Kisunla (donanemab-azbt) — J0175

Kisunla and the anti-amyloid class

Kisunla (donanemab-azbt) bills under J0175, 2 mg per billing unit, from Eli Lilly. It is one of two anti-amyloid antibodies for early symptomatic Alzheimer's disease, alongside Leqembi (lecanemab-irmb, J0174, Eisai / Biogen). The two are not interchangeable, and neither is a biosimilar of the other.

A payer may require one before the other: 3 of the 20 commercial payers in the Clearance corpus require documented Leqembi therapy, intolerance or contraindication before they authorize Kisunla (see Coverage & access).

Vials and NDCs

One vial size covers every dose. Each titration step is a whole multiple of the 350 mg vial (1, 2, 3 or 4 vials for 350, 700, 1,050 or 1,400 mg), so the billing-units calculator always draws a whole number of vials with nothing left over.

This reference does not recommend one anti-amyloid antibody over the other. The payer's own step-therapy rule, not a clinical preference, decides which one a given patient can start on.

Kisunla dosing

Donanemab-azbt titrates over the first three infusions, 350 mg, then 700 mg, then 1,050 mg, before reaching its 1,400 mg maintenance dose at infusion 4, all given every 4 weeks. Every step is a whole multiple of the 350 mg vial, so JZ applies on every infusion and JW never does.

Boxed warning and the MRI schedule

ARIA — amyloid related imaging abnormalities — is the safety signal common to anti-amyloid antibodies; the FDA's language, in full:

The label requires a baseline brain MRI before the first infusion, then an MRI before infusions 2, 3, 4 and 7 to monitor for ARIA. Consider stopping dosing once amyloid PET imaging shows plaques reduced to minimal levels.

If an infusion is missed, resume at the same dose every 4 weeks as soon as possible; the schedule does not restart from infusion 1.

Pre-treatment documentation

• Confirm amyloid beta pathology (amyloid PET or CSF) before the first infusion; the label requires it, and a Leqembi-first payer's step-therapy rule may also apply (see Coverage & access).
• Obtain a baseline brain MRI within the prior year, then repeat before infusions 2, 3, 4 and 7 to monitor for ARIA.
• For a Medicare patient, enroll the prescriber in a CMS-approved registry before the claim; NCD 200.3 pays under coverage with evidence development, and the registry enrollment is a claim fact as well as a clinical one.
• Document the cognitive-scale response supporting reauthorization; commercial policies renew on documented response, not on a fixed calendar alone.

Need the units for a patient's dose? Convert dose to J0175 billing units →

Kisunla billing reference

HCPCS

J0175 bills 2 mg per unit. A 350 mg infusion is 175 units, 700 mg is 350 units, 1,050 mg is 525 units, and the 1,400 mg maintenance dose is 700 units.

NDC

One package size, one NDC. See the vial table in Drug & products above. The 11-digit claim-form NDC is 00002-9401-01, and it does not change across the titration schedule, since every step draws from the same 350 mg vial.

Administration

Administration is a single code, not a choice: Kisunla is a 30-minute therapeutic infusion, billed with 96365 alone. CPT 96365–96366 carries the complete code definitions.

Modifiers

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

Every titration step draws a whole number of 350 mg vials (1, 2, 3 or 4), with nothing left over, so JZ applies on every Kisunla infusion and JW never does. See the worked vial breakdown in the billing-units calculator.

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

Claim form

CMS-1500 / 837P field map for a separately payable J0175 claim.

Kisunla coverage

The Clearance corpus carries 20 payers and 186 rules for donanemab. 15 of the 20 require prior authorization, and 3 require documented Leqembi therapy, intolerance or contraindication before they authorize Kisunla.

• 18 of 21 commercial payer policy sets require prior authorization; 3 do not say clearly, so confirm those on the call
• 3 of 20 payers require documented Leqembi therapy, intolerance or contraindication first: BCBS Florida, BCBS Minnesota and BCBS Massachusetts.
• 12 rules set a quantity limit, most writing in the 1,400 mg every 4 weeks maintenance cap, and 6 require reauthorization on documented response.
• 4 rules carry site-of-care language across the anti-amyloid class.

Prior authorization, step therapy and reauthorization

Premera limits the maintenance dose directly: “The maintenance dose is limited to 1,400 mg every 4 weeks.” Anthem's quantity limit reads the same figure by volume, “4 vials (80 mL) per 4 weeks,” and Centene's matches Premera's: “1,400 mg every 4 weeks.”

CareFirst and BCBS Tennessee both grant an initial “authorization of 7 months,” renewed at “12 months (first reauthorization after the initial 7-month approval period).” UnitedHealthcare's initial authorization “will be for no more than 12 months,” and Kaiser reviews continued use “every 12 months while on treatment.”

ICD-10-CM by indication

Two indications, two codes, each requiring confirmed amyloid pathology before the claim.

Medicare: coverage with evidence development

Medicare pays donanemab under NCD 200.3, coverage with evidence development. The prescriber must enroll the patient in a CMS-approved registry, ALZ-NET is the most used, and confirmed amyloid pathology must be on file before the first infusion. The registry enrollment and the amyloid result are claim facts as well as clinical ones.

Reauthorization follows documented cognitive-scale response rather than a fixed calendar alone: commercial payers write initial approvals of 6 to 12 months and renew on the same kind of evidence Medicare's registry collects.

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

Kisunla cost & financial access

Medicare ASP+6%: $4.185 / 2 mg · $2,929.50 / 1,400 mg. Administration (96365) allows $67.14 more, so the 1,400 mg maintenance claim allows $2,996.64 total; at 20% coinsurance with the Part B deductible met, the patient owes $599.33.

13 doses a year (1,400 mg every 4 weeks, the maintenance dose) at $2,996.64 per infusion — drug plus 96365 administration — total $38,956.32 before the sequester. That is the full annual drug-plus-administration cost for a patient staying on schedule, before benefits or assistance.

Each earlier titration step allows less: 350 mg allows $732.38, 700 mg allows $1,464.75, and 1,050 mg allows $2,197.13 for the drug alone, all at the $2.0925/mg ASP rate before the 96365 administration fee.

At 20% coinsurance with the $283 Part B deductible already met, the patient owes $599.33 of the 1,400 mg maintenance claim ($585.90 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 J0175 rate.

Aetna's all-states commercial median is $4.19 per unit, close to the $4.185 ASP+6% Medicare rate. At 700 units, that prices the maintenance dose at $2,933.00, about $3.50 more than Medicare allows for the drug alone.

Patient cost

Patient responsibility = payer allowed rate − benefits adjustment − assistance. Confirm which infusion in the titration schedule the encounter reflects before estimating: the drug portion alone ranges from $732.38 at the first infusion to $2,929.50 at the 1,400 mg maintenance dose.

Calculate a Kisunla patient estimate →

Copay & financial assistance

The Kisunla Savings Card Program covers a commercially insured patient's drug cost at $0, up to $10,600 a year, but it pays only the drug, never the infusion or the visit, and it excludes Medicare, Medicaid and any government plan.

Lilly Cares Foundation Patient Assistance ships Kisunla free to the provider for a patient who is uninsured or is on Medicare and meets the program's rules, drug cost only; the administration is billed separately.

See current Kisunla assistance programs →

Common Kisunla errors & fixes