HCPCS
J9329
1 mg = 1 unit
Phase 1
Identify what you're billing
Confirm the right code, dose, and PD-L1 status before billing.
Tevimbra vs. the rest of the PD-1 class Class compare May 2026
Same mechanism as Keytruda and Opdivo, very different billing infrastructure and payer status. Verify formulary position before initiating therapy.
Tevimbra (tislelizumab-jsgr) is BeOne Medicines' anti-PD-1 monoclonal antibody, FDA-approved March 13, 2024 for second-line unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. The label was expanded in December 2024 to add HER2-negative gastric or gastroesophageal junction (G/GEJ) adenocarcinoma 1L (in combination with platinum + fluoropyrimidine chemo, for PD-L1-positive tumors) and ESCC 1L (in combination with platinum-containing chemo). It is the same mechanistic class as Keytruda (pembrolizumab, J9271) and Opdivo (nivolumab, J9299) but it is a distinct molecule, distinct BLA (761417), and distinct J-code — switching among the three is a new PA event, not a substitution.
| Tevimbra | Keytruda | Opdivo | |
|---|---|---|---|
| HCPCS | J9329 | J9271 | J9299 |
| Generic | tislelizumab-jsgr | pembrolizumab | nivolumab |
| Manufacturer | BeOne Medicines (BeiGene) | Merck Sharp & Dohme | Bristol-Myers Squibb |
| BLA | 761417 (Mar 2024) | 125514 (Sept 2014) | 125554 (Dec 2014) |
| Vial | 100 mg / 10 mL | 100 mg / 4 mL | 40, 100, 240 mg vials |
| NDC | 72579-121-01 | 00006-3026-02/04 | 00003-3772/74/77/79 |
| Standard adult dose | 200 mg Q3W | 200 mg Q3W / 400 mg Q6W | 240 mg Q2W / 480 mg Q4W |
| First infusion time | 60 min | 30 min | 30 min |
| Subsequent infusion time | 30 min | 30 min | 30 min |
| FDA-approved US indications | 2 (ESCC, G/GEJ) | 21+ | 15+ |
| Q2 2026 ASP+6%/mg | $58.270 | $61.251 | $33.624 |
| Typical payer position | Non-preferred | Preferred | Preferred |
Where Tevimbra fits clinically: The 2L+ ESCC indication is the cleanest use case — prior platinum
chemo without prior PD-(L)1 inhibitor is the eligibility checkpoint, and Tevimbra is competitive with
Keytruda (J9271) in this niche. The 1L gastric/GEJ PD-L1-positive combo is a head-on
commercial fight with Keytruda + chemo — expect step therapy.
Not approved in NSCLC in the US. RATIONALE-307 (1L squamous NSCLC + chemo) and RATIONALE-304
(1L non-squamous NSCLC + chemo) supported EU and China approvals but the current US label (revised Dec 2025)
does not include NSCLC. Off-label NSCLC use will be denied. For NSCLC, use Keytruda (J9271),
Opdivo (J9299), Libtayo (J9119), or Tecentriq (J9022).
Dosing & unit math FDA label Dec 2025
From FDA prescribing information, label revised December 2025 (BLA 761417).
Adult flat dosing — all FDA-approved schedules
- 200 mg IV every 3 weeks (most common, used in all pivotal trials; 17 doses/year)
- 150 mg IV every 2 weeks (alternative; 26 doses/year)
- 300 mg IV every 4 weeks (alternative; 13 doses/year)
- 400 mg IV every 6 weeks (extended interval; 8–9 doses/year)
- All schedules deliver equivalent annual drug exposure. 1 mg = 1 unit of J9329.
