Quick Answer: Entyvio's 2026 cash price runs about $8,700 to $10,500 per 300 mg IV infusion, close to Takeda's wholesale acquisition cost of roughly $8,700 per vial; a full year of maintenance dosing (about 6.5 infusions after induction) totals near $40,900 in ASP-based value, and the first year with three induction doses runs closer to $56,600. Medicare pays providers about $19.79 per mg under the 2026 Average Sales Price schedule for HCPCS code J3380, so beneficiaries typically owe a 20% coinsurance of roughly $1,187 to $1,259 per infusion after the $283 2026 Part B deductible. The self-injectable Entyvio Pen, used for maintenance after IV induction, runs about $3,500 to $3,700 per 108 mg dose and is generally billed through the Part D or medical pharmacy benefit rather than as a Part B infusion claim. Takeda's EntyvioConnect copay card can lower commercially insured patients' cost to $0 per dose (up to $20,000 per year), and the separate Help At Hand Patient Assistance Program supplies Entyvio free to uninsured or underinsured patients earning up to 500% of the federal poverty level. Entyvio was not part of the first two Inflation Reduction Act negotiation rounds, but CMS selected it in January 2026 for round three, with a negotiated Maximum Fair Price effective January 1, 2028.
Entyvio is Takeda Pharmaceuticals' brand name for vedolizumab, an integrin receptor antagonist that blocks the alpha4beta7 integrin on white blood cells so they cannot migrate into inflamed gut tissue. The FDA first approved Entyvio in May 2014 as an intravenous infusion for adults with moderately to severely active ulcerative colitis or Crohn's disease who have not responded well to conventional therapy. Takeda supplies standard Entyvio as a 300 mg single-dose vial reconstituted and infused over about 30 minutes, dosed at weeks 0, 2, and 6 for induction, then every 8 weeks for maintenance. In 2023, the FDA also approved the Entyvio Pen, a 108 mg subcutaneous self-injector used only for maintenance dosing after IV induction, never for the initial three infusions. Because standard Entyvio requires administration by a healthcare professional, it bills under Medicare Part B and commercial medical benefits using HCPCS code J3380, while the self-injected Entyvio Pen typically flows through a specialty pharmacy and the Part D or medical pharmacy benefit instead.
Takeda's 2026 wholesale acquisition cost for a 300 mg Entyvio vial is approximately $8,700, and cash-paying patients without insurance should expect a similar range of $8,700 to $10,500 depending on the dispensing specialty pharmacy or infusion site. Annualized maintenance treatment (about 6.5 infusions per year on the every-8-week schedule) totals close to $40,900 in ASP-based drug value, while the first year of therapy, which adds three induction doses on top of maintenance, runs closer to $56,600. Where treatment happens changes the total significantly: hospital outpatient departments commonly add a separate facility fee that pushes a single infusion to $14,000 or more, while physician offices and freestanding infusion centers generally charge less for the identical dose because they carry lower overhead. Patients managing ulcerative colitis or Crohn's disease over years should also budget for periodic lab monitoring and infusion-center visit fees layered on top of the drug charge itself.
CMS opened Medicare drug price negotiation to Part B drugs for the first time in its third negotiation cycle, announced January 27, 2026, and Entyvio was one of four primarily Part B drugs selected alongside Botox, Cimzia, and Orencia. Takeda had until February 28, 2026 to sign the negotiation agreement, and CMS is scheduled to publish the actual negotiated Maximum Fair Price by November 30, 2026, with that price taking effect January 1, 2028. Patients should not expect a lower IRA-negotiated price for Entyvio before 2028, so the manufacturer copay card, Patient Assistance Program, and standard Part B coinsurance rules described below remain the primary cost-management tools through 2026 and 2027. Patients comparing biologic options for inflammatory bowel disease should also review Humira cost and Stelara pricing, since anti-TNF and IL-12/23 biologics are common alternatives when Entyvio is denied or not tolerated. Uninsured patients evaluating any of these options should check the federal poverty level guidelines that manufacturer assistance programs use to set income eligibility.
