Kisunla (donanemab-azbt) — HCPCS J0175
CareCost Estimate · Billing Cheat Sheet
Eli Lilly and Company
350 mg / 20 mL single-dose vial
IV infusion (~30 min) every 4 weeks
Reviewed: May 2, 2026
ASP: Q2 2026
HCPCS
J0175
1 unit = 2 mg (NOT 1 mg)
Maint. dose
700 units
1,400 mg q4wk · 4 vials
Modifier
JZ
Single-dose vial, fixed dose
Admin CPT
96365
Therapeutic IV (non-chemo)
Medicare ASP+6%
$4.140
/2 mg unit ($2.070/mg) Q2 26
UNIT BASIS TRAP: J0175 descriptor is "Inj, donanemab-azbt, 2 mg" — 1 unit = 2 mg, not 1 mg. Bill 350 units (not 700) for the 700 mg titration dose, and 700 units (not 1,400) for the 1,400 mg maintenance dose. Mis-coding 1 mg per unit will double the units billed and trigger denial / overpayment recoupment.
Codes & NDC
| HCPCS | J0175 — "Injection, donanemab-azbt, 2 mg" (effective 1/1/2025; pre-permanent code period used J3490) |
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| NDC | 0002-2024-01 (10) / 00002-2024-01 (11) — 350 mg / 20 mL vial · N4 qualifier |
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| Vial | 350 mg / 20 mL (17.5 mg/mL) single-dose |
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| Sister drug | Leqembi (lecanemab, J0174) — 1 mg = 1 unit, q2wk weight-based, indefinite duration |
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| Benefit | Medical (provider buy-and-bill); Medicare Part B with CMS CED registry |
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Dosing — titration then maintenance
- Doses 1–3: 700 mg IV q4wk (titration) — 2 vials per dose
- Dose 4+: 1,400 mg IV q4wk (maintenance) — 4 vials per dose
- Fixed dose (NOT weight-based) — major billing differentiator vs Leqembi
- Infusion ~30 min; q4wk = 13 doses/year max
- Discontinue at amyloid PET clearance (typically 6–18 mo) — finite duration
| Phase | mg/dose | Units (J0175) | Vials |
|---|
| Titration (3 doses) | 700 mg | 350 units | 2 |
| Maintenance | 1,400 mg | 700 units | 4 |
Kisunla vs Leqembi — bill differently
| Kisunla (J0175) | Leqembi (J0174) |
|---|
| Unit basis | 2 mg = 1 unit | 1 mg = 1 unit |
| Dosing | Fixed (700 / 1,400 mg) | Weight-based (10 mg/kg) |
| Frequency | Every 4 weeks | Every 2 weeks |
| Duration | Finite (PET clearance) | Indefinite |
| MRI schedule | Pre-2, 3, 4, 7 | Pre-5, 7, 14 |
| APOE4 homo ARIA | ~40% | ~32% |
MRI surveillance (mandatory)
| When | Why |
|---|
| Baseline (within 1 yr) | Pre-treatment ARIA risk + microhemorrhage screen |
| Before infusion 2 | Detect early ARIA |
| Before infusion 3 | ARIA peak window |
| Before infusion 4 | Post-titration check |
| Before infusion 7 | Maintenance phase check |
Bill MRI separately: CPT 70551 (MRI brain w/o) or 70553 (w/ & w/o). Document any new ARIA-E or ARIA-H findings before each subsequent infusion.
Pre-treatment workup
- Amyloid biomarker: PET (
78814/78815 + radiotracer A9586/A9599) OR CSF (83520)
- APOE genotyping:
81401 — document homozygous status (highest ARIA risk on Kisunla)
- Baseline MRI:
70551 or 70553
- CMS CED registry enrollment (NCD 210.20) — mandatory for Part B coverage
ICD-10 — Alzheimer's family
| Code | For |
|---|
G30.0 | Alzheimer's, early onset |
G30.1 | Alzheimer's, late onset |
G30.8 | Other Alzheimer's |
G30.9 | Alzheimer's, unspecified |
F02.80 | Dementia in AD w/o behavioral disturbance |
F02.81 | Dementia in AD w/ behavioral disturbance |
G31.84 | Mild cognitive impairment (MCI due to AD) |
Stage matters: approved ONLY for early symptomatic AD (MCI or mild dementia). Moderate/severe AD = denial.
Administration & modifiers
| Code | When |
|---|
96365 | Therapeutic IV, ~30 min (primary) — non-chemo |
96366 | Each additional hour (rare) |
96413 | Not appropriate — donanemab is non-chemo biologic |
| JZ | Single-dose vial, fixed dose — minimal/no waste typical |
| JW | Only if off-protocol partial-vial waste |
Payer requirements (May 2026)
| Payer | PA | Step / Preference |
|---|
| Medicare Part B | Yes (CED) | CMS-approved registry mandatory (NCD 210.20) |
| UnitedHealthcare | Yes | Amyloid + APOE + MRI baseline; preference may shift Kisunla vs Leqembi by contract |
| Aetna | Yes | Specific PA criteria; CPB-defined early AD population only |
| BCBS plans | Yes | Generally aligned with FDA label + CMS CED |
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% per unit (2 mg) | $4.140 |
| ASP + 6% per mg | $2.070 |
| 700 mg dose (350 units) | $1,449.00 |
| 1,400 mg dose (700 units) | $2,898.00 |
| Year 1 (3 titration + 10 maint) | ~$33,327 |
| Lifetime cost (12–18 mo) | ~$30K–$50K (capped by PET clearance) |
Site of care
| Setting | POS | Notes |
|---|
| Neurology / memory clinic infusion | 11 | Preferred |
| Ambulatory infusion suite | 49 | Common |
| Hospital outpatient | 19/22 | Most payers steer away |
| Patient home | 12 | Rare; ARIA monitoring concerns |
Patient assistance — Lilly
- Lilly Answers Center: 1-800-545-5979
- Lilly Cares Foundation: free drug for uninsured / Medicare hardship
- Kisunla Co-pay program: commercial copay (verify current cap)
- Foundations: PAN, HealthWell — verify open AD funds quarterly
- Web: kisunla.com / lillypatientone.com
BOXED WARNING — ARIA + IRR: Amyloid-related imaging abnormalities (ARIA-E vasogenic edema, ARIA-H microhemorrhages, superficial siderosis) AND infusion-related reactions including anaphylaxis. APOE4 homozygotes ~40% ARIA incidence. Permanently discontinue if severe ARIA.
DISCONTINUATION CRITERION: Kisunla can be STOPPED when amyloid PET shows clearance (typically 6–18 mo). Do NOT continue indefinitely — payer audits will recoup post-clearance infusions.