Infusion rate — rate up if tolerated
| Dose | First infusion | Second infusion | Subsequent infusions (if tolerated) |
|---|---|---|---|
| 150 mg / 200 mg | 60 min | 30 min | 30 min |
| 300 mg | 90 min | 60 min | 30 min |
| 400 mg | 120 min | 60 min | 30 min |
Combination regimens (per FDA label)
- ESCC 1L (PD-L1 TAP ≥1%): Tevimbra 200 mg Q3W + investigator's choice platinum-containing chemotherapy (RATIONALE-306)
- ESCC 2L+: Tevimbra 200 mg Q3W monotherapy after prior systemic chemo (no prior PD-(L)1); no biomarker requirement (RATIONALE-302)
- HER2-negative G/GEJ adenocarcinoma 1L (PD-L1 TAP ≥1%): Tevimbra 200 mg Q3W + platinum (cisplatin or oxaliplatin) + fluoropyrimidine (5-FU or capecitabine) (RATIONALE-305 used TAP ≥5% enrollment; FDA label is broader at ≥1%)
Worked example — first-year billing for ESCC 2L mono (200 mg Q3W)
# 17 doses/year (200 mg Q3W schedule)
Drug units billed per dose: 200 (J9329)
HCPCS: J9329 · Modifier: JZ · Vials: 2 × 100 mg
Admin (first dose): 96413 (chemo IV, up to 1 hr) for 60-min infusion
Admin (subsequent): 96413 alone (30-min infusion fits in 1-hr code)
# Year-1 totals
Total doses: 17
Total drug units billed: 3,400 (17 × 200)
Total drug cost (Q2 2026 ASP+6%): ~$198,118 before sequestration
Drug units billed per dose: 200 (J9329)
HCPCS: J9329 · Modifier: JZ · Vials: 2 × 100 mg
Admin (first dose): 96413 (chemo IV, up to 1 hr) for 60-min infusion
Admin (subsequent): 96413 alone (30-min infusion fits in 1-hr code)
# Year-1 totals
Total doses: 17
Total drug units billed: 3,400 (17 × 200)
Total drug cost (Q2 2026 ASP+6%): ~$198,118 before sequestration
No routine premedication for monotherapy
Tevimbra mono does not require pre-infusion methylprednisolone or antihistamine. For chemo combos (ESCC 1L, G/GEJ 1L), premedicate per the chemo backbone protocol (e.g., antiemetics for cisplatin / oxaliplatin; calcium/magnesium for oxaliplatin). Bill premed drugs and supportive care separately.
NDC reference FDA NDC Directory verified May 2026
| NDC | Strength | Package Size | Units/Vial |
|---|---|---|---|
72579-121-01 / 72579-0121-01 |
100 mg / 10 mL (10 mg/mL) | Single-dose vial, 1 vial per carton | 100 units (1 mg = 1 unit J9329) |
Only one SKU. Unlike Opdivo (40 / 100 / 240 mg vial options) or Keytruda (single + dual vial cartons),
Tevimbra is sold only as the 100 mg / 10 mL single-dose vial. Every standard adult dose is built from
these vials: 200 mg = 2 vials, 300 mg = 3 vials, 400 mg = 4 vials. The 150 mg Q2W schedule is the only one
that produces vial waste.
Use the 11-digit NDC on the claim line. Convert 10-digit
72579-121-01 to
11-digit 72579-0121-01 (5-4-2 format) in the 24A shaded area of CMS-1500. The N4 qualifier
prefix is required. Units of measure: ML (or each), quantity: 10 (mL per vial) × number of vials.
Phase 2
Code the claim
Chemo admin codes apply. The first dose runs 60 minutes — watch the 96413 vs. 96415 split.
Administration codes CPT verified May 2026
Tislelizumab is billed as chemotherapy administration. The 60-minute first dose still fits inside 96413.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for every Tevimbra dose. First dose runs 60 minutes — that is the upper bound of 96413, not a trigger for 96415. Subsequent 30-min doses also bill 96413. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Only if the documented infusion time exceeds 60 minutes (e.g., first 300 mg dose at 90 min, first 400 mg dose at 120 min, or any clinically necessary slow-down). Document start/stop times. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Pembrolizumab, nivolumab, tislelizumab, and other complex monoclonal antibody immunotherapies bill under chemo admin codes per AMA classification. |
96417 |
Chemotherapy administration, IV infusion; each additional sequential infusion of different drug | For chemo combo doses: bill 96413 for the initial drug (whichever is given first), then 96417 for each additional drug in sequence (e.g., Tevimbra after carboplatin/oxaliplatin/cisplatin + 5-FU). |
Why chemo admin for immunotherapy: CPT chemotherapy administration codes (96409–96425)
apply to complex monoclonal antibody administration regardless of mechanism of action. Tislelizumab (like all
other PD-(L)1 inhibitors) is billed under chemo admin codes per AMA classification. This pays materially
more than 96365 therapeutic infusion.
First-dose timing trap: The FDA label specifies 60 minutes for the first 200 mg infusion.
