CareCost Prior authorization
Required
Check what the payer requires before you schedule Entyvio.
30 payers, 458 rules, and 24 of them require another product first.
30 payer policy sets hold a vedolizumab policy · source-linked · reviewed August 2026
Aetna + Crohn’s disease is shown as a live example until you choose a payer.
This payer requires an approval on file before Entyvio is purchased or infused for this member.
Precertification of vedolizumab (Entyvio) is required of all Aetna participating providers and members in applicable plan designs.
Covered under ICD-10 K50.
For treatment of moderately to severely active CD
What opens in CareCost
Aetna · Entyvio · Crohn’s disease
For every requirement: the exact payer criteria, the source citation, a check-off, and a save to the patient’s chart.
In CareCost: check off each requirement · save to the patient · print for the chart
Aetna · Entyvio · Crohn’s disease
You have already checked the policy, indication and covered dose. Open the remaining requirements and work them as a patient checklist.
CareCost tracks Entyvio coverage requirements across 30 payer policy sets.
Aetna · Anthem / Elevance · Cigna · UnitedHealthcare · Kaiser Permanente WA · CareFirst BCBS · BCBS plans + more
Coverage clearance is only the first step.
CareCost carries the same patient through the entire workflow.
Finish this patient’s estimate →28 of 30 payers with a vedolizumab policy require prior authorization. Every payer in this corpus covers both ulcerative colitis and Crohn’s disease; what separates them is what has to happen before Entyvio, not whether the diagnosis is covered. Step therapy, reauthorization timing and site-of-care rules vary by plan.
The 458 rules break out as 193 clinical prerequisites, 62 covered-indication rules (Entyvio carries two ICD-10 families, each its own clearance key, each held by all 30 payers), 34 dosing rules, 31 prior-authorization rules, 24 reauthorization rules, 23 combination rules, 22 billing-and-coding rules, 21 contraindication exclusions, 18 rules requiring another product first, 17 site-of-care rules, 12 quantity limits and 1 continuation-of-therapy rule.
28 require PA · 30 have clinical criteria · 17 restrict site of care
28 of the 30 payers CareCost has read require an approval on file before vedolizumab is covered. BCBS South Carolina’s rule reads plainly: “Coverage of Vedolizumab (Entyvio) is provided when the FDA-approved indications below are met and there has been a trial and failure of preferred therapy.” The other 2 do not carry a formal prior-authorization label but still work through the same clinical documentation.
Before a biologic is even discussed, most payers want to see 5-ASA products, corticosteroids or a thiopurine tried and documented as ineffective, not tolerated or contraindicated. Anthem, for Crohn’s disease: “Individual has had an inadequate response to or is intolerant of conventional therapy (such as systemic corticosteroids or immunosuppressants [such as thiopurines or methotrexate]).” Centene, for ulcerative colitis: “Failure of an 8-week trial of systemic corticosteroids.” BCBS Minnesota asks for “a minimum 3-month* trial of conventional therapy” documented as failed, contraindicated or ineffective at maximum tolerated doses.
24 of the 30 payers in this corpus will not approve Entyvio until another product has been tried, failed or ruled out. Blue Shield of California names its preferred agent outright: “Inadequate response or intolerable side effect with BSC-preferred agent [infliximab (Avsola or Inflectra)] or contraindication to preferred agent.” Capital BlueCross asks for “a minimum 3-month trial of a TNF modifier such as adalimumab, certolizumab” for Crohn’s disease, and adalimumab or golimumab for ulcerative colitis. CareFirst requires two things in sequence: “a. At least ONE conventional therapy option… b. At least ONE TNF-alpha inhibitor indicated for UC.” Centene routes ulcerative colitis patients through a specific biosimilar trial: for Entyvio, the member must fail a 3-month trial of Avsola, Inflectra, or Renflexis (infliximab), or have a history of failure of two TNF blockers, unless contraindicated or clinically significant adverse effects are experienced. BCBS Mississippi is the exception on this specific step: its policy places IV vedolizumab in “Table 2: Medical Covered Agents (no step therapy requirement),” though it still requires failure of at least one conventional agent first — see below.