What Entyvio Costs by Point of Pay (2026)
The price you pay depends almost entirely on WHERE you pay. The same entyvio can cost many times more at a hospital than at your local pharmacy:
2026 Entyvio Price by Point of Pay| Where you pay | Typical cost | Notes |
|---|
| Medicare Part B ASP rate (2026) | $5,937 ASP value; Medicare pays providers ~$6,294 (ASP + 6%); patient owes ~$1,187 - $1,259 (20% coinsurance) | Applies after the $283 2026 Part B deductible; Medigap or Medicare Advantage OOP maximums can eliminate the coinsurance |
| Cash/list price (no insurance) | $8,700 - $10,500/infusion (300 mg IV vial) | Wholesale acquisition cost is about $8,700; specialty pharmacy dispensing fees and site-of-care markups vary |
| Commercial insurance (after prior authorization) | $0 - $500+/infusion until annual out-of-pocket max is met | Prior authorization documenting failure of conventional therapy (5-ASA, corticosteroids, immunomodulators, or anti-TNF) is standard; some plans place Entyvio on a specialty formulary tier under the medical benefit rather than a pharmacy formulary tier |
| Takeda EntyvioConnect copay card | $0/dose, up to $20,000/year (commercial insurance only) | Ineligible if you have Medicare, Medicaid, TRICARE, VA, or no insurance |
| Medicaid | $0 - $4/infusion, with PA | Most states waive or minimize cost-sharing for biologic IBD infusions; step-therapy rules vary by state Medicaid program |
Costs reflect the 2026 CMS ASP Pricing Files, Takeda's published wholesale acquisition cost, and specialty pharmacy survey data. Your actual bill depends on your specific plan design, site of care, and whether prior authorization was approved before the infusion.
Source: CMS Medicare Part B ASP Pricing Files (2026), Takeda published wholesale acquisition cost, specialty pharmacy pricing data
Why Hospitals Charge So Much
Hospital outpatient departments charge more for Entyvio infusions than physician offices or freestanding infusion centers because they add a separate facility fee on top of the drug charge, covering nursing time, monitoring, and campus overhead. A single 300 mg Entyvio infusion that costs roughly $8,700 to $10,500 in cash/list terms can appear on a hospital itemized bill at $14,000 to $26,000 or more once facility fees, pharmacy handling, and observation charges are layered on. Medicare pays a uniform national rate (ASP plus 6%) regardless of where the infusion happens, but commercial insurers negotiate separately with each hospital system, and those negotiated rates are rarely disclosed to patients before treatment begins.
Takeda supplies standard Entyvio in a single 300 mg vial, and hospitals bill HCPCS code J3380 in 1 mg units, meaning a 300 mg dose should appear on the claim as 300 units, not as a single line item or a flat vial count. Comparing your itemized bill's billed units against your prescribed milligram dose is one of the fastest ways to catch an overcharge. A bill showing more than 300 units for a standard induction or maintenance dose, or an unexplained second drug line for the same infusion date, is worth disputing with the billing department before payment. Patients using the self-injected Entyvio Pen should also confirm the claim was routed through their pharmacy or medical benefit correctly, since Pen doses filled at a specialty pharmacy do not use the J3380 infusion code at all.
HCPCS J-Codes: What Appears on Your Bill
Standard IV Entyvio is billed under a single HCPCS Level II code, J3380, regardless of whether the dose is for induction or maintenance. The self-injected Entyvio Pen has no separate HCPCS code because it is typically dispensed through a specialty pharmacy under the Part D or medical pharmacy benefit rather than administered and billed by a provider.
HCPCS J-codes for Entyvio| Code | Description | What to look for |
|---|
| J3380 | Injection, vedolizumab, intravenous, 1 mg | Confirm billed units equal your prescribed dose (300 units for a standard 300 mg dose); a flat unit count of 1 or a vial count instead of milligrams is a common billing error worth disputing. |
HCPCS Level II J-codes are public-domain identifiers maintained by CMS for Medicare Part B drug billing.
