HCPCS
J1323
1 mg = 1 unit
Phase 1
Identify what you're billing
Step-up dosing is fixed (not weight-based). Get the schedule right or you trigger CRS audits.
Step-up dosing schedule FDA label verified 2026
Elrexfio uses fixed-dose step-up (NOT weight-based like Tecvayli). Three escalating doses before the first full treatment dose, with mandatory 48-hour hospitalization after each.
Step-up Day 1
12 mg
Premedicate. SC injection. Hospitalize 48 hr.
Step-up Day 4
32 mg
2–4 days after Day 1. Premedicate. Hospitalize 48 hr.
First full dose Day 8
76 mg
2–4 days after Day 4. Premedicate. Hospitalize 48 hr.
Maintenance
76 mg
Weekly thru cycle 6, then q2wk in responders.
48-hour inpatient observation required after step-up doses 1, 2, AND the first full 76 mg dose on Day 8.
Do NOT discharge between step-up doses without monitoring. CRS onset is typically within 1–2 days of dosing.
After completion of all three observation periods, subsequent 76 mg doses can be administered in the outpatient
setting in patients with no prior CRS or ICANS at the prior dose.
Premedication (required for step-up doses 1, 2, and first full treatment dose)
- Dexamethasone 20 mg PO or IV (or equivalent corticosteroid)
- Diphenhydramine 25–50 mg PO or IV (or equivalent H1 antihistamine)
- Acetaminophen 650–1000 mg PO
- Administer ~1 hour before Elrexfio
Spacing rule: Step-up doses 1, 2, and the first full treatment dose must be spaced 2–4 days
apart. If >14 days have elapsed between any of these doses (e.g., for AE management or scheduling), restart
step-up dosing from the beginning per FDA label restart criteria. Same applies if >6 weeks pass between
maintenance doses without resumption.
Maintenance dosing & unit math FDA label verified 2026
Weekly maintenance (cycles 1–6, weeks 1–24)
- 76 mg SC weekly starting Day 8 (first full treatment dose) and continuing through cycle 6
- Each Elrexfio cycle = 28 days = 4 weekly doses
- Cycle 1 includes the two step-up doses (12 mg, 32 mg) plus the first full treatment dose (76 mg) and three more weekly 76 mg doses
- Bill 76 units of J1323 per weekly maintenance dose
Biweekly (q2wk) maintenance (cycle 7+, week 25+)
- 76 mg SC every 2 weeks for patients who have received Elrexfio for at least 24 weeks AND achieved a response (≥partial response per IMWG criteria)
- Continue until disease progression or unacceptable toxicity
- Biweekly dosing is Elrexfio's signature differentiator vs Tecvayli (which stays weekly with optional q2wk)
- Bill 76 units of J1323 per q2wk maintenance dose
Worked example — first-year billing for a relapsed/refractory MM patient (response by cycle 6)
# Cycle 1 (28 days): 6 doses
Day 1 step-up: 12 units (J1323) + JZ + 96401 + 48-hr inpatient
Day 4 step-up: 32 units (J1323) + JZ + 96401 + 48-hr inpatient
Day 8 first full: 76 units (J1323) + JZ + 96401 + 48-hr inpatient
Days 15, 22 weekly: 76 units × 2 = 152 units
Cycle 1 drug units: 272
# Cycles 2–6 (5 cycles × 4 weekly doses = 20 doses)
76 units × 20 doses = 1,520 units
# Cycles 7–13 (q2wk maintenance, ~14 doses thru year-end)
76 units × 14 doses = 1,064 units
# Year-1 totals (assumes response by cycle 6)
Total drug units: 2,856
Total drug cost (Q2 2026 ASP+6%): ~$533,475 before sequestration
Total chair-time visits: 40 (vs ~52 if weekly forever)
Day 1 step-up: 12 units (J1323) + JZ + 96401 + 48-hr inpatient
Day 4 step-up: 32 units (J1323) + JZ + 96401 + 48-hr inpatient
Day 8 first full: 76 units (J1323) + JZ + 96401 + 48-hr inpatient
Days 15, 22 weekly: 76 units × 2 = 152 units
Cycle 1 drug units: 272
# Cycles 2–6 (5 cycles × 4 weekly doses = 20 doses)
76 units × 20 doses = 1,520 units
# Cycles 7–13 (q2wk maintenance, ~14 doses thru year-end)
76 units × 14 doses = 1,064 units
# Year-1 totals (assumes response by cycle 6)
Total drug units: 2,856
Total drug cost (Q2 2026 ASP+6%): ~$533,475 before sequestration
Total chair-time visits: 40 (vs ~52 if weekly forever)
Why q2wk matters financially: A patient who transitions to q2wk at cycle 7 saves ~12 doses
per year (76 units × ~$14,196 = ~$170,000 in drug cost) AND ~12 chair-time visits versus weekly-only
BCMA bispecifics. Site-of-care steerage often anchors to this cycle-6 transition point.
