Tocilizumab biosimilars — verify HCPCS at billing time CMS HCPCS + FDA verified May 2026
Tofidence (Q5135) is permanent; Tyenne and Avtozma are newer and may temporarily bill under NOC codes (J3490 / C9399) until permanent Q-codes are assigned.
| HCPCS | Brand | Mfr | Status | Q2 2026 ASP+6% / 1 mg |
|---|---|---|---|---|
J3262 |
Actemra (tocilizumab) | Genentech (Roche) | Reference product | $5.530 |
Q5135 |
Tofidence (tocilizumab-bavi) | Biogen | FDA-approved biosimilar (permanent code, eff. 2024) | verify |
| Verify | Tyenne (tocilizumab-aazg) | Fresenius Kabi | FDA-approved biosimilar (newer; HCPCS may be NOC initially) | verify |
| Verify | Avtozma (tocilizumab-anoh) | Celltrion | FDA-approved biosimilar (newest; HCPCS may be NOC initially) | verify |
J3490 (unclassified drug) or C9399 (unclassified drug,
hospital outpatient) with the NDC and dose documented. Note that Q5142 = Simlandi (adalimumab),
not a tocilizumab code — do not use Q5142 for any tocilizumab product.
All tocilizumab products carry the same FDA boxed warning for serious infections (TB, invasive fungal, bacterial, viral, opportunistic). TB screening pre-therapy is required regardless of brand. Hepatitis B serology is recommended due to HBV reactivation risk.
IV vs. SC channel — J3262 covers IV only FDA labels verified 2025–2026
The Actemra subcutaneous prefilled syringe and ACTPen are not billed under J3262 — they go through specialty pharmacy under the pharmacy benefit by NDC.
| Actemra IV (J3262) | Actemra SC (PFS / ACTPen) | |
|---|---|---|
| Route | Intravenous infusion (60 min) | Subcutaneous self-injection |
| HCPCS | J3262 — "Injection, tocilizumab, 1 mg" | NOT under J3262. Billed by NDC under pharmacy benefit. |
| Benefit channel | Medical (provider buy-and-bill) | Pharmacy (specialty pharmacy dispense) |
| Strengths / vials | 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL SDV (20 mg/mL) | 162 mg/0.9 mL prefilled syringe; 162 mg ACTPen autoinjector |
| Approved indications | RA, PJIA, SJIA, GCA (IV q4wk available), CRS (CAR-T), COVID-19 (hospitalized), SSc-ILD (some IV use) | RA, GCA (preferred), SSc-ILD, PJIA / SJIA select dosing |
| Frequency | q4wk (RA, PJIA, GCA), q2wk (SJIA), single dose (CRS, COVID) | Weekly or every other week per indication |
| Practice impact | Infusion suite buy-and-bill economics; weight-based dosing → JW common | Specialty pharmacy ships direct to patient; no medical-benefit billing |
Dosing matrix per FDA-approved indication FDA Actemra label + ACR / NCCN / NIH guidelines
Six approved indications, each with its own dosing logic. All weight-based regimens trigger partial-vial waste — expect JW.
| Indication | Patient population | Dose | Frequency / max |
|---|---|---|---|
| RA | Adults | 4 mg/kg (may escalate to 8 mg/kg based on response) | q4wk · max 800 mg per dose |
| Polyarticular JIA (PJIA) | ≥ 2 yr, < 30 kg | 10 mg/kg | q4wk |
| Polyarticular JIA (PJIA) | ≥ 2 yr, ≥ 30 kg | 8 mg/kg | q4wk |
| Systemic JIA (SJIA) | ≥ 2 yr, < 30 kg | 12 mg/kg | q2wk |
| Systemic JIA (SJIA) | ≥ 2 yr, ≥ 30 kg | 8 mg/kg | q2wk |
| Giant cell arteritis (GCA) | Adults | SC 162 mg weekly preferred; IV q4wk available (per label, in combination with tapering glucocorticoids) | q4wk IV (when used) |
| CAR-T-induced CRS | Adults & pediatric ≥ 2 yr | 8 mg/kg IV (12 mg/kg if < 30 kg per CRS protocol) | Single dose · may repeat q8h up to 4 doses · max 800 mg/dose |
| COVID-19 (hospitalized) | Adults & pediatric ≥ 2 yr requiring supplemental O₂ / MV / ECMO + corticosteroids | 8 mg/kg IV | Single dose · max 800 mg |
| SSc-ILD | Adults | Generally SC 162 mg weekly; some IV use per protocol | Weekly SC |
- RA 4 mg/kg × 70 kg = 280 mg = 280 units
- RA escalated 8 mg/kg × 70 kg = 560 mg = 560 units
- SJIA 12 mg/kg × 25 kg = 300 mg = 300 units
- CRS / COVID 8 mg/kg @ 100 kg, capped = 800 mg = 800 units
NDC reference — Actemra IV vials FDA NDC Directory verified May 2026
Pad to 11 digits with a leading zero in the middle segment for CMS-1500 Box 24A.
