Help paying · Medicare negotiated price · pharmacy cost · cycle 2028
Biktarvy (bictegravir): where help paying exists, where Medicare's negotiation stands and what pharmacies pay
CMS has selected Biktarvy 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. ClinicalTrials.gov lists 12 recruiting trials that name bictegravir.
Every package CMS lists
Packages the CMS file lists for Biktarvy, with NADAC per unit where the benchmark has one (per unit, as the files state).
| NDC | Product | Unit | CMS price status | NADAC |
|---|---|---|---|---|
| 61958-2501-01 | Biktarvy | EA | Selected; price takes effect January 1, 2028, not yet published | $137 |
| 61958-2501-03 | Biktarvy Blister Pack | EA | Selected; price takes effect January 1, 2028, not yet published | $137 |
| 61958-2505-01 | BIKTARVY 30/120/15 mg TABLETS | EA | Selected; price takes effect January 1, 2028, not yet published | $137 |
| 61958-2506-01 | BIKTARVY 30 mg/120 mg/15 mg LD tablets | EA | Selected; price takes effect January 1, 2028, not yet published | $137 |
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 |
|---|---|---|---|---|---|
| NDA210251 | Biktarvy, Biktarvy 30 Mg/120 Mg/15 Mg Ld Tablets, Biktarvy 30/120/15 Mg Tablets, Biktarvy Blister Pack | November 8, 2036 | July 30, 2032 | November 8, 2036 | patent 10548846; 29 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 Biktarvy of $3.46 billion in 2024, across 840,772 claims and 92,246 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 | $3.46 billion | 840,772 | 92,246 | $4,111 |
| 2023 | $3.15 billion | 756,486 | 83,843 | $4,167 |
| 2022 | $2.70 billion | 686,161 | 75,791 | $3,940 |
| 2021 | $2.20 billion | 594,197 | 66,319 | $3,700 |
| 2020 | $1.78 billion | 500,405 | 55,805 | $3,549 |
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 4 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 |
|---|---|---|---|
| PR | 7,733 | $31,950,869 | All record types |
| NH | 84 | $337,423 | All record types |
| MS | 55 | $295,161 | Fee-for-service only |
| KY | 52 | $172,398 | All record types |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (1 state and package figure is marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 104 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 Gilead Advancing Access page lists co-pay savings of up to $8,500 per calendar year (Bixlenvo), $8,000 (Yeztugo), $9,600 (Sunlenca), $7,200 (Biktarvy, Descovy, Genvoya, Truvada), $6,000 (Odefsey, Stribild, Complera), $3,600 with a $300 monthly maximum (Emtriva) and $600 with a $50 monthly maximum (Tybost). Yeztugo and Sunlenca amounts include up to $100 per visit for injection administration. The card auto-renews January 1 each year.
Read November 7, 2026; quote matched against the saved page text.
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 July 30, 2025 (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 12 interventional trials that name bictegravir and are recruiting, and 3 more not yet recruiting. By phase: Phase 4: 4, Phase 2: 3, PHASE2/PHASE3: 2, Phase 3: 2, 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 |
|---|---|---|---|---|---|
| NCT06337032 | A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV TreatmentsHIV-1-infection | Phase 4 | Gilead Sciences | November 6, 2026 | Argentina, Panama, South Africa and 3 more |
| NCT07266831 | A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)Human Immunodeficiency Virus Type 1 (HIV-1) Infection | Phase 2 / Phase 3 | Merck Sharp & Dohme LLC | November 4, 2026 | United States, Argentina, Canada and 6 more |
| NCT07841990 | Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus LevelsHIV-1 Infection | Phase 2 | Gilead Sciences | October 23, 2026 | United States |
| NCT07645287 | A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1HIV-1-infection | Phase 2 | Gilead Sciences | October 15, 2026 | United States, Australia, Canada and 1 more |
| NCT05719441 | A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV RemissionAcute HIV Infection | Phase 2 | National Institute of Allergy and Infectious Diseases (NIAID) | October 14, 2026 | United States, Brazil, Peru |
| NCT07708727 | Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 TreatmentHIV-1-infection | Phase 2 / Phase 3 | Gilead Sciences | October 13, 2026 | United States, Canada, Puerto Rico |
| NCT07476339 | REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidEHIV -1 Infection; HIV (Human Immunodeficiency Virus); HIV | Phase 4 | CAN Community Health | September 3, 2026 | United States |
| NCT07683000 | Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment RegimensHIV-1-infection | Phase 3 | Gilead Sciences | July 30, 2026 | United States |
| NCT07727642 | Optimization of Antiretroviral Therapy in Patients With AIDS-Related LymphomaAIDS-related Lymphoma; HIV Infection | Not applicable | Shanghai Public Health Clinical Center | July 27, 2026 | China |
| NCT07075146 | DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or ObesityHIV - Human Immunodeficiency Virus; Obesity; Overweight and/or Obesity | Phase 3 | José Antonio Mata Marín | August 24, 2025 | Mexico |
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 Biktarvy?
CMS has selected Biktarvy 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 Biktarvy?
No program in our finder lists this drug yet.
When could a generic version of Biktarvy arrive?
For Biktarvy, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA210251, November 8, 2036. 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 Biktarvy?
ClinicalTrials.gov lists 12 recruiting interventional trials that name bictegravir (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 Biktarvy?
CMS's Medicare Part D spending dataset reports gross spending on Biktarvy of $3.46 billion in 2024, across 840,772 claims and 92,246 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/biktarvy.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.