HCPCS
J0490
1 billing unit = 10 mg
MUE 160 units/day for J0490
Benlysta and the belimumab product family
No belimumab biosimilar exists. The one priced IV alternative in the file is Saphnelo, a different product with its own payer corpus. ASP comparison lives in Current Benlysta pricing.
| Brand | HCPCS | Manufacturer | Generic |
|---|---|---|---|
| Benlysta (IV) (this page) | J0490 | GSK | belimumab |
| Saphnelo | J0491 | AstraZeneca | anifrolumab-fnia |
Saphnelo is not a belimumab biosimilar: it prices at $18.46 per mg, a fixed 300 mg dose, and it is approved for SLE only, not lupus nephritis. Benlysta's own 200 mg subcutaneous autoinjector and prefilled syringe deliver belimumab as a weekly pharmacy-benefit product, never a J0490 claim.
None of the 26 payers in the belimumab corpus names Saphnelo or another product as preferred ahead of Benlysta. The corpus gates instead on documentation and standard therapy already in place; see Benlysta coverage.
Benlysta's dose, vial sizes and administration coding are covered in full below; see Benlysta dosing.
Benlysta dosing
Both indications share one intravenous schedule: 10 mg/kg over 1 hour at weeks 0, 2 and 4, then every 4 weeks, for adults and children from 5 years. The label sets no dose ceiling.
Limitation of use: the efficacy of Benlysta has not been evaluated in patients with severe active central nervous system lupus, and its use is not recommended in that situation. Benlysta is contraindicated in patients with a prior history of anaphylaxis, or of Stevens-Johnson syndrome or toxic epidermal necrolysis, with belimumab.
| Indication | Starting dose | Continuing dose | Notes |
|---|---|---|---|
| Systemic lupus erythematosus, active, on standard therapy (5 years and older) | 10 mg/kg IV at weeks 0, 2 and 4 (each over 1 hour) | 10 mg/kg q4wk thereafter | The worked example on these pages: 10 mg/kg for 80 kg is 800 mg = 80 units of J0490 from two 400 mg vials, no waste (JZ), 96365 alone. The label sets no maximum dose; the J0490 MUE is 160 units (1,600 mg) a day. |
| Lupus nephritis, active, on standard therapy (5 years and older) | 10 mg/kg IV at weeks 0, 2 and 4 (each over 1 hour) | 10 mg/kg q4wk thereafter | The same schedule and the same units as SLE; only the diagnosis code changes (M32.14 or M32.15). Lupus nephritis appears at 22 of the 26 payers in the corpus. |
| Children 5 years and older (SLE or lupus nephritis) | 10 mg/kg IV at weeks 0, 2 and 4 (each over 1 hour) | 10 mg/kg q4wk thereafter | The label doses children from 5 years on the same 10 mg/kg intravenous schedule as adults. A 30 kg child receives 300 mg = 30 units from one 400 mg vial with 100 mg (10 units) discarded on a JW line, or from three 120 mg vials with 60 mg discarded; the subcutaneous autoinjector is labeled for children from 5 years at 15 kg and over, but the prefilled syringe has not been studied under 18 years. |
Pretreatment workup
Administer Benlysta where anaphylaxis can be managed, and consider premedication for infusion and hypersensitivity reactions before each intravenous dose. Assess the risk of depression and suicide before treatment and continue to monitor for it throughout.
Duration of therapy
Treatment is open-ended: the label sets no stopping point, and its limitation of use is severe active central nervous system lupus, where Benlysta is not recommended. The corpus carries a single reauthorization rule, so continuation is governed by each payer's standard renewal on documented response. The label allows a switch to the subcutaneous 200 mg autoinjector or syringe, a pharmacy-benefit product that takes the patient off the buy-and-bill claim.
Subcutaneous route
The label also lists a subcutaneous regimen: 200 mg once weekly for active SLE, and 400 mg once weekly for 4 doses then 200 mg once weekly for active lupus nephritis. Both the autoinjector and the prefilled syringe are pharmacy-benefit products, not a buy-and-bill claim.
Need the billing units for a patient? Convert dose to J0490 billing units →
Benlysta billing reference
HCPCS
J0490: 10 mg per billing unit. MUE 160 units per day (1,600 mg); the label sets no dose ceiling.
NDCs
Two vial sizes, GSK labeler 49401. Pad to 11 digits with a leading zero in the 3-digit product segment for CMS-1500 Box 24A.
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
49401-101-01 | 49401-0101-01 | 120 mg single-dose vial |
49401-102-01 | 49401-0102-01 | 400 mg single-dose vial |
11-digit NDC required on most claim forms. Use the
N4 qualifier in CMS-1500 Box 24A shaded area with unit of measure and quantity actually drawn from the vial.
