HCPCS
J9011
1 unit = 1 mg
Phase 1
Identify what you're billing
Confirm the indication (breast vs lung) and run the unit math against weight before any other coding.
Dosing & unit math FDA label verified May 2026
From the FDA prescribing information on DailyMed for Datroway (datopotamab deruxtecan-dlnk); label most recently revised March 2026 (includes 2025 NSCLC supplement).
Adult dosing — both approved indications
- 6 mg/kg IV on Day 1 of every 21-day cycle (one infusion per cycle, both HR+/HER2- mBC and EGFR-mutated NSCLC)
- Continue until disease progression or unacceptable toxicity
- First infusion: 90 minutes. Observe for at least 60 minutes after the first dose.
- Subsequent infusions: 30 minutes if first dose tolerated. Observe at least 30 minutes after each subsequent dose.
- Calculate dose using actual body weight. FDA label specifies a maximum dose of 540 mg for patients weighing ≥90 kg (per DailyMed setid 2950227c-6230-4ca4-a135-46e44d9424a0, Mar 2026 revision)
Reconstitution and preparation
- Each 100 mg single-dose vial contains lyophilized powder.
- Reconstitute each vial with 5 mL of Sterile Water for Injection → 20 mg/mL clear, colorless to slightly yellowish solution.
- Calculate volume needed for the patient's dose (mg ÷ 20 = mL); withdraw and add to an infusion bag of 5% Dextrose Injection to a final concentration per institutional protocol.
- Use immediately if possible; per label, stored reconstituted vial is stable for limited time at controlled room temperature or refrigerated — verify current PI for exact stability windows. Protect from light.
- Use 5% Dextrose only as the diluent for the infusion bag — saline can cause aggregation. Use polyolefin or PVC infusion bags and DEHP- or non-DEHP-containing infusion sets per label.
Premedication
- Antiemetics — Datroway is moderate emetogenic potential; a 5-HT3 antagonist with or without dexamethasone is appropriate per NCCN antiemesis guidelines.
- Corticosteroid dosing (e.g., dexamethasone 8 mg) may be considered before infusion to reduce stomatitis severity per institutional protocol.
- Ocular care: initiate preservative-free ocular lubricant prophylactically; advise patients to avoid contact lenses during therapy and report any ocular symptoms immediately.
- H1/H2 blockers for infusion reaction prophylaxis on first dose per institutional policy.
Worked example — 75 kg patient with HR+/HER2- mBC, full year
# Per-dose math
Dose: 75 kg × 6 mg/kg = 450 mg
Vials drawn: 450 / 100 = 4.5 → 5 vials (500 mg total drawn)
Drug billed: 450 mg = 450 units (J9011 + JZ)
Drug wasted: 50 mg = 50 units (J9011 + JW, separate line)
Admin: 96413 (first hr) ± 96415 (first dose only, 90 min infusion)
# Per cycle (Day 1 only)
Doses per cycle: 1
Drug units billed per cycle: 450 administered + 50 wasted
# Year-1 (~17 cycles)
Total infusions: 17
Total drug units administered: ~7,650 units (administered)
Total drug cost (Q2 2026 ASP+6%): ~$394,097 before sequestration
Dose: 75 kg × 6 mg/kg = 450 mg
Vials drawn: 450 / 100 = 4.5 → 5 vials (500 mg total drawn)
Drug billed: 450 mg = 450 units (J9011 + JZ)
Drug wasted: 50 mg = 50 units (J9011 + JW, separate line)
Admin: 96413 (first hr) ± 96415 (first dose only, 90 min infusion)
# Per cycle (Day 1 only)
Doses per cycle: 1
Drug units billed per cycle: 450 administered + 50 wasted
# Year-1 (~17 cycles)
Total infusions: 17
Total drug units administered: ~7,650 units (administered)
Total drug cost (Q2 2026 ASP+6%): ~$394,097 before sequestration
Dose schedule difference vs Trodelvy: Datroway is one infusion per cycle (q21d). Trodelvy is two infusions per cycle (Days 1 + 8 of q21d). Annualized drug units are similar in magnitude, but per-encounter chair time, copay events, and PA renewal cadence differ.
