FAVLYXA
FAVLYXA currently does not have a permanent HCPCS code and should be billed using a miscellaneous code.
Drug & Product Overview
How to Bill FAVLYXA Now
Until CMS assigns a permanent product-specific code, bill this drug with a miscellaneous / not-otherwise-classified (NOC) code and identify the product by its NDC and package details. A NOC code is only valid while no product-specific code exists; once a permanent code is effective, NOC claims for this drug will deny.
| Setting | Claim Form | Billing Code | Notes |
|---|---|---|---|
| Physician office / Part B | CMS-1500 / 837P | J9999 | Enter the drug name and dosage in Item 19 (or the 837P equivalent). The claim is manually priced by the MAC. |
| Hospital outpatient (OPPS) | UB-04 / 837I | C9399 | Unclassified/NOC drug or biological. Separately payable and manually priced by the MAC using AWP-based methodology. |
WAC pricing is not required for the claim, but a payer may reference it as a benchmark when manually pricing a NOC-coded drug.
About FAVLYXA
FAVLYXA (fluorouracil) is a provider-administered antineoplastic injection from Avyxa Pharma, given by intravenous infusion. Fluorouracil is a pyrimidine antimetabolite used in the treatment of certain cancers. As a newly launched product, FAVLYXA does not yet have its own permanent product-specific HCPCS code; CMS assigns and crosswalks permanent drug codes on a quarterly cycle, so a product-specific code commonly takes several months to a year after launch.
Until then, FAVLYXA is billed with the not-otherwise-classified antineoplastic code (J9999), identifying the product by its NDC, dosage, and units. A NOC code is valid only while no product-specific code applies to the NDC; once one is effective, NOC claims for this product will deny. See the Billing Guidance below for how to bill it in each setting, plus NDC pricing, WAC/AWP references, and the anticipated permanent code.
NDC Code Information
Identify the product on the claim by its NDC and package details. The list of NDCs below is not exhaustive.
| NDC Code | Package | Manufacturer | WAC | AWP |
|---|---|---|---|---|
| 83831-0143-01 | 250 MG / 10 MLOne Single-Dose Vial 250mg/10mL (25mg/mL) | AVYXA Pharma LLC | $350.00 | $420.00 |
| 83831-0164-10 | 500 MG / 100 MLOne Multiple-Dose Vial 2,500mg/100mL (25mg/mL) | AVYXA Pharma LLC | $3,500.00 | $4,200.00 |
Effective 4/1/26 (WAC & AWP)
FAVLYXA Pricing & Reimbursement
No ASP-based Medicare payment limit exists until a permanent code is assigned. The figures below are published list-price benchmarks and initial-period references.
Figures reflect NDC 83831-0143-01 — see the NDC table for all packages.
Because no permanent code has been assigned, there is no HCPCS billing unit yet, so pricing is shown per package (per NDC). No ASP-based Medicare payment limit exists. WAC and AWP are published list-price benchmarks, not guaranteed payment; the Part B figure (up to 103% of WAC) is an initial-period reference point, not a payer’s final allowed amount.
Anticipated HCPCS Coding
The permanent product-specific code expected for FAVLYXA once CMS completes its review.
This is a projection, not a confirmed assignment. CMS reviews and assigns permanent HCPCS codes on a quarterly cycle and does not guarantee a code or effective date in advance. Confirm current coding with CMS and your payer before billing.
FAVLYXA Clinical Information
Indications and drug classification.
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