Entyvio (vedolizumab) — HCPCS J3380

Entyvio IV vs. Entyvio Pen (SC) — J3380 vs. J3590 FDA verified May 2026

Same molecule, two formulations — only the IV uses J3380. SC bills under unclassified biologic on medical benefit, and is usually routed to pharmacy benefit.

Vedolizumab launched in May 2014 as an IV-only product (300 mg lyophilized vial, q8wk maintenance after induction). In September 2023, FDA approved a subcutaneous maintenance formulation for UC, followed by Crohn's disease in April 2024. The molecule is identical; the dose, route, and billing pathway differ. Most payers route the SC formulation to the pharmacy benefit (specialty pharmacy fill, self-injected at home), but it can appear on the medical benefit under J3590 when administered in office or when the patient's plan does not have a specialty pharmacy carve-out.

Dosing & unit math FDA label current

From the FDA prescribing information (BLA 125476).

IV induction + maintenance — UC and Crohn's (identical schedule)

"300 mg infused intravenously at Weeks 0, 2 and 6, and then every 8 weeks thereafter."

• Induction: 300 mg IV at Week 0, Week 2, Week 6 (3 induction doses)
• Maintenance: 300 mg IV every 8 weeks beginning Week 14
• Per dose: 1 vial (300 mg lyophilized) reconstituted to 60 mg/mL, diluted in 250 mL 0.9% NaCl or LR
• Infusion duration: approximately 30 minutes
• 1 mg = 1 unit: bill 300 units of J3380 per IV dose
• Dose intensification: some payers permit q4wk maintenance for loss of response (typically requires PA)
• Discontinuation: if no benefit by Week 14, consider stopping

SC maintenance — UC and Crohn's (identical schedule)

• After at least 2 IV induction doses, patients may transition to 108 mg SC every 2 weeks
• The first SC dose is given in place of the next scheduled IV maintenance dose
• Self-administered via Entyvio Pen or prefilled syringe (108 mg / 0.68 mL)
• No requirement for in-office observation after the first SC dose if tolerated

Worked example — first-year IV billing (UC or Crohn's)

Pre-infusion checks (no REMS — standard W&P only)

• TB screening prior to initiation (latent TB risk on integrin inhibitors)
• Hepatitis B status
• Up-to-date immunizations (live vaccines should be given before initiation when feasible)
• Assess for active or chronic infection
• Baseline LFTs; monitor for liver injury during therapy
• Document UC or Crohn's diagnosis activity (Mayo, CDAI, or equivalent)

NDC reference FDA NDC Directory verified May 2026

SC Entyvio Pen billing — J3590 + NDC Payer-specific — verify channel

The subcutaneous formulation has no permanent J-code. On the medical benefit it is billed as unclassified biologic.

Vedolizumab subcutaneous (Entyvio Pen 108 mg/0.68 mL prefilled autoinjector and prefilled syringe) was approved for UC maintenance on September 27, 2023 and for Crohn's maintenance on April 18, 2024. As of May 2026, CMS has not assigned a permanent J-code specifically for the SC formulation. When billed under the medical benefit, the SC pen and PFS fall under J3590 ("Unclassified biologics") and require manual pricing tied to the NDC.

How payers actually handle SC vedolizumab

• Pharmacy benefit (most common): the SC pen is dispensed by a specialty pharmacy and self-injected by the patient at home. The medical claim path is bypassed entirely. PA is run by the PBM, not the medical-side UM vendor.
• Medical benefit (less common): dose administered in office or at infusion center; bill J3590 with NDC 64764-108-21 (pen) or 64764-107-11 (PFS), document the milligram amount in the line description, and attach the invoice for manual pricing if the payer requests it.
• Hybrid: some plans run the IV under medical benefit and the SC under pharmacy benefit with a single combined PA across both phases.

Documented payer position changes

• BCBS Michigan, March 2024: removed prior authorization on subcutaneous vedolizumab under the medical benefit, in favor of standard pharmacy-benefit dispensing flow. This is a directional indicator for other regional Blues.
• UnitedHealthcare and Aetna: SC vedolizumab is treated as the maintenance formulation of record under their site-of-care optimization programs — conversion from IV maintenance to SC is generally encouraged once the patient is on stable maintenance dosing.

SC admin code (when billed in office)

For the rare case where a clinician administers the SC dose in office, use CPT 96372 (therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular). Patient-self-injection at home generates no admin code.

Administration codes CPT verified May 2026

Vedolizumab is non-chemotherapeutic — use therapeutic infusion codes, not chemo.

Modifiers CMS verified May 2026 — verify JZ list

JZ — whole-vial use, default expectation

Effective July 1, 2023, CMS requires JZ on all claims for single-dose container drugs when no drug is discarded — but only for codes on the CMS single-dose container list. Entyvio's 300 mg IV dose uses one full single-dose vial after reconstitution with no discard, so JZ is the expected modifier when J3380 appears on that list. Verify against the current CMS single-dose container list at billing time; the list is updated periodically.