Actemra (J3262) — Genentech labeler 50242
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
50242-135-01 | 50242-0135-01 | 80 mg / 4 mL single-dose vial |
50242-136-01 | 50242-0136-01 | 200 mg / 10 mL single-dose vial |
50242-137-01 | 50242-0137-01 | 400 mg / 20 mL single-dose vial |
Tofidence (Q5135) — Biogen / Bio-Thera
Verify current Tofidence labeler and packaging NDCs at billing time. Strengths mirror Actemra (80, 200, 400 mg SDV at 20 mg/mL).
Tyenne — Fresenius Kabi
Newer biosimilar. Verify HCPCS (may be NOC initially) and NDCs at billing time.
Avtozma — Celltrion
Newest biosimilar (FDA approved 2024–2025). Verify HCPCS and NDCs at billing time.
50242-136-01 → 50242-0136-01. Use
N4 qualifier in CMS-1500 Box 24A shaded area with unit of measure (ML) and quantity actually
drawn from the vial.
Administration codes CPT verified May 2026
Tocilizumab is a non-cytotoxic biologic IL-6 receptor antagonist. Use therapeutic infusion codes (96365/96366), not chemotherapy codes (96413/96415).
| CPT | Description | Use for |
|---|---|---|
96365 |
Therapeutic, prophylactic or diagnostic IV infusion; up to 1 hour | Standard for J3262 IV. Actemra infusion is 60 min — 96365 alone covers most cases. |
96366 |
Therapeutic IV infusion; each additional hour | Rare for tocilizumab (60-min infusion). Add only if infusion extends beyond 60 min. |
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance | Not appropriate. Tocilizumab is non-cytotoxic. Billing 96413 is a denial trigger. |
96415 |
Chemotherapy administration, IV infusion technique; each additional hour | Not appropriate. Same as 96413 above. |
96372 |
Therapeutic SC injection | For office-administered SC tocilizumab (drug supplied by patient via specialty pharmacy — rare) |
First-dose administration setting
Tocilizumab does not carry the same hospital-outpatient mandate that some IL-6 / monoclonal-antibody infusions do. Most RA, PJIA, SJIA, and GCA patients receive Actemra in an office (POS 11) or ambulatory infusion center (POS 49). CRS is by definition inpatient (POS 21 or hospital outpatient at the CAR-T center). Hospitalized COVID-19 dosing is inpatient.
Modifiers — JZ, JW, and weight-based waste CMS verified May 2026
All Actemra vials are single-dose. Weight-based dosing means partial-vial waste is the rule, not the exception.
JZ — required when no drug discarded
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. For tocilizumab, JZ would apply only when the calculated dose exactly matches the vial set drawn (rare with weight-based dosing). The 800 mg cap (CRS / COVID / max RA escalation) hits exactly two 400 mg vials — a JZ scenario.
JW — required for documented waste of unused single-dose-vial drug
Because almost every tocilizumab indication uses weight-based mg/kg dosing (4, 8, 10, or 12 mg/kg), the calculated dose rarely matches an integer combination of 80, 200, and 400 mg vials. CMS requires the JW modifier on a separate claim line for the discarded units (rounded per CMS rules), with wastage documented in the medical record. Bill administered units (with JZ) and discarded units (with JW) on two separate lines, same date of service.
Apply each MAC’s rounding convention. Vial selection should minimize total waste and document why the chosen combination was used. Refer to your local MAC billing article for the exact rounding rule.
JG / TB — 340B drug pricing
Hospitals that purchase tocilizumab through 340B and bill Medicare report the JG modifier (acute-care hospitals) or TB modifier (rural sole community / critical-access hospitals), per CMS guidance.