NDC reference FDA NDC Directory verified May 2026
| NDC | Strength | Package Size | Units/Vial |
|---|---|---|---|
65597-801-01 / 65597-0801-01 |
100 mg | Single-dose vial — 1 vial per carton | 100 units (1 mg = 1 unit) |
Use carton-level NDC. Submit
65597-0801-01 with the N4 qualifier on the claim line.
Vial-level NDC will trigger denial. Multi-vial doses (typical for weight-based dosing) bill multiple carton-NDC quantities for the
unit-of-measure ML.
NDC unit-of-measure reminder: Each reconstituted 100 mg vial yields 5 mL at 20 mg/mL. NDC quantity
on the claim should reflect total mL drawn from vials (not mg, not units). For a 450 mg dose, 5 vials ×
5 mL = 25 mL drawn from vials; the actual administered volume is 22.5 mL after waste.
ILD/pneumonitis monitoring FDA label / NCCN verified May 2026
Class effect for deruxtecan ADCs — payer PA reviews and appeal documentation routinely expect baseline pulmonary status + monitoring plan in the chart.
Datroway shares the deruxtecan (DXd) payload class with Enhertu (trastuzumab deruxtecan, J9358), which carries a boxed warning for ILD/pneumonitis including fatal cases. Datroway's prescribing information includes similar warnings without (as of this writing) a formal boxed warning — verify current FDA label revision for any boxed-warning escalation.
- Baseline: pulmonary history, baseline chest imaging (CT preferred), spirometry/DLCO if indicated
- During therapy: monitor for new or worsening respiratory symptoms (cough, dyspnea, fever); maintain low threshold for high-resolution CT chest
- Suspected ILD (any grade): hold dose; promptly evaluate with imaging and pulmonology consult; initiate corticosteroids per label guidance
- Grade 2 or higher confirmed ILD: permanently discontinue Datroway
Documentation for payer appeals: for ILD-related denials or step-edit appeals, include baseline pulmonary assessment notes, imaging report dates, and the institution's ADC pneumonitis monitoring protocol. Several commercial payers (UHC, Aetna) expect this in PA submissions for any deruxtecan-class ADC by 2026.
Phase 2
Code the claim
Chemo admin codes apply — Datroway is a true cytotoxic ADC (DXd topoisomerase I inhibitor payload). JZ + JW both expected on most claims.
Administration codes CPT verified May 2026
Datroway delivers a deruxtecan payload (DXd) intracellularly — chemotherapy administration codes are unambiguously correct.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for every Datroway infusion. Covers the first 60 minutes of any infusion. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Required for the first dose only — 90-min infusion = 96413 + 96415 × 1. Subsequent 30-min infusions need 96413 alone. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Datroway is a cytotoxic ADC (DXd topoisomerase I inhibitor payload) by AMA classification. |
96360 / 96361 |
Hydration IV | Bill separately if IV hydration administered alongside infusion. Use modifier 59 / X-modifier as appropriate. |
Infusion-time math: First-dose 90-min infusion bills 96413 × 1 + 96415 × 1.
All subsequent 30-min infusions bill 96413 × 1 only. Document actual infusion start/stop times in the medical record — CMS audits look for
chair-time documentation matching billed units, and a recurring 96415 on subsequent cycles is an audit flag.
Modifiers CMS verified May 2026
JZ + JW — both apply on most claims
Effective July 1, 2023, CMS requires either JZ (no waste) or JW (drug discarded from a single-dose container) on every J9011 claim. Because Datroway is dosed by weight (6 mg/kg) and only available in 100 mg single-dose vials, partial-vial waste is the rule, not the exception.
- JZ on the administered units (the actual mg given to the patient = units, since 1 unit = 1 mg).
- JW on the discarded units (drawn-but-not-administered mg = units), reported on a separate claim line.
- Both lines must reconcile against the total mg drawn from vials (vials drawn × 100 = total mg drawn = administered + wasted).