Elrexfio vs. Tecvayli vs. Talvey — bispecific comparison May 2026
Three FDA-approved bispecifics for relapsed/refractory MM (≥4 prior lines). Two hit BCMA (Elrexfio, Tecvayli); one hits GPRC5D (Talvey). Same boxed warnings, different billing details.
| Elrexfio | Tecvayli | Talvey | |
|---|---|---|---|
| Generic | elranatamab-bcmm | teclistamab-cqyv | talquetamab-tgvs |
| Manufacturer | Pfizer | Janssen / J&J | Janssen / J&J |
| Target | BCMA × CD3 | BCMA × CD3 | GPRC5D × CD3 |
| HCPCS | J1323 | J9286 | J3055 |
| Step-up dose type | Fixed (12 / 32 / 76 mg) | Weight-based (0.06 / 0.3 / 1.5 mg/kg) | Weight-based |
| Full treatment dose | 76 mg SC | 1.5 mg/kg SC (~120 mg avg) | 0.4 mg/kg SC weekly OR 0.8 mg/kg q2wk |
| Maintenance schedule | Weekly → q2wk by label after cycle 6 | Weekly (optional q2wk after ≥4 cycles) | Weekly OR q2wk per label option |
| Hospitalization | 48 hr after each step-up dose + first full dose | 48 hr after each step-up dose + first full dose | 48 hr after each step-up dose + first full dose |
| REMS program | ELREXFIO REMS | TECVAYLI REMS | TALVEY REMS |
| CRS rate (any grade) | ~58% | ~72% | ~76% |
| ICANS rate (any grade) | ~3.4% | ~6% | ~10% |
| Distinguishing AE | Lower ICANS than peers | BCMA-class infections | Dysgeusia, nail/skin AEs (GPRC5D) |
| FDA approval | Aug 2023 (accelerated) | Oct 2022 (accelerated) | Aug 2023 (accelerated) |
Sequencing note: Patients who progress on one BCMA bispecific generally cannot be re-treated
with another BCMA-targeted therapy effectively (BCMA antigen loss / T-cell exhaustion). Talvey (GPRC5D)
is the typical post-BCMA option. Cross-link to Darzalex (anti-CD38) —
anti-CD38 mAb exposure is a prerequisite for all three bispecifics per label (≥4 prior lines including
proteasome inhibitor + immunomodulator + anti-CD38 mAb).
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Package | Use |
|---|---|---|
0069-1019-01 / 00069-1019-01 |
40 mg / 1 mL (40 mg/mL) single-dose vial | Step-up dose 1 (12 mg) and step-up dose 2 (32 mg) — partial vial; JW for waste |
0069-1018-01 / 00069-1018-01 |
76 mg / 1.9 mL (40 mg/mL) single-dose vial | First full treatment dose and all subsequent 76 mg maintenance doses; bill JZ (no waste) |
Verify NDC at billing time. NDCs above reflect Pfizer's primary US market presentations
as of label review. Confirm against the FDA NDC Directory and your wholesaler invoice for current
package/lot numbers. Use the carton-level NDC on claim forms unless your payer has documented otherwise.
