Help paying · Medicare negotiated price · pharmacy cost · cycle 2026
Stelara (ustekinumab): where help paying exists, what Medicare negotiated and what pharmacies pay
1 assistance program lists ustekinumab, each with its income ceiling and when we read it. Medicare's negotiated price for a 30-day supply is $4,695 (in force since January 1, 2026). CMS's file lists all 9 packages of Stelara as deselected from the negotiation program, with the negotiated price ending December 31, 2026. After that date there is no negotiated price for them. The file does not say why. Per unit, the negotiated price is 30% of NADAC, the pharmacy acquisition benchmark. 6 non-manufacturing label changes are dated in the last 12 months in the FDA's file. The FDA's enforcement reports name this drug's packages in 1 recall entry. ClinicalTrials.gov lists 17 recruiting trials that name ustekinumab.
One package, side by side
Price per unit for one package of Stelara. The negotiated price applies to Medicare Part D; NADAC is a survey of what retail pharmacies pay to buy the drug.
Swipe to read across
Every package we can price
Per-unit prices (per mL, as the files state). "Scheduled" is a price the CMS file already dates for the future.
| NDC | Product | Unit | Negotiated now | Scheduled | NADAC | Share |
|---|---|---|---|---|---|---|
| 57894-0054-27 | STELARA 130 mg/26 mL (5 mg/mL) | n/a | $25.11 | ends 2026-12-31 | n/a | no NADAC price |
| 57894-0060-02 | STELARA 45MG/0.5ML | n/a | $8,980 | ends 2026-12-31 | n/a | no NADAC price |
| 57894-0060-03 | STELARA 45MG/0.5ML - prefilled syringe | ML | $8,980 | ends 2026-12-31 | $29,874 | 30% |
| 57894-0061-02 | (name not listed) | n/a | $8,980 | ends 2026-12-31 | n/a | no NADAC price |
| 57894-0061-03 | STELARA 90MG/1.0ML - prefilled syringe | ML | $8,980 | ends 2026-12-31 | $29,793 | 30% |
| 57894-0440-01 | Ustekinumab 45mg/0.5mL PFS | n/a | $8,980 | ends 2026-12-31 | n/a | no NADAC price |
| 57894-0440-03 | Ustekinumab 45mg/0.5mL Vial | n/a | $8,980 | ends 2026-12-31 | n/a | no NADAC price |
| 57894-0441-01 | Ustekinumab 90mg/mL PFS | n/a | $8,980 | ends 2026-12-31 | n/a | no NADAC price |
| 57894-0444-01 | Ustekinumab 130mg/26mL Vial | n/a | $25.11 | ends 2026-12-31 | n/a | no NADAC price |
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Stelara of $3.38 billion in 2024, across 132,865 claims and 24,754 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 | $3.38 billion | 132,865 | 24,754 | $25,424 |
| 2023 | $2.99 billion | 117,068 | 22,930 | $25,522 |
| 2022 | $2.34 billion | 96,974 | 19,969 | $24,121 |
| 2021 | $1.57 billion | 70,502 | 16,156 | $22,233 |
| 2020 | $1.11 billion | 53,677 | 12,914 | $20,611 |
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 Stelara. 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 |
|---|---|---|---|---|---|
| J3358 | 2026 Q4 | $10.25 | 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
- Stelara (ustekinumab) is a reference product in the FDA Purple Book (BLA 125261, approved September 25, 2009). The Purple Book lists 0 biosimilars and 10 interchangeable products that name it as their reference product.
Interchangeable: Wezlana, interchangeable since October 31, 2023; Wezlana, interchangeable since October 31, 2023; Steqeyma, interchangeable since April 30, 2025; Selarsdi, interchangeable since April 30, 2025; Imuldosa, interchangeable since June 5, 2026; Pyzchiva, interchangeable since April 30, 2025; Otulfi, interchangeable since April 30, 2025; Yesintek, interchangeable since April 30, 2025; Starjemza, interchangeable since May 22, 2025; Pyzchiva, interchangeable since April 30, 2025 - Stelara (ustekinumab) is a reference product in the FDA Purple Book (BLA 761044, approved September 23, 2016). The Purple Book lists 0 biosimilars and 10 interchangeable products that name it as their reference product.
