HCPCS
J9350
1 mg = 1 unit
Phase 1
Identify what you're billing
Step-up vs maintenance, IV vs SC bispecifics, and fixed-duration vs indefinite therapy.
The CD20 × CD3 bispecific landscape FDA verified May 2026
Lunsumio was the first CD20×CD3 bispecific for B-cell lymphoma, approved December 2022. It's IV; the more recent peers Epkinly and Columvi are different.
Bispecific T-cell engagers (BiTEs) for B-cell lymphoma redirect cytotoxic T cells against CD20+ malignant B cells. Three bispecifics now share this space, but they differ on indication, route, and dosing schedule. Coding teams must pick the right HCPCS, route, and step-up schedule for each.
| Lunsumio (mosunetuzumab-axgb) | Epkinly (epcoritamab-bysp) | Columvi (glofitamab-gxbm) | |
|---|---|---|---|
| HCPCS | J9350 | J9321 | J9286 |
| Manufacturer | Genentech (Roche) | AbbVie / Genmab | Genentech (Roche) |
| Indication | R/R FL (≥2 prior lines) | R/R DLBCL (≥2 prior lines) | R/R DLBCL (≥2 prior lines) |
| FDA approval | Dec 22, 2022 (accelerated) | May 19, 2023 (accelerated) | Jun 15, 2023 (accelerated) |
| Route | IV | SC | IV |
| Maintenance dose | 30 mg IV q3wk (C3+) | 48 mg SC q4wk (after C9) | 30 mg IV q3wk (C3+) |
| Treatment duration | Fixed: 8 or up to 17 cycles | Until progression | Fixed: 12 cycles |
| Step-up complexity | 3 doses (C1: 1 / 2 / 60 mg) | 3 doses (priming / intermediate / full) | 2 doses (C1: 2.5 / 10 mg) + obinutuzumab pretreatment |
| Admin CPT | 96413 + 96415 | 96401 (chemo SC) | 96413 + 96415 |
| REMS? | No | No | No |
| Boxed warning | CRS | CRS, ICANS | CRS |
IV vs SC matters operationally. Lunsumio's IV infusion mandates infusion-suite chair time
(4 hr first dose, 2 hr subsequent). Epkinly's SC injection takes minutes and can fit into office workflows
once cycle-1 inpatient observation completes. Columvi is IV like Lunsumio but for DLBCL, not FL.
Don't confuse with BCMA bispecifics. Tecvayli (teclistamab-cqyv, J9380), Elrexfio
(elranatamab-bcmm), and Talvey (talquetamab-tgvs) are SC bispecifics for multiple myeloma — different
target (BCMA, not CD20), different indication, and they carry formal FDA REMS. Lunsumio does NOT.
Step-up dosing & cycle math FDA label verified May 2026
Cycle 1 uses mandatory step-up to mitigate CRS. Cycle 2 is one full dose. Cycle 3 onward is the maintenance dose.
Cycle 1 step-up schedule (mandatory)
| Day | Dose | Units billed (J9350) | Premedication | Post-dose observation |
|---|---|---|---|---|
| C1 Day 1 | 1 mg IV (step-up dose 1) | 1 unit | Yes — corticosteroid + antihistamine + antipyretic 60 min prior | 24 hours |
| C1 Day 8 | 2 mg IV (step-up dose 2) | 2 units | Yes — same regimen | 24 hours |
| C1 Day 15 | 60 mg IV (first treatment dose) | 60 units | Yes — same regimen | 24 hours (per label for first full dose) |
Cycle 2 onward
| Cycle | Day | Dose | Units billed | Notes |
|---|---|---|---|---|
| C2 | Day 1 | 60 mg IV | 60 units | One full treatment dose; premed required if any prior Gr 2+ CRS |
| C3 onward | Day 1 (q21 days) | 30 mg IV | 30 units | Maintenance dose every 3 weeks; premed may be discontinued if no Gr 2+ CRS in prior cycle |
Worked example — complete responder finishing 8 cycles
# Cycle 1 (3 doses, step-up)
Day 1: 1 unit · Day 8: 2 units · Day 15: 60 units = 63 units
# Cycle 2 (one 60 mg dose)
60 units
# Cycles 3-8 (six 30 mg maintenance doses)
6 × 30 = 180 units
# Total over 8-cycle CR course
Total drug units billed: 303 units
Total drug cost (Q2 2026 ASP+6%): ~$198,326 before sequestration
# Partial responder extending to 17 cycles adds 9 more 30 mg doses
9 × 30 = 270 additional units → total 573 units over 17 cycles
Day 1: 1 unit · Day 8: 2 units · Day 15: 60 units = 63 units
# Cycle 2 (one 60 mg dose)
60 units
# Cycles 3-8 (six 30 mg maintenance doses)
6 × 30 = 180 units
# Total over 8-cycle CR course
Total drug units billed: 303 units
Total drug cost (Q2 2026 ASP+6%): ~$198,326 before sequestration
# Partial responder extending to 17 cycles adds 9 more 30 mg doses
9 × 30 = 270 additional units → total 573 units over 17 cycles
Premedication
Required 60 minutes before each step-up dose (C1 Day 1, Day 8, Day 15) and the first full treatment dose (C2 Day 1):
- Corticosteroid: dexamethasone 20 mg IV
- Antihistamine: diphenhydramine 50–100 mg IV or PO
- Antipyretic: acetaminophen 500–1000 mg PO
From cycle 3 onward, premedication may be discontinued if the patient experienced no Grade 2 or higher CRS in any prior cycle.