Worked example — 75 kg patient, 450 mg dose
# Vials and waste
Vials drawn: 5 × 100 mg = 500 mg total
Administered: 450 mg = 450 units → J9011-JZ
Discarded: 50 mg = 50 units → J9011-JW
# Claim lines
Line 1: J9011-JZ × 450 units
Line 2: J9011-JW × 50 units
Line 3: 96413 (admin, first hr)
Line 4: 96415 (admin, addl hr) — first dose only (90 min); omit for subsequent 30-min doses
Vials drawn: 5 × 100 mg = 500 mg total
Administered: 450 mg = 450 units → J9011-JZ
Discarded: 50 mg = 50 units → J9011-JW
# Claim lines
Line 1: J9011-JZ × 450 units
Line 2: J9011-JW × 50 units
Line 3: 96413 (admin, first hr)
Line 4: 96415 (admin, addl hr) — first dose only (90 min); omit for subsequent 30-min doses
Common error: Forgetting the JW line entirely on weight-based doses where vials had to be rounded up.
For a 450 mg dose drawn from 5 × 100 mg vials, 50 mg of waste must be reported on a separate JW line. CMS audits routinely
catch under-reported waste and over-reported waste — both are recoupable.
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., toxicity assessment with dose modification decision after a stomatitis or ILD event). Routine pre-infusion clinical assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired Datroway, follow your MAC's current 340B modifier policy. As of May 2026, JG (340B-acquired, normal payment) and TB (340B-acquired, informational) policy varies by region; verify with your MAC.
ICD-10-CM by indication FY2026 verified May 2026
Use the most specific code supported by encounter documentation; pair breast cancer codes with ER/PR/HER2 status Z-codes, and pair lung cancer codes with EGFR mutation status documentation in chart.
| Indication | Primary ICD-10 | Required supporting codes |
|---|---|---|
| HR+/HER2- metastatic breast cancer | C50.x1 (right breast) / C50.x2 (left breast) by quadrant |
Z17.0 (ER+ status) and/or Z17.1 (PR+ status); HER2- documentation in chart; C79.x for metastatic sites (e.g., C79.81 bone, C79.31 brain, C78.7 liver, C78.0x lung) |
| EGFR-mutated metastatic NSCLC (post-EGFR TKI + platinum chemo) | C34.x1 (right lung) / C34.x2 (left lung) by lobe |
EGFR mutation status documentation in chart (mutation type, e.g., exon 19 deletion / L858R); C79.x for metastatic sites; prior EGFR TKI + platinum chemo documented in treatment history |
Common breast cancer C50 codes by quadrant
| Code family | Location |
|---|---|
C50.0x | Nipple and areola |
C50.1x | Central portion of breast |
C50.2x | Upper-inner quadrant |
C50.3x | Lower-inner quadrant |
C50.4x | Upper-outer quadrant |
C50.5x | Lower-outer quadrant |
C50.6x | Axillary tail |
C50.8x | Overlapping sites |
C50.9x | Unspecified |
Common NSCLC C34 codes
| Code | Location |
|---|---|
C34.01 / C34.02 | Main bronchus (R/L) |
C34.11 / C34.12 | Upper lobe (R/L) |
C34.2 | Middle lobe (right) |
C34.31 / C34.32 | Lower lobe (R/L) |
C34.81 / C34.82 | Overlapping sites (R/L) |
C34.91 / C34.92 | Unspecified part (R/L) |
C77-C79 | Secondary metastatic sites as appropriate |
Indication-specific PA criteria are the norm. Most payers require ICD-10 + line of therapy
documentation + biomarker status (receptor status for breast, EGFR mutation type for lung) + prior-therapy documentation. ICD-10 alone is not sufficient
for PA approval — you must show the patient meets the post-line-of-therapy criteria for each indication.
EGFR NSCLC indication is accelerated approval (Jun 2025). Coverage is well-established as of May 2026 across major payers, but post-marketing confirmatory data is still maturing.
Verify current FDA label and your payer's medical policy before billing J9011 with C34.x ICD-10. NCCN NSCLC compendium support typically present.