The label itself has no every-4-week dose. When a rule in this corpus permits a 4-week interval, it is a payer allowing a patient to escalate beyond the standard every-8-week schedule, not cutting the dose below what the FDA allows. BCBS Florida writes both halves: “The dosage does not exceed 300 mg IV every 8 weeks (if for CD or UC)” as the baseline, and a separate rule permitting “300 mg IV every 4 weeks” when additional criteria are met. BCBS Massachusetts frames it the same way: “escalated dosing frequency of 1 single use vial (300 mg) every 4 weeks if additional criteria is met.” Capital BlueCross caps maintenance dosing at “300 mg every 4 weeks” as the upper bound; Cigna sets a similar ceiling, capping the maximum dose at 300 mg administered intravenously no more often than a set interval. Regence limits the count directly: “Up to 6 doses (six 300 mg infusions) in a 6-month period…” BCBS HCSC states the standard fill instead: “Entyvio Vedolizumab For IV Solution 300 MG 300 MG 1 Vial 56 Days,” 56 days being the label’s own 8-week interval.
The label’s own stopping rule — discontinue if there is no evidence of therapeutic benefit at that point — shows up directly in payer reauthorization timing. BCBS HCSC: “Entyvio for Crohn’s disease or ulcerative colitis: 14 weeks.” Capital BlueCross: “Initial coverage will be provided for 14 weeks and may be renewed annually thereafter.” From there, most payers settle into an annual cycle. CareFirst: “Authorization of 12 months may be granted for all members… who meet all initial authorization criteria and achieve or maintain positive clinical response.” UnitedHealthcare: “Reauthorization will be for no more than 12 months.” BCBS Michigan ties renewal to documented benefit rather than a fixed calendar: “Clinical documentation must be provided to confirm that current criteria are met and that the medication is providing clinical benefit.”
Kaiser is the strictest: “Must be administered in a non-hospital setting.” Florida Blue adds paperwork rather than a ban: “If intravenous vedolizumab (Entyvio) is administered in a hospital-affiliated outpatient setting, additional requirements may apply depending on the member’s benefit.” CareFirst allows the hospital setting only at the start: “To determine tolerance of the therapy, the first two infusions may be permitted in the hospital outpatient setting.” BCBS Michigan points toward the subcutaneous pen instead of a facility at all: “The member will self-administer Entyvio unless clinically unable to do so.” Premera, Aetna, Arkansas BCBS, Horizon, UnitedHealthcare and several others route the review through a separate site-of-service policy rather than writing the rule into the drug policy itself.
23 rules in this corpus prohibit Entyvio alongside a second biologic or a Janus kinase inhibitor. The rule is about concurrent use, not sequence: a patient can fail a TNF inhibitor and move to Entyvio, but cannot run both, or Entyvio and a JAK inhibitor such as tofacitinib or upadacitinib, at the same time.
Vedolizumab is a gut-selective integrin antagonist, and most payers in this corpus want a TNF inhibitor tried before it, billed under its own J-code, alongside two interleukin-inhibitor alternatives.
| Product | Code | Maker | Role in this corpus |
|---|---|---|---|
| Entyvio (IV) | J3380 | Takeda | This page |
| Remicade | J1745 | Janssen | Reference TNF inhibitor; several payers name its biosimilars (Avsola, Inflectra, Renflexis) as the required first step |
| Stelara (IV induction) | J3358 | Janssen | Alternative interleukin-inhibitor pathway |
| Skyrizi (IV induction) | J2327 | AbbVie | Alternative interleukin-inhibitor pathway |
| Simponi Aria | J1602 | Janssen | TNF inhibitor alternative |
CareCost reads 30 payer policies for vedolizumab. 24 of them require a documented trial of conventional therapy and, at most, a biologic before Entyvio is approved — almost always a TNF inhibitor. Blue Shield of California is the most specific: “Inadequate response or intolerable side effect with BSC-preferred agent [infliximab (Avsola or Inflectra)] or contraindication to preferred agent.” Kaiser requires “at least one preferred TNF-inhibitor (infliximab-dyyb…)” (such as Inflectra) for ulcerative colitis, and for Crohn’s disease, “contraindication, or intolerance, to at least two TNF-” inhibitors. BCBS Arkansas takes the opposite route for Crohn’s disease: prior receipt of “a biologic (e.g., adalimumab, infliximab, certolizumab pegol, risankizumab, ustekinumab, natalizumab, vedolizumab) or Janus Kinase Inhibitor” can itself satisfy the step, which is why Stelara and Skyrizi appear in the same table — a prior trial of either one can clear the same requirement as a TNF inhibitor.