That is the exact upper bound of 96413's "up to 1 hour" definition — not a 96415 trigger. Only add
96415 if the documented infusion time exceeds 60 minutes. Bills that pair 96413 + 96415 on a clean
60-minute first dose will be downcoded.
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. Because Tevimbra ships only as a 100 mg / 10 mL single-dose vial and the standard adult flat doses (200 mg, 300 mg, 400 mg) are whole-vial multiples, JZ applies to virtually every Tevimbra claim.
JW — only when actually discarding drug
JW reports the discarded portion of a single-dose vial. With Tevimbra, this comes up only when the prescribed dose is not a multiple of 100 mg — principally the 150 mg Q2W schedule. The 150 mg dose draws from two 100 mg vials and discards 50 mg. Report both lines on the claim:
# 150 mg Q2W dose — worked example
Vials used: 2 × 100 mg (200 mg available)
Drug administered: 150 mg → Line 1: J9329, 150 units, modifier JZ
Drug discarded: 50 mg → Line 2: J9329, 50 units, modifier JW
Total billed units: 200 (paid for both administered and reasonably wasted)
Vials used: 2 × 100 mg (200 mg available)
Drug administered: 150 mg → Line 1: J9329, 150 units, modifier JZ
Drug discarded: 50 mg → Line 2: J9329, 50 units, modifier JW
Total billed units: 200 (paid for both administered and reasonably wasted)
# 200 mg Q3W dose — standard schedule
Vials used: 2 × 100 mg → 200 mg, no waste
Single drug line: J9329, 200 units, modifier JZ
Vials used: 2 × 100 mg → 200 mg, no waste
Single drug line: J9329, 200 units, modifier JZ
One of JZ or JW must be on every J9329 claim. CMS edits will reject claims missing both
modifiers on a single-dose vial drug. The 200 / 300 / 400 mg flat schedules are zero-waste → JZ; the 150 mg
Q2W schedule is the only one that needs JW.
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. Routine pre-infusion clinical assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired Tevimbra, follow your MAC's current 340B modifier policy. BeOne does not publish 340B-specific billing instructions; defer to your MAC bulletin and the OPPS 340B payment policy in effect for the claim's date of service.
ICD-10-CM by indication FY2026 verified May 2026
Tevimbra has 2 FDA-approved US indication groups as of December 2025. Use the most specific code supported by encounter documentation.
| Indication | ICD-10 family | Notes |
|---|---|---|
| Esophageal squamous cell carcinoma (ESCC) — 1L combo + 2L mono | C15.3 (upper third) / C15.4 (middle third) / C15.5 (lower third) / C15.8 / C15.9 | Histology must be squamous cell (not adenocarcinoma). 2L mono requires prior systemic chemo without prior PD-(L)1. |
| Gastric adenocarcinoma 1L (HER2-, PD-L1 TAP ≥1%) | C16.0–C16.6, C16.8, C16.9 | Combo with platinum + fluoropyrimidine chemo. PD-L1 IHC (VENTANA SP263) required with PA. (RATIONALE-305 enrollment was TAP ≥5%; FDA label is broader at ≥1%.) |
| Gastroesophageal junction (GEJ) adenocarcinoma 1L (HER2-, PD-L1 TAP ≥1%) | C16.0 | GEJ tumors map to C16.0 (cardia). Same combo + PD-L1 requirements as gastric. |
Histology and biomarker on every ESCC/GEJ claim. Most payers require documentation of
squamous histology (for ESCC) or PD-L1 status with the assay name (for G/GEJ) in the PA. Don't submit on
ICD-10 alone — attach the pathology and molecular reports.
Off-label use will be denied. NSCLC (C34.x), hepatocellular (C22.0), and other tumor types
with positive Tevimbra Phase 3 data outside the US are not on the US label. Off-label
claims will be returned. Use the appropriate on-label PD-1 (Keytruda, Opdivo, Libtayo, Tecentriq) instead.
