Help paying · Medicare negotiated price · pharmacy cost · cycle 2028
Entyvio (vedolizumab): where help paying exists, where Medicare's negotiation stands and what pharmacies pay
CMS has selected Entyvio for the 2028 negotiation cycle. The CMS file we read (November 6, 2026) lists its negotiated price as taking effect January 1, 2028 and holds no price for it yet, so this page shows no negotiated price. 2 non-manufacturing label changes are dated in the last 12 months in the FDA's file. ClinicalTrials.gov lists 26 recruiting trials that name vedolizumab.
Every package CMS lists
Packages the CMS file lists for Entyvio, with NADAC per unit where the benchmark has one (per unit, as the files state).
| NDC | Unit | CMS price status | NADAC |
|---|---|---|---|
| 64764-0107-10 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 64764-0107-11 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 64764-0108-20 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 64764-0108-21 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 64764-0300-20 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Entyvio of $129.25 million in 2024, across 14,773 claims and 2,863 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
| Year | Gross spending | Claims | Beneficiaries | Average spending per claim |
|---|---|---|---|---|
| 2024 | $129.25 million | 14,773 | 2,863 | $8,749 |
| 2023 | $100.00 million | 11,695 | 2,238 | $8,551 |
| 2022 | $75.97 million | 9,428 | 1,837 | $8,058 |
| 2021 | $58.92 million | 7,791 | 1,505 | $7,562 |
| 2020 | $47.06 million | 6,552 | 1,311 | $7,182 |
Source: CMS Medicare Part D spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. All manufacturers combined; the figures are a drug-level aggregate of claims and say nothing about a formulary or coverage.
Medicare Part B payment limit
CMS publishes a quarterly payment limit for the HCPCS code that its NDC crosswalk links to Entyvio. It is a ceiling for providers who bill Medicare Part B, not a price a patient pays, and a code's presence says nothing about whether Medicare covers a product.
| HCPCS code | Quarter | Payment limit | Per dosage descriptor | Effective | Read |
|---|---|---|---|---|---|
| J3380 | 2026 Q4 | $20.95 | 1 MG | October 1, 2026 through December 31, 2026 | November 7, 2026 |
Source: CMS ASP pricing files (october-2026-medicare-part-b-payment-limit-files-final.zip and the matching NDC-HCPCS crosswalk). CMS ASP pricing files page.
Biosimilar status
- Entyvio (vedolizumab) is a reference product in the FDA Purple Book (BLA 125476, approved May 20, 2014). The Purple Book lists 0 biosimilars and 0 interchangeable products that name it as their reference product.
- Entyvio; Entyvio Pen (vedolizumab) is a reference product in the FDA Purple Book (BLA 761133, approved September 27, 2023). The Purple Book lists 0 biosimilars and 0 interchangeable products that name it as their reference product.
This is what the FDA Purple Book lists on the read date. It is a record, not a forecast of when any product will launch or be substituted.
Source: FDA Purple Book (purplebook-2026-10), read November 7, 2026. Purple Book data file.
Rare-disease (orphan) designations
The FDA's orphan drug database lists 3 designations for Vedolizumab; vedolizumab. A designation is not an approval and not a statement that the drug treats the condition; the status column is the database's own.
| Designated | Designated use | Status | Sponsor |
|---|---|---|---|
| March 15, 2021 | Treatment of Pouchitis | Designated | Takeda Development Center Americas, Inc. |
| March 21, 2017 | Treatment of graft versus host disease | Designated/Designation Withdrawn or Revoked | Takeda Development Center Americas, Inc. |
| August 4, 2016 | Prevention of graft versus host disease. | Designated/Designation Withdrawn or Revoked | Takeda Development Center Americas, Inc. |
Source: FDA Orphan Drug Designations and Approvals database, read November 7, 2026. FDA orphan drug search.
Medicaid use by state
CMS's State Drug Utilization Data records, for 2025, how many prescriptions each state's Medicaid program paid for under this drug's packages and what it reimbursed. The 10 states with the largest reimbursement are shown of 28 with data. Reimbursement is before the rebates manufacturers pay states, so it is not a net cost and not a price a patient pays.
| State | Medicaid-paid prescriptions | Medicaid reimbursed | Covers |
|---|---|---|---|
| NY | 663 | $4,356,028 | All record types |
| AZ | 471 | $3,078,761 | All record types |
| NC | 382 | $2,562,437 | Fee-for-service only |
| PA | 442 | $2,548,099 | Fee-for-service only |
| OH | 338 | $2,361,421 | Fee-for-service only |
| WA | 316 | $2,085,472 | Fee-for-service only |
| KY | 307 | $1,851,490 | Fee-for-service only |
| IN | 254 | $1,704,459 | All record types |
| IL | 240 | $1,677,117 | Fee-for-service only |
| MI | 242 | $1,629,518 | Fee-for-service only |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (13 state and package figures are marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 51 older-year figures are held and left out of the table.
Source: CMS State Drug Utilization Data (State Drug Utilization Data 2025, modified 2026-07-13T15:28:32Z), read November 7, 2026. CMS dataset page. State-reported data compiled by CMS; aggregate by state and package, no provider or patient data.
Where help paying exists
No program in our finder currently lists this drug as open to new patients.
