Ultomiris (ravulizumab-cwvz) — HCPCS J1303

Ultomiris vs. Soliris — J1303 vs. J1299 FDA verified May 2026

Same indications, same REMS platform — different molecule, different dosing frequency, different unit basis.

Ultomiris (ravulizumab-cwvz) is Alexion's longer-acting C5 complement inhibitor, FDA-approved December 2018 as the successor to Soliris (eculizumab). Ravulizumab was engineered with four amino-acid substitutions that recycle the antibody back into circulation via the neonatal Fc receptor, extending the half-life to approximately 50 days — roughly 4× longer than eculizumab's ~11 days. The clinical implication: q8wk maintenance dosing instead of q2wk, eliminating roughly 20 IV infusions per year for a chronic patient.

Both drugs share the combined ULTOMIRIS and SOLIRIS REMS platform (UltSolREMS.com), but enrollment is product-specific: a prescriber, pharmacy, or infusion site enrolled for one drug is NOT automatically authorized for the other. Soliris also has two FDA-approved biosimilars (Bkemv from Amgen, Q5152; Epysqli from Samsung Bioepis, Q5151); Ultomiris currently has no approved biosimilar.

Weight-banded dosing & unit math FDA label current

From DailyMed Ultomiris prescribing information (BLA 761108, 2024 revision with s037 SC supplement).

FDA-labeled IV dose schedule — PNH and aHUS (adult):

gMG and NMOSD (adult, ≥40 kg): identical weight-banded loading and q8wk maintenance schedule.

Pediatric PNH and aHUS (≥1 month, ≥5 kg): separate weight-banded table with q4wk maintenance for <20 kg patients and q8wk for ≥20 kg. Refer to FDA label, Table 1, for the full pediatric schedule.

• 1 unit = 10 mg: divide milligram dose by 10 to get billable J1303 units
• Schedule flexibility: maintenance doses may be given ±7 days from scheduled date — except the first maintenance dose, which must be given exactly on Day 15
• Dilution: dilute to 5 mg/mL with 0.9% NaCl prior to IV infusion
• Premedication: not routinely required, but not contraindicated
• Supplemental dosing required after concomitant plasma exchange / fresh frozen plasma infusion (per label, Table 6)

Worked example — adult PNH, 75 kg patient, first year

Required pre-infusion checks (per ULTOMIRIS REMS)

• Confirm patient is enrolled in ULTOMIRIS REMS and current on monitoring
• Confirm meningococcal vaccination current per ACIP — serogroups A, C, W, Y, AND B
• Verify REMS Patient Safety Card is in patient's possession
• Screen for signs/symptoms of meningococcal infection (fever, headache, neck stiffness, rash)
• For PNH: hemoglobin, LDH, reticulocyte count, breakthrough hemolysis screen
• For aHUS: platelet count, LDH, serum creatinine, schistocyte review
• For gMG: MG-ADL or QMG (clinical response monitoring)
• For NMOSD: relapse activity assessment
• No active infection (any source)

NDC reference FDA NDC Directory verified May 2026

All single-dose vials at 100 mg/mL concentration; SC cartridge at 70 mg/mL.

IV concentrate (single-dose vials)

SC OnBody Injector (cartridge)

Cartridge package suffix varies by kit configuration; confirm current 11-digit NDC against the cartridge box at fill.

Vial-mix planning for waste minimization

Because doses are weight-banded (2,400 / 2,700 / 3,000 / 3,300 / 3,600 mg) and vials come in 300 mg and 1,100 mg sizes only, certain combinations produce unavoidable waste. Plan vial draws against this table:

ULTOMIRIS REMS — mandatory enrollment Alexion verified May 2026

Ultomiris is available only through the ULTOMIRIS REMS program — shared platform with Soliris on UltSolREMS.com, but separate enrollment per drug.

Per FDA, "ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ULTOMIRIS REMS." The combined ULTOMIRIS and SOLIRIS REMS platform (UltSolREMS.com) provides one portal for both Alexion C5 inhibitors, but each prescriber, pharmacy, and infusion site must enroll per-drug. A Soliris REMS-certified site is not automatically authorized to administer Ultomiris.