Modifier 25 — same-day E/M
Append modifier 25 to the same-day E/M code if a significant, separately identifiable evaluation occurred (DAS-28 reassessment for next-cycle decision in RA, GCA flare reassessment, etc.). Routine pre-infusion check-in is bundled.
ICD-10-CM diagnosis codes FY2026 verified May 2026
Use the most specific code supported by chart documentation. Each FDA indication has a distinct code family.
| Indication | ICD-10 family | Examples |
|---|---|---|
| RA — w/ rheumatoid factor | M05.x |
M05.79 (RA w/ RF, multi-site, w/o organ involvement); M05.9 (RA w/ RF, unspec) |
| RA — w/o rheumatoid factor | M06.x |
M06.09 (RA w/o RF, multi-site); M06.9 (RA, unspec) |
| Polyarticular JIA / Systemic JIA | M08.x |
M08.00 (PJIA, unspec site); M08.20 (SJIA, unspec site); M08.3 (juvenile polyarthritis seronegative) |
| Giant cell arteritis (GCA) | M31.6 |
M31.6 (other giant cell arteritis); M31.5 (giant cell arteritis with polymyalgia rheumatica) |
| CAR-T cytokine release syndrome | T80.89XA |
T80.89XA (other complications following infusion / transfusion / therapeutic injection, initial); D89.83x (cytokine release syndrome) |
| COVID-19 (hospitalized) | U07.1 |
U07.1 (COVID-19, virus identified); pair with respiratory failure / pneumonia codes (J96.0x, J12.82) |
| Systemic sclerosis (SSc-ILD) | M34.x + J84.10 |
M34.0 (progressive systemic sclerosis); M34.1 (CR(E)ST); J84.10 (interstitial lung disease, unspec) |
Site of care & place of service Verified May 2026
RA, PJIA, SJIA, GCA infusions move easily to office or AIC. CRS and COVID dosing is inpatient.
| Setting | POS | Claim form | Electronic | Typical use |
|---|---|---|---|---|
| Physician office / infusion suite | 11 | CMS-1500 | 837P | RA, PJIA, GCA chronic dosing — payer-preferred |
| Ambulatory infusion center (AIC) | 49 | CMS-1500 | 837P | RA, PJIA, GCA — payer-preferred site post cycle 1 |
| On-campus hospital outpatient | 22 | UB-04 / CMS-1450 | 837I | SJIA pediatric infusions; first-dose with reaction history |
| On-campus hospital outpatient (alt) | 19 | UB-04 / CMS-1450 | 837I | Hospital-affiliated rheumatology |
| Inpatient hospital | 21 | UB-04 / CMS-1450 | 837I | CRS, COVID-19 hospitalized, severe RA flare — bundled into DRG |
Payer site-of-care steering
UnitedHealthcare, Aetna, Cigna, and most BCBS plans apply site-of-care UM to specialty infusion drugs. For chronic Actemra (RA, PJIA, GCA), payers typically require dosing at office (POS 11) or in-network AIC (POS 49) where facility fees are lower. The 60-minute Actemra infusion fits these sites cleanly. Hospital outpatient (POS 19/22) is generally limited to first-dose with reaction history or pediatric SJIA scenarios where a tertiary-center setting is medically necessary.
Claim form field mapping Genentech billing PDF + payer guides
CMS-1500 / 837P (physician office, AIC; POS 11/49) example for a 280 mg RA dose of J3262.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | Format: N450242013601ML10.0 for one 200 mg vial; one line per NDC drawn |
| HCPCS J3262 + JZ | 24D (drug line) | 280 mg = 280 units; JZ when no waste (exact-match dose) |
| HCPCS J3262 + JW (when waste) | 24D (separate line) | Discarded units (per weight-based dosing & vial choice) |
| Drug units | 24G | 280 (or split: administered + waste) |
| CPT 96365 (+ 96366 if >1 hr) | 24D (admin lines) | 1 unit 96365 covers 60-min infusion; add 96366 only if extended |
| ICD-10 | 21 | Indication-specific (M05.x, M06.x, M08.x, M31.6, T80.89XA, U07.1, M34.x) |
| Dates of service | 24A | Same date for drug + admin lines |
| NPI | 17b / 24J / 33a | Rendering and billing provider NPI |
| PA number (when required) | 23 | Required by UHC, Aetna, Cigna, most BCBS for chronic-use indications (RA, GCA, JIA) |
| JG / TB modifier (340B sites only) | 24D | Hospital outpatient 340B claims only |
Source: Genentech Actemra Billing & Coding Brochure; payer-specific medical policy documents.