Source: CMS HCPCS Level II code set, 2026
Patient Assistance Programs
Takeda, the manufacturer of Entyvio, runs two distinct programs, and which one applies depends entirely on your insurance status. Commercially insured patients use the EntyvioConnect copay card; uninsured and underinsured patients apply to the separate Takeda Help At Hand Patient Assistance Program, which can supply Entyvio free of charge to income-eligible applicants. EntyvioConnect case managers can also help commercially insured patients navigate prior authorization and appeals at no cost.
Patient assistance programs for Entyvio| Manufacturer program | Cost / Benefit | How to apply |
|---|
| EntyvioConnect Co-Pay Program | $0 per dose for commercially-insured patients, up to a $20,000 annual maximum benefit; covers both Entyvio IV and the Entyvio Pen | entyvio.com/copay-support |
| Takeda Help At Hand Patient Assistance Program | Free Entyvio for uninsured or underinsured patients with household income up to approximately 500% of the federal poverty level ($79,800 for an individual in 2026) | helpathandpap.com |
| NeedyMeds Drug Discount Card | Variable discount accepted at participating pharmacies; primarily useful for the self-injected Entyvio Pen, not the provider-administered infusion | needymeds.org |
Federal anti-kickback law (42 U.S.C. Section 1320a-7b) bars manufacturer coupons and copay cards, including the EntyvioConnect card, from being used by anyone on Medicare, Medicaid, TRICARE, or VA benefits. If you have government insurance, apply to the Takeda Help At Hand Patient Assistance Program instead, or ask about a state Medicare Savings Program.
Source: Takeda EntyvioConnect, Takeda Help At Hand Patient Assistance Program, NeedyMeds.org
Medicare Part D
Standard Entyvio infusions fall under Medicare Part B, not Part D, because a healthcare professional must administer the drug in a clinic, physician office, or hospital outpatient department. The self-injected Entyvio Pen is different: when a specialty pharmacy dispenses it for a patient to inject at home, most Medicare Advantage and Part D plans process it through the pharmacy or medical drug benefit instead, and it counts toward the 2026 Part D annual out-of-pocket cap of $2,100 rather than Part B coinsurance.
Original Medicare beneficiaries receiving Part B infusions owe a standard 20% coinsurance after the $283 2026 Part B deductible, with no separate annual Part B out-of-pocket cap under Original Medicare. A Medigap policy can eliminate that coinsurance entirely, and a Medicare Advantage plan's annual out-of-pocket maximum will cap the total, but neither Medigap nor a standalone Part D plan covers a Part B-administered infusion like standard Entyvio. Beneficiaries who cannot afford the coinsurance should ask about a Medicare Savings Program through their state Medicaid agency or contact an independent charity such as the Patient Access Network Foundation for oncology and specialty-drug copay grants.
Common Entyvio Billing Errors
Patients who receive an Entyvio bill higher than $500 with commercial insurance, or above $1,300 in Part B coinsurance for a single infusion, should check for these issues before paying:
- J3380 units billed incorrectly, for example as 1 unit or as a vial count, instead of the actual milligram dose, inflating the drug charge.
- A hospital facility fee added to the drug charge without being itemized as a separate line so patients cannot verify it independently.
- Prior authorization that lapsed between infusion cycles, causing a mid-treatment denial even though the induction series was approved.
- The hospital's full chargemaster (list) rate applied to an insured patient's claim instead of the negotiated in-network rate.
- Entyvio Pen doses billed as a J3380 infusion claim when the drug was actually self-injected at home and dispensed by a specialty pharmacy under the pharmacy benefit.
- Part B coinsurance charged after a Medigap policy or Medicare Advantage annual out-of-pocket maximum should have already covered the balance.
Frequently Asked Questions
Is there a generic or biosimilar for Entyvio?
No generic or FDA-approved biosimilar for Entyvio (vedolizumab) exists as of 2026. Entyvio is a biologic monoclonal antibody, so it cannot have a small-molecule generic; competition can only come through the biosimilar pathway. Takeda's core patent protection runs through approximately 2028, with some formulation patents extending toward 2032. Alvotech has submitted the first Entyvio biosimilar applications (AVT16 for IV, AVT80 for the subcutaneous Pen), with a possible FDA decision on AVT16 as early as the first quarter of 2027.