Site of care & place of service Verified May 2026
UnitedHealthcare, Aetna, Cigna, and most major BCBS plans run aggressive site-of-care UM for immune checkpoint inhibitors. Aetna CPB 0892 explicitly steers ICIs out of HOPD after the first 3 months unless on combo chemo or active toxicity management. Tevimbra falls under the same site-of-care policies as the rest of the PD-1 class; expect the same downstream pressure as Keytruda and Opdivo.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician oncology office | 11 | CMS-1500 / 837P | Preferred by commercial UM |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM |
| Oncology ASC | 24 | CMS-1500 / 837P | Acceptable |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored after first 3 months |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored after first 3 months |
| Patient home | 12 | CMS-1500 (with home infusion) | Not appropriate — first-dose monitoring requires clinical setting |
Home is not on the table for Tevimbra. Even at the 30-min subsequent rate, PD-1 inhibitors
carry irAE risk (pneumonitis, colitis, hepatitis, endocrinopathies) that requires clinical observation. No
major payer covers home infusion for PD-(L)1 monoclonal antibodies; HOPD / AIC / office / ASC only.
Claim form field mapping CMS-1500 verified May 2026
Outpatient / physician-office claims use CMS-1500 / 837P. HOPD claims use UB-04 / 837I with revenue code 0335 (chemo admin) or 0636 (drugs requiring detailed coding).
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b / 24J / 33a | Rendering provider, billing provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 72579-0121-01 + ML + total mL administered (20 mL for 200 mg = 2 vials) |
| HCPCS J9329 + JZ (or JW for 150 mg waste line) | 24D (drug line) | JZ on virtually every claim; JW only on 150 mg Q2W schedule discard line |
| Drug units | 24G | 200 (for 200 mg Q3W); actual mg administered on the JZ line |
| CPT 96413 (admin line) | 24D (admin line) | Primary chemo IV admin code — covers both 60-min first dose and 30-min subsequent |
| CPT 96415 (additional hour) | 24D (admin line) | Only if documented infusion time > 60 min |
| ICD-10 | 21 | C15.x (ESCC) or C16.x (G/GEJ); attach histology + PD-L1 results to PA |
| PA number | 23 | Required by all major commercial payers; not required by Medicare FFS |
HOPD revenue codes: UB-04 / 837I HOPD claims pair revenue code 0636
(drugs requiring detailed coding) for the J9329 drug line with 0335 (chemo admin) for the
96413/96415 administration line. Confirm your MAC's specific revenue code requirements.
Phase 3
Get paid
Step therapy from a preferred PD-1 is the dominant access barrier. PD-L1 documentation is non-negotiable for gastric.
Payer policy snapshot + PD-L1 requirements Reviewed May 2026
Major commercial payers treat Tevimbra as non-preferred against Keytruda/Opdivo. Plan ahead for step therapy and PD-L1 documentation.
| Payer | PA? | Step therapy from preferred PD-1 | PD-L1 enforcement (G/GEJ) |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes | Yes — documented failure of, intolerance to, or contraindication to a preferred PD-(L)1 (Keytruda or Opdivo) typically required for non-ESCC-2L use | Strict — PD-L1 TAP ≥1% (VENTANA SP263 or comparable) required for G/GEJ 1L and ESCC 1L combo per current FDA label |
| Aetna CPB 1057 (tislelizumab-jsgr) + CPB 0892 (ICI SOC) |
Yes | Yes for G/GEJ 1L — step from Keytruda preferred; ESCC 2L mono is cleanest path (no step required) | Strict for G/GEJ 1L and ESCC 1L combo (PD-L1 TAP ≥1%); no biomarker required for ESCC 2L+ mono |
| Cigna / EviCore Oncology drug policy |
Yes | Yes — site-of-care + non-preferred PD-1 review | Strict — PD-L1 result required with PA for G/GEJ |
| BCBS plans Vary by plan |
Yes | Plan-specific; most have a preferred PD-1 step requirement before Tevimbra | Generally aligned with FDA label (PD-L1 TAP ≥1% for G/GEJ 1L and ESCC 1L combo) |
| Medicare FFS MAC LCDs |
No (FFS) | No step therapy | Coverage per FDA label + NCCN; documentation in chart, not on claim |
PD-L1 test billing (separate from drug claim)
| Test | CPT | For Tevimbra indications |
|---|---|---|
| PD-L1 IHC (VENTANA SP263 was the trial assay) | 88360 (manual) / 88361 (computer-assisted) | G/GEJ 1L combo and ESCC 1L combo (required, TAP ≥1% per current FDA label); ESCC 2L+ mono: not required |
| HER2 IHC (for G/GEJ histology workup) | 88360 | G/GEJ must be HER2-negative for Tevimbra; HER2-positive G/GEJ goes to Herceptin + chemo ± Keytruda |
| HER2 ISH (reflex if IHC 2+) | 88377 | Confirm HER2 status before Tevimbra G/GEJ submission |
NCCN guideline references
NCCN Guidelines® for Esophageal and Esophagogastric Junction Cancers and for Gastric Cancer include tislelizumab-jsgr as a recommended option in both the 1L combo settings (G/GEJ PD-L1 TAP ≥1%; ESCC 1L + chemo) and the 2L mono setting (ESCC after prior chemo without prior PD-[L]1). Verify the current version of the NCCN guideline for the patient's tumor type before submission — payer policies frequently cross-reference the most recent NCCN release.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9329
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$58.270
per mg / per unit
200 mg dose (Q3W)
$11,654.00
200 units × ASP+6%
Annualized (200 mg Q3W × 17)
$198,118
Pre-sequestration
Schedule equivalence: 150 mg Q2W (26 doses), 200 mg Q3W (17 doses), 300 mg Q4W (13 doses),
and 400 mg Q6W (8–9 doses) all deliver roughly equivalent annual drug exposure (~$195,000–$200,000 at Q2 2026 ASP+6%, pre-sequestration).
