Help paying · Medicare negotiated price · pharmacy cost · cycle 2028
Cimzia (certolizumab pegol): where help paying exists, where Medicare's negotiation stands and what pharmacies pay
CMS has selected Cimzia 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. The FDA's enforcement reports name this drug's packages in 2 recall entries. ClinicalTrials.gov lists 9 recruiting trials that name certolizumab pegol.
Every package CMS lists
Packages the CMS file lists for Cimzia, with NADAC per unit where the benchmark has one (per unit, as the files state).
| NDC | Product | Unit | CMS price status | NADAC |
|---|---|---|---|---|
| 50474-0700-62 | (name not listed) | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 50474-0710-79 | Cimzia Prefilled Syringe | EA | Selected; price takes effect January 1, 2028, not yet published | $6,098 |
| 50474-0710-81 | Cimzia Starter Kit | EA | Selected; price takes effect January 1, 2028, not yet published | $6,073 |
| 50474-0750-10 | (name not listed) | 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 Cimzia of $19.57 million in 2024, across 1,162 claims and 1,116 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 | $19.57 million | 1,162 | 1,116 | $16,841 |
| 2023 | $18.29 million | 1,070 | 1,028 | $17,097 |
| 2022 | $17.36 million | 1,088 | 1,047 | $15,958 |
| 2021 | $16.65 million | 1,117 | 1,079 | $14,907 |
| 2020 | $14.28 million | 1,013 | 950 | $14,102 |
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 Cimzia. 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 |
|---|---|---|---|---|---|
| J0717 | 2026 Q4 | $3.14 | 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
- Cimzia (certolizumab pegol) is a reference product in the FDA Purple Book (BLA 125160, approved April 22, 2008). 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.
FDA safety program (REMS)
- Cimzia (application BLA125160): listed as released, without Elements to Assure Safe Use. Program dated April 22, 2008, last modified July 29, 2011. 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 1 designation for certolizumab pegol. 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 2, 2026 | prevention of placenta-mediated adverse pregnancy outcomes in pregnant patients with antiphospholipid syndrome | Designated | UCB, 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 5 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 |
|---|---|---|---|
| OH | 670 | $4,381,826 | Fee-for-service only |
| SD | 91 | $976,389 | All record types |
| MN | 123 | $181,376 | Fee-for-service only |
| MO | 93 | $76,834 | All record types |
| UT | 61 | $52,765 | 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 (3 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. 79 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
The FDA file lists no non-manufacturing label change for these applications since November 11, 2025. The most recent one it lists is dated September 23, 2025 (Labeling).
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 Cimzia by its NDC: 2 entries, 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 27, 2026D-0546-2026 | Class II | Ongoing | UCB Biosciences Inc. | Lack of Assurance of Sterility | 4 |
| May 16, 2018D-0763-2018 | 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 9 interventional trials that name certolizumab pegol and are recruiting, and 1 more not yet recruiting. By phase: Phase 2: 3, Phase 3: 2, Not applicable: 2, Phase 4: 2. The 9 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 |
|---|---|---|---|---|---|
| NCT04991025 | Adding Certolizumab to Chemotherapy + Nivolumab in People Who Have Lung Cancer That Can Be Treated With SurgeryLung Cancer; Lung Cancer Stage II; Lung Cancer Stage III | Phase 2 | Memorial Sloan Kettering Cancer Center | October 2, 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 |
| NCT03414502 | Treatment of Rheumatoid Arthritis With DMARDs: Predictors of ResponseRheumatoid Arthritis | Phase 3 | University of Nebraska | June 17, 2026 | United States |
| NCT03152058 | IMPACT Study: IMProve Pregnancy in APS With Certolizumab TherapyHigh Risk Pregnancy; Pregnancy Complications; Antiphospholipid Syndrome in Pregnancy | Phase 2 | David Ware Branch | April 1, 2026 | United States, Canada |
| NCT07491913 | Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained RemissionTakayasu Arteritis | Not applicable | Marmara University | March 25, 2026 | Turkey (Türkiye) |
| NCT05305066 | Stand UP to Rheumatoid Arthritis (SUPRA)Rheumatoid Arthritis | Not applicable | Marie Hudson, MD | February 3, 2026 | Canada |
| NCT07149792 | A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular BiomarkersPsoriasis; Psoriasis Arthritis; Biologics | Phase 4 | Taichung Veterans General Hospital | September 2, 2025 | Taiwan |
| NCT02714634 | Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate or LeflunomideRheumatoid Arthritis; Insufficient Response to Methotrexate or Leflunomide | Phase 4 | University Hospital, Strasbourg, France | March 12, 2025 | France |
| NCT05930613 | Certolizumab in Recurrent Implantation Failure (RIF)Recurrent Unexplained Implantation Failure | Phase 3 | Assistance Publique - Hôpitaux de Paris | December 11, 2023 | France |
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 Cimzia?
CMS has selected Cimzia 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 Cimzia?
No program in our finder lists this drug yet.
Can I join a clinical trial for Cimzia?
ClinicalTrials.gov lists 9 recruiting interventional trials that name certolizumab pegol (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 Cimzia?
CMS's Medicare Part D spending dataset reports gross spending on Cimzia of $19.57 million in 2024, across 1,162 claims and 1,116 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/cimzia.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.