Who must enroll

• Prescribers: certified per drug; must agree to monitoring, reporting, and patient counseling obligations
• Pharmacies / specialty distributors: only ULTOMIRIS REMS–certified pharmacies may dispense Ultomiris
• Infusion centers / hospital outpatient sites: must complete site enrollment before administering
• Patients: enrolled with prescriber, receive REMS Patient Safety Card and Medication Guide, complete vaccination requirements

Meningococcal vaccination requirement (boxed warning)

• Vaccinate against Neisseria meningitidis serogroups A, C, W, Y, AND B per current ACIP recommendations
• Complete vaccination at least 2 weeks before the first Ultomiris dose
• If urgent therapy is required before vaccination is complete: antibacterial prophylaxis for at least 2 weeks after vaccination is administered
• Re-vaccinate per current ACIP guidance throughout therapy
• Counsel patients on early signs of meningococcal infection (fever, headache, neck stiffness, photophobia, rash) and the need to seek immediate care

Required monitoring

• Disease-specific labs (PNH: LDH, reticulocyte count, hemoglobin; aHUS: platelets, creatinine, schistocytes; gMG: MG-ADL/QMG; NMOSD: relapse activity)
• Breakthrough hemolysis surveillance (PNH) — particularly between week 6 and dose 8 in q8wk cycle
• Infection screening at each encounter
• Confirm REMS Patient Safety Card is in patient's possession at each visit
• Continue meningococcal infection surveillance for 8 months after the last dose
• Report meningococcal infections, opportunistic infections, hospitalizations, and deaths to UltSol REMS

Billing implications

There is no separate REMS HCPCS code — REMS enrollment is not billable. However, documentation of ULTOMIRIS REMS enrollment is a frequent payer audit target. Notes should reference the REMS enrollment ID on each infusion encounter, along with current meningococcal vaccination status (date and serogroups). Most payers' Ultomiris PA criteria require attestation that the prescriber and patient are enrolled in ULTOMIRIS REMS and that vaccination requirements are met.

Contact: ULTOMIRIS & SOLIRIS REMS / Alexion, 1-888-765-4747. Web: UltSolREMS.com.

SC Ultomiris OnBody Injector — billing pathway FDA s037 verified May 2026

FDA approved March 4, 2024 (s037 supplement). Adult PNH only. Different benefit pathway from IV.

The Ultomiris OnBody Injector is a wearable, single-use device that delivers 490 mg ravulizumab subcutaneously once weekly via two 245 mg/3.5 mL cartridges. Approved indication: adult PNH only (other indications remain IV-exclusive as of Q2 2026). Patients self-administer at home in the abdomen, thigh, or upper arm after IV loading is complete.

Key billing differences vs IV

Transitioning a patient from IV to SC

1. Confirm eligibility: adult, PNH only, currently on IV maintenance with stable disease control
2. Re-verify REMS: ULTOMIRIS REMS enrollment must remain current — SC is the same drug, no new REMS authorization needed but documentation should reflect SC transition
3. Coordinate with specialty pharmacy: most payers require an SP fill rather than buy-and-bill; SP will ship cartridges and OnBody Injectors to the patient
4. First SC dose typically administered or observed in-clinic for patient training and tolerance assessment — bill E/M + drug administration code (96401 or 96372 per payer guidance) under medical benefit
5. Subsequent doses: patient self-administers at home; no professional admin code billable; refills run through SP under pharmacy benefit
6. Storage at home: patient must refrigerate cartridges at 2–8°C; OneSource provides device training and storage instructions

Administration codes CPT verified May 2026

Ultomiris is non-chemotherapeutic — use therapeutic infusion codes, not chemo.

Infusion duration by dose (per label dose-rate table)

Per FDA label, IV infusion times vary by dose volume and patient weight band:

• Maintenance doses (3,000–3,600 mg): typically 30–45 minutes — bill 96365 only
• Loading doses (2,400–3,000 mg): typically 1.7–2.4 hours — bill 96365 + 96366 × 1 or × 2
• Pediatric and lower weight bands: shorter infusion times per label; verify against current Table 4 in the prescribing information

Modifiers CMS verified May 2026 — JW common for J1303

JZ — whole-vial use, when applicable

Effective July 1, 2023, CMS requires JZ on all single-dose container drug claims when no drug is discarded. For J1303, JZ applies when the vial-mix exactly matches the prescribed dose — primarily the 3,300 mg maintenance dose (1 × 1,100 mg + 7 × 300 mg = 3,300 mg exact) or doses filled entirely with 300 mg vials (e.g., 3,000 mg as 10 × 300 mg).