After ~2% sequestration: ~$194,000/year actual paid for the 200 mg Q3W schedule.
Coverage
No NCD specific to tislelizumab-jsgr. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9329 for FDA-approved on-label indications (ESCC 1L combo + 2L mono; HER2-negative G/GEJ 1L combo PD-L1 TAP ≥1%) with appropriate ICD-10 and pathology documentation. Off-label uses (NSCLC, hepatocellular, etc.) are routinely denied.
Code history
- J9329 — permanent code, effective July 1, 2025 (CMS HCPCS Q3 2025 update). Initial FDA approval was March 13, 2024; claims between approval and code activation used unclassified
J3590(orC9399in HOPD) with NDC and dose documentation.
Pre-J9329 claims may still be reprocessed. If you have outstanding J3590 / C9399 claims
for Tevimbra from before July 1, 2025, confirm whether your payer requires resubmission under J9329 for the
new code period only, or accepts the bridging unclassified code for the entire pre-J9329 window.
Patient assistance — myBeOne Support BeOne verified May 2026
- myBeOne Support Patient Support Program for Tevimbra: 1-833-234-4363 (Mon–Fri 8 AM – 8 PM ET) — benefits investigation, prior authorization assistance, appeal support, dedicated Oncology Nurse Advocate
- Tevimbra Co-pay Program: eligible commercially-insured patients may pay $0 per prescription; excludes Medicare, Medicaid, TRICARE, VA, and other federal program patients
- BeOne Patient Assistance Program: free product for uninsured / underinsured patients meeting income requirements
- Foundations: for Medicare patients, refer to PAN Foundation, HealthWell, CancerCare — verify open ESCC / gastric oncology funds quarterly. Funds open and close frequently.
- Enrollment options: online at mybeonesupport.com/tevimbra or fax enrollment form to 1-877-828-5593
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J9329 pre-loaded.
Phase 4
Fix problems
Step therapy from preferred PD-1, missing PD-L1, and off-label NSCLC are the top three denial reasons.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Step therapy — preferred PD-1 required first | PA submitted for non-preferred Tevimbra without documented preferred-PD-1 failure / intolerance / contraindication | Submit a structured step-therapy exception with clinical rationale: prior adverse reaction to Keytruda / Opdivo, contraindication, or specific clinical reason Tevimbra is required. ESCC 2L mono has the lightest step burden — prior platinum chemo is itself the qualifying step. |
| PD-L1 not documented (G/GEJ 1L or ESCC 1L combo) | PA submitted without PD-L1 IHC result or with TAP <1% | Run PD-L1 IHC (VENTANA SP263 preferred for label-aligned scoring); submit report showing TAP ≥1%. If TAP <1%, Tevimbra combo is not a labeled option for these indications. |
| Off-label NSCLC denial | Provider requested Tevimbra for 1L or 2L+ NSCLC | Switch to an on-label PD-(L)1 for NSCLC: Keytruda (J9271), Opdivo (J9299), Libtayo (J9119), or Tecentriq (J9022). The US Tevimbra label does not include NSCLC. |
| HER2 status not documented (G/GEJ) | Tevimbra G/GEJ requires HER2-negative; PA submitted without HER2 IHC/ISH | Submit HER2 IHC (and reflex ISH if IHC 2+). HER2-positive G/GEJ goes to trastuzumab + chemo ± Keytruda; Tevimbra is HER2-negative only. |
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413. Tevimbra is chemo admin per CPT classification despite being immunotherapy. |
| 96415 added on a 60-min first dose | Coder paired 96413 + 96415 because the first dose runs 60 minutes | Drop 96415. The "up to 1 hour" 96413 description includes 60 minutes. 96415 is only for documented infusion time > 60 min. |
