Ultomiris (ravulizumab-cwvz) — J1303

Ultomiris and related complement inhibitors

Ultomiris (ravulizumab-cwvz) bills under J1303, 10 mg per billing unit, from Alexion (AstraZeneca Rare Disease). It is a complement inhibitor dosed every 8 weeks after loading, one of several complement-targeting therapies used across paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis and neuromyelitis optica spectrum disorder; the family file lists no ravulizumab-cwvz biosimilar.

A payer’s step-therapy rule decides which product a patient starts on, and it varies by indication: 25 of 29 payers require another product first for at least one indication, such as Anthem's “trial and inadequate response or intolerance to an acetylcholinesterase inhibitor” for gMG (see Coverage & access).

Vials and NDCs

Two vial sizes cover all seven bands. The 3,300 mg maintenance dose (60 to under 100 kg) draws three 1,100 mg vials exactly; the 2,700 mg loading dose at the same band draws nine 300 mg vials, or a substitute two 1,100 mg plus two 300 mg vials with a 100 mg (10-unit) JW remainder.

This reference does not recommend one complement inhibitor over another. The payer's step-therapy rule decides which product a patient can start on, and it varies by indication before ravulizumab-cwvz is authorized.

Ultomiris dosing

Every regimen is weight-banded and flat, never per kilogram: a loading dose at treatment start, then a maintenance dose two weeks later and every 8 weeks after (every 4 weeks under 20 kg). The worked example here is the 60 to under 100 kg adult band: 2,700 mg loading (270 units), then 3,300 mg (330 units, three 1,100 mg vials), no waste (JZ).

Least-waste draws and the JW contingency

Every one of the seven bands draws whole vials by default, so JZ applies at every dose. A pharmacy short on 300 mg vials can draw the 2,700 mg loading dose from two 1,100 mg vials plus two 300 mg vials instead of nine, leaving a 100 mg (10-unit) remainder on a JW line, billed at $2,264.54 (see the billing-units calculator).

Pre-treatment and concomitant therapy

• Vaccinate against meningococcal serogroups A, C, W, Y and B per ACIP at least 2 weeks before the first dose; if urgent, give antibacterial prophylaxis and vaccinate as soon as possible.
• The prescriber must be enrolled in the ULTOMIRIS and SOLIRIS REMS.
• Monitor for at least 1 hour after each infusion for infusion-related reactions.
• A supplemental dose is required after plasma exchange, plasmapheresis or a completed IVIg cycle, within 4 hours of the procedure (label Table 3).

Need the units for a patient's dose? Convert dose to J1303 billing units →

Ultomiris billing reference

HCPCS

J1303 bills 10 mg per unit. The seven weight bands range from a 300 mg maintenance dose (30 units) to a 3,600 mg maintenance dose (360 units); the 60 to under 100 kg adult maintenance dose is 3,300 mg (330 units).

NDC

Two vial sizes, two NDCs. See the vial table in Drug & products above. The 11-digit claim-form NDCs are 25682002501 (300 mg) and 25682002801 (1,100 mg); the vial count changes by weight band, not the strength.

Administration

Administration is a single code, not a choice: every Ultomiris infusion, at every weight band, bills 96365 alone at the label's minimum infusion times, which are all under 90 minutes; 96366 is added only if the drip actually runs past 90 minutes. CPT 96365–96366 carries the complete code definitions.

Modifiers

JZ: required when no drug is discarded. JW: required for documented waste.

The least-waste draw lands on whole vials at every band, so JZ applies by default; a substitution for scarce 300 mg vials can leave a documented remainder on a JW line. The J1303 MUE is 360 units (3,600 mg) a day, the top maintenance band.

Full unit, vial and modifier math for any dose: calculate Ultomiris billing units →

Claim form

CMS-1500 / 837P field map for a separately payable J1303 claim.

Ultomiris coverage

The Clearance corpus carries 29 payers and 527 rules for ravulizumab-cwvz across four indications. 26 of the 29 require prior authorization, and 25 require another product first for at least one indication.

• 27 of 29 commercial payer policy sets require prior authorization; 2 do not say clearly, so confirm those on the call
• 25 of 29 payers require another product first for at least one indication: pyridostigmine, immunosuppressants or a preferred FcRn product for generalized myasthenia gravis, rituximab or Uplizna and Enspryng for neuromyelitis optica spectrum disorder, while PNH and aHUS rules mostly confirm the diagnosis.
• 20 rules set a quantity limit, most restating the label's weight-band table in vials or units, and 6 rules at 4 payers set reauthorization terms (12 months at BCBS Michigan and Capital Blue, 3 months initially at HMSA).
• 15 rules address site of care across 14 payers, including CareFirst's 45-day hospital-outpatient window for a patient new to therapy.

Prior authorization, step therapy and reauthorization

Generalized myasthenia gravis carries the deepest requirement to try another product first: Anthem requires “a trial and inadequate response or intolerance to an acetylcholinesterase inhibitor,” BCBS Kansas requires “Trial and failure … to one immunosuppressive therapy (e.g., glucocorticoids … tacrolimus),” and UnitedHealthcare requires “failure of at least two immunosuppressive agents over the course of at least 12 months.”