Fixed-duration therapy — major differentiator FDA label verified May 2026
Lunsumio is NOT continued indefinitely. This is a critical billing and capacity-planning fact.
Lunsumio is administered as a fixed-duration regimen, in contrast to most multiple myeloma bispecifics (Tecvayli, Elrexfio) which dose until disease progression. The duration depends on response assessment at the end of cycle 8:
| Response at C8 | Total cycles | Implication |
|---|---|---|
| Complete response (CR) | 8 cycles total — treatment stops | Patient is observed off therapy; surveillance imaging per NCCN |
| Partial response (PR) | Up to 17 cycles — treatment may continue | Continue 30 mg q3wk; reassess response throughout |
| Stable disease / progression | Discontinue | Move to next-line therapy (CAR-T, allogeneic SCT, clinical trial) |
Why fixed-duration matters for billing: Annual cost projections must account for the
finite course rather than indefinite dosing. A CR patient who starts in Q1 will complete drug administration
within ~6 months (8 cycles × 21-day intervals + step-up). A PR patient extending to 17 cycles will be
on therapy ~12–13 months. After completion, J9350 charges stop entirely — the patient transitions
to surveillance.
Contrast with MM bispecifics. Tecvayli, Elrexfio, and Talvey continue dosing until
progression. A multiple myeloma patient may be on bispecific therapy for years. A FL patient on Lunsumio
will have a defined endpoint — this changes annual billing forecasts and patient counseling.
NDC reference FDA NDC Directory verified May 2026
| Vial | Use | Notes |
|---|---|---|
| 1 mg / 1 mL single-dose vial | Cycle 1 step-up doses (Day 1 = 1 mg; Day 8 = 2 mg requires 2 vials) | Used during step-up only; not used after C1 |
| 30 mg / 30 mL single-dose vial | Cycle 1 Day 15 (60 mg = 2 vials), Cycle 2 (60 mg = 2 vials), Cycle 3+ maintenance (30 mg = 1 vial) | Standard treatment-dose vial |
Pull manufacturer NDC at billing time. Genentech publishes carton-level NDCs in their
Lunsumio access materials. Always use the carton-level NDC on CMS-1500 box 24A shaded area with the N4
qualifier and ML unit-of-measure (volume in mL).
Vial waste accounting: The 1 mg vial used for the C1 D8 (2 mg) dose requires 2 vials with
no waste. The 30 mg vial used for 30 mg maintenance dose has no waste. The 60 mg dose uses 2 × 30 mg
vials with no waste. JZ applies to all standard adult dosing; JW only if a partial vial is discarded
(unusual at label doses).
Phase 2
Code the claim
Chemo admin codes (96413 + 96415) for IV bispecific. JZ on every claim.
Administration codes CPT verified May 2026
Lunsumio is billed as chemotherapy administration (complex monoclonal antibody) despite being immunotherapy in mechanism.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for every Lunsumio infusion. Covers the first hour of infusion. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Required. Pair with 96413: first 60 mg dose (~4 hr) bills 96413 + 96415 × 3; subsequent 30 mg maintenance (~2 hr) bills 96413 + 96415 × 1. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Lunsumio is a complex monoclonal antibody and bills under chemo admin per AMA classification. |
96401 |
Chemotherapy administration, SC/IM | NOT applicable to Lunsumio (IV only). Use for Epkinly SC formulation, not Lunsumio. |
Why chemo admin for bispecific antibody: CPT chemotherapy administration codes
(96409–96425) apply to complex monoclonal antibody administration regardless of mechanism of action.