| JZ missing on adult claim | Single-dose vial claim without JZ or JW | Resubmit with JZ for the 200 / 300 / 400 mg schedules (no waste). Use JZ for administered + JW for waste on the 150 mg Q2W schedule. |
| Wrong NDC format | 10-digit NDC submitted instead of 11-digit billing format | Convert 72579-121-01 to 11-digit 72579-0121-01 (5-4-2 format). N4 qualifier required. |
| Site of care (HOPD) | HOPD administration after first 3 months on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required (e.g., on active toxicity management). |
| Histology mismatch (ESCC) | Adenocarcinoma of esophagus submitted under Tevimbra ESCC indication | Tevimbra's ESCC indication is squamous cell only. Esophageal adenocarcinoma is in the G/GEJ adenocarcinoma group (C16.0); confirm histology and reassign indication. |
| Pre-J9329 claim under wrong unclassified code | Pre-7/1/2025 claim submitted under wrong unclassified code or now under J9329 by mistake | For DOS < 7/1/2025, use J3590 (or C9399 in HOPD) with NDC; for DOS ≥ 7/1/2025, use J9329. Confirm payer's bridging policy. |
Frequently asked questions
What is the HCPCS code for Tevimbra?
Tevimbra (tislelizumab-jsgr) is billed under HCPCS J9329 — "Injection, tislelizumab-jsgr,
1 mg." Each milligram equals one billable unit, so the standard 200 mg Q3W flat dose is billed as 200 units.
J9329 became effective July 1, 2025 (CMS HCPCS Q3 2025 update); claims before that date
used unclassified J3590 (or C9399 in HOPD) with NDC and dose documentation while
the permanent code was pending.
How many units do I bill for a 200 mg Tevimbra dose?
Bill 200 units of J9329 per 200 mg dose. Tevimbra is supplied as a single
100 mg / 10 mL single-dose vial (NDC 72579-121-01), so a 200 mg dose uses two vials with zero
waste — bill JZ. The FDA label also recognizes 150 mg Q2W, 300 mg Q4W, and 400 mg Q6W as alternative
schedules; bill the actual mg administered.
What administration CPT do I use for Tevimbra?
CPT 96413 — "Chemotherapy administration, IV infusion technique; up to 1 hour, single or
initial substance/drug." The first dose is infused over 60 minutes, which sits at the upper bound of 96413
— do not add 96415 unless the documented infusion time exceeds 60 minutes. Subsequent doses run 30
minutes and still bill 96413. Do NOT bill 96365.
Do I bill JZ or JW for Tevimbra?
Bill JZ on virtually every Tevimbra claim. The 200, 300, and 400 mg flat-dose schedules are
whole-vial multiples (zero waste). JW applies only to the 150 mg Q2W schedule, which discards
50 mg from a 200 mg draw — bill 150 units JZ on the drug line and 50 units JW on the waste line. One
of JZ or JW must be on every J9329 claim per CMS's July 2023 single-dose container policy.
What is the Medicare reimbursement for J9329?
For Q2 2026, the Medicare Part B payment limit for J9329 is $58.270 per mg (ASP + 6%). The standard 200 mg Q3W dose reimburses at approximately $11,654.00 per infusion. Annualized at 200 mg Q3W (17 doses/year): approximately $198,118. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%. ASP is updated quarterly by CMS; the next update is July 1, 2026 for Q3.
How does Tevimbra compare to Keytruda for 1L NSCLC?
As of the December 2025 US label revision, Tevimbra is NOT FDA-approved for NSCLC in the United States. RATIONALE-307 (1L squamous NSCLC + chemo) and RATIONALE-304 (1L non-squamous NSCLC + chemo) supported EU and China approvals but the US label currently lists only ESCC (1L combo and 2L+ mono) and HER2-negative gastric/GEJ 1L combo (PD-L1 positive). For NSCLC, US payers will direct providers to Keytruda (J9271), Opdivo (J9299), Libtayo (J9119), or Tecentriq (J9022).