JW — rarely applies

The 300 mg dose uses one full vial; no drug is discarded in routine use. JW applies only when documented wastage occurs (very rare for vedolizumab, since the single-vial dose is exact at 300 mg).

Modifier 25 — situational

Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion. Routine pre-infusion assessment is bundled into the admin code.

340B modifiers (JG, TB)

For 340B-acquired Entyvio, follow your MAC's current 340B modifier policy. Some MACs require JG on covered entity claims; others use TB.

ICD-10-CM diagnosis codes FY2026 verified May 2026

Entyvio's full diagnosis space — UC family AND Crohn's family. Same codes as Humira / Remicade for the IBD indications.

Ulcerative colitis (K51)

Crohn's disease (K50)

Site of care & place of service Verified May 2026

Entyvio IV's ~30-minute infusion time fits ambulatory infusion settings cleanly and is a high-priority site-of-care optimization target for major payers. UHC, Anthem/Carelon, and BCBS regional plans actively steer Entyvio away from hospital outpatient toward physician offices, ambulatory infusion centers, and home infusion. Conversion from IV maintenance to SC pen (pharmacy benefit, self-injected) is the strongest site-of-care intervention available.

Claim form field mapping Verified May 2026

CMS-1500 / 837P (physician office, AIC; POS 11/49). IV claim shown.

Form references: NUCC (CMS-1500).

Payer policy snapshot Reviewed May 2026

Universal prior authorization. TNF inhibitor step therapy is the dominant pattern. SC pen routes through pharmacy benefit at most plans.

What to document for approval

• Confirmed UC or Crohn's diagnosis with disease-activity scoring (Mayo for UC; CDAI or HBI for Crohn's)
• Documented inadequate response or intolerance to at least one TNF inhibitor (or contraindication, where the policy allows)
• Documentation that conventional therapies (corticosteroids, immunomodulators) have been tried where appropriate
• TB screening (latent TB ruled out) prior to initiation
• Hepatitis B serology
• For dose intensification (q4wk): documented loss of response on q8wk dosing

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.

Coverage

No NCD specific to vedolizumab. Coverage falls under the generic drug-coverage LCD framework (e.g., LCD L33394 and MAC-equivalents). All MACs cover J3380 for FDA-approved on-label IBD indications. Bill with K51.x for UC or K50.x for Crohn's.

SC formulation under Medicare

For Medicare patients on the SC Entyvio Pen, billing depends on benefit channel. Under Part B (medical benefit), use J3590 with the SC NDC — pricing is manual. Under Part D (pharmacy benefit through specialty pharmacy), the dispensing pharmacy bills the Part D plan directly. Most Medicare patients on the SC formulation will be in the Part D pathway.

Code history

• 2014 — FDA approval (May); initially billed under unclassified codes (J3490 / J3590 / C9399)
• J3380 — permanent code, "Injection, vedolizumab, 1 mg" (1 mg = 1 unit), effective shortly after launch
• 2023 — SC pen approved for UC maintenance (Sept 27); no dedicated J-code assigned for SC
• 2024 — SC pen approved for Crohn's maintenance (April 18)

Patient assistance — EntyvioConnect Takeda verified May 2026

• EntyvioConnect: 1-800-352-2236 (M–F) · Fax: 844-595-6272
• Entyvio Co-Pay Program: as little as $5/dose, up to $20,000/year for eligible commercially-insured patients (excludes Medicare, Medicaid, federal program patients)
• Patient Assistance Program (PAP): free product for eligible uninsured / underinsured patients meeting income criteria
• Bridge / Quick Start program: for coverage gaps and PA delays
• Foundation grants (when copay programs unavailable, e.g., Medicare):
  • PAN Foundation — Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel Disease funds
  • HealthWell Foundation — Inflammatory Bowel Disease (Medicare Access), Autoimmune (Medicare Access) funds
• Web: entyvio.com · entyviohcp.com · entyvioconnect.com

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Entyvio?

Entyvio (vedolizumab) is billed under HCPCS J3380 — "Injection, vedolizumab, 1 mg." Each milligram equals one billable unit, so the standard 300 mg IV dose is billed as 300 units. Note: the subcutaneous Entyvio Pen does NOT use J3380 — when administered under the medical benefit, the SC formulation bills under J3590 (unclassified biologic). In practice, the SC pen is most often dispensed through specialty pharmacy under the pharmacy benefit.

How is Entyvio dosed?

IV induction: 300 mg IV at Week 0, Week 2, and Week 6 (both UC and Crohn's). IV maintenance: 300 mg IV every 8 weeks starting at Week 14. Some payers permit dose-intensification to every 4 weeks for loss of response, typically requiring prior authorization. SC maintenance (after at least 2 IV induction doses): 108 mg subcutaneous every 2 weeks; the first SC dose replaces the next scheduled IV maintenance dose.