How do I apply for the Takeda Help At Hand patient assistance program?
Call Takeda Help At Hand at 1-800-830-9159 or visit helpathandpap.com to start an application. Download the form, complete the patient section, and have your gastroenterologist's office complete and sign the prescription and diagnosis section. Gather proof of household income, proof of US residency, and, if Medicare Part D eligible, a denial letter from Extra Help. Mail or fax the completed application to Takeda Help At Hand, P.O. Box 5727, Louisville, KY 40255-0727. Approved patients receive Entyvio shipped to their provider at no cost for up to 1 year.
Can I use the EntyvioConnect savings card with Medicare?
No. Federal anti-kickback law bars manufacturer copay cards, including EntyvioConnect, from being used by anyone enrolled in Medicare, Medicaid, TRICARE, or VA benefits. The card is reserved for commercially insured patients and can lower the cost to $0 per dose, up to $20,000 per year. Medicare beneficiaries who need help affording their 20% Part B coinsurance should instead apply to the Takeda Help At Hand Patient Assistance Program or ask their state Medicaid agency about a Medicare Savings Program.
What if my insurance denies coverage for Entyvio?
Request the written denial notice, which must state the specific reason, then have your gastroenterologist file a formal appeal within the plan's deadline, typically 60 days. Most Entyvio denials involve missing documentation that conventional therapy (5-ASA, corticosteroids, immunomodulators, or an anti-TNF drug) failed under the plan's step-therapy protocol. Your gastroenterologist can request a peer-to-peer review and, if denied again, escalate to an external review through your state's Department of Insurance. If appeals fail, the Takeda Help At Hand Patient Assistance Program can help cover cost while you pursue coverage.
Does the IRA negotiated price apply to Entyvio in 2026?
Not yet. Entyvio was not among the first 10 drugs negotiated under the Inflation Reduction Act (effective 2026) or the 15 drugs in round two (effective 2027), both of which covered only Part D drugs. CMS opened negotiation to Part B drugs for the first time in round three, announced January 27, 2026, and selected Entyvio alongside Botox, Cimzia, and Orencia. Takeda signed the negotiation agreement by the February 28, 2026 deadline, and CMS is scheduled to publish the negotiated Maximum Fair Price by November 30, 2026, taking effect January 1, 2028.
What does Entyvio cost without insurance at the infusion center?
Cash price for standard IV Entyvio in 2026 runs about $8,700 to $10,500 per 300 mg infusion, close to Takeda's wholesale acquisition cost of roughly $8,700 per vial. Because Entyvio must be administered by a healthcare professional, it is not available through a retail pharmacy the way a pill or self-injectable pen would be, though the Entyvio Pen (used only for maintenance) is dispensed by specialty pharmacies for about $3,500 to $3,700 per dose. Uninsured patients earning up to about 500% of the federal poverty level should apply to the Takeda Help At Hand Patient Assistance Program before paying cash.
Do I qualify for the Takeda Help At Hand patient assistance program?
Eligibility depends on insurance status and household income. Takeda's published thresholds are $79,800 or less for an individual, $108,200 or less for a couple, and $165,000 or less for a family of four in 2026, all approximately 500% of the federal poverty level. Applicants generally need to be uninsured or facing documented hardship despite having some coverage, a valid Entyvio prescription from a US-licensed provider, and proof of US residency. Medicare Part D-eligible applicants must first apply for and be denied the Extra Help program. See the household-size table above for exact figures.
What is the difference between Entyvio IV infusion and the Entyvio Pen?
Entyvio IV is the original 300 mg intravenous formulation, infused by a healthcare professional over about 30 minutes at weeks 0, 2, and 6 for induction, then every 8 weeks for maintenance. The Entyvio Pen is a 108 mg subcutaneous self-injector, FDA-approved in 2023, used only for maintenance dosing after completing IV induction, never for the first three doses. Coverage and billing differ: IV Entyvio bills under Medicare Part B and the medical benefit using HCPCS code J3380, while the Entyvio Pen is typically dispensed by a specialty pharmacy and billed under the Part D or medical pharmacy benefit instead.