Step-up vial waste: The 12 mg Day 1 dose drawn from a 40 mg vial discards 28 mg
(bill JW + 28 units of waste). The 32 mg Day 4 dose drawn from a 40 mg vial discards 8 mg (bill JW +
8 units). The 76 mg full treatment dose uses the 76 mg vial cleanly (bill JZ; no waste).
Phase 2
Code the claim
Chemo SC admin code (96401) typically applies; some payers accept 96372 instead.
Administration codes CPT verified May 2026
Bispecific T-cell engagers are administered SC. CPT chemo SC code is most common; some commercial payers accept therapeutic SC injection code.
| Code | Description | When to use |
|---|---|---|
96401 |
Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic | Primary code for Elrexfio. Per AMA classification, complex monoclonal antibody SC administration falls under chemotherapy administration codes regardless of mechanism. |
96372 |
Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular | Some commercial payers prefer this code for bispecifics (or for inpatient Elrexfio administration). Pays materially less than 96401. Verify per-payer policy. |
96401 + E/M with 25 modifier |
Same-day E/M for new toxicity / response assessment | Routine pre-dose clinical assessment is bundled into the admin code; only bill separate E/M when significant, separately identifiable. |
Inpatient billing during the 48-hour observation period: The Elrexfio administration during
the inpatient observation stay is bundled into the inpatient DRG (typically MS-DRG 837 chemotherapy with
acute leukemia or 846 chemotherapy without acute leukemia w MCC). Drug cost is part of the DRG payment
for inpatient stays; J1323 is not separately billable on the inpatient claim. For step-up doses delivered
in observation status (POS 22) rather than inpatient admission, J1323 is separately billable.
Modifiers CMS verified May 2026
JZ — required on every full-vial 76 mg dose
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. The 76 mg dose drawn from the 76 mg/1.9 mL vial uses the entire vial with zero waste — JZ applies to every weekly and q2wk maintenance claim.
JW — required for step-up vial waste
JW reports the discarded portion of a single-dose vial. Both step-up doses (12 mg, 32 mg) are drawn from the 40 mg vial, leaving discarded drug:
- Day 1 (12 mg dose): bill 12 units administered (J1323) + JW line for 28 units of waste
- Day 4 (32 mg dose): bill 32 units administered (J1323) + JW line for 8 units of waste
- Day 8+ (76 mg dose): bill 76 units administered (J1323) with JZ; no waste
- One of JZ or JW must be on every J1323 claim per CMS's July 2023 single-dose container policy
Common error: Forgetting to bill the JW waste line on step-up doses. The wasted portion
is reimbursable but must be reported on a separate claim line. Missing JW is a frequent CMS audit finding.
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 SC injection. Routine pre-dose clinical assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired Elrexfio, follow your MAC's current 340B modifier policy. Pfizer's billing materials do not provide 340B-specific instructions.
ICD-10-CM — multiple myeloma FY2026 verified May 2026
All Elrexfio claims will use the C90 family. Most patients are in relapse (C90.02).
| Code | Description | Notes |
|---|---|---|
C90.00 | Multiple myeloma not having achieved remission | Active disease, never in remission |
C90.01 | Multiple myeloma in remission | Rare for Elrexfio (drug is for active R/R disease) |
C90.02 | Multiple myeloma in relapse | Most common for Elrexfio — relapsed/refractory after ≥4 prior lines |
Indication-specific PA criteria. All major payers require documentation of ≥4 prior lines
of therapy including a proteasome inhibitor (bortezomib, carfilzomib, ixazomib), an immunomodulatory agent
(lenalidomide, pomalidomide), AND an anti-CD38 monoclonal antibody (Darzalex / Darzalex Faspro / Sarclisa).
ICD-10 alone is not sufficient. Submit complete prior-therapy history with PA.