Bispecific T-cell engagers are billed under chemo admin codes per AMA classification. This pays materially
more than 96365 therapeutic infusion.
Modifiers CMS verified May 2026
JZ — required on virtually every claim
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Lunsumio dosing aligns to whole-vial multiples at every label dose: 1 mg uses one 1 mg vial; 2 mg uses two 1 mg vials; 30 mg uses one 30 mg vial; 60 mg uses two 30 mg vials. JZ applies to virtually every Lunsumio claim.
JW — report partial-vial waste
JW reports the discarded portion of a single-dose vial. For Lunsumio at standard label doses, JW rarely applies because every dose lands on whole-vial multiples. If a partial dose is administered (e.g., dose adjustment for toxicity managed at the bedside) and a portion is discarded, bill JW with the actual discarded units on a separate claim line. One of JZ or JW must be on every J9350 claim.
Modifier 25 — same-day E/M
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 (e.g., a CRS workup during cycle 1 step-up). Routine pre-infusion clinical assessment is bundled with 96413.
340B modifiers (JG, TB)
For 340B-acquired Lunsumio, follow your MAC's current 340B modifier policy. Genentech's billing guide does not provide 340B-specific instructions.
ICD-10-CM — follicular lymphoma family FY2026 verified May 2026
Lunsumio is approved for adult R/R follicular lymphoma. Use the most specific C82 code supported by histology and biopsy documentation.
| ICD-10 | Description | Notes |
|---|---|---|
C82.00–C82.09 | Follicular lymphoma grade 1, by site | Common low-grade FL |
C82.10–C82.19 | Follicular lymphoma grade 2, by site | Common low-grade FL |
C82.20–C82.29 | Follicular lymphoma grade 3, by site | Higher-grade FL; treatment patterns may differ |
C82.30–C82.39 | Follicular lymphoma grade 3a, by site | Subset of grade 3 |
C82.40–C82.49 | Follicular lymphoma grade 3b, by site | Subset of grade 3; treated more like aggressive lymphoma |
C82.50–C82.59 | Diffuse follicle center lymphoma, by site | Variant FL pattern |
C82.60–C82.69 | Cutaneous follicle center lymphoma, by site | Cutaneous variant; verify per-payer eligibility |
Documentation requirements: Most payers require documented FL diagnosis (with histology
confirmation by IHC), prior treatment with at least 2 lines of systemic therapy (typically including
anti-CD20 mAb such as rituximab or obinutuzumab plus chemoimmunotherapy
like R-CHOP or R-bendamustine), and disease progression or refractory status before Lunsumio PA approval.
Site of care & place of service Verified May 2026
Lunsumio's 24-hour observation requirement after each step-up dose has historically pushed cycle 1 administration into hospital outpatient or even inpatient observation status. However, many cancer centers now run 24-hour observation in extended-stay outpatient infusion suites with telemetry capability — this is increasingly viewed as outpatient-manageable, distinguishing Lunsumio from MM bispecifics that require 48-hour inpatient observation.
| Setting | POS | Claim form | Lunsumio applicability |
|---|---|---|---|
| Outpatient cancer center (extended observation) | 22 / 11 | Varies | Increasingly common for cycle 1 step-up; ideal site once site has 24-hr obs capability |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Common for cycle 1 step-up; subsequent doses may shift to lower-acuity setting |
| Hospital inpatient observation | 21 | UB-04 / 837I | Sometimes used for first dose if site lacks extended OP observation capability |
| Physician oncology office | 11 | CMS-1500 / 837P | Acceptable for C3+ maintenance once CRS risk has stabilized |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Acceptable for C3+ maintenance with CRS protocols in place |
| Patient home | 12 | CMS-1500 | Not appropriate — requires CRS-capable site |
Outpatient cancer center capability is the differentiator. A site that can run 24-hour
telemetry-capable observation in an outpatient infusion suite can keep Lunsumio cycle 1 entirely outpatient,
avoiding inpatient admission and the higher cost-share that comes with it. Sites without that capability
will default to hospital outpatient observation status or short inpatient admission.