Independence requires “inadequate response … to efgartigimod alfa-fcab (Vyvgart) IV” for gMG, and UnitedHealthcare requires “History of failure of, contraindication, or intolerance to rituximab therapy” for NMOSD. Reauthorization runs on documented response: BCBS Michigan sets “…One year at a time,” and Regence's gMG renewal requires a scoring tool such as the MG-ADL.

PNH and aHUS: diagnosis, not step therapy

Two hematologic diagnoses are confirmed by lab-value thresholds, not a treatment history. Aetna requires “at least 5% PNH cells, at least 51% of GPI-AP deficient poly-morphonuclear cells” for PNH and an “ADAMTS 13 activity level above 5%” for aHUS, and Anthem requires “Lactate dehydrogenase greater than 1.5 times the upper limit of normal.”

STEC-HUS is excluded everywhere the label excludes it: BCBS Florida states “Ravulizumab is not indicated for … Shiga toxin E.coli related hemolytic uremic syndrome (STEC-HUS).” Aetna requires the drug “will not be used in combination with another complement inhibitor (e.g., Empaveli, Fabhalta, PiaSky, Soliris),” and BCBS Michigan's one PNH step requires “Trial and failure … to Empaveli.”

Site of care

Fourteen payers turn the administration setting into a claim requirement across 15 rules. CareFirst “provides coverage for administration of Ultomiris in an outpatient hospital setting for up to 45 days when a member is new to therapy,” and Blue Shield of California lists a “preferred site of service, including the home, a physician’s office, or an independent infusion center.”

ICD-10-CM by indication

Four indications, four codes, each with its own share of the Clearance corpus.

Quantity limits and the J1303 MUE

CMS sets the J1303 Medically Unlikely Edit at 360 units a day, 3,600 mg, the labeled maximum for any single dose. Twenty payer rules write their own quantity limit alongside it: Anthem caps fills at “Ultomiris 1100 mg/11 mL vial^ 3 vials per 56 days,” and BCBS Louisiana requires “Dose does not exceed 3,600 mg every 8 weeks.”

Capital Blue's quantity limit (and BCBS Minnesota's dosing rule) write the schedule in units: “300 units on Day 0 followed by 360 units on Day 14 and every 8 weeks thereafter.” BCBS South Carolina's PNH limit instead restates the eculizumab table — “900 mg weekly x 4 doses …” — a payer-side error: that schedule belongs to Soliris.

Check the patient’s actual policy: See Ultomiris coverage by payer →

Ultomiris cost & financial access

Medicare ASP+6%: $226.454 / 10 mg · $74,729.82 / 3,300 mg. Administration (96365) allows $67.14 more, so the 3,300 mg claim allows $74,796.96 total; at 20% coinsurance after the $283 Part B deductible, the patient owes $14,959.39.

7 doses a year (3,300 mg IV every 8 weeks for a 60 to under 100 kg adult, 2 weeks after the 2,700 mg loading dose; every 8 weeks gives 6 or 7 infusions in a calendar year, 7 here) at $74,796.96 per infusion — drug plus 96365 administration — total $523,578.72 before the sequester. That is the full annual drug-plus-administration cost for a patient staying on schedule, before benefits or assistance.

The other adult bands price the same way, drug line only: 40 to under 60 kg allows $54,348.96 loading / $67,936.20 maintenance; 100 kg and over allows $67,936.20 loading / $81,523.44 maintenance. The 2,700 mg loading dose here allows $61,142.58, and a 100 mg JW remainder allows $2,264.54.

At 20% coinsurance after the $283 Part B deductible, the patient owes $14,959.39 of the 3,300 mg maintenance claim ($14,945.96 drug plus $13.43 infusion). Commercial plans pay a contracted rate that varies by payer and state; 36 of 36 payer price files in this site's data carry a J1303 rate.

Aetna's all-states commercial median is $232.46 per unit (10 mg), above the $226.454 ASP Medicare rate. At 330 units, that prices the 3,300 mg dose at $76,711.80, about $1,981.98 more than Medicare allows for the drug alone ($74,729.82).

Patient cost

Patient responsibility = payer allowed rate − benefits adjustment − assistance. Confirm which weight band and which dose type, loading or maintenance, the encounter reflects before estimating: the drug portion alone ranges from $6,793.62 at the smallest pediatric maintenance dose (300 mg) to $81,523.44 at the largest adult maintenance dose (3,600 mg).

Calculate an Ultomiris patient estimate →

Copay & financial assistance

The Alexion OneSource Co-pay Program caps a commercially insured patient's drug cost at as little as $0 per prescription, with a yearly cap that is not published on current terms (last published $15,000 a year), but it pays only the drug, never the infusion, and it excludes Medicare, Medicaid, TRICARE, VA and government plans. At a commercial plan with 20% coinsurance priced at the Medicare reference rate, the drug line alone on one 3,300 mg infusion is $14,945.96, so a single infusion consumes nearly the entire $15,000 annual cap.

Alexion does not run a free-drug program for Ultomiris (checked September 28, 2026). Seven foundation funds also match the J-code: PAN's PNH and Myasthenia Gravis funds; The Assistance Fund's PNH, aHUS, Myasthenia Gravis and NMOSD funds; and Good Days' Neuromyelitis Optica fund (check each fund's current status on the funds list). Two PAN funds do not match J1303 and are not counted.

See current Ultomiris assistance programs →

Common Ultomiris errors & fixes