HCPCS
J1299
2 mg = 1 unit (was J1300, 10 mg)
Phase 1
Identify what you're billing
Confirm the right code post-J1300-deactivation, the right product (reference vs biosimilar), and REMS coverage.
HCPCS J1300 → J1299 transition CMS verified May 2026
The biggest eculizumab billing change in a decade — a 5× unit-math shift effective April 1, 2025.
From 2008 through March 31, 2025, eculizumab billed under a single HCPCS code — J1300
("Injection, eculizumab, 10 mg") — with one billable unit per 10 mg of drug. Effective April 1,
2025, CMS deactivated J1300 and replaced it with three distinct codes, all at 2 mg per
unit: J1299 for the Soliris reference product, Q5151 for the Epysqli
biosimilar, and Q5152 for the Bkemv interchangeable biosimilar. The change was driven by the
2024-2025 arrival of two FDA-approved biosimilars and the need for product-specific ASP tracking.
Side-by-side: old vs new unit math
| Element | Before 4/1/2025 | On/after 4/1/2025 |
|---|---|---|
| HCPCS | J1300 (Soliris + biosimilars) | J1299 (Soliris) · Q5151 (Epysqli) · Q5152 (Bkemv) |
| Per-unit basis | 10 mg = 1 unit | 2 mg = 1 unit |
| 900 mg dose units | 90 units | 450 units (5×) |
| 1,200 mg dose units | 120 units | 600 units (5×) |
| 600 mg dose units | 60 units | 300 units (5×) |
| Status | Deleted | Active |
Hard rejection risk. Submitting J1300 for any date of service on or after April 1, 2025 will
reject as an invalid HCPCS code. Submitting J1299 with the old 10-mg unit count (e.g., 90 units for a 900 mg
dose) will pay at one-fifth the correct amount — an underpayment that may not be caught on first review
because the claim line balances internally. Audit your eculizumab claims for any DOS in April-June 2025 for
both errors.
Worked transition example — PNH 900 mg maintenance dose
# DOS prior to 3/31/2025 (legacy J1300):
Drug units billed: 90 · HCPCS: J1300 · 10 mg/unit
# DOS on or after 4/1/2025 (new J1299):
Drug units billed: 450
HCPCS: J1299 · 2 mg/unit · Modifier: JZ (whole-vial use, 3 × 300 mg vials, no waste)
Admin: 96365 (35-min therapeutic IV)
# Same drug, same dose — just different units and code:
900 mg / 10 mg per unit = 90 units (old)
900 mg / 2 mg per unit = 450 units (new)
Drug units billed: 90 · HCPCS: J1300 · 10 mg/unit
# DOS on or after 4/1/2025 (new J1299):
Drug units billed: 450
HCPCS: J1299 · 2 mg/unit · Modifier: JZ (whole-vial use, 3 × 300 mg vials, no waste)
Admin: 96365 (35-min therapeutic IV)
# Same drug, same dose — just different units and code:
900 mg / 10 mg per unit = 90 units (old)
900 mg / 2 mg per unit = 450 units (new)
Source documents for the transition
- CMS HCPCS quarterly file (April 2025 update) — J1300 marked terminated 3/31/2025; J1299 added effective 4/1/2025.
- Noridian April 2025 HCPCS update bulletin — MAC notice of the J1300→J1299 transition with biosimilar code introduction.
- CMS MCD Article A54548 — Eculizumab and biosimilars billing article, updated for the new HCPCS structure.
Some payer remittance systems carried J1300 in a "terminated" state for several weeks of bridge claims; by Q3 2025, all payers we monitor had fully retired the legacy code.
Soliris vs biosimilars — J1299 vs Q5151 vs Q5152 FDA verified May 2026
Same molecule, three HCPCS, three NDCs, three pricing tiers — and one indication (NMOSD) that only Soliris carries.
Soliris is the originator eculizumab, FDA-approved March 16, 2007 by Alexion (now AstraZeneca Rare Disease). Two FDA-approved biosimilars have entered the market: Bkemv (eculizumab-aeeb, Amgen) was FDA-approved May 28, 2024 as the first interchangeable biosimilar to Soliris; it launched at roughly a 10% WAC discount. Epysqli (eculizumab-aagh, Samsung Bioepis with US distribution through Teva) was FDA-approved July 2024 (PNH, aHUS) and added gMG in November 2024; it launched in April 2025 at roughly a 30% WAC discount. Neither biosimilar carries the NMOSD indication — that remains exclusive to the Soliris reference product.