Label changes
FDA actions on the applications behind Entyvio dated since November 11, 2025, leaving out manufacturing (CMC) changes. 2 changes in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| February 25, 2026 | Labeling | BLA125476 | 66 | Label (PDF) posted March 2, 2026FDA letter posted February 27, 2026 |
| February 25, 2026 | Labeling | BLA761133 | 14 | Label (PDF) posted March 2, 2026FDA letter posted February 27, 2026 |
Source: FDA Drugs@FDA data file, read November 7, 2026. Dates are the FDA action dates; the documents are on FDA's own site. FDA data file. All recent changes across these drugs: label changes feed.
Clinical trials recruiting
ClinicalTrials.gov lists 26 interventional trials that name vedolizumab and are recruiting, and 5 more not yet recruiting. By phase: Phase 4: 9, Phase 3: 7, Phase 2: 6, PHASE2/PHASE3: 2, Phase 1: 1, Not applicable: 1. The 10 most recently updated are below. A listing is not an offer of free drug and not medical advice. Whether a trial fits is decided by the study team and your own clinician.
| Trial | Title and conditions | Phase | Lead sponsor | Last updated | Countries |
|---|---|---|---|---|---|
| NCT05837897 | A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's DiseaseCrohn's Disease | Phase 3 | Takeda | November 2, 2026 | China |
| NCT06031233 | Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological ImmunotherapieOncology; Infusion Reaction | Phase 4 | Isala | October 29, 2026 | Netherlands |
| NCT06581328 | A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community SettingUlcerative Colitis; Crohn's Disease | Phase 4 | Takeda | October 28, 2026 | United States |
| NCT05928039 | PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's DiseaseCrohn Disease | Phase 4 | University of Calgary | October 26, 2026 | Canada |
| NCT06405087 | A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)Ulcerative Colitis; Crohn's Disease | Phase 3 | Takeda | October 9, 2026 | United States, Belgium, Bulgaria and 7 more |
| NCT06337695 | Vedolizumab for the Prevention of ICI Related Diarrhea or Colitis in Patients With CancerIrAE; Immune-related Adverse Event; Diarrhea | Phase 2 / Phase 3 | AHS Cancer Control Alberta | August 27, 2026 | Canada |
| NCT06443502 | A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic PouchitisPouchitis | Phase 3 | Takeda | August 3, 2026 | Belgium, Croatia, Czechia and 5 more |
| NCT06100289 | A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's DiseaseUlcerative Colitis; Crohn's Disease | Phase 3 | Takeda | August 3, 2026 | United States, Belgium, Bulgaria and 7 more |
| NCT03219359 | Autologous Stem Cell Transplant for Crohn's DiseaseCrohn Disease | Phase 2 | Aaron Etra | July 24, 2026 | United States |
| NCT03819296 | Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With CancerClinical Stage 0 Cutaneous Melanoma AJCC v8; Clinical Stage I Cutaneous Melanoma AJCC v8; Clinical Stage IA Cutaneous Melanoma AJCC v8 | Phase 1 | M.D. Anderson Cancer Center | July 15, 2026 | United States |
Source: ClinicalTrials.gov, registry data processed November 6, 2026, summarized and trimmed by OmniRx. Search on ClinicalTrials.gov.
Questions
What is the Medicare negotiated price of Entyvio?
CMS has selected Entyvio for the 2028 negotiation cycle. The CMS file we read (November 6, 2026) lists its negotiated price as taking effect January 1, 2028 and holds no price for it yet, so this page shows no negotiated price. When CMS publishes a price it will be a Medicare Part D price agreed with the manufacturer, not what a person pays at the counter.
How does the negotiated price compare with what pharmacies pay?
No negotiated price is published yet, so there is nothing to compare with the pharmacy acquisition benchmark.
Is there help paying for Entyvio?
No program in our finder lists this drug yet.
Can I join a clinical trial for Entyvio?
ClinicalTrials.gov lists 26 recruiting interventional trials that name vedolizumab (registry data processed November 6, 2026). A listing is not an offer of free drug and not medical advice. Whether a trial fits is decided by the study team and your own clinician.
How much does Medicare Part D spend on Entyvio?
CMS's Medicare Part D spending dataset reports gross spending on Entyvio of $129.25 million in 2024, across 14,773 claims and 2,863 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
For developers: this drug as data
One call returns price, generic-entry upper bound, label history, recalls, trials, assistance, and where facts exist the FDA safety program (REMS), DEA schedule, orphan designations, safety notices and Medicaid use by state, each with receipts.
Example file: https://omnirx.org/api/v1/dossier/entyvio.json
The licence page sets out what a data licence covers, and the API page documents these files.
Evaluation files with receipts; contract may change; not clinical advice.
Sources and terms. CMS Medicare Drug Price Negotiation Program data file (read November 6, 2026; the CMS page states no licence or restriction); CMS NADAC from data.medicaid.gov under the labels in the OmniRx licence ledger; program details read from each program's own pages; CMS Medicare Part D spending by drug; CMS ASP pricing files; FDA Purple Book; FDA Drugs@FDA and Orange Book data files; ClinicalTrials.gov registry data. Figures are stored with their sources in the OmniRx library (edition 2026-11). Free to cite with attribution. Not medical, legal or financial advice. Report an error through the contact page. Licence the data.