Payer policy snapshot — tocilizumab UM 2026 Reviewed May 2026
RA new starts almost universally require step therapy from a TNF inhibitor. CRS and COVID inpatient indications generally bypass PA because the drug is hospital-billed under DRG.
| Payer | PA? | Step therapy (RA) | Biosimilar steerage | CRS / COVID inpatient |
|---|---|---|---|---|
| UnitedHealthcare commercial Tocilizumab medical drug policy |
Yes | Yes — TNFi failure required for RA new starts | Tofidence (Q5135) trending preferred | No PA — hospital DRG |
| Aetna commercial Pharmacy CPB |
Yes | Yes — TNFi failure for RA | Biosimilar-preferred trending | No PA — hospital DRG |
| Cigna commercial Tocilizumab coverage policy |
Yes | Yes — TNFi failure for RA | Biosimilar-preferred trending | No PA — hospital DRG |
| BCBS (most plans) Plan-by-plan |
Yes | TNFi step common; verify plan | Biosimilar trending; verify plan | No PA — hospital DRG |
| CVS Cordavis / ESI Quallent Private-label biosimilar programs |
n/a (drug source) | n/a | Yes — may steer to Tofidence (Q5135) or other biosimilar | n/a |
2026 trend — biosimilar steerage
Tofidence (Q5135) launched in 2024 as the first tocilizumab biosimilar; Tyenne and Avtozma have since added competition. CVS Cordavis and ESI Quallent — the private-label biosimilar arms of CVS Health and Express Scripts — are increasingly steering practices to biosimilar tocilizumab. Expect formal biosimilar-preferred designations from major payers during 2026 as competition matures, mirroring the rituximab and trastuzumab biosimilar transitions of 2023–2025.
What to document for step-therapy approval
- TNFi tried (drug name, HCPCS / NDC, dates of administration, dose)
- Duration of trial (most policies: at least 3 months adequate dosing)
- Documented inadequate response, intolerance, or contraindication (with objective measures: DAS-28, CDAI, CRP, ESR)
- For GCA: glucocorticoid taper documentation; tocilizumab is steroid-sparing
- For SJIA / PJIA: pediatric rheumatology consult notes, growth parameters, joint count
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. J3262 refreshes every quarter; biosimilar ASPs (where assigned) refresh on the same cycle.
Q2 2026 payment snapshot — J3262 Actemra
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
Dose-band reimbursement at Q2 2026 ASP+6%
| Scenario | Dose (mg) | Units | Reimbursement |
|---|---|---|---|
| RA 4 mg/kg @ 60 kg | 240 | 240 | $1,327.20 |
| RA 4 mg/kg @ 70 kg | 280 | 280 | $1,548.40 |
| RA 4 mg/kg @ 80 kg | 320 | 320 | $1,769.60 |
| RA escalated 8 mg/kg @ 70 kg | 560 | 560 | $3,096.80 |
| SJIA 12 mg/kg @ 25 kg child | 300 | 300 | $1,659.00 |
| CRS / COVID 8 mg/kg, capped | 800 | 800 | $4,424.00 |
Annual reimbursement — chronic RA
At 4 mg/kg q4wk for a 70 kg patient (280 mg / dose, 13 doses / year), annual J3262 reimbursement is approximately $20,129 at Q2 2026 ASP+6%. Escalated 8 mg/kg dosing roughly doubles this. Biosimilar dispense (Tofidence Q5135 or other) is generally lower — verify current biosimilar ASP at billing time.
Coverage
No NCD specific to tocilizumab. Each MAC publishes a billing & coding article covering the drug with covered ICD-10 ranges per indication. All MACs cover J3262 for FDA-approved indications. CRS and COVID-19 inpatient dosing is bundled into the DRG — no separate Part B claim. Hospitalized COVID-19 use follows NIH treatment guidelines (8 mg/kg for hospitalized adults requiring O₂ / MV / ECMO with corticosteroids).
Canonical code source: CMS HCPCS quarterly update file.