Every payer in this corpus that covers Entyvio still requires the covered-indication documentation below regardless of which step-therapy path applies; the prior-product requirement is layered on top of that prerequisite, not a replacement for it.
Ulcerative colitis and Crohn’s disease are billed under separate ICD-10 families in Entyvio’s manifest, and all 30 payers in this corpus cover both. Each carries its own clearance key — ulcerative_colitis and crohns_disease — and a payer’s step-therapy language can differ between the two: Capital BlueCross, for instance, names adalimumab and certolizumab as the TNF step for Crohn’s disease, and adalimumab or golimumab for ulcerative colitis.
| Indication | ICD-10 | Notes |
|---|---|---|
| Ulcerative colitis, moderately to severely active | K51.90 | Billable code; dxKey ulcerative_colitis, 30 of 30 payers |
| Crohn’s disease, moderately to severely active | K50.90 | Billable code; dxKey crohns_disease, 30 of 30 payers |
CareCost’s diagnosis picker above offers both. Verified against the NLM Clinical Table Search Service on 2026-09-21.
Medicare Part B covers Entyvio as a physician-administered biologic under standard medical-necessity review: no coverage-with-evidence-development framework and no patient registry attaches to vedolizumab. This is the Original Medicare answer. Medicare Advantage plans deliver that same Part B benefit but are free to impose utilization-management steps of their own, such as a separate prior-authorization request or a site-of-care restriction. Confirm the specific plan’s rules directly, rather than presuming Original Medicare’s terms carry over.
Entyvio is a 30-minute infusion billed with 96365 (therapeutic infusion, initial hour) alone, non-facility PFS $67.14; 96366 (each additional hour) does not apply at this infusion length, and 96413 (chemotherapy administration) is the wrong code family for an integrin receptor antagonist. The J3380 MUE is 300 units per day, matching the single 300 mg vial: no waste, no JW modifier, on a standard claim.
Payer citation language above is drawn from CareCost’s own vedolizumab policy corpus (30 payers, 458 rules). Check the specific payer’s language →
It depends on the payer and plan. 28 of the 30 vedolizumab policies CareCost has read require prior authorization before Entyvio is covered. The other 2 do not carry a formal prior-authorization label but still apply the same clinical documentation review. Check this patient’s payer →
Almost always conventional therapy first: 5-ASA products, corticosteroids or a thiopurine, documented as ineffective, not tolerated or contraindicated. 24 of 30 payers then require a biologic as well, usually a TNF inhibitor such as infliximab, adalimumab or golimumab, and Blue Shield of California names its preferred infliximab biosimilars, Avsola or Inflectra, specifically. BCBS Mississippi is the exception: it places vedolizumab in a table with no step therapy requirement. Check this patient’s payer →
It varies by payer. BCBS HCSC and Capital BlueCross open with a 14-week authorization, matching the label’s week-14 checkpoint for evidence of benefit, then renew for 12 months at a time. CareFirst grants 12 months once initial criteria are met, and UnitedHealthcare caps reauthorization at no more than 12 months. Check this patient’s payer →
Yes, under Part B when the diagnosis and dosing match the FDA label; vedolizumab carries no national registry or evidence-development requirement. A Medicare Advantage plan is still bound by that Part B benefit design, but it can attach its own prior-authorization request or site restriction. See the Medicare detail →
Yes, at 17 of 30 payers. Kaiser requires a non-hospital setting outright. CareFirst permits only the first two infusions in a hospital outpatient setting before steering elsewhere. BCBS Michigan expects the member to self-administer Entyvio, using the subcutaneous pen, unless clinically unable to do so. Check this patient’s payer →
Data current: payer policies Aug 2026 · reviewed dates come from each payer
Payer medical and pharmacy policies · prior-authorization criteria · clinical coverage criteria. ICD-10 codes verified against the NLM Clinical Table Search Service. Medicare coverage and fee-schedule amounts from the CMS Medicare Coverage Database and the Medicare Physician Fee Schedule. Every CareCost requirement links back to its source policy.