Administration
Benlysta's 60-minute infusion is billed with 96365 alone. 96413 and 96415, CPT's chemotherapy administration codes, are the wrong family for a non-oncology monoclonal antibody.
| CPT | Description | Use for |
|---|---|---|
96365 | Intravenous infusion, for therapy, prophylaxis or diagnosis; initial, up to 1 hour | The Benlysta infusion ($67.14, Medicare PFS national non-facility, 2026) |
96366 | Intravenous infusion, for therapy, prophylaxis or diagnosis; each additional hour | Only when the infusion runs more than 30 minutes past the first hour, past 90 minutes total ($21.38, Medicare PFS national non-facility, 2026) |
96413 | Chemotherapy administration, IV infusion technique; up to 1 hour | Wrong family for Benlysta: reserved for chemotherapy, not a non-oncology monoclonal antibody |
Modifiers
JZ: required when no drug is discarded. JW: required for documented waste. The calculators on these pages draw the fewest 120 mg and 400 mg vials that cover the dose, which at the 80 kg reference weight wastes nothing.
Effective July 1, 2023, CMS requires JZ on every no-waste claim and JW on a separate line for documented waste. The 800 mg dose (10 mg/kg for an 80 kg adult) draws two 400 mg vials, no waste, JZ. A 70 kg patient's 700 mg dose also draws two 400 mg vials but discards 100 mg = 10 units on a JW line; a 100 kg patient's 1,000 mg dose draws three 400 mg vials, discarding 200 mg = 20 units.
| Weight | Dose | Vial draw | Administered | Waste / modifier |
|---|---|---|---|---|
| 80 kg | 800 mg (10 mg/kg) | two 400 mg vials | 800 mg | None, JZ |
| 70 kg | 700 mg (10 mg/kg) | two 400 mg vials | 700 mg | 100 mg = 10 units, JW |
| 100 kg | 1,000 mg (10 mg/kg) | three 400 mg vials | 1,000 mg | 200 mg = 20 units, JW |
Claim form
CMS-1500 / 837P (physician office, AIC; POS 11/49) field map for a J0490 claim.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | Format: N4 qualifier + 11-digit NDC + UN + quantity drawn |
| HCPCS J0490 (administered; JZ only if no waste) | 24D (drug line) | Administered units, per MAC rounding |
| HCPCS J0490 + JW (when waste) | 24D (separate line) | Discarded units, per MAC rounding |
| Drug units | 24G | Administered + waste split across two lines, same DOS |
| CPT 96365 | 24D (admin line) | 1 unit for the initial hour; add 96366 only past 90 minutes |
| ICD-10 | 21 | M32.9 (systemic lupus erythematosus), or the code matching the treated indication — see ICD-10 codes by indication |
| NPI | 17b / 24J / 33a | Rendering and billing provider NPI |
| PA number (when required) | 23 | Required by most commercial payers in 2026 |
Benlysta coverage
- 25 of 26 commercial payer policy sets require prior authorization; 1 do not say clearly, so confirm those on the call
- Requirements vary by diagnosis, payer and site of care
- Documentation is the recurring prerequisite: autoantibody positivity or an active SELENA-SLEDAI score for SLE, biopsy-confirmed lupus nephritis for LN, and standard therapy already in place
- Site of care review applies at 12 of 26 payers, steering the infusion toward an office, infusion center or the patient's home
- Another product tried first is required at only 10 of 26 payers; documentation and standard therapy already in place is the more common gate
ICD-10 codes by indication
Two FDA-indicated diagnoses, each mapped to its own dxKey in the payer corpus.
| Indication | ICD-10 | Payers matching this dxKey |
|---|---|---|
| Systemic lupus erythematosus | M32.9 | 26 of 26 |
| Lupus nephritis | M32.14 | 22 of 26 |
Prior authorization and prerequisites
24 of 26 commercial payers require prior authorization. Rule mix across the 296-rule corpus: clinical prerequisite 172, covered indication 46, prior authorization 26, contraindication/exclusion 18, dosing 16, site of care 12, quantity limit 4, step external 1, reauthorization 1.
Quantity limits, quoted verbatim: BCBS MI, "Quantity Limits: Align with FDA recommended dosing"; BCBS TN, "Initial: 10mg/kg every 2 weeks for 3 doses Maintenance: 10mg/kg every 4 weeks"; Centene, "Commercial – 6 months or to member’s renewal date, whichever is longer" (an authorization duration, not a dose cap).