Patient assistance — per manufacturer Manufacturer sites verified May 2026
- Actemra (J3262, Genentech):
- Genentech Access Solutions: 1-866-422-2377 — benefits investigation, PA support, appeals.
- Actemra Co-pay Card: eligible commercially-insured patients, up to $25,000/year.
- Genentech Patient Foundation: free drug for uninsured/underinsured (income-eligible).
- Independent foundations (PAN, HealthWell) for Medicare patients — verify open funds quarterly.
- Tofidence (Q5135, Biogen): Biogen Patient Support — benefits investigation, copay support for eligible commercially-insured patients, free-drug pathway for qualifying uninsured patients.
- Tyenne (Fresenius Kabi): Fresenius Kabi Patient Support — manufacturer support program for eligible patients.
- Avtozma (Celltrion): Celltrion patient support — verify program details at billing time as program is newer.
Boxed warning & ongoing monitoring FDA Actemra label verified 2025–2026
Pre-therapy screening
- TB screening required: interferon-gamma release assay (IGRA, e.g., QuantiFERON-TB Gold) or tuberculin skin test (PPD) before initiating tocilizumab.
- Treat latent TB before starting Actemra. Continue TB-directed therapy concurrent with tocilizumab if active TB diagnosed during screening.
- Hepatitis B serology: screen HBsAg and anti-HBc; consult hepatology for HBV-positive or occult-infected patients prior to starting due to HBV reactivation risk.
- Lipid panel: baseline lipids; tocilizumab causes lipid elevations (total cholesterol, LDL, triglycerides).
- CBC + LFTs: baseline neutrophil count, platelets, ALT, AST, total bilirubin.
Other significant warnings & precautions
- GI perforation: reported in tocilizumab-treated patients, especially with diverticulitis history. Use caution and educate patients to report acute abdominal pain.
- Hepatotoxicity: serious hepatic injury (some fatal, requiring transplant) reported. Monitor LFTs at baseline and every 4–8 weeks.
- Laboratory abnormalities: neutropenia, thrombocytopenia, transaminitis, lipid elevations — monitor q4–8wk per label. Hold dose if ANC < 1,000 / mm³, platelets < 100,000 / mm³, or ALT/AST > 5× ULN.
- Hypersensitivity / anaphylaxis: reported with IV and SC. Have resuscitation equipment available.
- Demyelinating disorders: rare CNS demyelinating events reported.
- Live vaccines: avoid concurrent live vaccines.
- Pregnancy: limited data; pregnancy registry available.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong admin code (96413/96415 instead of 96365/96366) | Biller defaulted to chemo admin code; tocilizumab is non-cytotoxic biologic | Resubmit admin lines as 96365 (and 96366 only if >1 hr). Tocilizumab is non-chemo. |
| Step therapy not met (RA new start) | New RA start on J3262 without documented TNFi failure / intolerance / contraindication | Submit TNFi trial documentation (drug, dates, dose, objective response measures) on appeal. |
| JZ missing | Single-dose-vial claim without JZ when no drug was discarded | Resubmit with JZ on the J3262 line (exact-match doses: 800 mg cap = 2×400 mg vials). |
| JW missing on weight-based claim | Weight-based dose with vial waste not reported | Add separate line with JW for discarded units (per CMS rounding); document waste in chart. |
| SC product billed under J3262 | Actemra SC PFS or ACTPen billed on medical benefit | Re-route to specialty pharmacy under pharmacy benefit. J3262 is IV-only. |
| Wrong J-code (J3262 instead of biosimilar) | Reference Actemra billed when patient received Tofidence/Tyenne/Avtozma | Verify drug administered. Match HCPCS to NDC drawn: Q5135 = Tofidence; verify Tyenne/Avtozma codes. |
| Q5142 used for tocilizumab | Coder confused Q5142 (Simlandi adalimumab) with a tocilizumab biosimilar code | Q5142 is NOT tocilizumab. Use Q5135 for Tofidence; verify current code for Tyenne / Avtozma. |
| TB screening not documented | Audit-vulnerable; payer requests pre-treatment IGRA / PPD per FDA boxed warning | Confirm pre-treatment IGRA / PPD result in chart; supply on appeal. |
| Site-of-care denial (HOPD) | Chronic Actemra at hospital outpatient when payer requires office / AIC | Move infusion to POS 11 or 49; or submit medical-necessity justification (rare). |
| NDC format / qualifier missing | 10-digit NDC submitted; missing N4 qualifier or unit-of-measure | Use 11-digit NDC with N4 qualifier in CMS-1500 Box 24A shaded area; report ML and quantity drawn. |
| Duplicate billing — CRS / COVID inpatient | Hospital billing J3262 to Part B when drug is bundled into inpatient DRG | Inpatient tocilizumab is bundled. Do not file separate Part B claim. |
| ICD-10 mismatch | Diagnosis does not match approved indication (e.g., M06.x for SJIA — should be M08.x) | Re-verify diagnosis and resubmit with correct ICD-10 family for the indication. |
Frequently asked questions
What is the HCPCS code for Actemra?