| Soliris (reference) | Bkemv (interchangeable) | Epysqli (biosimilar) | |
|---|---|---|---|
| HCPCS | J1299 | Q5152 | Q5151 |
| Generic | eculizumab | eculizumab-aeeb | eculizumab-aagh |
| Manufacturer | Alexion / AstraZeneca Rare Disease | Amgen | Samsung Bioepis (Teva US) |
| FDA approval | March 16, 2007 (BLA 125166) | May 28, 2024 (interchangeable) | July 2024 (PNH, aHUS); gMG added 11/2024 |
| US launch | 2007 | 2024 (~10% WAC discount) | April 2025 (~30% WAC discount) |
| Vial | 300 mg / 30 mL SDV | 300 mg / 30 mL SDV (identical) | 300 mg / 30 mL SDV (identical) |
| Per-unit basis | 2 mg = 1 unit | 2 mg = 1 unit | 2 mg = 1 unit |
| PNH | Yes | Yes | Yes |
| aHUS | Yes | Yes | Yes |
| gMG (anti-AChR+) | Yes | Yes | Yes (added 11/2024) |
| NMOSD (anti-AQP4+) | Yes | NO | NO |
| REMS | Soliris REMS | Soliris REMS (same) | Soliris REMS (same) |
| Q2 2026 ASP+6% | $44.699 / 2 mg | $41.789 / 2 mg | $31.928 / 2 mg |
NMOSD is reference-only. Coding G36.0 (NMOSD) under
Q5151 or Q5152
is an off-label use that triggers a label-mismatch denial at most payers. NMOSD patients must remain on
Soliris (J1299) or transition to Ultomiris (J1303), which carries the NMOSD label. PNH, aHUS, and gMG patients
can be billed under any of the three eculizumab codes per payer preference.
Interchangeability matters at the pharmacy level — not yet at the medical-benefit level.
Bkemv's FDA interchangeable designation theoretically permits pharmacy-level substitution without prescriber
intervention. In practice, eculizumab is provider buy-and-bill (medical benefit, not retail pharmacy), so the
interchangeable label is more relevant to payer-formulary positioning than to dispensing workflow. Most large
commercial PBMs and Medicare Advantage plans now prefer either Bkemv or Epysqli over reference Soliris for
new starts in PNH, aHUS, and gMG.
Pricing matures unevenly. As of Q2 2026, ASP+6% rates are J1299 $44.699, Q5152 (Bkemv) $41.789,
Q5151 (Epysqli) $31.928. Epysqli's ~28% discount to reference is consistent with its launch positioning;
Bkemv's narrower discount reflects its earlier launch and interchangeable designation. Expect both biosimilar
ASPs to drift down further in subsequent quarters.
Dosing & unit math FDA label current
Indication-specific induction and maintenance, per the 2025 Soliris USPI (BLA 125166).
Adult dose schedule by indication
| Indication | Induction | Maintenance | Maintenance units (J1299) |
|---|---|---|---|
| PNH | 600 mg IV weekly × 4 weeks, then 900 mg week 5 | 900 mg q2wk | 450 units |
| aHUS | 900 mg IV weekly × 4 weeks, then 1,200 mg week 5 | 1,200 mg q2wk | 600 units |
| gMG | 900 mg IV weekly × 4 weeks, then 1,200 mg week 5 | 1,200 mg q2wk | 600 units |
| NMOSD | 900 mg IV weekly × 4 weeks, then 1,200 mg week 5 | 1,200 mg q2wk | 600 units |
- 1 unit = 2 mg under J1299, Q5151, and Q5152 (post-4/1/2025)
- Per dose: 900 mg = 3 vials (3 × 300 mg); 1,200 mg = 4 vials (4 × 300 mg); 600 mg = 2 vials
- Dilution: dilute to 5 mg/mL with 0.9% NaCl (or compatible diluent per label)
- Infusion rate: ~35 minutes total infusion time in adults ≥40 kg
- Maintenance window: may be administered within ±2 days of the scheduled interval
- Storage: refrigerate vials at 2-8°C; if needed, may be kept at ≤25°C for up to 3 days; protect from light
- No premedication required per label (different from many other monoclonal antibodies)
Pediatric dosing
For pediatric aHUS (≥1 month) and pediatric gMG (≥6 years) patients under 40 kg, the FDA label provides weight-band-specific induction and maintenance doses (see Table in Section 2 of the USPI). Soliris is NOT FDA-approved for pediatric PNH or pediatric NMOSD. Weight-band dosing in pediatrics often produces partial-vial waste; bill the discarded mg on a separate JW line.
