Help paying · Medicare negotiated price · pharmacy cost · cycle 2028
Xolair (omalizumab): where help paying exists, where Medicare's negotiation stands and what pharmacies pay
1 assistance program lists omalizumab, each with its income ceiling and when we read it. CMS has selected Xolair 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. 1 non-manufacturing label change is dated in the last 12 months in the FDA's file. The FDA's enforcement reports name this drug's packages in 4 recall entries. ClinicalTrials.gov lists 12 recruiting trials that name omalizumab.
Every package CMS lists
Packages the CMS file lists for Xolair, with NADAC per unit where the benchmark has one (per unit, as the files state).
| NDC | Unit | CMS price status | NADAC |
|---|---|---|---|
| 50242-0040-62 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 50242-0214-01 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 50242-0214-03 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 50242-0214-55 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 50242-0215-01 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 50242-0215-03 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 50242-0215-55 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 50242-0227-01 | n/a | Selected; price takes effect January 1, 2028, not yet published | n/a |
| 50242-0227-55 | 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 Xolair of $313.12 million in 2024, across 95,356 claims and 11,011 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 | $313.12 million | 95,356 | 11,011 | $3,284 |
| 2023 | $254.06 million | 79,113 | 9,161 | $3,211 |
| 2022 | $208.23 million | 68,699 | 8,052 | $3,031 |
| 2021 | $161.21 million | 54,013 | 6,736 | $2,985 |
| 2020 | $150.60 million | 49,179 | 6,456 | $3,062 |
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 Xolair. 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 |
|---|---|---|---|---|---|
| J2357 | 2026 Q4 | $45.69 | 5 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
- Xolair (omalizumab) is a reference product in the FDA Purple Book (BLA 103976, approved June 20, 2003). The Purple Book lists 0 biosimilars and 1 interchangeable product that name it as their reference product.
Interchangeable: Omlyclo, interchangeable since March 7, 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)
- Xolair (application BLA103976): listed as released, without Elements to Assure Safe Use. Program dated July 24, 2009, last modified December 22, 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.
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 49 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 | 7,098 | $23,356,298 | Fee-for-service only |
| CA | 6,197 | $21,529,169 | Fee-for-service only |
| NC | 3,835 | $14,599,925 | Fee-for-service only |
| PA | 3,336 | $10,369,879 | Fee-for-service only |
| FL | 2,694 | $9,152,320 | Fee-for-service only |
| OH | 2,994 | $9,052,204 | Fee-for-service only |
| MI | 3,043 | $9,031,796 | Fee-for-service only |
| VA | 2,832 | $7,400,292 | Fee-for-service only |
| MA | 2,299 | $7,105,699 | Fee-for-service only |
| WI | 2,077 | $6,948,258 | All record types |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (65 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. 41 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
Programs in our finder that list omalizumab. 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.
- Genentech/Roche Access Solutions manufacturer
Household income under $150,000 for 1 to 4 people if uninsured or your plan does not cover the medicine (Genentech Patient Foundation)
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 Xolair dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| August 6, 2026 | Labeling | BLA103976 | 5253 | Label (PDF) posted August 11, 2026FDA letter posted August 10, 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 Xolair by its NDC: 4 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 |
|---|---|---|---|---|---|
| August 13, 2025D-0571-2025 | Class II | Ongoing | Cardinal Health Inc. | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. | 9 |
| August 13, 2025D-0572-2025 | Class II | Ongoing | Cardinal Health Inc. | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. | 9 |
| July 14, 2021D-0650-2021 | Class II | Terminated | Genentech Inc | Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point. | 9 |
| May 16, 2018D-0758-2018 | 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 12 interventional trials that name omalizumab and are recruiting, and 1 more not yet recruiting. By phase: Phase 2: 6, Phase 4: 4, Phase 3: 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 |
|---|---|---|---|---|---|
| NCT06824649 | Biologics in Chronic Rhinosinusitis With Nasal PolyposisChronic Sinusitis; Nasal Polyps | Phase 4 | Medical University of South Carolina | November 3, 2026 | United States |
| NCT07845552 | Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food AllergyFood Allergy | Phase 4 | Johns Hopkins University | October 28, 2026 | United States |
| NCT07816328 | Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 WeeksChronic Spontaneous Urticaria | Phase 3 | Novartis Pharmaceuticals | October 13, 2026 | Hong Kong, Japan, South Korea |
| NCT07356713 | A Study to Find a Suitable Dose of Exl-111 for Further ResearchAllergic Disease | Phase 1 | Excellergy Inc. | September 22, 2026 | Australia, New Zealand |
| NCT07059091 | Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPDChronic Obstructive Pulmonary Disease (COPD); Allergies | Phase 2 | Johns Hopkins University | September 4, 2026 | United States |
| NCT06934200 | Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE LevelsFood Hypersensitivity | Phase 2 | Johns Hopkins University | June 8, 2026 | United States |
| NCT06943534 | Omalizumab Weight-Based Dosing Efficacy TrialAllergies; Food Allergy | Phase 2 | Massachusetts General Hospital | February 5, 2026 | United States |
| NCT07342803 | Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma PatientsAllergic Asthma | Phase 2 | Longbio Pharma | January 15, 2026 | China |
| NCT05332067 | Omalizumab Before Onset of ExacerbationsAsthma in Children; Atopy; Viral Upper Respiratory Infection | Phase 2 | Children's National Research Institute | July 14, 2025 | United States |
| NCT06618963 | Effect of Omalizumab in the Skin of Food Allergy PatientsFood Allergy; Food Allergy in Children | Phase 4 | National Jewish Health | May 2, 2025 | 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 Xolair?
CMS has selected Xolair 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 Xolair?
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 Xolair?
ClinicalTrials.gov lists 12 recruiting interventional trials that name omalizumab (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 Xolair?
CMS's Medicare Part D spending dataset reports gross spending on Xolair of $313.12 million in 2024, across 95,356 claims and 11,011 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/xolair.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.