Site of care & place of service Verified May 2026
Elrexfio site-of-care is dictated more by the 48-hour observation requirement during step-up than by commercial UM steering. Step-up doses essentially require inpatient or observation-status administration at a REMS-certified facility. Maintenance doses can move to office or AIC after step-up completion if no prior CRS/ICANS.
| Setting | POS | Use case | Notes |
|---|---|---|---|
| Inpatient (admission) | 21 | Step-up doses 1, 2, first full dose | Drug bundled in DRG; J1323 not separately billable |
| Hospital outpatient observation | 22 | Step-up doses if observation only (no admission) | J1323 separately billable; UB-04 / 837I |
| Hospital outpatient (PBD on-campus) | 22 | Maintenance after step-up if patient prefers HOPD | Disfavored long-term by commercial payers |
| Physician oncology office | 11 | Maintenance 76 mg weekly → q2wk after step-up | Preferred by commercial UM; office must be REMS-certified |
| Ambulatory infusion suite (AIC) | 49 | Maintenance dosing | Acceptable; AIC must be REMS-certified |
| Patient home | 12 | Not appropriate for Elrexfio | Home administration is NOT supported — CRS risk + REMS site requirement |
Site-of-care opportunity: Once a patient transitions to q2wk maintenance at cycle 7, moving
from HOPD (POS 22) to physician office (POS 11) reduces commercial site-of-care UM denials AND lowers
chair-time burden. Some payers will mandate this transition by policy.
Claim form field mapping Pfizer Onc Together 2026
From Pfizer Oncology Together coding & coverage materials for Elrexfio.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider (must be REMS-certified prescriber) |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + carton NDC + ML + total volume (0.3 mL for 12 mg, 0.8 mL for 32 mg, 1.9 mL for 76 mg) |
| HCPCS J1323 + JZ (or JW for step-up waste) | 24D (drug line) | JZ on 76 mg full doses; JW + waste units on step-up doses |
| Drug units administered | 24G | 12, 32, or 76 (per dose) |
| JW waste line (step-up only) | 24D second line | 28 units (Day 1) or 8 units (Day 4) |
| CPT 96401 (admin line) | 24D (admin line) | Chemo SC; verify payer accepts vs 96372 |
| ICD-10 | 21 | C90.02 (most common) or C90.00 |
| PA number + REMS confirmation | 23 + attachments | Required by all major payers; some need REMS site ID |
Phase 3
Get paid
REMS certification, CRS readiness, and prior-therapy documentation are the gates.
ELREXFIO REMS — required Pfizer REMS verified 2026
Elrexfio is available only through a restricted distribution program because of the risks of life-threatening CRS and ICANS.
No site can prescribe, dispense, or administer Elrexfio without REMS certification. All
four parties — site (healthcare facility), prescriber, pharmacy, and patient — must be enrolled
and certified before the first dose. Patients must carry a wallet card at all times during treatment and
for 4 weeks after the last dose.
What sites must do
- Designate an authorized representative to enroll the site in ELREXFIO REMS
- Train all relevant staff (clinicians, nursing, pharmacy) on REMS materials
- Verify ability to admit patients for 48-hour observation post step-up + first full dose
- Verify access to tocilizumab (Actemra) and ICU-level supportive care for CRS rescue
- Maintain documentation of patient enrollment + wallet card distribution
What prescribers must do
- Complete REMS training program and successfully pass knowledge assessment
- Counsel each patient on CRS and ICANS signs and symptoms
- Provide patient wallet card at first dose
- Re-counsel at each visit; document counseling in chart
What pharmacies must do
- Enroll in ELREXFIO REMS as authorized dispensing pharmacy
- Verify prescriber and patient REMS enrollment before dispensing
- Track inventory and report to Pfizer REMS administrator
How to enroll
- Phone: 1-844-353-7394 (ELREXFIO REMS Coordinating Center)
- Web: elrexfiorems.com
- Pfizer Oncology Together (clinical/access support): 1-877-744-5675
Common error: Assuming TECVAYLI REMS or TALVEY REMS certification covers Elrexfio.
Each bispecific has its own separate REMS program. Sites treating multiple bispecifics must enroll in
each REMS independently.
CRS / ICANS management FDA label + ASTCT 2026
Boxed warning. Both syndromes are life-threatening. Sites must have tocilizumab on hand and ICU access available before first dose.