Worked example — PNH first-year billing
# Induction (weeks 1-4): 600 mg weekly
Drug units per dose: 300 · HCPCS: J1299 · Vials: 2 × 300 mg
Doses: 4 (weeks 1, 2, 3, 4)
# Transition dose (week 5): 900 mg
Drug units: 450 · Vials: 3 × 300 mg
# Maintenance (week 7 onward): 900 mg q2wk
Drug units per dose: 450 · Vials: 3 × 300 mg
Doses in remainder of year-1: ~24 (q2wk for 47 weeks)
# Total year-1 dose count: ~29 doses
# Admin code per dose: 96365 (35-min therapeutic IV)
Drug units per dose: 300 · HCPCS: J1299 · Vials: 2 × 300 mg
Doses: 4 (weeks 1, 2, 3, 4)
# Transition dose (week 5): 900 mg
Drug units: 450 · Vials: 3 × 300 mg
# Maintenance (week 7 onward): 900 mg q2wk
Drug units per dose: 450 · Vials: 3 × 300 mg
Doses in remainder of year-1: ~24 (q2wk for 47 weeks)
# Total year-1 dose count: ~29 doses
# Admin code per dose: 96365 (35-min therapeutic IV)
Required pre-infusion checks (per Soliris REMS)
- Confirm meningococcal vaccination status (MenACWY + MenB) and currency of boosters per ACIP
- Document REMS prescriber certification number on file
- No active or untreated infection
- Patient has received Patient Safety Card and counseling on signs/symptoms of meningococcal infection
NDC reference FDA NDC Directory verified May 2026
| Product | NDC (10-digit) | NDC (11-digit, claim form) | Package | Manufacturer |
|---|---|---|---|---|
| Soliris (J1299) | 25682-001-01 |
25682-0001-01 |
300 mg eculizumab in 30 mL (10 mg/mL) preservative-free SDV | Alexion / AstraZeneca |
| Bkemv (Q5152) | 55513-251-01 (verify) |
11-digit padded form | 300 mg / 30 mL SDV (identical) | Amgen |
| Epysqli (Q5151) | Samsung Bioepis labeler (verify) | 11-digit padded form | 300 mg / 30 mL SDV (identical) | Samsung Bioepis / Teva US |
11-digit NDC required on most claim forms. For Soliris, pad the middle segment with a leading
zero: 25682-0001-01. Use the
N4 qualifier in CMS-1500 Box 24A and UB-04 Box 43.
Confirm Bkemv and Epysqli labeler codes against the current FDA NDC Directory before first claim —
biosimilar NDCs sometimes change between launch packaging and steady-state distribution.
NDC-to-HCPCS mapping is the audit point. The pharmacy must dispense the exact product whose
NDC matches the HCPCS billed. Dispensing a Bkemv vial (Amgen NDC) and billing J1299 is a substitution error
that triggers REMS and audit risk; dispensing Soliris and billing Q5152 underbills the claim. Confirm
product↔HCPCS↔NDC alignment on every encounter.
Soliris REMS — mandatory enrollment Alexion verified May 2026
Soliris is available only through the Soliris REMS program because of the boxed warning for life-threatening and fatal meningococcal infections.
The Soliris REMS exists because eculizumab inhibits terminal complement, which dramatically increases susceptibility to Neisseria meningitidis infections. CDC MMWR data show meningococcal disease rates in eculizumab-treated patients are 1,000 to 2,000× the general-population rate, and cases occur even in fully vaccinated patients. The REMS framework is mandatory; the same requirements apply to the Bkemv (Q5152) and Epysqli (Q5151) biosimilars.
Who must enroll
- Prescribers: certified through Soliris REMS; must agree to counseling and reporting obligations
- Pharmacies / specialty distributors: only REMS-certified channels may dispense
- Infusion centers: verify REMS certification before administering
- Patients: must receive the Patient Safety Card and counseling; must complete vaccination per ACIP
Vaccination requirement
- MenACWY (quadrivalent meningococcal conjugate vaccine) per ACIP schedule
- MenB (serogroup B meningococcal vaccine) per ACIP schedule
- Both must be completed at least 2 weeks before the first eculizumab dose
- If urgent eculizumab therapy is required and the patient is unvaccinated: administer antibacterial prophylaxis (typically penicillin-class) and vaccinate as soon as feasible
- Booster doses per ACIP recommendations while on therapy
- Patient counseling on signs/symptoms of meningococcal infection at every visit
Patient Safety Card
Every patient must receive (and carry) a Patient Safety Card describing the boxed warning, vaccination history, the prescriber's contact information, and instructions to seek immediate medical care for fever or other signs of infection. Documentation that the card was provided is a frequent payer audit target.
Billing implications
There is no separate REMS HCPCS code — REMS enrollment is not billable. However, documentation of REMS enrollment and meningococcal vaccination status is required by virtually every payer's prior authorization. Notes should reference REMS prescriber certification on each infusion encounter, and the vaccination dates should be in the chart.
Contact: Soliris REMS — through Alexion OneSource at 1-888-765-4747. Web: alexiononesource.com/soliris.
Vaccination noncompliance = liability. Eculizumab administration in an unvaccinated patient
without antibacterial prophylaxis is both a REMS violation and a potential malpractice exposure if
meningococcal infection occurs. Document MenACWY + MenB completion dates in the chart at induction and
confirm currency at each renewal.
The REMS travels with the molecule. Switching a patient from Soliris (J1299) to Bkemv (Q5152)
or Epysqli (Q5151) does not require new REMS enrollment if the prescriber and site are already certified
under Soliris REMS — the framework covers all three eculizumab products. Patient vaccination status
carries over.