JW — discarded amount, frequently applies to J1303

Unlike single-vial drugs (Tysabri, Ocrevus), Ultomiris's combination of weight-banded dosing (2,400/2,700/3,000/3,300/3,600 mg) and fixed vial sizes (300 mg, 1,100 mg) means partial-vial waste is common and reimbursable. Document the discarded amount on the line item with the JW modifier and the wasted-units count. Examples:

• 2,400 mg load: 2 × 1,100 mg + 1 × 300 mg = 2,500 mg drawn → 100 mg waste → bill 240 units administered (JZ?) + 10 units discarded (JW)
• 2,700 mg load: 2 × 1,100 mg + 2 × 300 mg = 2,800 mg drawn → 100 mg waste → bill 270 admin + 10 JW
• 3,600 mg maint: 2 × 1,100 mg + 5 × 300 mg = 3,700 mg drawn → 100 mg waste → bill 360 admin + 10 JW

SC OnBody — modifiers

For the SC formulation, the 490 mg dose is delivered via 2 × 245 mg cartridges used in full — no partial cartridges. JZ applies; JW essentially never applies. If routed through pharmacy benefit, NCPDP modifiers govern instead of CMS-1500 modifiers.

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 (or SC training visit). Routine pre-infusion REMS check is bundled.

340B modifiers (JG, TB)

For 340B-acquired Ultomiris (rare given the cost, but possible at participating disproportionate-share hospitals), follow your MAC's current 340B modifier policy.

ICD-10-CM diagnosis codes FY2026 verified May 2026

Ultomiris's full diagnosis space — PNH, aHUS, gMG, and NMOSD families. Same as Soliris.

Paroxysmal nocturnal hemoglobinuria (PNH)

Atypical hemolytic uremic syndrome (aHUS)

Generalized myasthenia gravis (gMG)

Neuromyelitis optica spectrum disorder (NMOSD)

Site of care & place of service Verified May 2026

Ultomiris's q8wk maintenance schedule (~30–45 min infusion) fits ambulatory infusion settings cleanly and is more amenable to home infusion than older C5 inhibitors due to fewer encounters per year. UHC, Aetna, Cigna, and Humana all run site-of-care UM programs that steer C5 inhibitors away from hospital outpatient toward non-hospital sites and home infusion after the first 1–2 cycles. The SC OnBody formulation eliminates the site-of-care question for adult PNH patients who tolerate it.

Claim form field mapping Verified May 2026

CMS-1500 / 837P (physician office, AIC; POS 11/49). UB-04 / 837I for hospital outpatient.

Form references: NUCC (CMS-1500), NUBC (UB-04).

Payer policy snapshot Reviewed May 2026

Most major payers PREFER Ultomiris over Soliris for new starts — lower total cost of care from q8wk vs q2wk.

What to document for approval

• Confirmed diagnosis with indication-specific evidence:
  • PNH: flow cytometry showing GPI-anchor-deficient cells (CD55/CD59); LDH elevation
  • aHUS: thrombocytopenia + microangiopathic hemolytic anemia + acute kidney injury; ADAMTS13 >5%/10% to rule out TTP
  • gMG: anti-AChR antibody positive; MGFA Class II–IV (clinical severity)
  • NMOSD: anti-AQP4 antibody positive; meets International Panel criteria
• ULTOMIRIS REMS enrollment confirmation (prescriber, site, patient)
• Documented meningococcal vaccination per ACIP (serogroups A, C, W, Y, AND B; dates)
• If switching from Soliris: documentation of stability or rationale for transition
• No active infection, no contraindicated immunosuppression

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.

Coverage

No NCD specific to ravulizumab. Coverage falls under the generic drug-coverage LCD framework for FDA-approved on-label indications. All MACs cover J1303 for PNH, aHUS, gMG (anti-AChR+), and NMOSD (anti-AQP4+). Confirm ICD-10 matches the on-label indication.

Code history

• December 21, 2018 — FDA approval (BLA 761108); initially billed under unclassified J3590
• October 1, 2019 — J1303 permanent code, "Injection, ravulizumab-cwvz, 10 mg"
• March 4, 2024 — FDA approval of SC OnBody Injector (s037 supplement, adult PNH only); J1303 retained for SC billing — no separate code issued

Patient assistance — Alexion OneSource Alexion verified May 2026

Single hub for Ultomiris, Soliris, Strensiq, and Voydeya patient support.