Cytokine Release Syndrome (CRS)
- Incidence (any grade): ~58% of patients in MagnetisMM-3
- Onset: typically within 1–2 days of dosing; almost all events occur during step-up
- Most common signs: fever, hypotension, hypoxia, tachycardia
- Grading: ASTCT consensus (Grade 1 = fever only; Grade 2 = hypotension responsive to fluids; Grade 3 = hypotension requiring vasopressor; Grade 4 = life-threatening)
Immune effector cell-associated neurotoxicity syndrome (ICANS)
- Incidence (any grade): ~3.4% of patients — lower than Tecvayli (~6%) and Talvey (~10%)
- Onset: typically within first 1–2 cycles
- Most common signs: tremor, confusion, dysgraphia, expressive aphasia, encephalopathy
- Assessment: ICE score (Immune Effector Cell-Associated Encephalopathy) at baseline and serially during step-up + first 2 cycles
Management essentials
- Grade 1 CRS: Supportive care (antipyretics, fluids); withhold next dose until resolved
- Grade 2 CRS: Tocilizumab (Actemra) 8 mg/kg IV (max 800 mg); supportive care; withhold dose
- Grade 3 CRS: Tocilizumab + dexamethasone 10 mg IV q6h; ICU monitoring; withhold dose; consider permanent discontinuation if recurrent
- Grade 4 CRS: Permanently discontinue Elrexfio; aggressive supportive care
- Any-grade ICANS: Withhold Elrexfio; dexamethasone ± anakinra; per ASTCT guidelines
Tocilizumab access is REMS-mandated. Sites must have at least 2 doses of tocilizumab
immediately available per patient before first Elrexfio dose. Most sites stock under Actemra (J3262)
for CAR-T / bispecific CRS rescue. Document tocilizumab inventory in REMS site enrollment.
Payer policy snapshot Reviewed May 2026
All major payers require PA, ≥4-prior-line documentation, and REMS confirmation.
| Payer | PA? | Step / Prior-therapy | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy + Optum Rx |
Yes | ≥4 prior lines: PI + IMiD + anti-CD38 mAb required; REMS confirmation required | Aggressive: maintenance steered to office (POS 11) or AIC (POS 49) post-step-up |
| Aetna Medical Drug + CPB |
Yes | ≥4 prior lines documentation required; REMS verification | Yes (separate Site-of-Care policy; bispecifics steered out of HOPD after step-up) |
| Cigna Medical Coverage Policy |
Yes | NCCN Category 1 / 2A indication; full prior-therapy documentation | Site-of-care Optum Health steering for maintenance |
| Medicare (MAC LCDs) All MACs |
No (Part B medical benefit) | FDA-approved indication + appropriate ICD-10; supports NCCN-listed off-label use with documentation | No formal SOC steering; site must be REMS-certified |
Step therapy
Elrexfio is a 5L+ regimen by FDA label, so step therapy through earlier lines is implicit in the prior-therapy requirement (PI + IMiD + anti-CD38 mAb). Some payers also require documentation of prior CAR-T cell therapy failure or ineligibility (e.g., Abecma, Carvykti) before approving bispecific therapy — verify per-payer.
Sequencing payer note: Some payers will require Tecvayli failure documentation before
approving Elrexfio (or vice versa). NCCN MM Guidelines list both as Category 2A options without preferred
ordering, but commercial UM has begun requiring step-through for the second BCMA bispecific.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J1323
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$186.791
per mg / per unit
76 mg full dose
$14,196.12
76 units × ASP+6%
32 mg step-up
$5,977.31
32 units × ASP+6%
Annualized cost (assumes response & q2wk transition at cycle 7): Cycle 1 (272 units) +
cycles 2–6 (1,520 units weekly) + cycles 7–13 (~1,064 units q2wk) = ~2,856 units = ~$533,475/year
Medicare ASP+6%, before sequestration. Without q2wk transition (weekly forever): ~3,876 units =
~$724,000/year. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
Coverage
No NCD specific to elranatamab-bcmm. Coverage falls under MAC LCDs for biologics + the generic Part B drug-coverage framework. All MACs cover J1323 for the FDA-approved relapsed/refractory MM indication with appropriate ICD-10 (C90.02 most common) and prior-therapy documentation. Off-label NCCN-listed use is generally supported with documentation.