Phase 2
Code the claim
Build the line items: admin code, modifiers, indication-specific ICD-10, site of care.
Administration codes CPT verified May 2026
Soliris is non-chemotherapeutic — use therapeutic infusion codes, not chemo.
| Code | Description | When to use |
|---|---|---|
96365 |
IV infusion, for therapy/prophylaxis/diagnosis; initial, up to 1 hour | Primary code. Soliris infuses over ~35 minutes in adults ≥40 kg. |
+96366 |
IV infusion, for therapy/prophylaxis/diagnosis; each additional hour | Rarely billed for monotherapy — the 35-minute infusion fits within the first hour. May apply for pediatric weight-band dosing where slower rates are used. |
96413 / 96415 |
Chemotherapy IV administration codes | Not appropriate. Eculizumab is a non-chemotherapeutic monoclonal antibody. |
96367 |
Each additional sequential infusion of new drug | If a separate concurrent therapy (e.g., iron) is administered the same day. |
Why not chemo: some payers historically denied 96413 for non-chemotherapeutic monoclonal
antibodies. Eculizumab has always billed under 96365. Don't be tempted to bill chemo admin codes for the
higher reimbursement — the documentation won't support it and it triggers audit risk.
Same admin code for biosimilars. Bkemv (Q5152) and Epysqli (Q5151) infusions also use 96365.
The drug HCPCS changes; the admin CPT does not.
Modifiers CMS verified May 2026 — verify JZ list
JZ — whole-vial use, default expectation
Effective July 1, 2023, CMS requires JZ on all claims for single-dose container drugs when no drug is discarded. The Soliris 300 mg vial paired with adult dosing yields whole-vial multiples for the standard regimens: 600 mg = 2 vials, 900 mg = 3 vials, 1,200 mg = 4 vials. JZ is the expected modifier on most adult claims. Verify against the current CMS single-dose container list at billing time — the list is updated quarterly and biosimilar inclusion has lagged the reference product.
JW — pediatric weight-band dosing
Pediatric aHUS and gMG patients under 40 kg receive weight-band-specific doses (e.g., 600 mg for a 10-20 kg patient = 2 vials with no waste, but 300 mg for a <10 kg patient uses 1 vial with no waste; intermediate doses can produce partial-vial waste). When a partial vial is discarded, bill the wasted mg on a separate line with the JW modifier. Document the wasted volume in the medical record.
Modifier 25 — situational
Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion. Routine pre-infusion REMS / vaccination check is bundled.
340B modifiers (JG, TB)
For 340B-acquired Soliris, follow your MAC's current 340B modifier policy. Many 340B-eligible centers use the biosimilars (Bkemv or Epysqli) preferentially because the 340B discount stacks more favorably on the biosimilar baseline.
Double-check single-dose container inclusion. Per CMS, the JZ requirement applies only to
codes on the published single-dose container list. J1299 (and the biosimilar Q-codes) were added to the list
for the April 2025 update cycle, but MAC implementation varies. Default behavior: include JZ when no drug is
wasted, and be prepared for occasional MAC inconsistencies during the first few quarters under the new codes.
ICD-10-CM diagnosis codes FY2026 verified May 2026
Soliris's full diagnosis space — PNH, aHUS, gMG, NMOSD.
| ICD-10 | Description | Indication | Eligible for biosimilars? |
|---|---|---|---|
D59.5 | Paroxysmal nocturnal hemoglobinuria (Marchiafava-Micheli) | PNH | Yes (Bkemv + Epysqli) |
D59.32 | Hereditary hemolytic-uremic syndrome (atypical HUS) | aHUS | Yes (Bkemv + Epysqli) |
D59.31 | Infection-associated hemolytic-uremic syndrome (Shiga-toxin HUS) | NOT eculizumab-eligible | No |
D59.39 | Other hemolytic-uremic syndrome | Verify; aHUS preferred under D59.32 | Per payer policy |
G70.00 | Myasthenia gravis without (acute) exacerbation | gMG (anti-AChR+) | Yes (Bkemv + Epysqli) |
G70.01 | Myasthenia gravis with (acute) exacerbation | gMG (anti-AChR+) | Yes (Bkemv + Epysqli) |
G36.0 | Neuromyelitis optica (Devic's disease) | NMOSD (anti-AQP4+) | NO — Soliris reference only |
Shiga-toxin HUS is a hard exclusion for aHUS coding. Eculizumab is FDA-approved for atypical
HUS (D59.32), not for Shiga-toxin-producing E. coli HUS (D59.31). Submitting D59.31 will deny.
Coverage criteria require positive ADAMTS13 activity (>10%) to rule out TTP and absence of Shiga-toxin
evidence. Document the differential explicitly in the chart.