Less stringent than MM bispecifics. Tecvayli, Elrexfio, and Talvey require 48-hour
observation after each step-up dose — effectively forcing inpatient admission. Lunsumio's 24-hour
requirement keeps it outpatient-manageable.
Claim form field mapping Genentech 2026
From Genentech Access Solutions Lunsumio coding & coverage materials.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + carton NDC + ML + total volume (1 mL for 1 mg dose; 30 mL for 30 mg dose; 60 mL for 60 mg dose) |
| HCPCS J9350 + JZ (or JW for partial-vial waste) | 24D (drug line) | JZ on virtually every adult claim |
| Drug units | 24G | 1 (C1D1), 2 (C1D8), 60 (C1D15 / C2D1), or 30 (C3+ maintenance) |
| CPT 96413 (admin line, initial hour) | 24D (admin line) | Always required for IV chemo admin |
| CPT 96415 (admin line, each additional hour) | 24D (admin line) | Add lines for hours beyond the first — 4 hr first dose = 96413 + 96415 × 3 |
| ICD-10 | 21 | Most specific C82.x code per histology and site |
| PA number | 23 | Required by all major payers |
Phase 3
Get paid
PA + documented ≥2 prior lines + IHC FL confirmation are the universal requirements.
Payer policy snapshot Reviewed May 2026
PA universal. Documentation of ≥2 prior systemic therapies + FL confirmation by histology required.
| Payer | PA? | Documentation required | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes | FL Dx (IHC), ≥2 prior systemic therapies (typically including anti-CD20 mAb + chemoimmuno), disease status | Aggressive: prefers extended-OP infusion centers; HOPD challenges after first cycle |
| Aetna CPB + Medical Drug policy |
Yes | FL confirmation (histology + IHC), prior therapies documentation, line of therapy ≥3 | Yes — separate Site-of-Care policy for oncology bispecifics |
| Cigna Oncology medical policy |
Yes | Aligned with FDA label and NCCN B-Cell Lymphoma Guidelines (FL bispecific antibody options) | Plan-specific; oncology UM via eviCore on some lines of business |
| BCBS plans Vary by plan |
Yes | Generally aligned with NCCN guidelines + FDA label | Plan-specific; most have oncology bispecific site-of-care steering |
| Medicare (Part B) | No (covered for label indication) | MAC LCDs cover for FDA-approved use with appropriate ICD-10 and prior-therapy documentation | No CMS site-of-care UM |
Step therapy
Effectively built into the FDA label: patients must have failed ≥2 prior systemic therapies, which in FL almost always includes an anti-CD20 monoclonal antibody (rituximab or obinutuzumab) and a chemoimmunotherapy regimen (R-CHOP, R-bendamustine, or BR). Document these prior lines clearly in the PA submission — missing prior-therapy documentation is the #1 PA denial reason.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9350
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$654.542
per mg / per unit
30 mg dose (C3+ maint)
$19,636.26
30 units × ASP+6%
60 mg dose (C1D15 / C2D1)
$39,272.52
60 units × ASP+6%
Course-total cost (CR responder, 8 cycles): 303 total units (1 + 2 + 60 + 60 + 6 × 30)
× $654.542 = ~$198,326 total drug cost (Medicare ASP+6%) before sequestration.
Partial responders extending to 17 cycles add ~$176,726 for the additional 270 units (9 × 30 mg).
After ~2% sequestration: ~$193,000 (CR) or ~$365,000 (PR up to 17 cycles).
Among the highest per-mg drugs in oncology. At $654.542/mg, J9350 is one of the most
expensive Part B drugs by unit cost. The fixed-duration nature partially offsets this for CR responders
but PR responders extending to 17 cycles approach $400K+ in total drug cost.
Coverage
No NCD specific to mosunetuzumab. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9350 for the FDA-approved R/R follicular lymphoma indication with appropriate ICD-10 and prior-therapy documentation.