Code history
- Pre-permanent code period: billed under unclassified
J3490/J3590/C9399with NDC documentation - J1323 — permanent HCPCS code "Injection, elranatamab-bcmm, 1 mg" assigned by CMS post-FDA approval
Patient assistance — Pfizer Oncology Together Pfizer verified May 2026
- Pfizer Oncology Together: 1-877-744-5675 / pfizeroncologytogether.com — benefits investigation, prior authorization assistance, appeal support, REMS enrollment help
- Elrexfio Co-Pay Savings Card: commercial copay support; eligible commercially-insured patients (excludes Medicare, Medicaid, federal program patients)
- Pfizer Patient Assistance Foundation: free product for uninsured / underinsured patients meeting income requirements (administered through the Pfizer Patient Assistance Foundation, Inc., a 501(c)(3))
- Foundations for Medicare patients: PAN Foundation (Multiple Myeloma fund), HealthWell Foundation, CancerCare Co-Payment Assistance Foundation, Leukemia & Lymphoma Society Co-Pay Assistance — verify open MM funds quarterly
- ELREXFIO REMS Coordinating Center: 1-844-353-7394
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J1323 pre-loaded with step-up
+ maintenance schedule.
Phase 4
Fix problems
REMS lapses, step-up restart triggers, and JW waste omissions are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| REMS not verified | Site / prescriber / pharmacy / patient REMS enrollment not documented in PA | Submit ELREXFIO REMS site ID + prescriber certification + patient enrollment confirmation. All four parties must be certified. |
| <4 prior lines documented | PA submitted without complete prior-therapy history | Submit therapy history showing PI + IMiD + anti-CD38 mAb exposure. Include line numbers and dates. |
| JW waste missing on step-up | Step-up dose billed without waste line | Add JW line: 28 units waste for Day 1 (12 mg dose), 8 units waste for Day 4 (32 mg dose). JZ on the administered units. |
| JZ missing on 76 mg dose | Single-dose 76 mg vial claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Wrong admin code (96372 denied) | Therapeutic SC injection billed when payer requires chemo SC | Resubmit with 96401. Per AMA classification, complex monoclonal antibody SC admin uses chemo admin codes. |
| Step-up restart not documented | >14 days elapsed between step-up doses without restart from beginning | Restart step-up from Day 1 (12 mg). Document interruption reason. Resubmit step-up sequence with new claim. |
| Site of care (HOPD) | Maintenance dose at HOPD after step-up complete on commercial plan with site-of-care UM | Move maintenance to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required. |
| Q2wk maintenance approval | Payer denies q2wk transition without response documentation | Submit IMWG response criteria documentation (≥PR) + 24-week treatment confirmation. Cite FDA label q2wk language. |
| Tocilizumab availability not documented | REMS site enrollment without on-site tocilizumab inventory | Document on-site tocilizumab inventory (at least 2 doses per patient) in REMS site file. Submit J3262 supply confirmation. |
Frequently asked questions
What is the HCPCS code for Elrexfio?
Elrexfio (elranatamab-bcmm) is billed under HCPCS J1323 — "Injection, elranatamab-bcmm,
1 mg." Each milligram equals one billable unit. The step-up Day 1 dose of 12 mg is billed as 12 units;
step-up Day 4 of 32 mg as 32 units; the first full treatment dose and all subsequent doses of 76 mg as
76 units.
What is the Elrexfio step-up dosing schedule?
Elrexfio uses fixed-dose (not weight-based) step-up dosing followed by weekly then biweekly maintenance. Step-up Day 1: 12 mg SC. Step-up Day 4 (2–4 days after Day 1): 32 mg SC. First treatment dose Day 8: 76 mg SC. Weekly maintenance through cycle 6 (week 24): 76 mg SC weekly. After cycle 6 in patients with response: transition to 76 mg SC every 2 weeks (q2wk biweekly maintenance) — Elrexfio's distinguishing feature versus Tecvayli's continuous weekly schedule.
Is ELREXFIO REMS required?
