Entyvio (vedolizumab) — J3380

Entyvio and the IBD biologic class

Entyvio (vedolizumab) bills under J3380, 1 mg per billing unit, from Takeda. It is a gut-selective integrin receptor antagonist for moderately to severely active ulcerative colitis and Crohn's disease. No vedolizumab biosimilar exists.

Payers frequently require a different product first: 24 of the 30 commercial payers in the Clearance corpus require another product before they authorize Entyvio, usually a trial of conventional therapy followed by a TNF inhibitor such as infliximab, adalimumab or golimumab, or the plan's preferred infliximab biosimilar (see Coverage & access).

Vials and NDCs

One vial size covers every infusion. Every dose, induction or maintenance, draws exactly one 300 mg vial, so the billing-units calculator always returns 300 units with nothing discarded.

This reference does not recommend one IBD biologic over another. The payer's own step-therapy rule, not a clinical preference, decides which product a given patient can start on.

Entyvio dosing

Vedolizumab uses the same 300 mg dose for both indications: induction infusions at weeks 0, 2 and 6, then one every 8 weeks. Every infusion draws exactly one 300 mg vial, so JZ applies on every infusion and JW never does.

After the two IV doses at weeks 0 and 2, or any time after week 6 while on IV maintenance, a patient may switch to the subcutaneous 108 mg pen or prefilled syringe every 2 weeks, dosed under the pharmacy benefit; the first subcutaneous dose replaces the next scheduled infusion. The pen carries no HCPCS code, so a patient who switches leaves this chapter's buy-and-bill claims entirely (see Cost & financial access).

Infusion reactions and hypersensitivity

Entyvio carries no boxed warning. Infusion-related and hypersensitivity reactions are the safety signal the label calls out; its language, in full:

Pre-treatment documentation

• Consider evaluating for tuberculosis infection before the first dose; update immunizations according to current guidelines.
• No pre-medication is required by the label.
• Confirm the payer's step-therapy requirement, conventional therapy then often a TNF inhibitor or the plan's preferred infliximab biosimilar, before scheduling the first infusion (see Coverage & access).
• Document the week-14 response; most payers use it as the first reauthorization checkpoint.

Need the units for a patient's dose? Convert dose to J3380 billing units →

Entyvio billing reference

HCPCS

J3380 bills 1 mg per unit. A 300 mg infusion — the same dose at every visit, induction or maintenance — is 300 units.

NDC

One package size, one code. See the vial table in Drug & products above. The 11-digit claim-form NDC is 64764-0300-20, and it does not change across the regimen, since every infusion draws exactly one 300 mg vial.

Administration

Administration is a single code, not a choice: Entyvio is a 30-minute therapeutic infusion, billed with 96365 alone. CPT 96365–96366 carries the complete code definitions.

Modifiers

JZ: required when no drug is discarded. JW: required for documented waste.

Every Entyvio infusion draws exactly one 300 mg vial, with nothing left over, so JZ applies on every infusion and JW never does. The billing-units calculator walks through that same vial math dose by dose.

Full unit, vial and modifier math for any dose: calculate Entyvio billing units →

Claim form

CMS-1500 / 837P field map for a separately payable J3380 line.

Entyvio coverage

The Clearance corpus carries 30 payers and 458 rules for vedolizumab — the richest coverage corpus of any drug not yet clustered in this reference. Both indications are covered widely: a Crohn's disease and an ulcerative colitis rule set exist at all 30 payers.

• 28 of 30 commercial payer policy sets require prior authorization; 2 do not say clearly, so confirm those on the call
• 24 of 30 payers require another product first, usually a trial of conventional therapy followed by a TNF inhibitor or the plan's preferred infliximab biosimilar.
• 17 rules set site-of-care requirements, including Kaiser's non-hospital-setting rule and BCBS Michigan's default to self-administration.
• 24 rules set a reauthorization period, most commonly 12 months, and several check response as early as week 14.
• 23 rules prohibit combining Entyvio with another biologic or a JAK inhibitor.

Prior authorization, step therapy and reauthorization

Most payers require conventional therapy first: Anthem's ulcerative-colitis criteria require “an inadequate response to or is intolerant of conventional therapy (such as 5-Aminosalicylic acid products, systemic corticosteroids, or immunosuppressants [such as thiopurines])”, and BCBS Minnesota requires “a minimum 3-month* trial of conventional therapy” before either indication. Several payers then require a TNF inhibitor specifically: Capital Blue requires “a minimum 3-month trial of a TNF modifier such as adalimumab, certolizumab” for Crohn's disease, and CareFirst's ulcerative-colitis criteria require both “At least ONE conventional therapy option” and “At least ONE TNF-alpha inhibitor indicated for UC”.

