Emrelis (telisotuzumab vedotin-tllv) — HCPCS J9326

Dosing, preparation & infusion FDA label verified May 2026

A single labeled regimen: 1.9 mg/kg IV every 2 weeks, capped at 190 mg per dose. Bill actual mg administered.

Reconstitution & dilution

• Reconstitute each 20 mg vial with 1.1 mL Sterile Water for Injection → 20 mg/mL solution
• Reconstitute each 100 mg vial with 5.2 mL Sterile Water for Injection → 20 mg/mL solution
• Withdraw the calculated dose volume; further dilute in an IV bag of 0.9% Sodium Chloride per the prescribing information
• Administer through a dedicated line with a 0.20 or 0.22 micron in-line filter (PES, PVDF, or polyamide)
• Do NOT administer as IV push or bolus

Worked unit math — 1.9 mg/kg q2w

NDC reference FDA NDC Directory verified May 2026

c-Met IHC biomarker — VENTANA MET (SP44) RxDx Assay FDA companion Dx verified May 2026

Emrelis is approved with a single FDA-approved companion diagnostic. Without a qualifying SP44 result on file, payer PA will be denied.

Administration codes CPT verified May 2026

Emrelis is a true cytotoxic ADC (MMAE / vedotin payload). Bills under chemotherapy administration codes, not therapeutic IV.

Modifiers CMS verified May 2026

JZ + JW — almost always both

Emrelis is supplied in 20 mg and 100 mg single-dose vials with weight-based dosing (1.9 mg/kg). The math virtually never lands on a clean multiple of available vial sizes. Bill JZ on the units administered and JW on the discarded units on a separate claim line. Worked example: 80 kg patient at 1.9 mg/kg = 152 mg administered, most efficiently drawn from one 100 mg vial + three 20 mg vials (160 mg total drawn) → bill 152 units with JZ on line 1 and 8 units with JW on line 2.

One of JZ or JW must be on every J9326 claim per CMS's July 2023 single-dose container policy. Missing the modifier triggers automatic denial.

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 Emrelis, follow your MAC's current 340B modifier policy. AbbVie's billing guide does not provide 340B-specific instructions.

ICD-10-CM by indication FY2026 verified May 2026

Emrelis is indicated only in non-squamous NSCLC. Pair the most specific lung site code with the relevant secondary metastatic site codes and Z51.11 on the admin claim line.

Site of care & place of service Verified May 2026

Emrelis is a clinic-administered IV infusion requiring monitoring and an in-line filter setup; it is not a candidate for home infusion. Commercial payers with active site-of-care UM (UnitedHealthcare, Aetna) prefer office or AIC settings over hospital outpatient after the first 1–2 cycles, in line with other ADCs.

Claim form field mapping AbbVie 2026

From AbbVie Emrelis Support Services HCP coding & reimbursement guide.

Payer policy snapshot Reviewed May 2026

All major payers require PA. SP44 IHC result + non-squamous histology + prior systemic therapy documentation are the standard gating items.

Step therapy

Emrelis is positioned as a 2L+ option (post-prior systemic therapy). Step therapy is the indication itself: most payers require documentation of platinum-based chemotherapy and a PD-1/PD-L1 inhibitor (unless contraindicated or refused) before approving Emrelis. The label does not specify which prior therapy is required — "at least one prior systemic therapy" is the FDA threshold — but commercial payers typically expect both classes.

NCCN alignment

Emrelis is referenced in the NCCN NSCLC compendium as a subsequent-therapy option for patients with c-Met protein-overexpressing (≥50% strong 3+ by IHC) advanced or metastatic non-squamous NSCLC after prior therapy. Cite the NCCN NSCLC guideline on PA submissions to anchor the medical necessity argument.

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.

Coverage

No NCD specific to telisotuzumab vedotin. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. MACs cover J9326 for the FDA-labeled indication with appropriate ICD-10, histology documentation, and SP44 IHC threshold met.