Site of care & place of service Verified May 2026
Datroway's first-dose 90-minute infusion plus 60-minute observation typically requires an infusion suite or physician oncology office. Subsequent 30-minute infusions are highly office-friendly. Major commercial payers (UnitedHealthcare, Aetna, BCBS) run aggressive site-of-care UM steering specialty oncology drugs out of HOPD. Datroway's shorter subsequent-infusion time (vs Trodelvy's 1–2 hour subsequent infusions) makes office-based delivery easier to operationalize after Cycle 1.
| 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 cycle by most commercial UM |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored after first cycle by most commercial UM |
| Patient home | 12 | CMS-1500 (with home infusion) | Rare for cytotoxic ADCs given ILD/pneumonitis monitoring requirements; clinic-based delivery preferred |
First-dose recommendation: Many oncology practices schedule the first Datroway dose in a
hospital outpatient or AIC with observation capability given the 60-minute post-infusion observation requirement
plus baseline pulmonary risk assessment. Subsequent 30-minute doses transition cleanly to office (POS 11) once tolerability is established. Document this clinical rationale in chart for any HOPD site-of-care UM appeal.
Claim form field mapping Daiichi Sankyo Reimbursement Guide 2026
Every Datroway claim with weight-based dosing typically has two J9011 lines — JZ and JW. Account for both.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 65597-0801-01 + ML + total volume drawn (e.g., 25 mL for 5 vials) |
| HCPCS J9011 + JZ (administered units) | 24D (drug line 1) | Units = administered mg (1 unit = 1 mg) |
| HCPCS J9011 + JW (wasted units) | 24D (drug line 2) | Units = discarded mg; required when partial-vial waste occurs |
| Drug units | 24G | Per line; ensure JZ + JW units sum to total mg drawn from vials |
| CPT 96413 (admin line) | 24D (admin line 1) | First hour of infusion (every Datroway encounter) |
| CPT 96415 (admin line) | 24D (admin line 2) | Additional hour — first dose only (90-min infusion); omit for subsequent 30-min doses |
| ICD-10 | 21 | Indication-specific (see ICD-10 table); pair with biomarker Z-codes and metastatic-site C79.x codes |
| PA number | 23 | Required by all major commercial payers |
Phase 3
Get paid
Confirm receptor status (breast) or EGFR mutation status (NSCLC) is documented in PA submission. ILD monitoring plan is increasingly expected.
Payer policy snapshot Reviewed May 2026
All major payers require PA. The NSCLC indication (June 2025 accelerated approval) is newer than the breast cancer indication — some payers are still tightening criteria.
| Payer | PA? | Documentation focus | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes | Strict for line of therapy: HR+/HER2- mBC requires endocrine + ≥1 prior chemo for metastatic disease; NSCLC requires documented EGFR mutation + prior EGFR TKI + platinum chemo; baseline pulmonary status increasingly requested | Aggressive: ICI/ADC steering away from HOPD via Optum-managed program |
| Aetna Medical Drug policies |
Yes | Aligned with NCCN Breast Cancer and NSCLC guidelines + FDA label; receptor status / EGFR mutation status required; ILD monitoring plan requested for appeals | Yes (separate Site-of-Care policy; cytotoxic ADCs steered out of HOPD after first cycle) |
| BCBS plans Vary by plan |
Yes | Generally aligned with NCCN guidelines + FDA label; some plans (Anthem) require baseline pulmonary assessment documentation given deruxtecan class effect | Plan-specific; most have ICI/ADC site-of-care steering after first cycle |
| Medicare All MACs — LCDs |
No (Part B medical benefit) | All MACs cover J9011 for FDA-approved indications with appropriate ICD-10 and biomarker (receptor status / EGFR mutation status) documentation | Limited; Medicare has no formal site-of-care UM |
Step therapy
Datroway is a later-line therapy by FDA label design (post-endocrine + 1 prior chemo for HR+/HER2- mBC; post-EGFR TKI + platinum chemo for NSCLC). Step therapy requirements are typically baked into the line-of-therapy documentation, not enforced as a separate gate. Expect payers to require evidence of prior CDK4/6 inhibitor exposure for HR+/HER2- breast cancer and prior osimertinib (or other EGFR TKI) + platinum doublet for NSCLC in the PA submission.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9011
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$51.516
per mg (1 unit = 1 mg)
450 mg dose (75 kg)
$23,182.20
450 units × ASP+6%
600 mg dose (100 kg)
$30,909.60
600 units × ASP+6%
Annualized cost (75 kg patient, 6 mg/kg q21d): 1 dose per cycle × ~17 cycles per year = 17 infusions; ~$394,000/year drug cost at Medicare ASP+6% before sequestration and before counting wasted-vial JW reimbursement (which adds modestly). After ~2% sequestration: ~$386,000/year actual paid.