Some payers name a preferred product directly: Blue Shield of California requires “Inadequate response or intolerable side effect with BSC-preferred agent [infliximab (Avsola or Inflectra)] or contraindication to preferred agent.” Centene's Crohn's disease criteria are similar in shape: a member must fail a 3-month trial of the infliximab biosimilars Inflectra or Renflexis, or have a history of failure of two TNF blockers, before Entyvio is authorized. Not every payer requires a step: BCBS Mississippi places IV vedolizumab in “Table 2: Medical Covered Agents (no step therapy requirement).”

Reauthorization runs on a documented-response clock more than a fixed calendar. BCBS Health Care Service Corporation sets the first review at “14 weeks,” and Capital Blue matches it: “Initial coverage will be provided for 14 weeks and may be renewed annually thereafter…” Most other payers set a first authorization of 12 months and renew on evidence of continued benefit; CareFirst requires members to “achieve or maintain positive clinical response,” and UnitedHealthcare states: “Reauthorization will be for no more than 12 months.”

ICD-10-CM by indication

Two codes, one per diagnosis, both covered at all 30 payers in the corpus.

Site of care and quantity limits

Kaiser's rule is the strictest of the seventeen: the drug must “be administered in a non-hospital setting,” while BCBS Michigan's rule points toward the pharmacy benefit instead: “The member will self-administer Entyvio unless clinically unable to do so” — a reference to the subcutaneous pen, not the IV infusion. CareFirst permits “the first two infusions… in the hospital outpatient setting” to establish tolerance before a stricter site applies, and BCBS Florida adds requirements when the infusion happens in a “hospital-affiliated outpatient setting.”

Twelve rules set a quantity limit, and most restate the label's own 300 mg dose rather than a stricter cap; several separately allow an every-4-week escalation the label itself does not define. BCBS Florida writes both: “The dosage does not exceed 300 mg IV every 8 weeks (if for CD or UC)”, and a separate rule permitting every 4 weeks. Regence caps a starting course at: “Up to 6 doses (six 300 mg infusions) in a 6-month period.”

Check the patient’s actual policy: See Entyvio coverage by payer →

Entyvio cost & financial access

Medicare ASP+6%: $20.949 / 1 mg · $6,284.70 / 300 mg. Administration (96365) allows $67.14 more, so the induction or maintenance claim allows $6,351.84 total; at 20% coinsurance with the Part B deductible met, the patient owes $1,270.37 ($1,256.94 drug plus $13.43 infusion).

7 doses a year (300 mg IV every 8 weeks after the week 0, 2 and 6 induction infusions (a maintenance year is about 6.5 infusions; the first year is 8)) at $6,351.84 per infusion — drug plus 96365 administration — total $44,462.88 before the sequester. That is the full annual drug-plus-administration cost for a patient staying on schedule, before benefits or assistance.

Every infusion, induction or maintenance, bills the same 300 mg claim: $6,351.84 allowed, drug plus 96365. The difference between the first year and a maintenance year is frequency, not dose: the first year adds the three induction infusions at weeks 0, 2 and 6 before the every-8-week schedule takes over, so it runs more infusions than a maintenance year of about 6.5.

Commercial plans pay a contracted rate that varies by payer and state; 37 of 37 payer price files in this site's data carry a J3380 rate. Aetna's all-states commercial median is $21.72 per unit, close to the $20.949 ASP-based Medicare rate. At 300 units, that prices the drug portion of the infusion at $6,516.00, against Medicare's $6,284.70 for the drug alone.

Patient cost

Patient responsibility = payer allowed rate − benefits adjustment − assistance. Every Entyvio infusion bills the same $6,284.70 drug line, so the estimate does not depend on which visit in the regimen the encounter is — only on the patient's plan, remaining deductible and assistance.

Calculate an Entyvio patient estimate →

Copay & financial assistance

EntyvioConnect Co-Pay Program covers a commercially insured patient's drug cost at $0 per dose, up to $20,000 a year; it does not cover the infusion administration, and it excludes Medicare, Medicaid, TRICARE, VA and other government plans. It is available for both the IV infusion and the subcutaneous pen.

No manufacturer free-drug program is on file. The IBD foundation funds in the bundle are HealthWell Inflammatory Bowel Disease ($2,100/year), TotalAssist Inflammatory Bowel Disease ($10,400/year), TotalAssist Ulcerative Colitis ($3,000/year) and HealthWell AutoImmune Medicare Access ($2,800/year); check each fund's current status on the funds list. The one open fund that matches J3380 in the bundle, HealthWell ANCA-Associated Vasculitis, covers a different disease and does not apply to a Crohn's or ulcerative colitis diagnosis.

See current Entyvio assistance programs →

Common Entyvio errors & fixes