Diagnostic confirmation is part of the PA. Most payers require:
- PNH: flow cytometry showing GPI-deficient (CD55/CD59-negative) clones with quantification
- aHUS: exclusion of Shiga-toxin HUS and ADAMTS13 activity >10% (rules out TTP)
- gMG: positive anti-AChR antibody titer (anti-MuSK gMG is NOT a covered indication)
- NMOSD: positive anti-AQP4-IgG, ideally by cell-based assay (preferred over ELISA)
NMOSD codes flow only to J1299. Coding G36.0 with Q5151 or Q5152 is an off-label-for-the-product
denial, even though eculizumab as a molecule is approved for NMOSD. The label belongs to Soliris (the reference
product), not to the biosimilars.
Site of care & place of service Verified May 2026
Soliris's 35-minute infusion + brief observation fits ambulatory infusion settings cleanly. UHC, Aetna, and Cigna all run site-of-care UM programs that steer high-cost biologics away from hospital outpatient toward non-hospital sites and home infusion. Many plans now require AIC or home infusion for stable maintenance eculizumab patients.
| Setting | POS | Claim form | Electronic |
|---|---|---|---|
| Physician office | 11 | CMS-1500 | 837P |
| Ambulatory infusion suite | 49 | CMS-1500 | 837P |
| Hospital outpatient | 19 or 22 | UB-04 / CMS-1450 | 837I |
| Patient home | 12 | CMS-1500 (with home-infusion HCPCS) | 837P |
REMS site requirement: regardless of POS, the site must be enrolled in Soliris REMS. Home
infusion vendors must be REMS-certified; confirm vendor REMS status before scheduling a home dose. The
patient's vaccination record must also be confirmed prior to each dose.
HOPD steering watch: at most major payers (UHC, Aetna, Cigna, Carelon), HOPD-administered
eculizumab is approved only when a clinically appropriate AIC or home option is unavailable. Continuing a
patient at HOPD without site-of-care justification frequently triggers redirection at re-authorization.
Claim form field mapping Verified May 2026
CMS-1500 / 837P (physician office, AIC; POS 11/49).
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | Format: N425682000101ML30 (Soliris 1 vial) |
| HCPCS J1299 + admin CPT 96365 | 24D | Each on its own line; 1299 carries the unit count, 96365 carries the admin time |
| Drug units | 24G | 450 (for 900 mg dose) or 600 (for 1,200 mg dose); 2 mg/unit basis |
| ICD-10 | 21 | D59.5 (PNH), D59.32 (aHUS), G70.00/G70.01 (gMG), G36.0 (NMOSD) |
| PA number | 23 | Required by virtually all payers |
| REMS reference (encouraged) | Box 19 / NTE segment | Soliris REMS prescriber certification number for audit-readiness |
| Vaccination dates (encouraged) | Documented in chart | MenACWY + MenB completion dates; commonly requested at PA renewal |
Form references: NUCC (CMS-1500).
Phase 3
Get paid
Strict PA, biosimilar step therapy spreading, and Ultomiris cost-minimization steering are the three trends to watch.
Payer policy snapshot Reviewed May 2026
Strict PA universal; biosimilar step therapy spreading rapidly; Ultomiris frequently preferred for new starts.
| Payer | PA? | Biosimilar step therapy? | Ultomiris preferred? | Re-auth |
|---|---|---|---|---|
| UnitedHealthcare Eculizumab medical policy |
Yes | Yes — Bkemv or Epysqli required first for PNH/aHUS/gMG (NMOSD exempt) | Often, for new starts | 12 mo w/ documented response |
| Aetna CPB on complement inhibitors |
Yes | Yes — biosimilar trial required at re-auth | Yes, for cost-minimization | 12 mo w/ response criteria |
| Anthem / Carelon CG-DRUG eculizumab/ravulizumab |
Yes | Yes — biosimilar preferred at new start | Often combined eculizumab/ravulizumab policy | w/ disease stability |
| Cigna Coverage policy 1018 |
Yes | Yes | Frequent steering to Ultomiris on cost-minimization | w/ documented response |
| Most Medicare Advantage | Yes | Increasingly | Plan-specific | Annual |
Key trend: two converging cost-control strategies are reshaping eculizumab coverage. (1)
Biosimilar step therapy: most major payers now require trial of Bkemv or Epysqli before approving Soliris for
on-label biosimilar indications. (2) Ultomiris steering: many of the same payers prefer Ultomiris over Soliris
on cost-minimization (4× fewer infusions per year = lower administration spend). Net effect: new-start
Soliris is increasingly limited to NMOSD (the only indication not on biosimilars and not always favored on
Ultomiris cost-min calculations).
Renewals are not automatic. Reauthorization requires documented clinical response: LDH
normalization for PNH, MG-ADL improvement for gMG, EDSS stability and absence of attacks for NMOSD, and
platelet/creatinine response for aHUS. Lab and clinical-scale documentation should be in the chart at every
re-auth window.