Contraindication and exclusion rules (18) recur around severe active CNS lupus: BCBS MI, "Patient does not have active central nervous system lupus"; Centene, "The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus." BCBS FEP and BCBS HCSC mark all other indications investigational.
Reauthorization, quoted verbatim: BCBS MI, "Clinical documentation must be provided to confirm that current criteria are met and that the medication is providing clinical benefit" — the only renewal rule written in the belimumab corpus.
Site of care / POS
Payer site-of-care UM decides the infusion setting: office (POS 11), AIC (POS 49), or hospital outpatient (POS 22 on-campus, 19 off-campus).
| Setting | POS | Claim form | Electronic | Typical use |
|---|---|---|---|---|
| Physician office / infusion suite | 11 | CMS-1500 | 837P | Most maintenance doses |
| Ambulatory infusion center (AIC) | 49 | CMS-1500 | 837P | Maintenance post site-of-care steering |
| On-campus hospital outpatient | 22 | UB-04 / CMS-1450 | 837I | First dose, reaction history |
| Off-campus hospital outpatient | 19 | UB-04 / CMS-1450 | 837I | First dose at off-campus HOPD |
| Patient home | 12 | CMS-1500 | 837P | Home infusion permitted by some payers (verify) |
Check the patient's actual policy: See Benlysta coverage by payer →
Current Benlysta pricing
Medicare ASP+6%: $58.333 / 10 mg · $4,666.64 / 800 mg. Sequestration reduces Medicare's 80% share by 2% (effective ASP+4.3% overall). Commercial plans pay a contracted rate that differs by payer and state.
13 doses a year (10 mg/kg IV every 4 weeks for an 80 kg adult after the week 0, 2 and 4 loading infusions; a maintenance year is 13 infusions and the first year is 15) at $4,733.78 per infusion — drug plus 96365 administration — total $61,539.14 before the sequester. That is the full annual drug-plus-administration cost for a patient staying on schedule, before benefits or assistance.
Other weights, drug line only: a 70 kg patient's 700 mg dose (two 400 mg vials, 100 mg = 10 units JW) prices at $4,083.31; a 100 kg patient's 1,000 mg dose (three 400 mg vials, 200 mg = 20 units JW) at $5,833.30. A 30 kg child's 300 mg dose (one 400 mg vial, 10 units JW) prices at $1,749.99, before administration or Medigap.
| Basis | Rate / unit (10 mg) | 800 mg total |
|---|---|---|
| Medicare ASP+6% (Q4 2026) | $58.333 | $4,666.64 |
| Aetna commercial median (37 of 37 payer files carry a rate) | $58.51 | $4,680.80 |
Look up commercial reimbursement →
Patient cost
The patient's actual responsibility depends on: payer allowed rate · benefits · − assistance · = patient responsibility.
Calculate a Benlysta patient estimate →
Copay & financial assistance
Commercial: the BENLYSTA Copay Program lets eligible commercially insured patients pay as little as $0 per dose, with an annual maximum set at GSK's discretion (call 1-800-741-0375 for the current cap); it is one of the few cards whose terms also reimburse up to $100 per administration toward the infusion fee. Uninsured: the GSK Patient Assistance Program ships Benlysta free to the provider for qualifying uninsured patients, with no drug-cost limit; Medicare Part D patients are not eligible even in the coverage gap.
Common Benlysta denials & fixes
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong admin code (96413 billed instead of 96365) | Biller defaulted to the chemotherapy family | Resubmit 96365; add 96366 only past 90 minutes total. |
| JW line missing, or JW billed on a JZ draw | Discarded drug not reported separately, or a no-waste draw mistakenly carries JW | Report discarded mg on a separate JW line only when the draw exceeds the dose; use JZ otherwise. |
| Units exceed the 160-unit MUE | Dose computed at 10 mg/kg for a patient over 160 kg (1,600 mg), triggering the J0490 daily MUE | Confirm the ordered dose against the 160-unit MUE before the draw; the label itself sets no ceiling. |
| Standard therapy not documented | PA submitted without evidence corticosteroids, antimalarials or immunosuppressants are already in place, or without autoantibody, SELENA-SLEDAI or biopsy documentation | Submit the standard-therapy record and the diagnosis-specific documentation the payer's policy names. |
| Severe active CNS lupus documented | Benlysta requested for a patient with severe active central nervous system lupus, which the label does not evaluate or recommend | Confirm the limitation of use before submitting; treat CNS lupus under a different protocol. |
| Reauthorization missing clinical-benefit documentation | Renewal submitted without confirmation the patient is responding, the one renewal rule in the belimumab corpus (BCBS MI) | Submit clinical documentation confirming current criteria are met and the medication is providing benefit. |
| Lupus nephritis diagnosis not biopsy-confirmed | PA submitted for lupus nephritis without a kidney biopsy showing active or chronic lesions, which several payers require | Submit the biopsy report confirming Class III, IV or V lupus nephritis, or the specialist confirmation the payer's policy names. |
| J0490 billed for the subcutaneous product | The 200 mg autoinjector or prefilled syringe is a pharmacy-benefit fill, not a medical-benefit infusion claim, but was billed under J0490 anyway | Bill the SC autoinjector or syringe through pharmacy benefit; reserve J0490 for the IV vials. |
| Site of care mismatch | Infusion billed at a setting the payer's site-of-care policy does not allow | Confirm the authorized site before scheduling. |
Frequently asked questions
What is the J code for Benlysta?