• Alexion OneSource: 1-888-765-4747 (M–F) — same number as UltSol REMS
• Web: alexiononesource.com/ultomiris
• Email: OneSource@alexion.com
• OneSource CoPay Program: commercial copay assistance for eligible patients (Medicare, Medicaid, VA, TRICARE, and other federal program patients are excluded by federal anti-kickback rules)
• OneSource Patient Assistance Program: free product for eligible uninsured / underinsured patients
• Bridge / interim supply programs: for coverage gaps during PA, appeals, or insurance transitions
• OnBody Injector training: nurse-led patient education, device demos, refrigeration counseling
• Government-insured patient referrals: NORD (rarediseases.org), PAN Foundation (panfoundation.org), HealthWell Foundation (healthwellfoundation.org)
• ULTOMIRIS REMS: 1-888-765-4747 / UltSolREMS.com (same hub)

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Ultomiris?

Ultomiris (ravulizumab-cwvz) is billed under HCPCS J1303 — "Injection, ravulizumab-cwvz, 10 mg." Each 10 mg equals one billable unit, so an adult PNH maintenance dose of 3,300 mg is billed as 330 units. J1303 became effective October 1, 2019, replacing the prior unclassified J3590 used since FDA approval in December 2018.

How is Ultomiris dosed for PNH and aHUS?

Weight-banded IV dosing: a single loading dose on Day 1, then maintenance starting on Day 15 and every 8 weeks thereafter. For 40–<60 kg: 2,400 mg load / 3,000 mg maintenance. For 60–<100 kg: 2,700 mg load / 3,300 mg maintenance. For ≥100 kg: 3,000 mg load / 3,600 mg maintenance. Maintenance schedule may vary ±7 days per dose (except the first maintenance dose at Day 15).

How many units do I bill for a 3,300 mg Ultomiris dose?

330 units. J1303 is descriptored at 10 mg per unit, so 3,300 mg ÷ 10 mg = 330 units. A 3,300 mg dose is built from one 1,100 mg vial (NDC 25682-028-01) plus 7 × 300 mg vials (NDC 25682-022-01 or 25682-025-01) — exactly 3,300 mg with no waste. Other weight bands have less convenient vial combinations and will sometimes generate a JW-eligible discard.

Does Ultomiris share REMS with Soliris?

Both drugs share the combined ULTOMIRIS and SOLIRIS REMS platform (UltSolREMS.com, 1-888-765-4747), but enrollment is product-specific. A prescriber, pharmacy, or infusion site enrolled for Soliris is NOT automatically authorized to dispense or administer Ultomiris — separate enrollment per drug is required despite the shared platform. Patients must receive meningococcal vaccination (serogroups A, C, W, Y, AND B) at least 2 weeks before the first dose, or antibacterial prophylaxis if treatment is urgent. The REMS Patient Safety Card must be carried during therapy and for 8 months after the last dose.

What is the boxed warning for Ultomiris?

Life-threatening and fatal meningococcal infections. Ravulizumab — like all C5 inhibitors — increases susceptibility to invasive Neisseria meningitidis disease. Patients must be vaccinated against meningococcal serogroups A, C, W, Y, AND B per current ACIP recommendations at least 2 weeks before the first dose, or receive antibacterial prophylaxis if treatment is urgent. Ultomiris is available only through the ULTOMIRIS REMS program; prescribers must enroll, certify, and ensure patient counseling.

What is the SC Ultomiris OnBody Injector and how is it billed?

FDA-approved March 2024, the Ultomiris OnBody Injector is a wearable device that delivers 490 mg ravulizumab subcutaneously once weekly (2 × 245 mg cartridges per dose) for adult PNH only. There is no separate SC-specific HCPCS code as of Q2 2026 — claims continue under J1303 with the cartridge NDC (25682-031-xx). Because the SC formulation is patient-self-administered at home, most payers route it through the pharmacy benefit (specialty pharmacy dispensing) rather than buy-and-bill. The first SC dose is typically administered or observed in-clinic; the office training visit may be billed as 96401 or 96372 depending on payer guidance.