Is Tevimbra interchangeable with other PD-1 inhibitors mid-treatment?
No. Tevimbra is a distinct molecule with its own BLA (761417), its own NDC, and its own J-code. Switching to or from Keytruda (pembrolizumab), Opdivo (nivolumab), or other PD-1 inhibitors mid-treatment requires a new prior authorization, a new clinical rationale, and may trigger payer step-therapy or non-preferred-product review. Payer formularies often pair preferred and non-preferred PD-1s; confirm the patient's plan-specific preferred PD-1 before initiating Tevimbra to avoid step-therapy denial.
What PD-L1 threshold is required for Tevimbra coverage in gastric cancer?
FDA approval for HER2-negative gastric or gastroesophageal junction adenocarcinoma 1L (in combination with platinum + fluoropyrimidine chemotherapy) requires PD-L1 expression with a tumor area positivity (TAP) score of 5% or greater, per the December 2024 approval (RATIONALE-305). Submit the PD-L1 IHC report with the PA — the diagnostic was tested using the VENTANA PD-L1 (SP263) assay in the registrational trial. Payers will deny without PD-L1 documentation.
Does step therapy apply for Tevimbra?
Yes on many commercial plans. UnitedHealthcare, Aetna, and several BCBS plans designate Keytruda and Opdivo as preferred PD-1 inhibitors on their oncology medical drug policies; Tevimbra is positioned as non-preferred in many formularies. Step therapy typically requires documented failure of, intolerance to, or contraindication to a preferred PD-1 before approving Tevimbra. The ESCC 2L+ mono indication is the cleanest path — prior platinum chemotherapy is itself the step, and Tevimbra fits the post-chemo, no-prior-PD-(L)1 niche.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- DailyMed — TEVIMBRA (tislelizumab-jsgr) Prescribing Information
- FDA Tevimbra label PDF (s000, 2024)
- FDA Drugs@FDA — Tevimbra approval package
- FDA — Tislelizumab-jsgr approved for ESCC (March 13, 2024)
- FDA — Tislelizumab-jsgr + chemo for HER2-negative G/GEJ (December 2024)
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J9329 reference
- Aetna CPB 1057 — Tislelizumab-jsgr (Tevimbra)
- Aetna CPB 0892 — Immune Checkpoint Inhibitors / ICI Site-of-Care
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- RATIONALE-302 — Tislelizumab vs chemo in 2L+ advanced ESCC
- RATIONALE-306 — Tislelizumab + chemo in 1L unresectable advanced ESCC
- RATIONALE-305 — Tislelizumab + chemo in HER2-negative G/GEJ adenocarcinoma 1L
- myBeOne Support — Tevimbra patient support program
- FDA National Drug Code Directory
- NCCN Guidelines — Esophageal/EGJ Cancer + Gastric Cancer
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 list | Event-driven | Tied to manufacturer document version + FDA label revision date. BeOne is actively expanding the Tevimbra label. |
Reviewer
SME-audited 2026-05-22 — corrections applied. This page is staff-authored from primary sources (FDA, CMS, BeOne /
BeiGene, payer documents — all linked above) and was audited 2026-05-22 against DailyMed setid 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a (label revised Feb 5, 2026).
Corrections: PD-L1 threshold for G/GEJ 1L and ESCC 1L combo updated from TAP ≥5% to TAP ≥1% to match current FDA label (RATIONALE-305 enrollment criterion was ≥5%; FDA label is broader).
Re-verify each cited source for high-stakes claims.
Change log
- — SME audit. PD-L1 TAP threshold for G/GEJ 1L and ESCC 1L combo corrected from ≥5% (RATIONALE-305 enrollment) to ≥1% (current FDA label). DailyMed label revision confirmed Feb 5, 2026 (setid 08ef1e3e-496f-4b0b-94ee-fbba3cc1985a). NSCLC remains not on US label.
- — Initial publication. ASP data: Q2 2026. FDA label: Dec 2025 revision (BLA 761417). HCPCS J9329 effective 7/1/2025. Indications: ESCC 2L mono (Mar 2024), G/GEJ HER2-negative PD-L1+ 1L combo (Dec 2024), ESCC 1L combo.
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 list is verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.