Intravenous Actemra (tocilizumab) is billed as J3262 — "Injection, tocilizumab, 1 mg."
One billing unit equals 1 mg of drug. Q5135 is Tofidence (tocilizumab-bavi, Biogen), the first
FDA-approved tocilizumab biosimilar (effective 2024). Tyenne (tocilizumab-aazg, Fresenius Kabi) and Avtozma
(tocilizumab-anoh, Celltrion) are newer biosimilars — verify their current HCPCS at billing time, as
new biosimilars may temporarily use J3490 / C9399 (NOC) until permanent Q-codes
are assigned. The subcutaneous Actemra prefilled syringe and ACTPen are dispensed through specialty
pharmacy and are NOT billed under J3262.
How many units of J3262 do I bill for a tocilizumab dose?
J3262 uses 1 unit = 1 mg. A 4 mg/kg dose for a 70 kg RA patient = 280 mg = 280 units. An 8 mg/kg CRS dose at the 800 mg cap = 800 units. A 12 mg/kg systemic JIA dose for a 25 kg child = 300 mg = 300 units. Because dosing is weight-based for almost every indication, partial-vial waste is the rule — expect to bill JZ on the administered units and JW on a separate line for discarded units.
What administration codes apply to Actemra?
Tocilizumab is a non-cytotoxic biologic, so administration uses 96365 (therapeutic IV
infusion, initial up to 1 hour) — not the chemotherapy codes 96413 /
96415. The standard Actemra IV infusion is 60 minutes, so 96366 (each additional
hour) is rarely needed. Billing 96413/96415 for tocilizumab is a denial trigger and a coding compliance
issue.
What is the Q2 2026 Medicare reimbursement for J3262 Actemra?
Q2 2026 ASP + 6% for J3262 (Actemra reference) is approximately $5.530 per 1 mg unit. A 4 mg/kg RA dose for a 70 kg patient (280 mg) reimburses ~$1,548. The 800 mg single-dose CRS or COVID-19 administration reimburses ~$4,424. Annual RA at q4wk dosing is ~$20,129 per 70 kg patient. Biosimilar pricing (Q5135 Tofidence and others) is generally lower — see the live snapshot.
Are Actemra biosimilars interchangeable?
Tofidence (tocilizumab-bavi, Q5135), Tyenne (tocilizumab-aazg), and Avtozma (tocilizumab-anoh)
are FDA-approved biosimilars to Actemra. Each is approved separately and has its own HCPCS code (verify
Tyenne and Avtozma codes at billing time — new biosimilars may temporarily use NOC codes).
FDA interchangeability designation is not automatic — pharmacy/infusion-center substitution depends
on FDA labeling and state law. Payers including CVS Cordavis and ESI Quallent are increasingly steering to
biosimilar tocilizumab in 2026.
Is the Actemra subcutaneous form billed under J3262?
No. The Actemra subcutaneous prefilled syringe (162 mg/0.9 mL PFS) and the ACTPen autoinjector are dispensed through specialty pharmacy under the pharmacy benefit, not the medical benefit. They are billed by NDC, not by J-code, and J3262 applies only to intravenous administration. Practices providing only IV Actemra need not address the SC channel; coordination is required when patients transition from IV (often initial GCA or RA induction) to SC self-injection.
Why is TB screening required before starting Actemra?
All tocilizumab products carry an FDA boxed warning for serious infections, including TB reactivation, invasive fungal infections (candidiasis, aspergillosis), bacterial sepsis, viral infections, and other opportunistic infections. The Actemra label requires TB screening (interferon-gamma release assay or tuberculin skin test) before starting therapy. Patients with latent TB must complete treatment before initiating tocilizumab. Hepatitis B serology is also recommended due to HBV reactivation risk.