Code history
- J9350 — permanent code, "Injection, mosunetuzumab-axgb, 1 mg" — replaced earlier unclassified J3490 / J9999 use during the post-approval / pre-permanent-code period
Patient assistance — Genentech Access Solutions Genentech verified May 2026
- Genentech Access Solutions: 1-866-422-2377 — benefits investigation, prior authorization assistance, appeal support, alternate funding identification
- Genentech Oncology Co-pay Assistance Program: commercial copay support up to $25,000/year ($0 copay for eligible commercially-insured patients; excludes Medicare, Medicaid, federal program patients)
- Genentech Patient Foundation: free product for uninsured / underinsured patients meeting income requirements
- Foundations: for Medicare patients, refer to PAN, HealthWell, CancerCare, Leukemia & Lymphoma Society Co-Pay Assistance — verify open lymphoma funds quarterly
- Web: genentech-access.com/hcp/brands/lunsumio.html
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J9350 pre-loaded.
Phase 4
Manage safety & fix denials
CRS protocols, Tocilizumab on hand, and clean PA documentation prevent the most expensive errors.
CRS management — Boxed Warning protocol FDA label verified May 2026
CRS occurred in ~39% of patients in the pivotal trial, most commonly during step-up cycle 1. Mostly Grade 1–2.
BOXED WARNING: Cytokine release syndrome (CRS), including life-threatening reactions,
can occur in patients receiving Lunsumio. Initiate Lunsumio according to the recommended step-up dosing
schedule. Administer pretreatment medications. Monitor patients for signs and symptoms of CRS. Withhold or
permanently discontinue Lunsumio based on severity.
CRS preparedness checklist
- Tocilizumab (Actemra) on hand — minimum 2 doses available before any Lunsumio administration
- Premedication completed 60 min before each step-up dose and first full treatment dose (corticosteroid + antihistamine + antipyretic)
- 24-hour post-dose observation in a setting with telemetry and rapid response capability after each step-up dose (C1 D1, D8, D15) and first full dose (C2 D1)
- Vital signs monitoring per CRS grading protocol
- CRS grading per ASTCT consensus criteria; intervention threshold typically Grade 2+
- Hospital admission contingency plan for Grade 3+ CRS
ICANS (neurotoxicity)
ICANS (immune effector cell-associated neurotoxicity syndrome) has been reported with Lunsumio but is NOT in the Boxed Warning. Monitor for neurologic symptoms (confusion, dysphasia, tremor, seizures). Manage per ASTCT ICANS consensus criteria; severe ICANS may require corticosteroids and supportive care.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Insufficient prior therapy documentation | PA submitted without clearly documenting ≥2 prior systemic therapies | Resubmit with clear treatment history: anti-CD20 mAb course, chemoimmunotherapy regimen, dates, response/progression. This is the #1 denial. |
| FL diagnosis not confirmed | Generic NHL ICD-10 used instead of specific C82.x | Use most specific C82.x code per histology. Submit IHC report confirming follicular pattern. |
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413 + 96415 (each additional hour). Lunsumio is chemo admin per CPT classification. |
| Missing 96415 add-on | Only 96413 billed for >1 hour infusion | Add 96415 lines for each additional hour. 4-hr first dose = 96413 + 96415 × 3. |
| JZ missing on claim | Single-dose vial claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Step-up dosing not followed | Patient billed for 60 mg on C1 D1 without step-up | Cycle 1 MUST follow 1 mg / 2 mg / 60 mg step-up. Skipping step-up is a label deviation and a CRS safety issue. |
| Site of care (HOPD) | HOPD billing for maintenance doses on commercial plan with site-of-care UM | Move C3+ maintenance to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required. |
| Confused with Columvi or Epkinly | Wrong HCPCS used (J9286 or J9321 instead of J9350) | Lunsumio = J9350 (FL). Columvi = J9286 (DLBCL, IV). Epkinly = J9321 (DLBCL, SC). Verify drug + indication match. |
Frequently asked questions
What is the HCPCS code for Lunsumio?
Lunsumio (mosunetuzumab-axgb) is billed under HCPCS J9350 — "Injection,
mosunetuzumab-axgb, 1 mg." Each milligram equals one billable unit. The 30 mg maintenance dose bills as
30 units; the 60 mg cycle 1 day 15 / cycle 2 day 1 dose bills as 60 units; step-up doses bill as 1 and 2
units respectively.
How is Lunsumio dosed?
Lunsumio uses fixed step-up dosing in cycle 1 only, then a fixed maintenance dose. Cycle 1: Day 1 = 1 mg IV (step-up dose 1), Day 8 = 2 mg IV (step-up dose 2), Day 15 = 60 mg IV (first treatment dose). Cycle 2: Day 1 = 60 mg IV. Cycle 3 and beyond: Day 1 = 30 mg IV every 21 days. Total treatment is fixed-duration: 8 cycles for complete response (CR) at C8, or up to 17 cycles for partial response (PR) at C8 — NOT continued indefinitely.