ASP is updated quarterly by CMS — next update: July 1, 2026 for Q3.
Coverage
No NCD specific to datopotamab deruxtecan-dlnk. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9011 for FDA-approved on-label indications with appropriate ICD-10 and biomarker (breast cancer receptor status; NSCLC EGFR mutation status) documentation.
Code history
- Pre-2026 — Datroway billed under unclassified
J3490/J9999or transitional pass-throughC9399with NDC and dose documentation following the January 17, 2025 FDA approval - J9011 — permanent code "Datopotamab deruxtecan, 1 mg," effective with the 2026 CMS HCPCS update; verify your MAC's exact crosswalk date for any claims that straddle the transitional period
Patient assistance — DATROWAY4U / Daiichi Sankyo Access Central Daiichi Sankyo verified May 2026
- DATROWAY4U: 1-855-DATRO4U (1-855-328-7648) / datroway4u.com — benefits investigation, prior authorization assistance, appeal support, copay program enrollment, and PAP referrals
- DATROWAY Patient Savings Program (commercial copay): eligible commercially insured patients may pay as little as $0 per infusion through the manufacturer copay program; verify current annual maximum benefit and program rules at enrollment (excludes Medicare, Medicaid, federal program patients)
- Daiichi Sankyo Patient Assistance Program (PAP) via Access Central: free Datroway for uninsured / underinsured patients meeting income eligibility criteria (typically ≤500% Federal Poverty Level — verify current threshold at enrollment); enrollment form at datroway4u.com PAP Enrollment Form
- Foundations for Medicare patients: refer to PAN Foundation, HealthWell Foundation, CancerCare, and Good Days — verify open breast cancer and NSCLC copay funds quarterly (oncology fund availability is highly volatile)
- Web: datrowayhcp.com (HCP) / datroway4u.com (patient) / Daiichi Sankyo Patient Assistance Programs
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and
OOP max? Run a CareCost Estimate — J9011 pre-loaded.
Phase 4
Fix problems
Cross-product unit confusion (vs Trodelvy), missing JW lines on weight-based doses, and ILD-monitoring documentation gaps are the recurring problems.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong HCPCS code submitted | Datroway accidentally billed under J9317 (Trodelvy) or J9358 (Enhertu) by ADC cross-confusion | Resubmit with J9011. Verify HCPCS matches actual product dispensed; document NDC 65597-0801-01 on claim line. |
| JW missing on weight-based claim | Wasted drug not reported when partial-vial waste occurred from 100 mg vial rounding | Add JW line with discarded units (mg discarded = units, since 1 unit = 1 mg). JZ on administered units; JW on wasted. |
| JZ + JW units don't reconcile to vials drawn | Math error: JZ + JW units should equal vials drawn × 100 mg | Recompute: total mg drawn = vials × 100; administered mg = JZ units; (drawn mg − admin mg) = JW units. |
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413 (every dose) and 96415 (first dose only). Datroway is cytotoxic chemotherapy by AMA classification. |
| 96415 on subsequent (30-min) infusions | Auto-billed 96415 every cycle by template; only first 90-min dose needs it | Audit infusion start/stop documentation; remove 96415 from subsequent-cycle claims unless infusion actually exceeded 60 minutes. |
| Wrong NDC format (vial vs carton) | Vial NDC submitted instead of carton NDC | Use carton NDC: 65597-0801-01 with N4 qualifier. |
| PA denial — sequence-of-therapy not documented | HR+/HER2- mBC: prior endocrine + chemo not documented; NSCLC: prior EGFR TKI + platinum not documented | Submit complete clinical history including all prior lines of therapy (CDK4/6 inhibitor, endocrine, chemo for breast; EGFR TKI, platinum doublet for NSCLC) with dates and outcomes. |
| PA denial — biomarker not documented | HR+/HER2- mBC: receptor status missing; NSCLC: EGFR mutation type missing | Resubmit with ER/PR/HER2 results (with IHC scores and ISH if applicable) for breast cancer, or EGFR mutation report (exon 19 deletion / L858R / other) for NSCLC. |
| Site of care (HOPD) | HOPD administration after first cycle on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49) for cycle 2+. Submit medical necessity letter if HOPD required (e.g., active toxicity management). |
| ILD-related appeal denial | Baseline pulmonary assessment not documented; ADC pneumonitis monitoring protocol absent from chart | Submit baseline chest imaging, pulmonary history, and institutional ADC pneumonitis monitoring protocol with appeal letter. |
| Confusion with Trodelvy unit conversion | Biller assumed 1 unit = 2.5 mg (Trodelvy convention) instead of 1 unit = 1 mg (J9011 convention) | Reconfirm: J9011 = 1 unit per mg (standard mAb/ADC convention). Resubmit with units = mg administered exactly. Only J9317 uses 2.5 mg/unit. |
Frequently asked questions
What is the HCPCS code for Datroway?
