) · AGGREGATES + DEIDENTIFIED DECISION EXCERPTS/REFERENCE IDS · METHODOLOGY