Code history

• J9326 — permanent code "Telisotuzumab vedotin-tllv, 1 mg"; effective 2026 on the CMS HCPCS file
• Pre-permanent-code period (mid-2025 post-approval) — transitional billing under unclassified C9399 or J3490
• FDA accelerated approval: May 14, 2025 (BLA 761384)

Patient assistance — AbbVie programs AbbVie verified May 2026

• Emrelis Support Services: 1-844-900-2228 / emrelishcp.com — benefits investigation, prior authorization assistance, appeal support, copay assistance for commercial patients
• Emrelis Patient Savings Program (commercial copay): eligible commercially insured patients may pay as little as $0 per infusion (excludes Medicare, Medicaid, federal program patients; income and program-rule limits apply)
• myAbbVie Assist (PAP): 1-800-222-6885 · fax 1-866-250-2803 · pap.my.site.com/PAS — free Emrelis for uninsured or underinsured patients meeting income and clinical eligibility criteria; submit the Emrelis-specific enrollment form
• Foundations (Medicare patients): refer to PAN Foundation, HealthWell Foundation, CancerCare, Good Days — verify open lung cancer funds quarterly (funds open and close based on donor availability)
• Mailing: AbbVie Patient Access Support, D-617927, AP5 NE, 1 N. Waukegan Rd., North Chicago, IL 60064
• Web: emrelis.com (patient) / emrelishcp.com (HCP)

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Emrelis (Teliso-V)?

Emrelis (telisotuzumab vedotin-tllv) is billed under HCPCS J9326 — "Telisotuzumab vedotin-tllv, 1 mg." One billable unit equals 1 mg. J9326 is a permanent code on the CMS HCPCS file with a Q2 2026 ASP listing. Pre-permanent-code claims (early post-approval, mid-2025) billed under unclassified C9399 or J3490; verify your MAC's transitional crosswalk if you are auditing very early-2025 dates of service.

What c-MET IHC threshold qualifies a patient for Emrelis coverage?

FDA-approved for adults with non-squamous NSCLC whose tumors show HIGH c-Met protein overexpression, defined as at least 50% of tumor cells with strong (3+) membrane staining by the VENTANA MET (SP44) RxDx Assay (Roche Diagnostics) — the FDA-approved companion diagnostic. Lower expression (1+ to 2+ staining, or <50% 3+) does NOT qualify under the label, and payers will deny PA without the SP44 result documenting the threshold. Order the SP44 IHC BEFORE submitting the Emrelis PA.

How is Emrelis different from c-MET exon 14 skipping drugs like Tabrecta or Tepmetko?

They target different molecular alterations. Emrelis (J9326) is an antibody-drug conjugate targeting the c-MET protein when it is OVEREXPRESSED on the tumor cell surface (measured by IHC, the SP44 assay). Tabrecta (capmatinib) and Tepmetko (tepotinib) are oral small-molecule kinase inhibitors targeting the activated c-MET kinase that results from a c-MET EXON 14 SKIPPING MUTATION (measured by next-generation sequencing of tumor DNA). The two biomarkers are not interchangeable. PA for Emrelis specifically requires the IHC SP44 result, not the NGS mutation report.

What's the billing unit for J9326?

1 unit = 1 mg, per the CMS HCPCS descriptor "Telisotuzumab vedotin-tllv, 1 mg." Total mg administered = units billed. Example: an 80 kg patient at 1.9 mg/kg = 152 mg = 152 units. Vials are 20 mg (0074-1044-01) and 100 mg (0074-1055-01) single-dose presentations — optimize vial selection to minimize waste, then bill actual mg administered as JZ units and discarded mg as JW units on a separate line.

What administration CPT do I use for Emrelis?

CPT 96413 — "Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug" — for every Emrelis infusion. The labeled infusion duration is 30 minutes through a 0.20 or 0.22 micron in-line filter (PES, PVDF, or polyamide). 96413 covers the full standard infusion within its 1-hour window; 96415 (each additional hour) is not needed for routine administration. Emrelis is a true cytotoxic ADC delivering an MMAE (vedotin) payload — chemotherapy administration codes apply per AMA classification, not the therapeutic IV codes 96365/96366.

Is peripheral neuropathy monitoring required for Emrelis?

Yes. Peripheral neuropathy is a known MMAE-payload class effect (also seen with Adcetris, Padcev, Polivy, Tivdak). Per the prescribing information, monitor for new or worsening neuropathy each cycle, hold the dose for Grade 2 neuropathy, dose-reduce per the label for persistent Grade 2 or Grade 3, and permanently discontinue for Grade 4. Document neurologic exam at each cycle in the chart — payer appeals on continued therapy after dose reduction routinely request this documentation. Other significant warnings include interstitial lung disease / pneumonitis, ocular toxicity, hepatotoxicity, and embryo-fetal toxicity.