Is Lunsumio IV or subcutaneous?
Lunsumio is IV infusion only. This distinguishes it from the BCMA bispecifics for multiple myeloma (Tecvayli, Elrexfio, Talvey) and the CD20×CD3 bispecific Epkinly (epcoritamab) for DLBCL, all of which are SC. The first treatment dose (60 mg, cycle 1 day 15) is infused over approximately 4 hours; subsequent doses over approximately 2 hours. Bill chemotherapy administration CPT 96413 plus 96415 for IV oncology biologic.
What administration CPT do I use for Lunsumio?
CPT 96413 for the initial hour, plus 96415 for each additional hour. The first
60 mg dose runs ~4 hours (96413 + 96415 × 3); the 30 mg maintenance doses run ~2 hours (96413 +
96415 × 1). Step-up cycle 1 doses also run extended infusion windows. Do NOT bill 96365 (therapeutic IV).
Does Lunsumio have a REMS program?
No formal FDA REMS for Lunsumio — unlike the multiple myeloma bispecifics (Tecvayli, Elrexfio, Talvey) which carry REMS programs for CRS and neurotoxicity. However, Lunsumio carries a Boxed Warning for Cytokine Release Syndrome (CRS), and sites must be equipped to recognize and manage CRS. Tocilizumab (Actemra) must be on hand. 24-hour observation is required after each step-up dose in cycle 1 — less stringent than the 48-hour observation MM bispecifics require.
What is the Medicare reimbursement for J9350?
For Q2 2026, the Medicare Part B payment limit for J9350 is $654.542 per mg (ASP + 6%) — among the highest per-mg drug reimbursements in oncology. The 30 mg maintenance dose reimburses at approximately $19,636.26; the 60 mg cycle 1 day 15 / cycle 2 day 1 dose at approximately $39,272.52; the step-up doses at $654.54 (1 mg) and $1,309.08 (2 mg). Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
What indication is Lunsumio approved for?
Lunsumio is FDA-approved for adult patients with relapsed or refractory follicular lymphoma (FL) after
at least 2 prior lines of systemic therapy. Approval was granted under accelerated approval (December
2022) by the FDA based on overall response rate; full approval is contingent on confirmatory trial readout.
ICD-10 codes are in the C82 family (follicular lymphoma): C82.00–C82.69
by histologic grade and pattern. Most patients have failed prior anti-CD20 therapy (rituximab/obinutuzumab)
and chemoimmunotherapy (e.g., R-CHOP, R-bendamustine) before reaching bispecific therapy.
How long do patients stay on Lunsumio?
Lunsumio is fixed-duration therapy — NOT continued indefinitely until progression. Patients with complete response (CR) at the end of cycle 8 stop treatment after 8 cycles total. Patients with partial response (PR) at C8 may continue up to a total of 17 cycles. After the fixed course completes, patients are observed off therapy. This is a major differentiator vs the indefinite multiple myeloma bispecific antibodies (Tecvayli, Elrexfio) which dose until progression.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- Genentech HCP — Lunsumio prescribing information
- FDA Lunsumio label PDF (BLA 761263)
- Genentech Access Solutions — Lunsumio coding & coverage
- CMS — Medicare Part B Drug ASP Pricing File
- NCCN B-Cell Lymphomas Guidelines
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna — CPB / Medical Drug policy for bispecific antibody therapies
- FDA National Drug Code Directory
- SEER CanMED — HCPCS J9350 reference
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 | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, Cigna, BCBS) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, indication | Event-driven | Tied to manufacturer document version + FDA label revision date. Watch for confirmatory trial readout that may convert accelerated approval to full approval. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS,
manufacturer, payer documents — all linked above). Editorial review in progress. Until that review is complete, treat this as a draft reference and verify each cited
source for high-stakes claims.
Change log
- — Initial publication. ASP data: Q2 2026. Manufacturer source: Genentech 2026 access materials. FDA label: accelerated approval Dec 22, 2022 (BLA 761263). Approved indication: R/R follicular lymphoma after ≥2 prior systemic therapies. CD20×CD3 bispecific landscape (Lunsumio IV / Epkinly SC / Columvi IV) referenced.
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. Indication and dosing are verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.