What to document for approval
- Confirmed diagnosis with required confirmatory testing (flow cytometry for PNH, ADAMTS13 for aHUS, anti-AChR for gMG, anti-AQP4 for NMOSD)
- Soliris REMS prescriber certification on file
- MenACWY + MenB vaccination completion dates ≥2 weeks before first dose (or antibacterial prophylaxis documentation)
- For PA at most payers: trial of biosimilar (Bkemv or Epysqli) for PNH/aHUS/gMG, OR documented clinical reason to use reference Soliris
- For NMOSD: positive anti-AQP4-IgG and rationale why Ultomiris is not appropriate (if payer prefers Ultomiris)
- Baseline labs (LDH/haptoglobin for PNH; CBC/LDH/creatinine for aHUS; MG-ADL for gMG)
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J1299 (Soliris reference)
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$44.699
per 2 mg unit
900 mg dose
$20,114.55
450 units × ASP+6%
1,200 mg dose
$26,819.40
600 units × ASP+6%
Eculizumab family pricing — Q2 2026
| HCPCS | Product | ASP+6% per unit | 900 mg dose | 1,200 mg dose |
|---|---|---|---|---|
J1299 | Soliris (reference) | $44.699 | $20,114.55 | $26,819.40 |
Q5152 | Bkemv (interchangeable) | $41.789 | $18,805.05 | $25,073.40 |
Q5151 | Epysqli (biosimilar) | $31.928 | $14,367.60 | $19,156.80 |
Annualized maintenance cost (PNH, 900 mg q2wk):
- J1299 (Soliris): ~26 doses/yr × $20,114.55 = ~$522,978/yr per patient
- Q5152 (Bkemv): ~$488,931/yr (~7% lower than Soliris)
- Q5151 (Epysqli): ~$373,558/yr (~29% lower than Soliris)
Coverage
No NCD specific to eculizumab. Coverage falls under the generic drug-coverage LCD framework, with the new CMS MCD Article A54548 providing eculizumab- and biosimilar-specific billing instructions (including the J1300→J1299 transition, biosimilar Q-codes, and required documentation). All MACs cover J1299 for FDA-approved on-label indications when the standard PA criteria are met.
Code history
- 2007 — FDA approval; initially billed under unclassified codes
- 2008 —
J1300assigned, "Injection, eculizumab, 10 mg" (10 mg = 1 unit) - April 1, 2024 —
Q5152Bkemv added (interchangeable biosimilar) - April 1, 2025 —
Q5151Epysqli added; J1300 deactivated;J1299activated ("Injection, eculizumab, 2 mg") — all eculizumab products move to 2 mg/unit basis
Patient assistance — Alexion OneSource Alexion verified May 2026
Single hub for the Alexion rare-disease portfolio (Soliris, Ultomiris, Strensiq, Voydeya).
- Alexion OneSource: 1-888-765-4747 (M–F)
- Insurance navigation + benefits investigation (commercial, Medicare, Medicaid)
- Soliris REMS enrollment support (prescriber, site, patient)
- Soliris Co-Pay Program: commercial copay assistance for eligible patients (income limit historically ~500% FPL; excludes Medicare, Medicaid, federal program patients)
- Independent foundation referral for Medicare and Medicaid patients (Alexion does not offer a free-product PAP for federal-program patients; routes via independent foundations)
- Bridge / replacement programs for coverage gaps
- In-home infusion coordination through REMS-certified vendors
- Email: OneSource@alexion.com
- Web: alexiononesource.com/soliris
Independent foundations (for Medicare / Medicaid / uninsured)
- NORD (National Organization for Rare Disorders) — PNH and aHUS funds historically open intermittently
- PAN Foundation — PNH, aHUS, gMG, and NMOSD funds open as funding allows; check status before each enrollment cycle
- Aimed Alliance — advocacy and limited financial support
- HealthWell Foundation — periodic disease-specific funds for the Soliris indications
Foundation funds open and close. Eculizumab's annual cost (~$500K+/year) means foundation
co-pay funds are typically depleted within weeks of opening. Set up alerts with NORD, PAN, and HealthWell;
enroll patients at the moment a fund opens.
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J1299 pre-loaded.