Benlysta (belimumab) bills under HCPCS J0490, where 1 billing unit equals 10 mg. An 80 kg adult at the label's 10 mg/kg dose receives 800 mg, reported as 80 units of J0490 on the administered line.
Is Benlysta billed with 96365 or 96413?
96365 (therapeutic infusion, initial hour). Benlysta is a B-lymphocyte stimulator inhibitor, not a chemotherapy agent, so 96413 and 96415, the chemotherapy codes, are the wrong family. The 1-hour infusion is 96365 alone; 96366 applies only past 90 minutes total, which a 1-hour drip does not reach unless it is slowed or held for a reaction.
How many units of Benlysta does an 80 kg patient need?
At 10 mg/kg, an 80 kg patient receives 800 mg, billed as 80 units of J0490 (1 unit = 10 mg). The draw pulls two 400 mg vials, covering the dose exactly with nothing discarded, so the line carries JZ.
What is the dosing for belimumab by indication?
Benlysta uses one intravenous schedule for both indications and every age from 5 years: 10 mg/kg at weeks 0, 2 and 4, then every 4 weeks, with no label ceiling and the subcutaneous route excluded here as a pharmacy-benefit product, not a buy-and-bill claim:
- Systemic lupus erythematosus = 10 mg/kg every 4 weeks with standard therapy such as corticosteroids, antimalarials or immunosuppressants
- Lupus nephritis = 10 mg/kg every 4 weeks with standard therapy for lupus nephritis
- Children 5 years and older = 10 mg/kg every 4 weeks
How often is Benlysta given?
Weeks 0, 2 and 4, then every 4 weeks: the same schedule applies to systemic lupus erythematosus and lupus nephritis, for adults and children from 5 years. Treatment is open-ended: the label sets no stopping point, and continuation depends on each payer's standard renewal on documented response, since the corpus carries only one reauthorization rule.
How is Benlysta waste billed?
Discarded drug from a single-dose vial goes on a separate J0490 line with modifier JW; a dose with nothing discarded takes JZ instead. The 800 mg dose for an 80 kg adult draws two 400 mg vials with no waste (JZ); a 70 kg patient's 700 mg dose also draws two 400 mg vials but discards 100 mg = 10 units on a JW line.
Does Benlysta require prior authorization?
Yes, at 24 of 26 payers in the belimumab corpus. The recurring gate is documentation: autoantibody positivity, an active SELENA-SLEDAI score, or a biopsy-confirmed lupus nephritis diagnosis, and standard therapy such as antimalarials, corticosteroids or immunosuppressants already in place. Another product tried first is required at only 10 of 26 payers.
Does the Benlysta co-pay program pay the infusion fee?
Yes, partly. The BENLYSTA Copay Program is one of the few manufacturer cards that reimburses the administration fee as well as the drug: eligible commercially insured patients can pay as little as $0 per dose, and the program's terms reimburse up to $100 per administration toward the infusion line, with the annual maximum set at GSK's discretion (call 1-800-741-0375 for the current cap); the example estimate on the assistance page applies the card to the drug line only. Residents of Massachusetts and Rhode Island are not eligible for the administration reimbursement, and the program excludes Medicare Part B/D, Medicaid, Medigap, VA, DoD, TRICARE and state pharmaceutical assistance programs.
Sources
- FDA label (DailyMed), BENLYSTA (belimumab), revised 08/2026
- CMS, Medicare Part B Drug ASP Pricing File, Q4 2026
- CMS, Physician Fee Schedule Look-Up Tool
- GSK patient support, BENLYSTA Copay Program and GSK Patient Assistance Program
- 26 commercial payer policies, current as of Aug 2026
Dataset dates: pricing Q4 2026 · payer policies Oct 2026 · assistance Sep 2026.
Reviewed September 21, 2026 by Erin Rose, CareCost Estimate founder. Methodology →