Datroway (datopotamab deruxtecan-dlnk) is billed under HCPCS J9011 — "Datopotamab deruxtecan, 1 mg."
One billable unit equals 1 mg, which is the standard mAb/ADC convention (unlike its TROP-2 sibling Trodelvy, where 1 unit = 2.5 mg).
J9011 became a permanent code effective in 2026; pre-2026 doses billed under unclassified J3490 or C9399 pass-through. Verify your MAC's current crosswalk if you are billing very early-2026 claims that straddle the transitional period.
How does Datroway differ from Trodelvy?
Both are TROP-2-directed antibody-drug conjugates (ADCs), but the payloads, dosing schedules, indications, and unit conversions differ. Datroway carries a deruxtecan payload (DXd; topoisomerase I inhibitor, same family as Enhertu), is dosed 6 mg/kg q3w, and is approved for HR+/HER2- mBC plus EGFR-mutated NSCLC. Trodelvy carries SN-38 (irinotecan metabolite), is dosed 10 mg/kg on Days 1 + 8 of a 21-day cycle, and is approved for metastatic TNBC and HR+/HER2- mBC. Datroway's toxicity profile centers on ILD/pneumonitis and stomatitis; Trodelvy's centers on severe neutropenia and severe diarrhea (boxed warning).
Is Datroway approved for HER2-low breast cancer or only HR+/HER2-?
Datroway's breast cancer label covers unresectable or metastatic HR+/HER2- disease in adults who have received prior endocrine-based therapy and chemotherapy in the metastatic setting. It is NOT approved for HER2-low specifically — Enhertu (J9358) holds that indication. Payer PA reviews focus on receptor status documentation: ER and/or PR positive, HER2 negative by IHC/ISH per ASCO/CAP guidelines, plus documentation of prior CDK4/6 inhibitor + endocrine therapy and at least one prior line of chemotherapy in the metastatic setting.
What's the billing unit for J9011?
1 unit = 1 mg, per the CMS HCPCS descriptor "Datopotamab deruxtecan, 1 mg." Total mg administered = units billed. Example: a 75 kg patient at 6 mg/kg = 450 mg = 450 units. Each 100 mg single-dose vial = 100 units. Round mg administered per institutional rounding policy (commonly nearest 5 or 10 mg), then bill that mg total directly as units.
What administration CPT do I use for Datroway?
CPT 96413 for every Datroway infusion. The first infusion is administered over 90 minutes (96413 + 96415 × 1 for the additional 30 minutes that push beyond the first hour).
Subsequent infusions are 30 minutes (96413 alone — no 96415 needed). Do NOT bill 96365 — Datroway is a true cytotoxic ADC (DXd is a topoisomerase I inhibitor) and chemo administration codes apply per AMA classification.
Does Datroway require lung function monitoring?