What is the Medicare reimbursement for J9326?

For Q2 2026, the Medicare Part B payment limit for J9326 is $145.994 per mg at ASP + 6%. An 80 kg patient at 1.9 mg/kg = 152 mg = 152 units × $145.994 ≈ $22,191.09 per dose. The 190 mg dose cap (≥100 kg patient) = 190 units ≈ $27,738.86 per dose. Infusions are every 2 weeks, so an annualized course is ~26 doses/year. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%. ASP is updated quarterly by CMS; next update July 1, 2026 for Q3.

What patient assistance is available for Emrelis?

AbbVie operates two complementary programs. Emrelis Support Services (1-844-900-2228) provides benefits investigation, prior authorization assistance, appeal support, and copay assistance for commercially insured patients (excludes Medicare, Medicaid, and federal program patients). myAbbVie Assist (1-800-222-6885; pap.my.site.com) provides free medicine to uninsured and underinsured patients who meet income and clinical eligibility criteria — submit the Emrelis-specific enrollment form (fax 1-866-250-2803). Medicare patients should be referred to PAN, HealthWell, CancerCare, and Good Days for lung cancer copay funds — verify open funds quarterly.

How does Emrelis compare to other antibody-drug conjugates in oncology?

Emrelis (J9326, anti-c-Met, MMAE payload) is the first c-Met-directed ADC approved in oncology and the only ADC labeled for c-Met protein-high non-squamous NSCLC. The MMAE/vedotin payload chemistry is shared with Adcetris (J9042, CD30), Padcev (J9177, Nectin-4), Tivdak (J9273, tissue factor), and Polivy (J9309, CD79b) — common class effects: peripheral neuropathy, infusion reactions. Other lung ADCs have different targets and payloads: Enhertu (J9358) targets HER2 with a deruxtecan (DXd) payload (NSCLC indication for HER2-mutant disease); Trodelvy (J9317) and Datroway (J9011) target TROP-2 (Trodelvy for breast/urothelial; Datroway for breast and EGFR-mutated NSCLC). Same class architecture, different targets, payloads, and patient populations.

Source documents

1. FDA — EMRELIS prescribing information (BLA 761384)
   FDA-approved label, initial approval May 14, 2025 (accelerated)
2. DailyMed — EMRELIS (telisotuzumab vedotin-tllv)
3. FDA — Accelerated approval announcement, telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression
4. AbbVie — FDA approval of Emrelis (press release, May 14, 2025)
5. AbbVie — EMRELIS Prescribing Information (PDF, rxabbvie.com)
6. EMRELIS HCP site — coding, coverage, and support services
7. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026
8. SEER CanMED — HCPCS J-code reference
9. Roche Diagnostics — VENTANA MET (SP44) RxDx Assay
   FDA-approved companion diagnostic for Emrelis eligibility
10. NCCN — Non-Small Cell Lung Cancer Guidelines
11. FDA National Drug Code Directory
12. myAbbVie Assist — Patient Assistance Program

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.

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Reviewer

Change log

• May 23, 2026 — SME audit. Reconfirmed J9326 Q2 2026 ASP ($145.994 per mg). Indication, dose (1.9 mg/kg IV q2w, max 190 mg), vial sizes (20 mg + 100 mg), and SP44 IHC threshold (≥50% strong 3+ staining) all verified against AbbVie HCP materials. No DailyMed entry yet; verification anchored to the FDA accelerated approval (May 14, 2025; BLA 761384) and AbbVie Emrelis HCP package.
• May 21, 2026 — Initial publication. ASP data: Q2 2026 ($145.994 per mg). Manufacturer source: AbbVie Emrelis HCP + myAbbVie Assist 2026. FDA label: May 14, 2025 (accelerated approval, BLA 761384). Single labeled indication: c-Met protein-high non-squamous NSCLC after prior systemic therapy. VENTANA MET (SP44) IHC companion diagnostic threshold called out prominently. c-Met overexpression vs c-MET exon 14 skipping (Tabrecta / Tepmetko) cross-confusion flagged as primary biller error trap. Two vial sizes (20 mg + 100 mg) with vial-selection guide and worked JZ/JW math.

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.