Help paying · Medicare negotiated price · pharmacy cost · cycle 2027
Breo Ellipta (fluticasone): where help paying exists, what Medicare negotiated and what pharmacies pay
1 assistance program lists fluticasone, each with its income ceiling and when we read it. Medicare's negotiated price for a 30-day supply is $67.00 on January 1, 2027. ClinicalTrials.gov lists 5 recruiting trials that name fluticasone.
Every package we can price
Per-unit prices (per each unit, as the files state). "Scheduled" is a price the CMS file already dates for the future.
| NDC | Product | Unit | Negotiated now | Scheduled | NADAC | Share |
|---|---|---|---|---|---|---|
| 00173-0859-10 | BREO ELLIPTA 100/25 MCG INHPWDR 30 DS NDPI TRD PACK X 1 | EA | n/a | $1.15 | $6.50 | - |
| 00173-0859-14 | BREO ELLIPTA 100/25 MCG INHPWDR 14 DOSE NDPI INST PAC X 1 | EA | n/a | $1.15 | $5.36 | - |
| 00173-0882-10 | BREO ELLIPTA 200/25 MCG INHPWDR 1X 30D | EA | n/a | $1.15 | $6.50 | - |
| 00173-0882-14 | BREO ELLIPTA 200/25 MCG INHPWDR 1X 14D INST | EA | n/a | $1.15 | $5.35 | - |
| 00173-0916-10 | BREO ELLIPTA 50/25MCG INH PWDR | EA | n/a | $1.15 | $6.48 | - |
| 66993-0135-97 | Fluticasone Furoate/Vilanterol | EA | n/a | $0.703 | $3.82 | generic, not compared |
| 66993-0136-97 | Fluticasone Furoate/Vilanterol | EA | n/a | $0.703 | $3.89 | generic, not compared |
When could a generic arrive
Each date below is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
| Application | Product | Latest listed patent expiry | Latest listed exclusivity expiry | Latest of the two | Set by |
|---|---|---|---|---|---|
| NDA204275 | Breo Ellipta 100/25 Mcg Inhpwdr 14 Dose Ndpi Inst Pac X 1, Breo Ellipta 100/25 Mcg Inhpwdr 30 Ds Ndpi Trd Pack X 1, Breo Ellipta 200/25 Mcg Inhpwdr 1x 14d Inst, Breo Ellipta 200/25 Mcg Inhpwdr 1x 30d and 2 more | April 11, 2031 | November 13, 2026 | April 11, 2031 | patent 8746242 with its pediatric extension; 28 dated entries listed |
Source: FDA Orange Book data files, edition September 2026, read November 7, 2026; patent listings are as submitted by applicants and not verified by FDA. FDA data file.
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Breo Ellipta of $1.36 billion in 2024, across 2,617,269 claims and 596,052 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 | $1.36 billion | 2,617,269 | 596,052 | $520 |
| 2023 | $1.37 billion | 2,470,935 | 556,799 | $556 |
| 2022 | $1.43 billion | 2,705,981 | 605,087 | $528 |
| 2021 | $1.52 billion | 3,064,737 | 653,396 | $497 |
| 2020 | $1.50 billion | 3,234,906 | 664,096 | $465 |
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.
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 12 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 |
|---|---|---|---|
| OK | 212 | $82,799 | Fee-for-service only |
| ME | 154 | $54,719 | All record types |
| TX | 136 | $50,396 | All record types |
| KY | 177 | $48,194 | Fee-for-service only |
| VT | 92 | $39,104 | All record types |
| GA | 82 | $24,301 | All record types |
| UT | 65 | $19,060 | All record types |
| NV | 61 | $18,754 | Fee-for-service only |
| SC | 58 | $14,710 | Fee-for-service only |
| VA | 61 | $14,095 | 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 (7 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. 168 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 fluticasone. 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.
- GSK Patient Assistance Program manufacturer
Income at or below $47,880 for one person (300% FPL)
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
The FDA file lists no non-manufacturing label change for these applications since November 11, 2025. The most recent one it lists is dated May 12, 2023 (Efficacy).
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 5 interventional trials that name fluticasone and are recruiting, and 2 more not yet recruiting. By phase: Not applicable: 2, Phase 4: 1, Phase 2: 1, Phase 3: 1. The 5 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 |
|---|---|---|---|---|---|
| NCT07192016 | 129-Xe MRI Study of Single Triple Therapy Inhaler Effects in COPD Patients With Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of ExacerbationChronic Obstructive Pulmonary Disease (COPD) | Phase 4 | Western University, Canada | July 31, 2026 | Canada |
| NCT07282886 | VENTURI (VENTilation Using Respiratory Imaging)Asthma | Phase 2 | University of Alabama at Birmingham | April 13, 2026 | United States |
| NCT06474039 | The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPDCOPD | Phase 3 | Mahidol University | May 6, 2025 | Thailand |
| NCT06066606 | U-LABA/ICS Effects on Exercise Performance, VilanterolExercise Performance | Not applicable | Morten Hostrup, PhD | April 10, 2025 | Denmark |
| NCT06077019 | Role of Lung Function for Exercise Capacity in Well-trained IndividualsExercise Performance | Not applicable | Morten Hostrup, PhD | April 9, 2025 | Denmark |
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 Breo Ellipta?
The CMS file publishes $67.00 from January 1, 2027. 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?
The two CMS files do not give a comparable per-unit price for this drug.
Is there help paying for Breo Ellipta?
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.
When could a generic version of Breo Ellipta arrive?
For Breo Ellipta, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA204275, April 11, 2031. Each date is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
Can I join a clinical trial for Breo Ellipta?
ClinicalTrials.gov lists 5 recruiting interventional trials that name fluticasone (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 Breo Ellipta?
CMS's Medicare Part D spending dataset reports gross spending on Breo Ellipta of $1.36 billion in 2024, across 2,617,269 claims and 596,052 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/breo-ellipta.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; 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.