Phase 4
Fix problems
J1300 legacy submissions, biosimilar substitution at re-auth, and NMOSD off-label-on-biosimilar are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Invalid HCPCS — J1300 | Legacy J1300 submitted for DOS on/after 4/1/2025 | Resubmit under J1299 (Soliris reference) with units recalculated at 2 mg/unit (multiply old unit count × 5). |
| Underpayment — correct HCPCS, wrong unit math | J1299 submitted with old 10-mg unit count (e.g., 90 units for 900 mg dose) | Resubmit corrected claim with proper 2-mg-per-unit count: 900 mg = 450 units, 1,200 mg = 600 units, 600 mg = 300 units. |
| Wrong product code — J1299 billed for Bkemv/Epysqli | Pharmacy dispensed biosimilar but claim coded as reference | Resubmit under correct Q-code (Q5151 for Epysqli, Q5152 for Bkemv). Confirm vial NDC matches HCPCS on every claim. |
| NMOSD denied under Q5151 / Q5152 | NMOSD (G36.0) coded against biosimilar HCPCS | NMOSD is reference-only. Resubmit under J1299 (Soliris) or transition patient to Ultomiris (J1303). Bkemv and Epysqli labels do NOT include NMOSD. |
| Biosimilar step therapy — Soliris denied as new start | Payer requires Bkemv or Epysqli trial first for PNH/aHUS/gMG | Submit biosimilar trial documentation OR clinical justification for reference (e.g., contraindication, demonstrated failure, NMOSD). Many payers accept "patient stable on reference" only when documented before policy change. |
| Ultomiris cost-minimization denial | Payer prefers Ultomiris (J1303) over Soliris on cost grounds | For PNH/aHUS/gMG: appeal with patient-specific reason (transition risk, prior intolerance, vascular access). For NMOSD: both products carry NMOSD — appeal requires clinical-not-cost rationale. |
| REMS not on file | Prescriber or site not enrolled in Soliris REMS | Complete Soliris REMS enrollment via Alexion OneSource (1-888-765-4747). Resubmit with REMS reference. REMS framework also covers Bkemv and Epysqli. |
| Vaccination not documented | Payer requires MenACWY + MenB completion dates ≥2 weeks before first dose | Submit vaccination history with dates. If urgent dose required pre-vaccination: document antibacterial prophylaxis administration. |
| aHUS confused with Shiga-toxin HUS | D59.31 (Shiga-toxin HUS) coded instead of D59.32 (aHUS) | Eculizumab is approved for D59.32 only. Document differential: ADAMTS13 >10% (rules out TTP), absence of Shiga-toxin evidence. Recode to D59.32. |
| gMG anti-MuSK denial | gMG without anti-AChR positivity | Soliris is approved for anti-AChR-positive gMG only. Anti-MuSK gMG patients are not eligible — consider rituximab or other agents. |
| JZ/JW modifier dispute | MAC interpretation of single-dose container list inconsistent during 2025 transition | Verify CMS list at billing time. Default: include JZ when no waste; document if rejected. |
| NDC format | 10-digit NDC submitted; payer requires 11-digit | Use 11-digit form: 25682-0001-01 with N4 qualifier (for Soliris). |
Frequently asked questions
What is the HCPCS code for Soliris?
Soliris (eculizumab) is billed under HCPCS J1299 — "Injection, eculizumab, 2 mg" —
for dates of service on or after April 1, 2025. The legacy code J1300 ("Injection, eculizumab,
10 mg") was deactivated effective March 31, 2025. Each 2 mg equals one billable unit, so the standard 900 mg
PNH maintenance dose is billed as 450 units of J1299. The biosimilars use separate codes: Q5151
for Epysqli (eculizumab-aagh) and Q5152 for Bkemv (eculizumab-aeeb), both also at 2 mg per unit.
Why was J1300 deactivated and what replaced it?
CMS deactivated J1300 (10 mg per unit) effective March 31, 2025 to align eculizumab billing with the new biosimilar landscape. Effective April 1, 2025, three new HCPCS codes — all at 2 mg per unit — replaced it: J1299 for the Soliris reference product, Q5151 for Epysqli (eculizumab-aagh, Samsung Bioepis/Teva), and Q5152 for Bkemv (eculizumab-aeeb, Amgen, the first FDA-designated interchangeable biosimilar). The change requires a 5× multiplier on unit math: a 900 mg dose was 90 units under J1300 but is 450 units under J1299/Q5151/Q5152.
How is Soliris dosed?
Indication-specific. PNH: 600 mg IV weekly × 4 weeks (induction), then 900 mg week 5, then 900 mg every 2 weeks. aHUS, gMG, and NMOSD: 900 mg IV weekly × 4 weeks (induction), then 1,200 mg week 5, then 1,200 mg every 2 weeks. Maintenance dosing may be administered within ±2 days of the scheduled interval. Pediatric aHUS and gMG patients under 40 kg use weight-band dosing per the FDA label. Soliris is NOT FDA-approved for pediatric PNH or pediatric NMOSD.
Does Soliris have a REMS program?
Yes. Soliris is available only through the Soliris REMS program because of the boxed warning for life-threatening and fatal meningococcal infections (risk 1,000 to 2,000× higher than the general population, even after vaccination). Prescribers must enroll. Patients must complete MenACWY plus MenB vaccination per ACIP at least 2 weeks before the first dose; if urgent therapy cannot wait, antibacterial prophylaxis must be administered while the patient is vaccinated. The biosimilars Bkemv (Q5152) and Epysqli (Q5151) carry the same REMS requirements.
What is the administration code for Soliris?
CPT 96365 — "Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to
1 hour." Soliris infuses over approximately 35 minutes in adults (≥40 kg), so the infusion fits within the
first hour and 96366 (each additional hour) is rarely billed. Eculizumab is non-chemotherapeutic, so 96413
(chemo administration) is NOT appropriate.