Interchangeable: Wezlana, interchangeable since October 31, 2023; Wezlana, interchangeable since October 31, 2023; Steqeyma, interchangeable since April 30, 2025; Selarsdi, interchangeable since April 30, 2025; Imuldosa, interchangeable since June 5, 2026; Pyzchiva, interchangeable since April 30, 2025; Otulfi, interchangeable since April 30, 2025; Yesintek, interchangeable since April 30, 2025; Starjemza, interchangeable since May 22, 2025; Pyzchiva, interchangeable since April 30, 2025
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.
FDA safety program (REMS)
- Stelara (application BLA125261): listed as released, without Elements to Assure Safe Use. Program dated September 25, 2009, last modified February 15, 2017. REMS@FDA program page.
A REMS is a safety program the FDA can require for a drug. Some restrict how it is prescribed or dispensed, for example through certified prescribers or pharmacies. This lists what the FDA's REMS@FDA files tie to the application; it does not say which prescribers or pharmacies take part, or whether a given patient needs the program.
Source: FDA REMS@FDA data files (rems-fda-files-2026-11-07-products-20a9945448dd), read November 7, 2026. REMS@FDA product file.
Rare-disease (orphan) designations
The FDA's orphan drug database lists 5 designations for ustekinumab, 2 with an approval recorded. 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 |
|---|---|---|---|
| July 18, 2017 | Treatment of pediatric systemic lupus erythematosus | Designated/Designation Withdrawn or Revoked | Janssen Biotech, Inc. |
| February 22, 2017 | Treatment of pediatric ulcerative colitis | Designated/Approved | Janssen Biotech, Inc. |
| May 18, 2016 | Treatment of pediatric Crohn's disease (0 through 16 years of age) | Designated/Approved | Janssen Research & Development, LLC |
| December 28, 2011 | Treatment of chronic sarcoidosis | Designated/Designation Withdrawn or Revoked | Janssen Biotech, Inc. |
| November 29, 2010 | Treatment of type 1 diabetes mellitus patients with residual beta-cell function. | Designated/Designation Withdrawn or Revoked | Johnson & Johnson Pharmaceutical & Development LLC |
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 2 states with the largest reimbursement are shown. 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 |
|---|---|---|---|
| IA | 66 | $917,599 | All record types |
| MO | 47 | $645,670 | All record types |
A state missing from the table means its figures were suppressed or not reported, not zero use. 110 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
Offers the program pages state
- Manufacturer savings card
The J&J withMe Stelara page states pay as little as $5 per dose for patients using commercial or private insurance. A maximum program benefit per calendar year applies but the amount is not stated in the text read; terms expire at the end of each calendar year and may change.
Read November 7, 2026; quote matched against the saved page text.
Programs in our finder that list ustekinumab. Each shows its income ceiling, when we read it and whether we checked it against the program's own document. Eligibility is decided by the program, not by us.
- Johnson & Johnson Patient Assistance Program manufacturer
Income at or below $46,950 for one person or $63,450 for two (J&J 2026 program limit, 300% of the 2025 poverty guideline)
Limit read October 19, 2026.
Check where your income sits against each ceiling: open the assistance finder. See what has changed and when we last verified each program on the program status board.
Label changes
FDA actions on the applications behind Stelara dated since November 11, 2025, leaving out manufacturing (CMC) changes. 6 changes in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| August 28, 2026 | Labeling | BLA125261 | 173 | Label (PDF) posted September 1, 2026FDA letter posted September 1, 2026 |
| August 28, 2026 | Efficacy | BLA761044 | 21 | Label (PDF) posted September 1, 2026FDA letter posted September 1, 2026 |
| July 15, 2026 | Labeling | BLA125261 | 174 | Label (PDF) posted July 29, 2026FDA letter posted July 16, 2026 |
| July 15, 2026 | Labeling | BLA761044 | 22 | No document linked in the FDA file |
| April 15, 2026 | Labeling | BLA125261 | 172 | Label (PDF) posted April 20, 2026FDA letter posted April 16, 2026 |
| April 15, 2026 | Efficacy | BLA761044 | 20 | Label (PDF) posted April 20, 2026FDA letter posted April 16, 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.