Yes. ELREXFIO REMS (Pfizer-managed) is required for all sites prescribing or dispensing Elrexfio because of the risk of life-threatening cytokine release syndrome (CRS) and neurologic toxicity including ICANS. The site, prescriber, pharmacy, and patient must all be certified before the first dose. Patients receive a wallet card and must be educated on signs and symptoms of CRS/ICANS. Enroll at 1-844-353-7394 or elrexfiorems.com.
What is the Medicare reimbursement for J1323?
For Q2 2026, the Medicare Part B payment limit for J1323 is $186.791 per mg (ASP + 6%) — among the highest per-mg drug costs in oncology. The 76 mg full treatment dose reimburses at approximately $14,196.12 per administration; the 32 mg step-up dose at $5,977.31; the 12 mg step-up dose at $2,241.49. ASP is updated quarterly by CMS.
What administration CPT do I use for Elrexfio?
CPT 96401 — "Chemotherapy administration, subcutaneous or intramuscular; non-hormonal
anti-neoplastic" is the most appropriate code for SC bispecific T-cell engagers like Elrexfio. Some payers
accept 96372 ("therapeutic, prophylactic, or diagnostic injection; SC or IM") instead. Verify
per-payer; chemo admin code (96401) typically pays materially more than 96372.
Is hospitalization required for Elrexfio step-up dosing?
Yes. Per the FDA label, hospitalization for 48 hours after administration of all doses within the step-up dosing schedule (12 mg Day 1, 32 mg Day 4, AND 76 mg first full treatment Day 8) is required because of the risk of CRS and ICANS. After completion of step-up dosing, subsequent 76 mg doses can be administered in the outpatient setting in monitored patients with no prior CRS or ICANS.
How does Elrexfio differ from Tecvayli (teclistamab)?
Both are BCMA × CD3 bispecific T-cell engagers for relapsed/refractory MM (≥4 prior lines). Tecvayli (J9286) is given weekly indefinitely (with optional q2wk transition after ≥4 cycles in responders). Elrexfio (J1323) follows a more flexible maintenance pattern: weekly through cycle 6 (24 weeks), then transitions to q2wk biweekly maintenance in responders by label. Elrexfio's q2wk maintenance is a key differentiator — fewer infusions long-term, lower chair-time burden, lower ASP impact per year. Elrexfio uses fixed step-up doses (12 / 32 / 76 mg); Tecvayli uses weight-based step-up.
What patient assistance is available for Elrexfio?
Pfizer Oncology Together (1-877-744-5675) provides benefits investigation, prior authorization assistance, and appeal support. Commercially insured patients may qualify for the Elrexfio Co-Pay Savings Card. Uninsured or underinsured patients meeting income requirements may qualify for free product through the Pfizer Patient Assistance Foundation. For Medicare patients, refer to PAN Foundation (Multiple Myeloma fund), HealthWell, and CancerCare — verify open MM funds quarterly.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- DailyMed — ELREXFIO (elranatamab-bcmm) Prescribing Information
- FDA Drugs@FDA — Elrexfio (BLA 761345) approval letter and label history
- ELREXFIO REMS Program — Pfizer-managed restricted distribution
- Pfizer Oncology Together — HCP coding, coverage, and patient access
- CMS — Medicare Part B Drug ASP Pricing File
- NCCN Clinical Practice Guidelines — Multiple Myeloma
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna CPB — Multiple Myeloma medical drug policies
- Cigna Medical Coverage Policies — Bispecific antibodies for MM
- SEER CanMED — HCPCS J1323 reference
- FDA National Drug Code Directory
- ASTCT Consensus Grading for CRS and ICANS (Lee et al., 2019)
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) | 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, REMS | Event-driven | Tied to manufacturer document version + FDA label revision date + Pfizer REMS bulletin. |
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: Pfizer Oncology Together 2026. FDA label: BLA 761345 (accelerated approval Aug 2023). ELREXFIO REMS active. Cross-reference comparison to Tecvayli (J9286) and Talvey (J3055) included.
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. Dosing and step-up schedule are verified against the current FDA label revision. REMS requirements are verified against the Pfizer ELREXFIO REMS program documents. We do not paraphrase from billing-software vendor blogs.