What indications does Soliris cover that the biosimilars do not?
NMOSD (neuromyelitis optica spectrum disorder, anti-AQP4 antibody positive) is approved for Soliris reference product only. The biosimilars Bkemv (Q5152) and Epysqli (Q5151) carry approvals for PNH, aHUS, and generalized myasthenia gravis (gMG) but NOT NMOSD. Coding NMOSD (G36.0) under Q5151 or Q5152 will trigger a label-mismatch denial.
Should patients be steered to the eculizumab biosimilars?
Increasingly, yes — for the on-label biosimilar indications. Bkemv (Amgen, FDA-approved May 2024 as the first interchangeable biosimilar to Soliris) launched at roughly a 10% WAC discount. Epysqli (Samsung Bioepis/Teva, launched April 2025) launched at roughly a 30% WAC discount. Many commercial payers and Medicare Advantage plans now require step therapy through Bkemv or Epysqli before approving Soliris for PNH, aHUS, or gMG. NMOSD remains the exclusive domain of the reference product.
How does Soliris compare to Ultomiris?
Ultomiris (ravulizumab-cwvz, J1303 at 10 mg per unit) is Alexion's longer-acting C5 inhibitor:
maintenance dosing every 8 weeks versus every 2 weeks for Soliris (4× less frequent). Same FDA-approved
indications (PNH, aHUS, gMG, NMOSD), same Alexion REMS framework. Many commercial payers now PREFER Ultomiris
over Soliris on cost-minimization grounds because four times fewer infusions per year means substantially
lower administration spend. Patient burden: 26 IV infusions per year on Soliris vs 6-7 on Ultomiris. There
is no biosimilar to Ultomiris yet.
What is the Medicare reimbursement for J1299?
For Q2 2026, the Medicare Part B payment limit for J1299 (Soliris reference) is $44.699 per 2 mg unit (ASP + 6%). The standard 900 mg PNH maintenance dose reimburses at approximately $20,114.55 (450 units × $44.699), and the 1,200 mg gMG/aHUS/NMOSD maintenance dose reimburses at approximately $26,819.40 (600 units × $44.699), both before sequestration. Q5151 (Epysqli) is $31.928 per unit and Q5152 (Bkemv) is $41.789 per unit. ASP is updated quarterly by CMS.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- FDA — Soliris (eculizumab) Prescribing Information, 2025
- DailyMed — SOLIRIS (eculizumab) Prescribing Information
- HCPCSdata — J1299 reference page
- Noridian — April 2025 HCPCS quarterly update
- CMS MCD — Article A54548 (Eculizumab and biosimilars billing)
- FDA — Bkemv (eculizumab-aeeb) approval announcement, May 28, 2024
- Teva / Samsung Bioepis — Epysqli launch announcement (April 2025)
- CDC MMWR — High Risk for Invasive Meningococcal Disease Among Patients Receiving Eculizumab
- Alexion OneSource — Soliris support hub
- CMS — Medicare Part B Drug ASP Pricing File
- CMS — HCPCS quarterly update file (canonical J-code source)
- FDA National Drug Code Directory
- AAPC — HCPCS J1299
About this page
We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing (J1299, Q5151, Q5152) | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, Carelon, Cigna) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules + CMS single-dose container list | Quarterly | JZ/JW applicability for J1299, Q5151, Q5152 still maturing post-transition. |
| NDC, dosing, FDA label | Event-driven | Tied to manufacturer document version + FDA label revision date. |
| Soliris REMS requirements | Annual | Reviewed against Alexion / Soliris REMS program documentation. |
| Biosimilar policy + Ultomiris steering | Quarterly | Both Bkemv/Epysqli step therapy and Ultomiris cost-minimization preferences are evolving. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS, manufacturer,
payer documents — all linked above). Final review by our SME, Catherine Rose (CPC), is in progress.
Until that review is complete, treat this as a draft reference and verify each cited source for high-stakes
claims, especially the J1300→J1299 unit-math change.
Change log
- — Initial publication. ASP data: Q2 2026 (J1299 = $44.699 per 2 mg unit; Q5152 Bkemv = $41.789; Q5151 Epysqli = $31.928). Code transition documented: J1300 deactivated 3/31/2025, J1299/Q5151/Q5152 active 4/1/2025 (all 2 mg/unit, 5× the prior unit count). Payer policies: UHC, Aetna, Anthem/Carelon, Cigna — all now require biosimilar step therapy for on-label indications; Ultomiris cost-minimization steering noted at multiple plans. NMOSD remains reference-only.
Methodology
Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. We do not paraphrase from billing-software vendor blogs. The J1300→J1299 transition is documented against the CMS HCPCS quarterly file, MAC bulletins (Noridian), and CMS MCD Article A54548. When MAC implementation guidance is inconsistent (as with single-dose container list inclusion in the months immediately following the transition), we surface the ambiguity rather than asserting a definitive answer.