How does Actemra dosing differ across indications?
Adult RA: 4 mg/kg q4wk (may escalate to 8 mg/kg q4wk, max 800 mg). Polyarticular JIA (≥ 2 yr): 10 mg/kg q4wk if < 30 kg, 8 mg/kg q4wk if ≥ 30 kg. Systemic JIA (≥ 2 yr): 12 mg/kg q2wk if < 30 kg, 8 mg/kg q2wk if ≥ 30 kg. GCA: SC 162 mg weekly is preferred; IV q4wk is available. CRS (CAR-T cytokine release syndrome): 8 mg/kg IV (max 800 mg), may repeat q8h up to 4 doses. COVID-19 (hospitalized requiring supplemental O₂ / MV / ECMO + corticosteroids): 8 mg/kg IV (max 800 mg) single dose. SSc-ILD: generally SC; some IV use.
What payer step-therapy applies to Actemra in 2026?
Most major payers (UnitedHealthcare, Aetna, Cigna, BCBS) require prior authorization plus step therapy from a TNF inhibitor for RA new starts. Biosimilar substitution policies are emerging in 2026 — CVS Cordavis and ESI Quallent are private-label biosimilar programs that may steer to Tofidence or Tyenne. CRS and COVID-19 inpatient indications generally do not require PA because the drug is hospital-billed under the inpatient DRG. Verify each payer’s medical drug policy before scheduling chronic-use patients.
Source documents
- AAPC — HCPCS J3262 (Actemra / tocilizumab)
- AAPC — HCPCS Q5135 (Tofidence / tocilizumab-bavi)
- FDA Actemra (tocilizumab) label
- Genentech — Actemra prescribing information
- Genentech — Actemra Billing & Coding resources (HCP)
- Genentech Access Solutions — Actemra
- Biogen — Tofidence (tocilizumab-bavi)
- Fresenius Kabi — Tyenne (tocilizumab-aazg)
- Celltrion — Avtozma (tocilizumab-anoh)
- UnitedHealthcare — Tocilizumab Commercial Medical Drug policy
- Aetna — Tocilizumab CPB
- ACR — Rheumatoid Arthritis & JIA Treatment Guidelines
- NCCN — CAR-T Cell-Related Toxicities (Cytokine Release Syndrome)
- NIH COVID-19 Treatment Guidelines — Tocilizumab
- CMS — Medicare Part B Drug ASP Pricing File
- CMS — HCPCS quarterly update file
- CMS — JW / JZ modifier guidance
About this page
We maintain this page as a living reference for the entire tocilizumab IV family. Medicare ASP pricing for J3262 (and Q5135 Tofidence where assigned) 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 manufacturer guide, FDA label, biosimilar approval, or major payer policy changes.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing (J3262, Q5135) | 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; biosimilar designations re-checked annually at year-start. |
| HCPCS / CPT / NCCI rules | Annual | Reviewed against CMS HCPCS quarterly files, AMA CPT releases, and NCCI edit updates. |
| Biosimilar HCPCS assignments | Event-driven | Tracked at FDA approval and CMS code publication; verify at billing time for new biosimilars. |
| NDC, dosing, FDA label | Event-driven | Tied to FDA label revision date and manufacturer document version. |
Reviewer
Change log
- — Initial publication of the tocilizumab IV family reference. ASP data: Q2 2026 (J3262 live; Q5135 verify). Indication coverage: RA, PJIA, SJIA, GCA, CRS (CAR-T), COVID-19 (hospitalized), SSc-ILD. Biosimilar coverage: Tofidence (Q5135) permanent; Tyenne and Avtozma flagged "verify HCPCS." Payer policies: UHC commercial, Aetna CPB, Cigna, BCBS step therapy from TNFi for RA. CVS Cordavis and ESI Quallent biosimilar steerage noted.
Methodology
Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File for J3262 and Q5135. Payer policies are read directly from each payer’s published medical policy documents. We do not paraphrase from billing-software vendor blogs. When the FDA label and clinical guidelines provide different dosing detail (e.g., GCA preferring SC 162 mg weekly while the IV q4wk option remains available), we surface both rather than picking a side.