Safety notices
FDA enforcement report entries that name a package of Stelara by its NDC: 1 entry, newest first. FDA assigns each a class by health risk: Class I is the most serious and Class III the least. An entry records what the recalling firm reported and FDA classified; it is not advice about any package you hold.
| Reported | Class | Status | Recalling firm | Reason (shortened) | Packages named |
|---|---|---|---|---|---|
| May 16, 2018D-0762-2018 | Class II | Terminated | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. | 1 |
Source: openFDA drug enforcement reports, file read November 7, 2026. openFDA data file. All recent recalls across these drugs: drug recalls feed.
Clinical trials recruiting
ClinicalTrials.gov lists 17 interventional trials that name ustekinumab and are recruiting, and 6 more not yet recruiting. By phase: Phase 4: 7, Phase 2: 4, Phase 3: 2, Not applicable: 2, PHASE1/PHASE2: 1, Phase 1: 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 |
|---|---|---|---|---|---|
| NCT07310095 | A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)Crohn Disease | Phase 4 | Xian-Janssen Pharmaceutical Ltd. | November 3, 2026 | China |
| NCT03167437 | An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With UstekinumabCrohn's Disease | Phase 1 / Phase 2 | National Institute of Allergy and Infectious Diseases (NIAID) | November 2, 2026 | United States |
| NCT07116967 | Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)Plaque Psoriasis | Phase 3 | Bristol-Myers Squibb | October 28, 2026 | United States, Argentina, Australia and 7 more |
| 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 |
| NCT06807593 | Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer PatientsCancer | Phase 2 | M.D. Anderson Cancer Center | September 14, 2026 | United States |
| NCT06274554 | Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's DiseaseCrohn's Disease; Inflammatory Bowel Diseases | Phase 3 | Weill Medical College of Cornell University | August 20, 2026 | United States |
| NCT07138898 | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder ArthroplastyRheumatic Disease | Phase 2 | NYU Langone Health | July 9, 2026 | United States |
| NCT07529236 | Digestive Evolution of Children With Crohn's Disease or Ulcerative Colitis Whose Anti-TNFα Treatment Was Switched to Ustekinumab Due to Paradoxical Psoriasis,Chronic Inflammatory Bowel Diseases | Not applicable | Centre Hospitalier Universitaire de Nice | June 25, 2026 | France |
| NCT05327790 | LFMT vs Placebo in New Biologic Start for Ulcerative ColitisUlcerative Colitis | Phase 2 | University of Alberta | May 6, 2026 | Canada |
| NCT05169593 | Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological TherapyCrohn Disease | Phase 4 | Universitaire Ziekenhuizen KU Leuven | May 5, 2026 | Belgium, Italy |
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 Stelara?
For a 30-day supply the price CMS published is $4,695, in force since January 1, 2026. CMS's file lists all 9 packages of Stelara as deselected from the negotiation program, with the negotiated price ending December 31, 2026. After that date there is no negotiated price for them. The file does not say why. This is a price CMS agreed with the manufacturer for Medicare Part D, not what a person pays at the counter.
How does the negotiated price compare with what pharmacies pay?
Across the 2 packages where both CMS files give a price per unit, the median negotiated price is 30% of NADAC, the pharmacy acquisition benchmark (NADAC as of November 4, 2026). NADAC is a survey average, not a quote.
Is there help paying for Stelara?
1 assistance program lists it in our finder. Eligibility depends on income, coverage and the program's current rules; each program's own page decides.
Can I join a clinical trial for Stelara?
ClinicalTrials.gov lists 17 recruiting interventional trials that name ustekinumab (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 Stelara?
CMS's Medicare Part D spending dataset reports gross spending on Stelara of $3.38 billion in 2024, across 132,865 claims and 24,754 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/stelara.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; openFDA drug enforcement reports; 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.