Does the JZ or JW modifier apply to Entyvio?

JZ applies when no drug is wasted — the 300 mg IV dose uses one full single-dose vial after reconstitution, so there is typically no discard. JW rarely applies for the standard 300 mg dose. As with all single-dose container drugs, verify J3380's inclusion on the current CMS single-dose container list at billing time.

What is the administration code for Entyvio?

CPT 96365 — "Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour." Vedolizumab is non-chemotherapeutic, so 96413 (chemo administration) is NOT appropriate. The label specifies a ~30-minute infusion, so 96366 (each additional hour) is typically not billed. Some legacy billing systems incorrectly map J3380 to 96413/96415 — that is a coding error.

Does Entyvio have a boxed warning?

No. Entyvio (vedolizumab) does NOT carry a boxed warning. This is a key clinical and payer-positioning differentiator versus Tysabri (natalizumab), which carries a PML boxed warning. Vedolizumab is gut-selective — it binds only the α4β7 integrin (which mediates lymphocyte trafficking to the gut), unlike natalizumab which also binds α4β1 (which mediates CNS trafficking, the mechanism behind PML risk). Standard warnings/precautions still apply: infusion and hypersensitivity reactions including anaphylaxis, increased risk of infections (TB screening required), and liver injury.

Is Entyvio approved for both UC and Crohn's disease?

Yes. Entyvio is FDA-approved for adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). The IV dosing schedule is identical for both indications. The SC maintenance pen is approved for both UC (approved September 27, 2023) and Crohn's (approved April 18, 2024).

Do payers require step therapy through a TNF inhibitor before Entyvio?

Most commercial plans require documented failure or intolerance of at least one TNF inhibitor (Humira/adalimumab, Remicade/infliximab, or biosimilar) before approving Entyvio. Some plans now allow vedolizumab as a first-line biologic for UC given its safety profile (no boxed warning), but step-through TNFi remains the default. Reauthorization is typically every 6–12 months with documented clinical response.

What is the Medicare reimbursement for J3380?

For Q2 2026, the Medicare Part B payment limit for J3380 is approximately $20.98 per mg (ASP + 6%). The standard 300 mg dose reimburses at approximately $6,294.00 before sequestration. ASP is updated quarterly by CMS.

How is the SC Entyvio Pen billed?

The Entyvio Pen (108 mg/0.68 mL) and prefilled syringe formulation do not have a dedicated permanent J-code as of May 2026. When billed under the medical benefit, they fall under J3590 (unclassified biologic) and must be priced manually with the NDC submitted on the claim. In practice, most payers route the SC formulation to the pharmacy benefit (specialty pharmacy fill, self-injected at home) rather than buy-and-bill. BCBS Michigan, for example, removed PA on SC vedolizumab under the medical benefit in March 2024 in favor of pharmacy-benefit dispensing.

Source documents

1. DailyMed — ENTYVIO (vedolizumab) Prescribing Information
   FDA-approved label (BLA 125476)
2. Takeda — Entyvio HCP portal
   Manufacturer-hosted prescribing information, dosing, administration resources
3. EntyvioConnect (Takeda)
   Patient support, copay assistance, PAP — 1-800-352-2236
4. FDA — ENTYVIO label (BLA 125476, original approval 2014)
   Initial FDA approval May 20, 2014
5. FDA — SC Entyvio approval (UC maintenance, Sept 27, 2023; Crohn's maintenance, April 18, 2024)
   Subcutaneous formulation regulatory milestones
6. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026
7. CMS — HCPCS quarterly update file (canonical J-code source)
8. AAPC — HCPCS J3380
9. Aetna Clinical Policy Bulletin — Vedolizumab
10. UnitedHealthcare — Vedolizumab (Entyvio) medical/pharmacy policy
11. FDA National Drug Code Directory
    NDC verification: 64764-300-20 (IV), 64764-108-21 (Pen), 64764-107-11 (PFS)
12. PAN Foundation — Crohn's, UC, IBD funds
13. HealthWell Foundation — IBD Medicare Access, Autoimmune Medicare Access

About this page

We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

Reviewer

Change log

• May 2, 2026 — Initial publication. ASP data: Q2 2026 (J3380 = $20.98/mg). Payer policies: UHC, Aetna CPB, Carelon, BCBS regional (incl. BCBSM March 2024 SC PA removal), Cigna. Documents IV (J3380) vs SC (J3590 / pharmacy benefit) split. Notes legacy admin-code mapping bug (96413/96415) — correct codes are 96365/96366.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. We do not paraphrase from billing-software vendor blogs. When CMS guidance is ambiguous (as with the SC formulation J-code status or single-dose container list interpretations), we surface the ambiguity rather than asserting a definitive answer.