What is the administration code for Ultomiris IV?

CPT 96365 — "Intravenous infusion, for therapy/prophylaxis/diagnosis; initial, up to 1 hour" — for the first hour, plus 96366 ("each additional hour") for subsequent hours. Maintenance infusions typically run 30–45 minutes, while loading doses run longer (often 1.7–2.4 hours per the dose-rate table). Ravulizumab is non-chemotherapeutic, so 96413 (chemo administration) is NOT appropriate.

Are payers preferring Ultomiris over Soliris for new starts?

Increasingly, yes. Many major commercial payers and several Medicaid programs now PREFER Ultomiris over Soliris for new starts due to lower total cost of care: q8wk maintenance (vs Soliris q2wk) eliminates roughly 20 infusions per year, reducing chair time, administration costs, and patient burden. Common PA criteria include confirmed diagnosis (PNH, aHUS, gMG anti-AChR+, or NMOSD anti-AQP4+), documented UltSol REMS enrollment, and documented meningococcal vaccination per ACIP. Site-of-care steerage often forces the patient to home infusion or non-hospital outpatient after the first 1–2 cycles.

What is the Medicare reimbursement for J1303?

For Q2 2026, the Medicare Part B payment limit for J1303 is $223.675 per 10 mg (ASP + 6%). The standard adult PNH maintenance dose (3,300 mg = 330 units) reimburses at approximately $73,812.75 before sequestration. Six maintenance infusions per year (q8wk) plus one loading dose translate to roughly $480,000–$520,000 per patient per year — still substantially below Soliris's annual cost given the lower infusion frequency. ASP is updated quarterly by CMS.

Source documents

1. DailyMed — ULTOMIRIS (ravulizumab-cwvz) Prescribing Information
   FDA-approved label (BLA 761108); setid a9a590d9-0217-43c7-908d-e62a71279791; 2024 revision with s037 SC supplement
2. FDA — ULTOMIRIS Label (BLA 761108, s037 SC OnBody supplement)
   Subcutaneous OnBody Injector approval, March 2024 (adult PNH only)
3. Alexion — ULTOMIRIS Patient Site
   Manufacturer-hosted patient information and OneSource access
4. Alexion — ULTOMIRIS HCP Site (Coding & Billing Guide)
   Manufacturer coding/billing reference for HCPs — vial mix planning, weight bands, REMS
5. ULTOMIRIS & SOLIRIS REMS (UltSolREMS.com)
   1-888-765-4747 — mandatory enrollment for prescribers, sites, patients; separate per drug
6. Alexion OneSource — Ultomiris Patient Support
   CoPay Program, PAP, bridge supply, OnBody Injector training
7. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026
8. CMS — HCPCS quarterly update file (canonical J-code source)
9. AAPC — HCPCS J1303
   Code descriptor, unit basis, effective date reference
10. FDA National Drug Code Directory
    NDC verification for 25682-022/025/028 (vials) and 25682-031 (SC cartridge)
11. CDC ACIP — Meningococcal Vaccination Recommendations
    Serogroup A, C, W, Y, AND B requirements for complement inhibitor therapy
12. FDA Press — Ultomiris OnBody Injector approval (March 2024)
    Subcutaneous formulation indication and device approval announcement
13. UnitedHealthcare — Complement Inhibitor Policy
    Combined ravulizumab/eculizumab medical benefit policy; Ultomiris preference language
14. Aetna Clinical Policy Bulletins — Complement Inhibitors
    Ultomiris/Soliris PA criteria and preference logic

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

Reviewer

Change log

• May 2, 2026 — Initial publication. ASP data: Q2 2026 (J1303 = $223.675 per 10 mg). Payer policies: UHC, Aetna, Carelon Drug.00086, BCBS FEP 5.21.07/32, Cigna 1212. Includes SC OnBody Injector pathway (FDA s037, March 2024) and detailed Ultomiris-vs-Soliris (J1299) comparison. Reciprocal of forthcoming Soliris reference page.

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. Vial-mix waste calculations are derived from the FDA-labeled weight-banded dose schedule combined with the actual single-dose vial sizes (300 mg, 1,100 mg). When CMS guidance is ambiguous (as with the absence of a SC-specific HCPCS for the OnBody Injector), we surface the ambiguity and document current convention rather than asserting a definitive answer.