Yes. Like other deruxtecan-payload ADCs (Enhertu), Datroway carries a warning for interstitial lung disease (ILD) and pneumonitis, including fatal cases. The prescribing information recommends baseline pulmonary assessment and monitoring patients for new or worsening respiratory symptoms (cough, dyspnea, fever). Hold the dose for suspected ILD and permanently discontinue for any Grade 2 or higher ILD. Payer PA submissions and appeals should document baseline pulmonary status and the patient-management plan; some commercial plans request baseline CT chest documentation in the appeal record.
What is the Medicare reimbursement for J9011?
For Q2 2026, the Medicare Part B payment limit for J9011 is $51.516 per mg at ASP + 6%. A typical 450 mg dose for a 75 kg patient at 6 mg/kg = 450 units × $51.516 = $23,182.20 per dose. Cycles are every 21 days; an annualized course (~17 cycles per year) is roughly ~$394,000/year in drug cost (ASP + 6%) before sequestration and before counting JW vial-waste reimbursement (which adds modestly).
What patient assistance is available for Datroway?
The DATROWAY4U Patient Access Program from Daiichi Sankyo (1-855-DATRO4U / 1-855-328-7648) provides benefits investigation, prior authorization assistance, appeal support, and copay assistance. Eligible commercially insured patients may pay as little as $0 per infusion through the DATROWAY Patient Savings Program (excludes Medicare, Medicaid, federal program patients). Uninsured and underinsured patients meeting income criteria can apply to the Daiichi Sankyo Patient Assistance Program through Access Central for free product. Medicare patients should be referred to PAN Foundation, HealthWell Foundation, and CancerCare for breast and lung cancer copay funds — verify open funds quarterly.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- FDA — DATROWAY (datopotamab deruxtecan-dlnk) Prescribing Information
- DailyMed — DATROWAY Prescribing Information (setid 2950227c-...)
- FDA Drugs@FDA — Datroway BLA 761394
- FDA — Accelerated approval for EGFR-mutated NSCLC (June 23, 2025)
- CMS — Medicare Part B Drug ASP Pricing File
- CMS — HCPCS Quarterly Update
- DATROWAY HCP — Dosing & Administration
- DATROWAY HCP — Access & Support
- DATROWAY4U (patient)
- Daiichi Sankyo — Access Central / Patient Assistance Programs
- TROPION-Breast01 final OS analysis — Annals of Oncology, 2025
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna Medical Drug policies — oncology
- NCCN Clinical Practice Guidelines in Oncology — Breast Cancer + NSCLC (current versions)
- FDA National Drug Code Directory
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, 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. NSCLC accelerated approval (June 2025) under active monitoring for confirmatory data. |
Reviewer
SME-audited 2026-05-22 — corrections applied. This page was audited 2026-05-22 against DailyMed setid 2950227c-6230-4ca4-a135-46e44d9424a0 (Daiichi Sankyo label, revised March 2026). Corrections applied: (1) Label revision date updated from "2025 NSCLC supplement" to March 2026; (2) Weight cap corrected from "100 kg per typical institutional ADC policy" to FDA-labeled "maximum 540 mg for patients ≥90 kg"; (3) DailyMed setid added to source. Boxed warnings: NONE confirmed (ILD/pneumonitis remains a Warning & Precaution, not boxed). Indications confirmed: HR+/HER2- mBC and EGFR-mutated NSCLC; no additional 2025-2026 indication expansions identified. Verify each cited source for high-stakes claims.
Change log
- — SME audit. (1) Label revision date confirmed March 2026 per DailyMed setid 2950227c-6230-4ca4-a135-46e44d9424a0 (updated from "2025 NSCLC supplement"). (2) FDA-labeled maximum dose of 540 mg for patients ≥90 kg substituted for prior "100 kg cap per institutional policy" language. (3) No new indication expansions identified for 2025-2026. (4) Boxed warnings: NONE (ILD remains a Warning & Precaution, not boxed). (5) ASP/HCPCS unchanged (J9011 = $51.516/mg Q2 2026).
- — Initial publication. ASP data: Q2 2026 ($51.516 per mg). Manufacturer source: Daiichi Sankyo DATROWAY HCP + DATROWAY4U 2026. Two indications: HR+/HER2- mBC (full approval Jan 17, 2025), EGFR-mutated NSCLC (accelerated approval Jun 23, 2025).
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.